Patent Description:
A wide variety of implantable medical devices (IMDs) that deliver a therapy to and/or monitor a physiologic condition of a patient have been clinically implanted or proposed for clinical implantation in patients. IMDs may deliver therapy or monitor conditions with respect to a variety of organs, nerves, muscles or tissues of the patients, such as the heart, brain, stomach, spinal cord, pelvic floor or the like. In some cases, IMDs may deliver electrical stimulation therapy via one or more electrodes, which may be included as part of one or more elongated implantable medical leads.

For example, an implantable cardiac device, such as a cardiac pacemaker or implantable cardioverter-defibrillator, provides therapeutic stimulation to the heart by delivering electrical therapy signals such as pulses or shocks for pacing, cardioversion, or defibrillation via electrodes of one or more implantable leads. As another example, a neurostimulator may deliver electrical therapy signals, such as pulses, to a spinal cord, brain, pelvic floor or the like, to alleviate pain or treat symptoms of any of a number of neurological or other diseases, such as epilepsy, gastroparesis, Alzheimer's, depression, obesity, incontinence and the like.

Exposure of the IMD to a disruptive energy field may result in improper operation of the IMD, damage to the IMD and/or damage to tissue adjacent to portions of the IMD. The IMD may be exposed to the disruptive energy field for any of a number of reasons. For example, one or more medical procedures may need to be performed on the patient within whom the IMD is implanted for purposes of diagnostics or therapy. For example, the patient may need to have a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, electrocautery, diathermy or other medical procedure that produces a magnetic field, electromagnetic field, electric field or other disruptive energy field.

The disruptive energy field may induce energy on one or more of the implantable leads coupled to the IMD. The IMD may inappropriately detect the induced energy on the leads as physiological signals. Alternatively, or additionally, the induced energy on the leads may result in the inability to correctly detect physiological signals. In either case, detection of the induced energy on the leads as physiological signals may result in the IMD delivering therapy when it is not desired or withholding therapy when it is desired. In other instances, the induced energy on the leads may result in stimulation or heating of the tissue and/or nerve site adjacent to the electrodes of the leads or adjacent to the housing of the IMD. Such heating may result in thermal damage to the tissue, thus possibly compromising pacing and sensing thresholds at the site. <CIT> relates to a system and method for operating an implantable medical device in a disruptive energy field.

The claimed subject matter is defined by the devices according to independent claims <NUM> and <NUM>, by the method according to independent claim <NUM>, and by the system according to independent claim <NUM>.

In general, this disclosure relates to operation of an implantable medical device (IMD) in a disruptive energy field. In particular, this disclosure describes an IMD that is selectively configurable to support a plurality of programming options for enabling and disabling an exposure operating mode of the device. In one example, the IMD may support at least two of a manual exposure mode programming option in which the exposure operating mode is manually enabled and manually disabled, an automatic exposure mode programming option in which the exposure operating mode is automatically enabled and automatically disabled, or a semi-automatic exposure mode programming option in which the exposure operating mode is either automatically enabled and manually disabled or manually enabled and automatically disabled.

The exposure mode programming option may be selectable by a user, e.g., a physician, based on physician preference, patient preference, resource availability, experience scanning patients with IMDs, clinical practice within or across geographies, or other factor. In this manner, the IMD supports more than one way for enabling and disabling the exposure operating mode to provide flexibility in the clinical workflows associated with programming the IMD into an exposure operating mode for a medical procedure, such as an MRI scan.

In one example, this disclosure is directed to a medical device comprising a user interface that includes an output mechanism and an input mechanism, a processor to present, via the output mechanism of the user interface, a user with a plurality of exposure mode programming options supported by an implantable medical device for enabling and disabling an exposure operating mode of the implantable medical device and receive, via the input mechanism of the user interface, input from the user to select one of the plurality of exposure mode programming options, and a transmitter to send a communication to the implantable medical device that identifies the selected one of the plurality of exposure mode programming options.

