Abstract:
A system and method for temporary programming of an implantable medical device. The system and method include a repeater uploading temporary programming and instructions to a temporary memory of the device and then instructing the device to operate according to the temporary instructions. If during a first time period, the device is not in continuous periodic communication with the repeater, the device automatically reverts to operation under the normal operating instructions. At the end of the first time period, the caregiver or the patient may decide to revert to the normal programming. During a second time period, the device operates according to the temporary programming unless the caregiver or the patient instructs the device to revert to the normal programming, or the device fails to receive a periodic continuation signal from the repeater. Adverse health affects to the patient may also trigger the device to revert to the normal programming during either the first or second time period.

Description:
TECHNICAL FIELD  
       [0001]     The present invention generally relates to implanted medical devices and external repeaters. More specifically, the present invention relates to devices and methods for temporary programming of implanted medical devices.  
       BACKGROUND  
       [0002]     Current medical technology utilizes a number of implanted medical devices to provide a wide-range of therapy for patients. Such implanted medical devices (IMDs) may provide rhythm altering electrical impulses to a patient&#39;s heart or other types and forms of electrical or neuro-muscular stimulus. These IMDs may also infuse a variety of therapeutic agents. Many of these IMDs are implanted beneath the skin of a patient and frequent physical access to the devices for alteration of the intensity, duration or other characteristics of the therapy is not desirable.  
         [0003]     Current technology in the medical device industry allows for monitoring and communication with an implanted medical device without needing to directly access the IMD. Such access may even be accomplished remotely with telemetry tools capable of transmitting and receiving information via existing long-distance communication avenues, such as telephone, cellular communications or radio links. While these known techniques do permit remote alteration of the therapy delivered by an IMD, additional safety measures to guard against mistakes in the programming of the new therapy or unexpected consequences of application of the new therapy are desirable.  
         [0004]     Operation of an IMD based on a set of proposed or temporary operating parameters is also currently known. However, the current technology requires that a patient be physically present at a caregiver&#39;s location and within local telemetry range of the caregiver&#39;s programming equipment. In addition, once proper loading of the temporary parameters into the IMD has been verified, and IMD operation based on the temporary parameters has been verified, the caregiver&#39;s programming equipment is required to instruct the IMD to adopt the temporary parameters as normal operating parameters. Current IMD only permit operation in a temporary parameter mode when the IMD is proximate to and in continuous communication with the caregiver&#39;s programming equipment.  
       SUMMARY  
       [0005]     The present invention relates to a system for programming an implanted medical device. The system includes a medical device configured to be implanted within in a body of a patient. The medical device includes electrical circuitry to provide treatment to the patient, a first digital storage area for holding normal operation instructions and settings, a second digital storage area for holding temporary operating instructions and settings, a communications subsystem and a timing subsystem. The system also includes a repeater external of the patient&#39;s body, the repeater including a communication subsystem configured to communicate with the communications subsystem of the medical device.  
         [0006]     The implanted medical device is configured to provide therapy to the patient using the normal operation instructions and settings stored in the first digital storage area. The repeater is configured to transmit temporary operation instructions and settings to the medical device for storage in the second digital storage area. The medical device may be instructed by the repeater to use the temporary operating instructions and settings to provide therapy to the patient. After the medical device has begun providing therapy using the temporary operation instructions and settings, the medical device will revert to the normal operation instructions and settings if a continuation signal is not received from the repeater within a first predetermined period of time.  
         [0007]     The present invention further relates to a method of providing therapy to a patient with a programmable implantable device. The method includes providing the patient, the programmable implantable device and an external repeater remotely located from a caregiver treating the patient. The device delivers therapy to the patient based on normal operating instructions stored on the device. The caregiver communicates temporary operating instructions to the repeater. The repeater communicates the temporary operating instructions to the device and the device storing the temporary instructions in memory. The repeater communicates with the device to begin delivering therapy to the patient based on the temporary instructions. The device reverts to delivering therapy to the patient based on the normal instructions if the device does not maintain continuous periodic communication with repeater for a first predetermined period of time. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]     The accompanying drawings, which are incorporated in and constitute a part of the description, illustrate several aspects of the invention and together with the detailed description, serve to explain the principles of the invention. A brief description of the drawings is as follows:  
         [0009]      FIG. 1  is a schematic view of an implantable medical device implanted within a patient&#39;s body, a repeater in proximity of the body to communicate with the device and a physician at a caregiver facility located remotely from the device and the repeater communicating with the repeater.  
         [0010]      FIG. 2  is a schematic view of the implantable medical device of  FIG. 1 .  
