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"Systems and Methods for Providing Photo-Based Patient Verification for Use with Implantable Medical Device Programmers" in Patent Application...

May 22, 2014



"Systems and Methods for Providing Photo-Based Patient Verification for Use with Implantable Medical Device Programmers" in Patent Application Approval Process

By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventor Doudian, Berj A. (Sun Valley, CA), filed on October 30, 2012, was made available online on May 8, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: "A wide range of implantable medical devices are provided for surgical implantation within patients such as cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices or other implantable cardiac rhythm management devices (CRMDs.) Still other implantable medical devices include Spinal Cord Stimulation (SCS) devices, Deep Brain Stimulation (DBS) devices or the like. Implantable medical devices, particularly CRMDs, are often configured for use with a device programmer or other external instrument, which allows a clinician to program the operation of the implanted device to control, for example, specific parameters by which the device detects an arrhythmia and responds thereto. Additionally, the programmer may be configured to receive and display a wide variety of diagnostic information detected by the implanted device, such as intracardiac electrograms (IEGMs) sensed within the patient.

"Typically, a programming session begins with the device programmer interrogating the implanted device via radio-frequency (RF) telemetry to download data from the device, such as programmable parameters, stored IEGMs and diagnostic data pertaining to device operation. Traditionally, short-range telemetry was employed wherein a telemetry wand was placed over the chest of the patient to interrogate the device. However, medium-range and long-range RF communication techniques could instead be used to interrogate devices in the general vicinity of the device programmer. As such, circumstances can arise where multiple patients might be within the communication range of the device programmer, potentially resulting in downloading of data from a device within the wrong patient. That is, the clinician may believe data has been properly received from the implanted device within a particular patient, whereas the data was instead downloaded from the device of a different patient in the general proximity. If not detected by the clinician, the error could result in misdiagnosis of medical conditions within the patient and/or erroneous re-programming of device parameters, possibly triggering unwarranted pacing therapy within the patient or a failure to deliver needed therapy. As can be appreciated, the longer the range of RF communication, the more likely a number of patients may be within interrogation range of the device and the greater the chance of a device misidentification error. Such problems can arise, for example, during a post-implant 'follow up' session with the patient. Similar problems can also occur when a clinician is merely reviewing archived patient data; that is, the clinician may erroneously think he or she is reviewing the archived data from one patient when data from another patient is being reviewed, leading to possible misdiagnoses of conditions.

"Accordingly, it would be highly desirable to provide a simple and effective technique for avoiding the aforementioned device interrogation and patient identification problems, and it is to these ends that aspects of the invention are primarily directed. Other aspects of the invention are directed to providing a memory aid to help a clinician recall details of a patient when reviewing their chart, or when viewing patient information via a remote system."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventor's summary information for this patent application: "In an exemplary embodiment, systems and methods are provided for use by an external system equipped to communicate with implantable medical devices for implant within patients. The external system may be, for example, a device programmer, bedside monitor or other external instrument equipped to interrogate and program implanted devices. In one example, data is received by the external system from a device implanted in a patient using medium-range or long-range RF communication wherein the received data includes identifier data. Based on the identifier data, the external system retrieves a digital photograph or other suitable image data representative of the particular patient in which the device is implanted. The external system displays the retrieved image to the clinician or other user of the system to allow visual verification that the data received by the external system corresponds to an intended patient whose device is to be interrogated and another patient also within communication range.

"In this manner, the clinician, physician or other user of the external system can easily verify and corroborate that data received by the external system corresponds to a particular patient rather than another patient in the vicinity. Assuming the external system is found to be in communication with the implanted device of the intended patient, the clinician then proceeds with further device interrogation to download additional data, such as the current values of programmable pacing parameters, IEGM data and device diagnostic data. Otherwise, the clinician takes steps to correct the problem, such as by switching to a shorter-range communication technique to ensure that data received by the external system is received only from the device of the intended patient or otherwise choosing to interrogate the intended patient (i.e. if the clinician has inadvertently selected the wrong patient to begin with, the clinician can simply switch to the intended patient.)

"In an illustrative example, the identifier data received from the implanted device identifies the particular device implanted within the patient using a serial number. Based on the serial number, the external system queries a database to determine the name of the patient whose implanted device corresponds to the serial number, as well as to retrieve a digital photograph corresponding to the patient for display. The database may be installed within the external system itself or within a remote system such as a centralized server accessed via the Internet. In other examples, the identifier data specifies the name of the patient, which is then used to retrieve the digital photograph. In still other examples, the identifier data itself includes the digital photograph. That is, the implantable device stores a digital photo of the patient within on-board memory, which is then transmitted to the external device for display.

