Abstract:
Patients fitted with an implantable medical device (IMD) must typically return to their medical providers for follow-up sessions where the medical provider retrieves data from the patient&#39;s IMD for analysis. A remote monitoring device is described to allow patients to complete a follow-up session from the comfort of their own home or from some other remote location. Specifically, a user interface employing various audio signals, light indicators, and tactile features is described to aid patients with hearing and/or visual disabilities during the remote follow-up session. Different light indicator states are used to aid hearing impaired patients. Different audio sound states are used to aid visually impaired patients. Furthermore, tactile features are used to aid hearing and/or visually impaired patients.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
   This application claims priority under 35 U.S.C. §119(e) to commonly owned U.S. Provisional Patent Application No. 60/629,850, filed Nov. 19, 2004. 

   BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The present invention relates generally to systems for remotely monitoring patients fitted with an implantable medical device (IMD). 
   2. Background Art 
   Implantable medical devices (IMDs) fitted within a patient are often capable of transmitting data to sources outside the patient to relay information about the device and/or information the device has obtained about the patient. Typically, patients fitted with an IMD make follow-up visits to their medical provider so that information from the IMD can be obtained for analysis. 
   Rather than returning to the medical provider for these follow-up sessions, a system that allows patients to obtain data from their IMD and remotely transmit the data to their medical provider would allow the patients to complete these follow-up sessions from the comfort of their own home or from other remote locations. Such systems need to be accessible to older patients who may have hearing and/or visual disabilities. 
   What is needed is a system for remotely monitoring patients fitted with an IMD that includes a simple user interface for patients who may be hearing and/or visually impaired. 
   BRIEF SUMMARY OF THE INVENTION 
   A remote monitoring device is described that allows a patient fitted with an IMD to complete follow-up sessions from their own home or from other remote locations. The remote monitoring device includes a wand that can be placed near the patient&#39;s IMD to retrieve data from the IMD, a transceiver to relay the retrieved data to the medical provider, a speakerphone to communicate with the medical provider during the follow-up session, and light and/or audio indicators. 
   To aid patients with hearing and/or visual disabilities, a user interface utilizing different audio signals, light indicators, and tactile features is employed by the remote monitoring device. Different light indicator states are used to inform hearing impaired patients of the progress of the follow-up session. Different audio sound states are used to inform visually impaired patients of the progress of the follow-up session. Furthermore, tactile features are used to aid hearing and/or visually impaired patients. 
   Further embodiments, features, and advantages of the present invention, as well as the structure and operation of the various embodiments of the present invention, are described in detail below with reference to the accompanying drawings. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES 
     The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the present invention and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. 
       FIG. 1  is a block diagram of an exemplary system for remote monitoring of implantable medical devices. 
       FIG. 2A  is an illustration of a first view of an exemplary remote monitoring device. 
       FIG. 2B  is an illustration of a second view of the exemplary remote monitoring device. 
       FIG. 2C  is an illustration of a third view of the exemplary remote monitoring device. 
       FIG. 3  is a diagram of an exemplary installation of the exemplary remote monitoring device. 
       FIG. 4  is a flow chart describing the steps of an exemplary remote follow-up session using the exemplary remote monitoring device. 
   