         [0011]      FIGS. 3A and 3B  are a flow chart of a process for programming the implantable medical device of  FIG. 2  with temporary operating instructions.  
         [0012]      FIGS. 4A and 4B  are a flow chart of an alternative process for programming the implantable medical device of  FIG. 2  with temporary operating instructions. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0013]     Reference will now be made in detail to exemplary aspects of the present invention which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.  
         [0014]      FIG. 1  shows a patient  10  within whose body  12  is implanted an implantable medical device  14  (shown as a cardiac rhythm management device) to provide therapy to the patient. The device includes communication circuitry to permit wireless communication with an external repeater  16 . Repeater  16  may provide operating instructions to device  14  and may receive data from device  14  regarding therapy provided by device  14 . Repeater  16  may also collect data from device  14  regarding the reaction of patient  10  to the therapy being provided by device  14 .  
         [0015]     Also shown in  FIG. 1  is a caregiver facility  18 . Caregivers at facility  18  may provide instructions to and receive information from repeater  16 . While a caregiver at such a facility is preferably a physician who is treating patient  10  and familiar with the health situation of patient  10 , the caregiver may also be a specialist in the particular device implanted in patient  10  who is working in conjunction with the patient&#39;s physician. It is anticipated that device  14  could include devices providing electrical impulses to some portion of a patient&#39;s body (such as defibrillators or pacemakers) or may deliver therapeutic agents (such as infusion pumps). While the actions performed by the device may differ depending on the application and medical condition being treated, the functions and features described below for altering therapy instructions or parameters are applicable to any similar implanted medical devices (IMDs). The caregiver may be using a programming device at the facility to develop and store instructions to be uploaded to repeater  16  for transmission to device  14 . The programming device may also receive information from device  14  through repeater  16  to permit the caregiver to review and analyze the patient&#39;s response to therapy.  
         [0016]     If the caregiver and patient  10  are both located at caregiver facility  18 , the programming device may be integral with the repeater.  
         [0017]     Referring now to  FIG. 2 , device  14  includes a communication subsystem  20  and a therapy delivery subsystem  22 . Therapy delivery subsystem  22  via a conduit  28  to the portion of patient  10 &#39;s body  12  where therapy is desired. In the example shown above in  FIG. 1 , conduit  28  is an electrical lead connecting device  14  (a pacemaker) to the patient&#39;s heart. Therapy delivery subsystem  22  may also include a patient status sensing capability which allows device  14  to sense and record particular elements of patient  10 &#39;s condition which might be affected by the therapy delivered by device  14 . For example, subsystem  22  of the pacemaker of  FIG. 1  may collect and record data on heart rhythm which may be used to determine if different therapy protocols may be desirable for patient  10 . In another example, if device  14  were an infusion pump for delivering insulin, subsystem  22  may collect and record blood sugar levels.  
         [0018]     Device  14  also may include an on-board memory  24  for storing and maintaining normal programming, such as operating instructions and parameters, on which the normal therapy provided to the patient is based. Normal memory  24  may also referred to as permanent memory, although, as will be discussed below, memory  24  may be subject to being overwritten with new instructions and parameters of operation to alter the therapy provided to patient  10  by device  14 . Device  14  may also include a temporary on-board memory  26  for storing and maintaining new or temporary programming, such as operating instructions and parameters, for delivering therapy to patient  10 . Within device  14  may be a switch  30  which is able to toggle operation of device  14  between the two different sets of operating instructions and parameters that may be stored in memories  24  and  26 . Switch  30  may be a virtual or software switch which is operable based on instructions received by device  14  through repeater  16 , or based on programming within device  14 . Alternatively, switch  30  may also include a physical magnetic switch actuated by patient  10 , or the caregiver or another person adjacent patient  10  using a magnetic wand.  
         [0019]     Referring now to  FIGS. 3A and 3B , uploading and testing of new operating instructions to device  14  includes a number of guards to prevent detrimental effects to patient  10  caused by alterations of the programming of device  10 . While it is known to have a patient schedule an office visit with their caregiver to change or adjust the programming of the instructions used by an implanted medical device, such as device  10 , such office visits are sometimes not possible or may be impractical or inconvenient. Remote programming of medical devices is also known as possible, but has not been a viable approach due to a lack of appropriate and necessary safeguards to protect against mistakes in reprogramming and/or new programming which does not have the desired effect on the patient&#39;s health. The procedures laid out in  FIGS. 3A and 3B  illustrates one embodiment of remote programming of IMDs including adequate patient safeguards to permit secure and safe programming alterations.  