In another example, this disclosure is directed to a method comprising presenting, via an output mechanism, a plurality of exposure mode programming options supported by an implantable medical device for enabling and disabling an exposure operating mode of the implantable medical device, receiving, via an input mechanism, an input from the user to select one of the plurality of exposure mode programming options and transmitting a communication to the implantable medical device that identifies the selected one of the plurality of exposure mode programming options.

In a further example, this disclosure is directed to a medical device comprising means for presenting a plurality of exposure mode programming options supported by an implantable medical device for enabling and disabling an exposure operating mode of the implantable medical device, means for receiving input from the user to select one of the plurality of exposure mode programming options and means for transmitting a communication to the implantable medical device that identifies the selected one of the plurality of exposure mode programming options.

Other features, objects, and advantages will be apparent from the description and drawings, and from the statements provided below.

<FIG> is a conceptual diagram illustrating an environment <NUM> in which an implantable medical device (IMD) <NUM> is exposed to a disruptive energy field <NUM>. IMD <NUM> is implanted within patient <NUM> to provide therapy to and/or to monitor a physiological condition of patient <NUM>. The techniques, however, are not limited to devices implanted within patient <NUM>. For example, the techniques may be used in conjunction with an external medical device that is adversely affected by disruptive energy field <NUM>.

IMD <NUM> may be any of a variety of devices that provide therapy to patient <NUM>, monitor a condition of patient <NUM>, or both. For example, IMD <NUM> may be a device that provides electrical stimulation therapy via one or more implantable leads that include one or more electrodes (not shown in <FIG>). In some instances, IMD <NUM> may be a device that provides electrical stimulation therapy in the form of cardiac rhythm management therapy to a heart of patient <NUM> via leads implanted within one or more atria and/or ventricles of the heart. In other instances, IMD <NUM> may be a device that provides electrical stimulation to a tissue site of patient <NUM> proximate a muscle, organ or nerve, such as a tissue proximate a vagus nerve, spinal cord, brain, stomach, pelvic floor or the like.

In addition to providing electrical stimulation therapy, IMD <NUM> may sense one or more physiological parameters of patient <NUM>. When one or more leads are implanted within the heart of patient <NUM>, for example, electrodes of the leads may sense electrical signals attendant to the depolarization and repolarizatoin of the heart to monitor a rhythm of the heart or detect particular heart conditions, e.g., tachycardia, bradycardia, fibrillation or the like. IMD <NUM> may sense a variety of other physiologic parameters or other parameters related to a condition of patient <NUM>, including, for example, neurologic parameters, intracardiac or intravascular pressure, activity, posture, pH of blood or other bodily fluids or the like. In some instances, IMD <NUM> may be used solely for monitoring a condition of patient <NUM>. In other words, IMD <NUM> may not provide therapy to patient <NUM>, but simply sense a physiological or biological condition of patient <NUM>.

In yet other instances, IMD <NUM> may be a device that delivers a drug or therapeutic agent to patient <NUM>, e.g., via a catheter. IMD <NUM> may deliver, e.g., using a pump, the drug or therapeutic agent to a specific location of patient <NUM>. IMD <NUM> may deliver the drug or therapeutic agent at a constant or variable flow rate. Drug pumps, infusion pump or drug delivery devices may be used to treat symptoms of a number of different conditions. For example, IMD <NUM> may deliver morphine or ziconotide to reduce or eliminate pain, baclofen to reduce or eliminate spasticity, chemotherapy to treat cancer, or any other drug or therapeutic agent (including saline, vitamins, etc.) to treat any other condition and/or symptom of a condition.

Environment <NUM> includes an energy source that generates disruptive energy field <NUM> to which IMD <NUM> is exposed. In the example illustrated in <FIG>, the energy source is an MRI scanner <NUM>. Although the techniques of this disclosure are described with respect to disruptive energy field <NUM> generated by MRI scanner <NUM>, the techniques may be used to control operation of IMD <NUM> within environments in which other types of disruptive energy fields are present. For example, IMD <NUM> may operate in accordance with the techniques of this disclosure in environments in which disruptive energy field <NUM> is generated by a CT scanner, X-ray machine, electrocautery device, diathermy device, ablation device, radiation therapy device, electrical therapy device, magnetic therapy device, RFID security gate, or any other environment with devices that radiate energy to produce magnetic, electromagnetic, electric fields or other disruptive energy fields.