   The present invention will be described with reference to the accompanying drawings. The drawing in which an element first appears is typically indicated by the leftmost digit(s) in the corresponding reference number. 
   DETAILED DESCRIPTION OF THE INVENTION 
   Implantable medical devices include, for example and without limitation, pacemakers, pulse generators, and cardioverter defibrillators. The term “implantable medical device,” or simply “IMD,” is used herein to refer to, non-exclusively and without limitation, any pacemaker, pulse generator, or cardioverter defibrillator. As used herein, the term IMD also includes other implantable devices such as artificial organs, insulin pumps, drug delivery devices, and other implanted devices for sensing physiologic parameters or delivering electrical or pharmaceutical therapy to the body. 
   For examples of IMDs, see U.S. Pat. No. 4,809,697, entitled “Interactive Programming and Diagnostic System for use with Implantable Pacemaker” (Causey, III et al.); U.S. Pat. No. 4,944,299, entitled “High Speed Digital Telemetry System for Implantable Device” (Silvian); and U.S. Pat. No. 6,275,734, entitled “Efficient Generation of Sensing Signals in an Implantable Medical Device such as a Pacemaker or ICD” (McClure et al.), which patents are hereby incorporated herein by reference. 
   An IMD is generally capable of transmitting information obtained during its operation to external devices. The information retrieved from the IMD can be analyzed by the patient&#39;s medical provider to treat the patient and to ensure that the IMD is functioning properly. IMDs may utilize various mechanisms to transmit such information to external devices as would be appreciated by persons skilled in the relevant art. Such mechanisms may include, for example, the use of an RF transmitter. Typically, the information from the IMD is retrieved at a doctor&#39;s office, clinician&#39;s office, or follow-up center. 
   Rather than requiring a patient to physically visit his or her medical provider to retrieve the information from his or her IMD, a remote monitoring system can be utilized to allow a doctor or clinician to remotely obtain the desired information from the patient&#39;s IMD. 
     FIG. 1  is a block diagram of an exemplary system for remote monitoring of an IMD. As shown in  FIG. 1 , a patient with an IMD (not shown) can utilize a remote monitoring device  102  in the comfort of their own home or at a location separate from the medical provider to allow the medical provider to obtain information from the IMD. The information can be transmitted over a network  104  to a receiving device  106  at the medical provider&#39;s site. Network  104  may be a public telephone system, Internet, or other transmission system as would be appreciated by persons skilled in the relevant art. The receiving device  106  may be a computer or any other device capable of receiving the transmitted information as would be appreciated by persons skilled in the relevant art. 
     FIGS. 2A-2C  are illustrations of an exemplary remote monitoring device  102 . Device  102  includes a lid  226  to house a speakerphone  215 , left and right wrist straps  218  and  220 , and a wand  224 . Wand  224  is placed on the patient to receive data from the patient&#39;s IMD. The speakerphone is used to provide audio feedback to the patient and to act as a telephone. The speakerphone includes both a microphone (not shown) and a speaker  216 . Instructions  214  are included on the inside portion of lid  226 . Light indicators  202 ,  204 , and  206  provide information related to the operation of the remote monitoring device  102  to the patient. Volume control  222  controls the volume of the speaker  216 . The remote monitoring device further contains a power supply connection  208 , a telephone cord plug  212  for connecting the remote monitoring device  102  to a telephone network and a telephone jack  210  for connecting the remote monitoring device  102  to a telephone. 
   As would be appreciated by persons skilled in the relevant art, the remote monitoring device  102  shown is provided as an example and other devices for remotely monitoring IMDs may include additional or fewer elements as well as substitute elements. For example, instructions  214  may not be provided, a lid  226  may not be used to house the various components or start a session using the remote monitoring device  102 , or a wired or wireless broadband connection may be substituted for the telephone cord plug  212 . The exemplary remote monitoring device  102  shown in  FIGS. 2A-2C  will be used below to further describe a user interface suitable for patients that are visually and/or hearing impaired. 
     FIG. 3  is a diagram of an exemplary installation of the remote monitoring device  102  at a site remote from the medical provider. A power cord  306  is connected between the power supply connection  208  and a wall electrical outlet  308  to provide power to the remote monitoring device  102 . A telephone cord is connected between the telephone cord plug  212  and a wall phone jack  310  to provide the remote monitoring device  102  with access to the telephone network. Optionally, a telephone cord  312  is connected from the telephone jack  210  to an answering machine  304  or telephone  302 . As would be appreciated by persons skilled in the relevant art, different installations of a remote monitoring device may be required for different configurations of the remote monitoring device. 
     FIG. 4  is a flow chart describing the steps of an exemplary remote follow-up session using the exemplary remote monitoring device  102 . In step  400 , a clinician who is at a location remote from the patient contacts the patient to initiate a remote follow-up session. Typically, the clinician initiates the follow-up session by making a telephone call to the patient. The patient may also initiate the follow-up session by calling the clinician. 