         [0020]     To initiate the installation and testing of new programming for an IMD, patient  10  is in close proximity with repeater  16  so that repeater  16  may transmit signals to and receive signals from the IMD or device  14 . Device  14  is delivering therapy to patient  10  based on a set of normal programming of instructions stored in memory  24  on-board device  14 . At  100 , the caregiver is located remotely from patient  10  and repeater  16  and establishes communication with the repeater and patient  10  to begin the loading and testing of new programming for device  14 . “Remotely located” is defined to mean the caregiver and the patient (along with the IMD and the repeater) are not located at the same physical location. For example, the caregiver may be a physician at a hospital and the patient may be located at his or her home. On the other end of the spectrum, a patient (along with the IMD and the repeater) and caregiver located in the same room or treatment bay are not considered to be remotely located with respect to each other. The caregiver then uploads new programming to repeater  16  for communication to device  14  at  102 . The new programming is then transferred from repeater  16  to device  14 , which in turn stores the new programming in memory  26  on-board device  14  for temporary storage at  103 .  
         [0021]     Once the new programming has been uploaded from repeater  16  to device  14  and stored in memory  26 , the caregiver, through repeater  16 , instructs device  14  to begin delivering therapy to patient  10  based on the new programming for a first test period at  104 . The first test period is relatively short (preferably ranging from a few seconds to a few minutes) to determine if there are any immediate ill effects to the health of patient  10 . The first test period, at a minimum must extend long enough to verify that the new programming has been fully and correctly uploaded to memory  26 . The first test period also may extend long enough to collect data regarding certain parameters of heart function and patient reaction to the new programming. The first test period may further extend to permit a caregiver to access the data regarding the certain parameters of heart function and patient reaction to the new programming via remote communication between repeater  16  and caregiver facility  18 , so that the caregiver can verify that the new programming is initially functioning adequately.  
         [0022]     During this first test period, at  106 , patient  10  may remain within the immediate vicinity of repeater  16  so that repeater  16  is receiving a generally continuous stream of data regarding patient  10 &#39;s reaction to the new therapy regime. The nature of the communication stream may be periodic, with polling and response required at certain regular intervals, and still be continuous communication as referred to herein. Such a continuous, periodic stream of communication enables device  14  to conserve battery life during the process. At  118 , device  14  is configured at this stage to automatically revert to the prior normal programming if patient  10  moves away from the immediate vicinity of repeater  16 . Thus, if patient  10  has a strong negative reaction to the new programming and collapses or falls away from repeater  16 , device  14  will discontinue use of the new programming. As a safety measure, it is desirable that patient  10  remain near repeater  16  for the first test period so that data regarding the function of device  14  in response to the new programming can be verified. If patient  10  moves away from repeater  16  prior to completion of this first test period, device  14  will revert to the normal programming, even if no ill effects of the new programming have been detected.  
         [0023]     During the first test period and once the first test period has been completed, the patient may be given an opportunity to critique the new programming of device  14  and the effect that therapy based on this new programming may have had upon the patient&#39;s perceived health and quality of life, at  108 . If the patient&#39;s perception is that the therapy delivered by device  14  degrades comfort, interferes with the patient&#39;s normal daily activities, or otherwise has a deleterious impact on the patient, at  116 , device  14  may be instructed to revert to providing therapy based on the normal programming held by memory  24 . At  110 , during the first test period and upon completion of the first test period, the caregiver may review the function of device  14  at  108  to determine if the new programming results in the desired function of device  14  and the desired response to the new therapy is detected in patient  10 . If the caregiver determines that the level of function of device  14  is not having the desired results with regard to the patient&#39;s health, the caregiver may also, at  116 , direct device  14  to revert back to providing therapy based on the normal programming within memory  24 . At  116 , the instruction to device  14  to revert to therapy based on the normal programming is communicated through repeater  16  by the caregiver in consultation with patient  10 . Alternatively, repeater  16  may include a button, switch or other feature permitting patient  10  to provide the instruction to device  14  to revert to normal programming within memory  24 .  
         [0024]     The uploading of new programming and temporary operation of device  14  during the first test period have been described as remote from caregiver location  18 . It is anticipated that the uploading new programming and the first test period could also occur at caregiver location  18 .  