MRI scanner <NUM> uses magnetic and radio frequency (RF) fields to produce images of body structures for diagnosing injuries, diseases and/or disorders. In particular, MRI scanner <NUM> generates a static magnetic field, gradient magnetic fields and/or RF fields. The static magnetic field is a non-varying magnetic field that is typically always present around MRI scanner <NUM> whether or not an MRI scan is in progress. Gradient magnetic fields are pulsed magnetic fields that are typically only present while the MRI scan is in progress. RF fields are pulsed RF fields that are also typically only present while the MRI scan is in progress.

Some or all of the various types of fields produced by MRI scanner <NUM> may interfere with operation of IMD <NUM>. In other words, one or more of the various types of fields produced by MRI scanner <NUM> may make up disruptive energy field <NUM>. For example, the gradient magnetic and RF fields produced by MRI scanner <NUM> may induce energy on one or more of the implantable leads coupled to IMD <NUM>. In some instances, IMD <NUM> inappropriately detects the induced energy on the leads as physiological signals, which may in turn cause IMD <NUM> to deliver undesired therapy or withhold desired therapy. In other instances, the induced energy on the leads result in IMD <NUM> not detecting physiological signals that are actually present, which may again result in IMD <NUM> delivering undesired therapy or withholding desired therapy. The induced energy on the leads may be delivered to the tissue of patient <NUM> resulting in stimulation or heating of the tissue and/or nerve site adjacent to electrodes of the leads. Such heating may cause thermal damage to the tissue adjacent the electrodes, possibly compromising pacing and sensing thresholds at the site. In yet other instances, the induced energy may cause damage to one or more components of IMD <NUM>.

To reduce the undesirable effects of disruptive energy field <NUM>, IMD <NUM> is capable of operating in a mode that is less susceptible to undesirable operation during exposure to disruptive energy field <NUM>, referred to herein as the "exposure mode" or "exposure operating mode. " Prior to being exposed or upon being exposed to disruptive energy field <NUM>, IMD <NUM> is configured from a normal operating mode (e.g., the current operating mode) to the exposure operating mode.

In the normal operating mode, IMD <NUM> operates in accordance with all desired functionality using settings programmed by a physician, clinician or other user. When operating in the normal operating mode, IMD <NUM> may perform functions in a manner that does not specifically account for the presence of strong disruptive energy fields. The normal mode may correspond with the operating mode that a physician or other user feels provides a most efficacious therapy for patient <NUM>. While operating in accordance with the normal operating mode, IMD <NUM> may sense physiological events, deliver a number of different therapies, and log collected data. In some instances, the normal operating mode may include a number of different operating modes that change based on a condition of the patient. However, the normal operating modes typically do not account for the presence of strong disruptive energy fields.

In the exposure mode, IMD <NUM> may perform functions in a manner that specifically accounts for the presence of strong disruptive energy fields. While operating in the exposure mode, IMD <NUM> may be configured to operate with different functionality than when operating in the normal operating mode. IMD <NUM> may, in some instances, be configured to operate with reduced functionality. In other words, when configured to operate in the exposure mode, IMD <NUM> may have only a subset of the functionality of the normal operating mode. For example, IMD <NUM> may not provide sensing, not deliver therapy, delivery only a subset of possible therapies, not log collected data or the like. In other instances, IMD <NUM> may be operating with approximately the same functionality or even increased functionality in the exposure mode. For example, IMD <NUM> may use a different sensor or algorithm to detect cardiac activity of the heart of patient <NUM>, such as pressure sensor measurements rather than electrical activity of the heart.

The exposure operating mode of IMD <NUM> may be enabled and disabled in a number of different ways. For example, the exposure operating mode may be manually enabled and manually disabled, e.g., via communication with an external device, such as a programming device, a handheld activator or a home monitoring device. As another example, the exposure operating mode may be automatically enabled and automatically disabled, e.g., by detecting the MRI environment. In yet another example, the exposure operating mode may be automatically enabled and manually disabled or manually enabled and automatically disabled. In this case, the exposure operating mode may be viewed as being semi-automatic in that the exposure operating mode is either automatically enabled or disabled, but still requires some sort of manual intervention (e.g., the other of enabled or disabled).