   After the clinician and the patient are in contact, the patient, in step  402 , opens the lid  226  on the remote monitoring device  102 . Opening the lid  226  activates the remote monitoring device  102  and the power light  202  turns on. At this time and periodically thereafter, if the remote monitoring device  102  detects an internal problem, all of the lights  202 ,  204 , and  206  will blink at the same time and a series of double beeps will be played on the speaker  216  to inform the patient that the remote monitoring device  102  is not functioning properly. If the remote monitoring device  102  is functioning properly when activated, the speakerphone is enabled to allow the patient to speak with the clinician without the use of a telephone handset. Therefore, the patient may hang up any other telephones the patient may have used to communicate with the clinician before enabling the remote monitoring device  102 . 
   In step  404 , the patient places the left and right wrist straps  218  and  220  on the patient&#39;s wrists. The wrist straps may be used to obtain additional information about the patient during the follow-up session. 
   In step  406 , the clinician instructs the patient to position the wand  224  on the patient&#39;s body to receive data from the patient&#39;s IMD. The patient may lay down or sit upright and rest the wand  224  on his or her body near the IMD. Wand  224  may be placed on the skin or on top of the patient&#39;s clothing. Wand  224  may contain a special coating or a textured surface to facilitate gripping or sticking to the patient&#39;s clothing or skin. In step  407 , the clinician detects whether the wand is correctly positioned in proximity to the IMD. If not, the patient moves the wand until the correct position is indicated by appropriate lights, sounds or vibrations. When wand  224  is unable to receive data from the IMD, light indicator  206  may go into an ON state or may blink and/or a continuous series of beeps (e.g. three beeps) may be played on the speaker  216  to instruct the patient to reposition the wand  224 . 
   When the patient has positioned the wand  224  properly so that the remote monitoring device  102  can receive data from the IMD, light indicator  206  may go to an OFF state or may stop blinking and remain on and/or a single set of (three) slow beeps may be played on the speaker  216 . While the patient positions the wand  224  near the IMD, the clinician is able to hear the beeps played by the remote monitoring device  102  over the speakerphone. Hence, the clinician is able to provide guidance and determine if the patient has properly positioned the wand  224  to receive data from the IMD. Alternatively, the wand  224  may vibrate when it is not positioned properly to receive data from the IMD. At any time during the follow-up session, if the wand  224  becomes displaced or is unable to retrieve data from the IMD, the patient will receive similar light and sound indications as described above to instruct the patient to reposition the wand  224 . 
   Once the wand  224  is in proper position, data from the IMD is collected in step  408 . Data collection may be initiated by the clinician, who sends a signal from his or her receiving device  106  to the remote monitoring device  102  to start data collection. Alternatively, remote monitoring device  102  may be configured to allow the patient to initiate the data collection. Once data collection begins, telephone conversation over the speakerphone is disabled to allow the transmission of collected data over the telephone network to a receiving device at the clinician&#39;s site. During data collection and transmission, light indicator  206  remains on and a continuous beep at ten second intervals is played on the speaker  216 . At any time while the data is being collected, the patient may pick up a telephone handset or a TTY device to communicate with the clinician. In addition, in the event that the clinician wants to communicate with the patient, light indicator  204  will blink and a ringing will be played on the speaker  216  three times to indicate that the patient should pick up his or her telephone handset, use a TTY device, or speak with the clinician over the speakerphone. When the patient and clinician communicate over the telephone, TTY device or speakerphone, data collection is stopped. Data collection may be subsequently resumed. 
   In step  410 , if the clinician indicates over the telephone that the data collection is complete, the patient may finish the follow-up session as described in step  412 . Otherwise, steps  406  and  408  may be repeated until data collection is complete. 
   In step  412 , the patient returns the left and right wrist wraps  218  and  220  and the wand  224  to the housing of the remote monitoring device  102  and closes the lid  226  to end the follow-up session. Closing the lid  226  disables the remote monitoring device  102 . If after the data collection has been completed and the lid  226  is not closed for an hour, the remote monitoring device  102  may turn itself off. 
   As described above, the use of lights, sound, vibration, and position of physical components such as the lid  226  provides a user interface that is appropriate for visually and/or hearing impaired patients. Different audio signals are used to distinguish different conditions during the remote follow-up session for visually impaired patients. As would be appreciated by persons skilled in the relevant art, other types of audio indicators may be used instead of beeps to indicate various conditions. For example, music, tones and narratives as well as various combinations, sequences and repetitions of the various audio sounds may be utilized. Different light states are used to distinguish different conditions during the remote follow-up session for hearing impaired patients. As would be appreciated by persons skilled in the relevant art, other types of light states may be used to indicate various conditions. For example, combinations, sequences and repetitions of light flashes may be utilized. Furthermore, tactile features such as the opening of the lid  226  and vibration is useful for both hearing and visually impaired patients. The availability of the speakerphone allows the clinician to hear the remote monitoring device  102  and communicate with the patient when data is not being transmitted. The ability of the remote monitoring device  102  to switch as needed between transmitting data and allowing voice or TTY communication over the telephone network allows the clinician and the patient to stay in close communication during the follow-up session. 
   Table 1 below highlights the lights and sounds of one exemplary embodiment of the remote monitoring device  102  during a remote follow-up session. 
   