         [0025]     If the patient and caregiver concur that the function of device  14  and the patient&#39;s response to the function of device based on the new programming are adequate and desirable, device  14  can be instructed to operate for a second test period, at  112 . During this second test period, patient  10  and device  14  would not necessarily need to remain directly adjacent to repeater  16 , as required during the first test period. During the second test period, patient  10  may be ambulatory and would only need to periodically return to the proximity of repeater  16  so that repeater  16  can download information from device  14  to monitor function of device  14 . Patient  10  may need to have the repeater  16  query device  14  one or several times a day. Repeater  16  may then communicate the status information from device  14  and possibly from patient  10  regarding function of device  14  back to the caregiver. Device  14  may include a function which records when the periodic transfer of information from device  14  to repeater  16  occurs. If too great of a time gap exists since the last transfer, device  14  may be programmed to automatically revert to delivering therapy based on the normal programming in memory  24 , at  118 . The limit on the acceptable time gap prior to reversion to therapy delivery based on normal programming may be varied to meet the particular needs and circumstances of the patient.  
         [0026]     Provided that repeater  16  and device  14  remain in periodic communication, the operation of device  14  delivering therapy based on the new programming is allowed to continue for the duration of the second test period, at  120 . Upon completion of the second test period, at  122 , patient  10  is again queried as the effectiveness and desirability of therapy based on the new programming. At this point or at any time during the second test period, if the patient finds the therapy produces undesirable results, the patient may request that device  14  be instructed by repeater  16  to revert to therapy delivery based on the normal programming. At  124 , device  14  may be recording data regarding the health parameters of patient  10  which indicate the current or future health of the patient may be adversely affected, as compared to desirable or acceptable health parameters programmed into device  14 . If such adverse effects are sensed and/or recorded by device  14 , device  14  may be programmed to automatically revert to delivering therapy based on the normal programming, at  132 . Alternatively, repeater  16  may provide the analysis tools required to verify if the parameters sensed by device  14  are within pre-programmed acceptable parameters. If the parameters are determined by repeater  16  to be outside of an acceptable range, device  14  may be programmed to revert automatically to delivering therapy based on the normal programming, at  132 .  
         [0027]     At the completion of the second test period, or at any time during the second test period, the caregiver may also determine that the therapy delivered based on the new programming is acceptable or unacceptable, at  128 . At the completion of the second test period or at any time during the second test period, if the caregiver decides that the therapy based on the new programming is not acceptable, at  134 , the caregiver may communicate instructions to device  14  through repeater  16  to revert to delivering therapy based on the normal programming in memory  24 . Alternatively, repeater  16  may include a button, switch or other feature permitting patient  10  to provide the instruction to device  14  to revert to normal programming within memory  24 . Alternatively, patient  10  may be provided with a separate device, such as a hand-held device, to revert IMD to function according to the normal programming within memory  24 .  
         [0028]     If the caregiver determines the new programming and the therapy delivered based on the new programming are acceptable, at  130 , device  14  may be instructed to write the new programming into memory  24 , over-writing the existing normal programming. Once written into memory  24 , the new programming can be relabeled the normal programming, and device  14  can deliver therapy based on the programming newly written in memory  24  without additional contact with repeater  16  being required.  
         [0029]      FIGS. 4A and 4B  illustrate the uploading and testing of the delivery of therapy by device  14  based on new programming. The process of  FIGS. 4A and 4B  is similar to the process detailed above, with regard to  FIGS. 3A and 3B , with device  14  including a patient actuable switch  30  for reverting device  14  to therapy delivery based on the normal programming. At  108 , if patient  10  determines that the therapy delivery based on the new programming is not acceptable, patient  10  may, at  136 , deliver instructions to device  14  directly to revert to therapy based on the normal programming. Patient  10  need not involve the caregiver in the reversion. Instructions to device  14  from patient  10  may be delivered by actuation of switch  30 .  
         [0030]     In  FIG. 4B , during and following the second test period, the patient may also take the initiative to revert device  14  to delivering therapy based on the normal programming, at  126  and  138 . Patient  10  may still report acceptable or non-acceptable function of device  14  at  122  and the caregiver may send instructions to revert device  14  to delivering therapy based on the normal programming. However, patient  10  may still have the ability to revert device  14  to normal programming, at  138 . Instructions to device  14  from patient  10  may be delivered by actuation of switch  30 .  
         [0031]     The embodiments of the inventions disclosed herein have been discussed for the purpose of familiarizing the reader with novel aspects of the present invention. Although preferred embodiments have been shown and described, many changes, modifications, and substitutions may be made by one having skill in the art without unnecessarily departing from the spirit and scope of the present invention. Having described preferred aspects and embodiments of the present invention, modifications and equivalents of the disclosed concepts may readily occur to one skilled in the art. However, it is intended that such modifications and equivalents be included within the scope of the claims which are appended hereto.