In accordance with the techniques described in this disclosure, the manner in which the exposure operating mode of IMD <NUM> is enabled and disabled is selectively configurable. In other words, IMD <NUM> may support more than one way for enabling and disabling the exposure operating mode to provide flexibility in the clinical workflows associated with conducting an MRI scan of patient <NUM> or other medical or non-medical procedure in which IMD <NUM> is exposed to disruptive energy field <NUM>. For example, IMD <NUM> may support two or more exposure mode programming options corresponding to different ways for enabling and disabling an exposure operating mode of the implantable medical device, e.g., a manual exposure mode programming option in which the exposure operating mode is enabled and disabled manually, an automatic exposure mode programming option in which the exposure operating mode is enabled and disabled automatically, a semi-automatic exposure mode programming option in which the exposure operating mode is automatically enabled and manually disabled and/or a semi-automatic exposure mode programming option in which the exposure operating mode is manually enabled and automatically disabled. As such, an appropriate exposure mode programming option may be selectable by a user, e.g., a physician, based on physician preference, patient preference, resource availability, experience scanning patients with IMDs, clinical practice within or across geographies, or other factor.

Although described with respect to a medical environment that generates disruptive energy fields, the techniques of this disclosure may be used to operate IMD <NUM> within non-medical environments that include disruptive energy fields. Additionally, the techniques of this disclosure may also be used to operate IMD <NUM> within environments that produce disruptive energy fields that are intermittent in nature.

<FIG> is a conceptual diagram illustrating an example therapy system <NUM> that may be used to provide therapy to patient <NUM>. Therapy system <NUM> includes an IMD <NUM> and leads <NUM> and <NUM> that extend from IMD <NUM>. IMD <NUM> may, for example, correspond to IMD <NUM> of <FIG>.

In the example illustrated in <FIG>, IMD <NUM> is an implantable cardiac device that senses electrical activity of a heart <NUM> of patient <NUM> and/or provides electrical stimulation therapy to heart <NUM> of patient <NUM>. The electrical stimulation therapy to heart <NUM>, sometimes referred to as cardiac rhythm management therapy, may include pacing, cardioversion, defibrillation and/or cardiac resynchronization therapy (CRT). The combinations of cardiac therapies provided may be dependent on a condition of patient <NUM>. In some instances, IMD <NUM> may provide no therapy to patient <NUM>, but instead provide only sensing of electrical activity or other variable of heart <NUM>, such as in the case of an implantable loop recorder.

In the illustrated example, lead <NUM> is a right ventricular (RV) lead that extends through one or more veins (not shown), the superior vena cava (not shown), and right atrium <NUM>, and into right ventricle <NUM> of heart <NUM>. Lead <NUM> includes electrodes <NUM> and <NUM> located along a distal end of lead <NUM>. In the illustrated example, lead <NUM> is right atrial (RA) lead that extends through one or more veins and the superior vena cava, and into the right atrium <NUM> of heart <NUM>. Lead <NUM> includes electrodes <NUM> and <NUM> located along a distal end of lead <NUM>.

Electrodes <NUM> and <NUM> may take the form of extendable helix tip electrodes mounted retractably within an insulative electrode head (not shown) of respective leads <NUM> and <NUM>. Electrodes <NUM> and <NUM> may take the form of ring electrodes. In other embodiments, electrodes <NUM>, <NUM>, <NUM> and <NUM> may be other types of electrodes. For example, electrodes <NUM>, <NUM>, <NUM> and <NUM> may all be ring electrodes located along the distal end of the associated lead <NUM> or <NUM>. Additionally, either or both of leads <NUM> and <NUM> may include more than two electrodes or only a single electrode.