"Once the digital photograph is displayed to the clinician via the external system, the clinician verifies that the photo corresponds to the intended patient and enters an appropriate acknowledgement into the system, which then enables full interrogation and programming of the implanted device. That is, in this example, the photo-verification procedure is a pre-interrogation procedure performed prior to full interrogation of the device. In other examples, the photo-verification procedure may be performed concurrently with device interrogation and/or may be performed prior to any programming or reprogramming of the device. In still other examples, if several patient devices are within communication range of the external system, the system retrieves and displays digital photographs of each of the patients, as well as their names and the serial numbers of their devices. The clinician selects one of the patients for further device interrogation/programming, with the system then limiting its interrogation/programming commands to just the device of the selected patient. Although these techniques are particularly helpful when using medium-range or long-range telemetry (where multiple patients might be within communication range), it should be understood that aspects of the invention are applicable to short-range communication systems as well.

"Still further, the digital photos are preferably displayed along with patient data when archived data is being reviewed by the clinician, either on screen or via printed reports. That is, photo-verification is not limited for use during device interrogation or programming. Rather, patient photos can be generated whenever patient data is to be reviewed. By displaying a photo of the patient while archived data is being reviewed, the photo can serve as a memory aid to the clinician, while also helping to avoid data misidentification problems. In addition to being displayed on the programmer in archive mode or on printed reports, the photo can also be displayed on a patient data website (such as the Merlin.net.TM. website) when reviewing patient information via such a site.

"System and method implementations of these and other techniques are presented herein.

BRIEF DESCRIPTION OF THE DRAWINGS

"Features and advantages of the described implementations can be more readily understood by reference to the following description taken in conjunction with the accompanying drawings.

"FIG. 1 illustrates pertinent components of a medical system having an external instrument for communication with a CRMD implanted within a patient, wherein the external instrument is equipped for photo-verification;

"FIG. 2 summarizes a technique performed by the system of FIG. 1 for photo-verification wherein the external instrument retrieves a digital photo of the patient from a database using identifier data received from the CRMD;

"FIG. 3 illustrates an exemplary patient photo-verification database for use with the system of FIG. 1;

"FIG. 4 illustrates an exemplary implementation of the system of FIG. 1 where the photo-verification database is stored within the external instrument;

"FIG. 5 illustrates an exemplary implementation of the system of FIG. 1 where the photo-verification database is instead stored within a remote system;

"FIG. 6 summarizes an alternative technique performed by the system of FIG. 1 for photo-verification wherein the digital photo is received from the CRMD;

"FIG. 7 illustrates an exemplary implementation of the system of FIG. 1 where the digital photo is stored within the CRMD;

"FIG. 8 illustrates an exemplary display screen generated using the systems and techniques of FIGS. 1-7 showing a patient photo along with patient data and IEGM data, which may represent newly retrieved data or archived data;

"FIG. 9 illustrates an exemplary printed report created using the systems and techniques of FIGS. 1-7 showing a patient photo along with patient data and IEGM data, which may represent newly retrieved data or archived data;

"FIG. 10 illustrates an exemplary display screen generated using the systems and techniques of FIGS. 1-7 showing photos for a set of patients within communication range of the external instrument;

"FIG. 11 illustrates an exemplary implementation of the system of FIG. 1 where the digital photo is displayed via a patient care website; FIG. 12 illustrates an exemplary website browser display screen generated using the system of FIG. 11 showing a patient photo along with patient data;

"FIG. 13 is a simplified, partly cutaway view, illustrating the CRMD of FIG. 1 along with a set of leads implanted into the heart of the patient;

"FIG. 14 is a functional block diagram of the CRMD of FIG. 13, illustrating basic circuit elements that provide cardioversion, defibrillation and/or pacing stimulation in the heart and particularly illustrating on-board components for providing patient identifier data for use with the systems and techniques of FIGS. 1-10; and

"FIG. 15 is a functional block diagram illustrating components of the external programmer of FIG. 1, particularly illustrating components for controlling the systems and techniques of FIGS. 1-10."

URL and more information on this patent application, see: Doudian, Berj A. Systems and Methods for Providing Photo-Based Patient Verification for Use with Implantable Medical Device Programmers. Filed October 30, 2012 and posted May 8, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1240&p=25&f=G&l=50&d=PG01&S1=20140501.PD.&OS=PD/20140501&RS=PD/20140501

Keywords for this news article include: Patents, Therapy, Cardiology, Cardio Device, Medical Devices.

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Source: Politics & Government Week


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