     
       
             
           
             
             
             
             
           
         
             
               TABLE 1 
             
           
           
             
                 
             
             
               Remote monitoring device&#39;s lights and sounds during follow-up session 
             
           
        
         
             
               Lights 
               Sound 
               What it means 
               What the patient should do 
             
             
                 
             
             
               Power light 202 . . . OFF 
               No Sound 
               If the lid 226 is 
               If not in use, this is OK. 
             
             
               Phone light 204 . . . OFF 
                 
               closed, device 
               Otherwise the patient should 
             
             
               Wand light 206 . . . OFF 
                 
               102 is not 
               make sure the device is 
             
             
                 
                 
               powered on. If 
               installed properly as in FIG. 3 
             
             
                 
                 
               the lid 226 is 
               and make sure the lid 226 is 
             
             
                 
                 
               open, device 102 
               open. 
             
             
                 
                 
               is in standby 
             
             
                 
                 
               mode. 
             
             
               Power light 202 . . . ON 
               No Sound 
               Device 102 is 
               Patient should wait for 
             
             
               Phone light 204 . . . OFF 
                 
               powered on and 
               clinician&#39;s instructions. 
             
             
               Wand light 206 . . . OFF 
                 
               ready. 
             
             
               Power light 202 . . . ON 
               Continuous 
               Device 102 is 
               The patient should move the 
             
             
               Phone light 204 . . . OFF 
               series of 
               trying to locate 
               wand 224 over the patient&#39;s 
             
             
               Wand light 206 . . . BLINKING 
               three beeps 
               the IMD. The 
               IMD. 
             
             
                 
                 
               wand 224 is not 
             
             
                 
                 
               in the correct 
             
             
                 
                 
               position or has 
             
             
                 
                 
               moved out of the 
             
             
                 
                 
               correct position. 
             
             
               Power light 202 . . . ON 
               no sound 
               Device 102 has 
               Patient should wait for 
             
             
               Phone light 204 . . . OFF 
                 
               located the IMD 
               clinician&#39;s instructions. 
             
             
               Wand light 206 . . . ON 
                 
               and the wand 
             
             
                 
                 
               224 is in the 
             
             
                 
                 
               correct position. 
             
             
               Power light 202 . . . ON 
               Continuous 
               Device 102 has 
               Data transmission is in 
             
             
               Phone light 204 . . . OFF 
               beep at 10 
               located the IMD 
               progress and patient should 
             
             
               Wand light 206 . . . ON 
               second 
               and is retrieving 
               wait until the clinician 
             
             
                 
               intervals 
               data. 
               contacts the patient. 
             
             
               Power light 202 . . . ON 
               Transmitter 
               Clinician wants to 
               The patient should use the 
             
             
               Phone light 204 . . . BLINKING 
               rings three 
               speak with the 
               speakerphone or telephone 
             
             
               Wand light 206 . . . ON or OFF 
               times 
               patient. 
               handset to listen to clinician&#39;s 
             
             
                 
                 
                 
               instructions. 
             
             
               Power light 202 . . . BLINKING 
               Continuous 
               Device 102 did 
               Patient should unplug the 
             
             
               Phone light 204 . . . BLINKING 
               series of 
               not pass the self- 
               device 102&#39;s power cord and 
             
             
               Wand light 206 . . . BLINKING 
               double 
               test or some 
               plug it in again. If the self-test 
             
             
                 
               beeps 
               other type of 
               does not pass or an error 
             
             
                 
                 
               error occurred 
               occurs again, the patent 
             
             
                 
                 
               while in session. 
               should contact the clinician. 
             
             
                 
             
           
        
       
     
   
   Table 2 below describes the light indicator states of another exemplary embodiment of the remote monitoring device  102 . 
   
     
       
             
           
             
             
           
         
             
               TABLE 2 
             
           
           
             
                 
             
             
               Remote monitoring device&#39;s light indicator states 
             
           
        
         
             
               Light 
               Description 
             
             
                 
             
             
               Power light 202 . . . ON 
               Lid 226 is open. 
             
             
               Power light 202 . . . OFF 
               Lid 226 is closed. 
             
             
               Phone light 204 . . . OFF 
               Nothing requested of patient. 
             
             
               Phone light 204. . . BLINKING 
               Patient requested to pickup phone 
             
             
                 
               handset. 
             
             
               Wand light 206 . . . OFF 
               Device 102 is not searching for IMD. 
             
             
               Wand light 206 . . . ON 
               Device 102 located IMD successfully. 
             
             
               Wand light 206 . . . BLINKING 
               Device 102 is searching for IMD, 
             
             
                 
               wand 224 is out of position. 
             
             
               All lights blinking continuously 
               Device 102 failed self-test on power up. 
             
             
                 
             
           
        
       
     
   
   Table 3 below describes the audio states of a further exemplary embodiment of the remote monitoring device  102 . 
   
     
       
             
           
             
             
           
         
             
               TABLE 3 
             
           
           
             
                 
             
             
               Remote monitoring device&#39;s audio states 
             
           
        
         
             
               Sound 
               Description 
             
             
                 
             
             
               One beep 
               Device 102 has been plugged into a 
             
             
                 
               power source. 
             
             
               One short beep every ten seconds 
               Device 102 is transmitting data to the 
             
             
                 
               clinician. 
             
             
               A set of 3 beeps 
               Wand 224 has successfully located 
             
             
                 
               the IMD. 
             
             
               A set of 3 short beeps continuously 
               Wand 224 is out of position. 
             
             
               A set of 4 short beeps three times 
               Device 102 is going to voice mode 
             
             
                 
               and activity the speakerphone. The 
             
             
                 
               patient may alternatively pickup 
             
             
                 
               a telephone handset. 
             
             
                 
             
           
        
       
     
   
   While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.