Each of the electrodes <NUM>, <NUM>, <NUM> and <NUM> may be electrically coupled to a respective conductor within the body of its associated lead <NUM> and <NUM>. The respective conductors may extend from the distal end of the lead to the proximal end of the lead and couple to circuitry of IMD <NUM>. For example, leads <NUM> and <NUM> may be electrically coupled to a stimulation module, a sensing module, or other modules of IMD <NUM> via connector block <NUM>. In some examples, proximal ends of leads <NUM> and <NUM> may include electrical contacts that electrically couple to respective electrical contacts within connector block <NUM>. In addition, in some examples, leads <NUM> and <NUM> may be mechanically coupled to connector block <NUM> with the aid of set screws, connection pins or another suitable mechanical coupling mechanism.

When IMD <NUM> is capable of delivering electrical stimulation therapy, IMD <NUM> delivers the therapy (e.g., pacing pulses) to heart <NUM> via any combination of electrodes <NUM>, <NUM>, <NUM> and <NUM> to cause depolarization of cardiac tissue of heart <NUM>. For example, IMD <NUM> may deliver bipolar pacing pulses to right atrium <NUM> via electrodes <NUM> and <NUM> of lead <NUM> and/or may deliver bipolar pacing pulses to right ventricle <NUM> via electrodes <NUM> and <NUM> of lead <NUM>. In another example, IMD <NUM> may deliver unipolar pacing pulses to atrium <NUM> and ventricle <NUM> using a housing electrode (not shown) in conjunction with one of electrodes <NUM>, <NUM>, <NUM> and <NUM>. The housing electrode may be formed integrally with an outer surface of the hermetically-sealed housing of IMD <NUM> or otherwise coupled to the housing. In some examples, the housing electrode is defined by an uninsulated portion of an outward facing portion of the housing of IMD <NUM>.

Electrodes <NUM>, <NUM>, <NUM> and <NUM> may also sense electrical signals attendant to the depolarization and repolarization of heart <NUM>. The electrical signals are conducted to IMD <NUM> via one or more conductors of respective leads <NUM> and <NUM>. IMD <NUM> may use any combinations of the electrodes <NUM>, <NUM>, <NUM>, <NUM> or the housing electrode for unipolar or bipolar sensing. As such, the configurations of electrodes used by IMD <NUM> for sensing and pacing may be unipolar or bipolar depending on the application. IMD <NUM> may analyze the sensed signals to monitor a rhythm of heart <NUM> or detect an arrhythmia of heart <NUM>, e.g., tachycardia, bradycardia, fibrillation or the like. In some instances, IMD <NUM> provides pacing pulses (or other therapy) to heart <NUM> based on the cardiac signals sensed within heart <NUM>. In other words, pacing may be responsive to the sensed events.

As described above, exposure of IMD <NUM> to a disruptive energy field <NUM> (<FIG>) may result in undesirable operation. For example, gradient magnetic and RF fields produced by MRI scanner <NUM> (<FIG>) may induce energy on one or more of electrodes <NUM>, <NUM>, <NUM> and <NUM> of respective ones of implantable leads <NUM> and <NUM> or on the housing electrode. In some instances, IMD <NUM> inappropriately detects the induced energy on electrodes <NUM>, <NUM>, <NUM> and <NUM> as physiological signals, which may in turn cause IMD <NUM> to deliver undesired therapy or withhold desired therapy. In other instances, the induced energy on electrodes <NUM>, <NUM>, <NUM> and <NUM> result in IMD <NUM> not detecting physiological signals that are actually present, which may again result in IMD <NUM> delivering undesired therapy or withholding desired therapy. In further instances, the induced energy on electrodes <NUM>, <NUM>, <NUM> and <NUM> result in stimulation or heating of the tissue and/or nerve site adjacent to electrodes <NUM>, <NUM>, <NUM> and <NUM> or the housing of IMD <NUM>. Such heating may result in thermal damage to the tissue adjacent the electrodes, possibly compromising pacing and sensing thresholds at the site. Yet another possible adverse effect of disruptive energy field <NUM> is damage to circuitry within IMD <NUM>.

Configuring IMD <NUM> into an exposure operating mode may reduce, and possibly eliminate, the undesirable effects that may be caused by exposure to disruptive energy field <NUM>. As such, IMD <NUM> may be configured to operate in the exposure operating mode prior to or immediately subsequent to entering the environment in which the disruptive energy field <NUM> is present. In accordance with the techniques described in this disclosure, the manner in which the exposure operating mode of IMD <NUM> is enable and disabled is selectively configurable. In other words, IMD <NUM> may support more than one way for enabling and disabling the exposure operating mode to provide flexibility in the clinical workflows associated with conducting an MRI scan of patient <NUM> or other medical or non-medical procedure in which IMD <NUM> is exposed to disruptive energy field <NUM>.

A physician or other user may, for example, interact with a programming device <NUM> to select the manner in which the exposure operating mode of IMD <NUM> is enabled or disabled. For example, programming device <NUM> may include an electronic display via which programming device <NUM> presents the user with the programming options supported by IMD <NUM> for enabling and disabling the exposure operating mode. As described above, the programming options supported by IMD <NUM> may include a manual programming option in which the exposure operating mode is enabled and disabled manually, an automatic programming option in which the exposure operating mode is enabled and disabled automatically, a semi-automatic programming option in which the exposure operating mode is automatically enabled and manually disabled and/or a semi-automatic programming option in which the exposure operating mode is manually enabled and automatically disabled.

The user selects the desired programming option for enabling and disabling the exposure operating mode. The desired programming option selected by the user may be based on user preference, patient preference, resource availability, experience scanning patients with IMDs, clinical practice within or across geographies, or other factor. In response to the interaction of the user, programming device <NUM> transmits a communication to IMD <NUM> to configure IMD <NUM> to operate in accordance with the selected exposure mode programming option. IMD <NUM> receives the communication from programming device <NUM> and configures itself to the programming option specified in the communication. As such, IMD <NUM> is selectively configurable to different programming options for enabling and disabling the exposure operating mode.

In addition to configuring IMD <NUM> into the desired programming option for enabling and disabling the exposure operating mode, the user may interact with programming device <NUM> to select different settings within a particular programming option. For example, the user may interact with programming device <NUM> to select detection parameters for automatically enabling and/or disabling the exposure operating mode in the automatic programming option. Programming device <NUM> then transmits the selected settings of the particular programming option to IMD <NUM> in the communication along with the selected programming option or in a separate communication.

The user may further interact with programming device <NUM> to configure one or more parameters of the exposure operating mode. For example, the user may specify a pacing mode (e.g., atrial-based pacing mode, ventricular-based pacing mode or dual-chamber based pacing mode), pacing amplitude, pacing pulse width, and/or pacing rate of the therapy energy delivered during the exposure operating mode. Programming device <NUM> then transmits the selected settings of the particular programming option to IMD <NUM>. Additionally, the user may interact with the programming device <NUM> to enable the exposure operating mode when utilizing the manual programming option or the semi-automatic programming option in which the exposure operating mode is manually enabled or manually disabled.

The user may interact with a programming device <NUM> to communicate with IMD <NUM> for other purposes than selecting the exposure mode programming option of IMD <NUM>, manually enabling or disabling the exposure mode, or providing exposure mode operating parameters. For example, the user may interact with programming device <NUM> to retrieve physiological information, diagnostic information, logs of delivered therapies, or an assessment of the performance or integrity of IMD <NUM> or other components of therapy system <NUM>, such as leads or a power source of IMD <NUM>. Programming device <NUM> may transmit a communication requesting such information or receive the information without providing such a request.

The user may also interact with programming device <NUM> to program IMD <NUM>, e.g., select values for operational parameters of the normal operating mode of IMD <NUM>, such as a therapy progression, an electrode or combination of electrodes of leads <NUM> and <NUM> to use for delivering electrical stimulation (pulses or shocks), select parameters for the electrical pulse or shock (e.g., pulse amplitude, pulse width, or pulse rate), select electrodes or sensors for use in detecting a physiological parameter of patient <NUM>, or the like. Programming device <NUM> may transmit a communication that includes the selected operational parameters of the normal operating mode.

Programming device <NUM> may communicate with IMD <NUM> via wireless communication using any techniques known in the art. Examples of communication techniques may include, for example, magnetic telemetry, low frequency telemetry or RF telemetry, but other techniques are also contemplated. In some instances, programming device <NUM> and IMD <NUM> may communicate in the <NUM>-<NUM> frequency band in accordance with the Medical Implant Communications Service (MICS) frequency band regulation, in the <NUM>-<NUM> or <NUM>-<NUM> frequency bands in accordance with the Medical External Data Service (MEDS) band regulations, in the unlicensed industrial, scientific and medical (ISM) band, or other frequency band.

Programming device <NUM> may be a dedicated hardware device with dedicated software for programming of IMD <NUM>. Alternatively, programming device <NUM> may be an off-the-shelf computing device running an application that enables programming device <NUM> to program IMD <NUM>. In some examples, programming device <NUM> may be a handheld computing device or a computer workstation. Programming device <NUM> may, in some instances, include a programming head that may be placed proximate to the patient's body near the implant site of IMD <NUM> in order to improve the quality or security of communication between IMD <NUM> and programming device <NUM>. Programming device <NUM> may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), programmable logic circuitry, or the like, that may perform various functions and operations, such as those described herein.

The configuration of therapy system <NUM> illustrated in <FIG> is merely an example. In other examples, therapy system <NUM> may include more or fewer leads extending from IMD <NUM>. For example, IMD <NUM> may be coupled to three leads, e.g., a third lead implanted within a left ventricle of heart <NUM>. In another example, IMD <NUM> may be coupled to a single lead that is implanted within either an atrium or ventricle of heart <NUM>. As such, IMD <NUM> may be used for single chamber or multi-chamber cardiac rhythm management therapy.

In addition to more or fewer leads, each of the leads may include more or fewer electrodes. In instances in which IMD <NUM> is used for therapy other than pacing, e.g., defibrillation or cardioversion, the leads may include elongated electrodes, which may, in some instances, take the form of a coil. IMD <NUM> may deliver defibrillation or cardioversion shocks to heart <NUM> via any combination of the elongated electrodes and housing electrode. As another example, therapy system <NUM> may include leads with a plurality of ring electrodes, e.g., as used in some implantable neurostimulators.

In still other examples, a therapy system may include epicardial leads and/or patch electrodes instead of or in addition to the transvenous leads <NUM> and <NUM> illustrated in <FIG>. Further, IMD <NUM> need not be implanted within patient <NUM>. In examples in which IMD <NUM> is not implanted in patient <NUM>, IMD <NUM> may deliver electrical stimulation therapy to heart <NUM> via percutaneous leads that extend through the skin of patient <NUM> to a variety of positions within or outside of heart <NUM>.

The techniques of this disclosure are described in the context of cardiac rhythm management therapy for purposes of illustration. The techniques of this disclosure, however, may be used to operate an IMD that provides other types of electrical stimulation therapy. For example, the IMD may be a device that provides electrical stimulation to a tissue site of patient <NUM> proximate a muscle, organ or nerve, such as a tissue proximate a vagus nerve, spinal cord, brain, stomach, pelvic floor or the like. Moreover, the techniques may be used to operate an IMD that provides other types of therapy, such as drug delivery or infusion therapies. As such, description of these techniques in the context of cardiac rhythm management therapy should not be limiting of the techniques as broadly described in this disclosure.

<FIG> is a functional block diagram of an example configuration of components of IMD <NUM>. In the example illustrated by <FIG>, IMD <NUM> includes a control processor <NUM>, sensing module <NUM>, stimulation module <NUM>, disruptive field detector <NUM>, telemetry module <NUM>, memory <NUM> and power source <NUM>, all of which are interconnected by a data bus <NUM>.

As described above, IMD <NUM> is selectively configurable to support a plurality of programming options for enabling or disabling an exposure operating mode designed to perform functions of IMD <NUM> in a manner that specifically accounts for the presence of strong disruptive energy fields. Each of the programming options may correspond to a different manner of enabling and/or disabling exposure operating mode of IMD <NUM>. For example, IMD <NUM> may support two or more of a manual programming option, an automatic programming option or a semi-automatic programming option. The manual programming option requires that a user manually enable and disable the exposure operating mode of IMD <NUM> using programming device <NUM> or other external device that is capable of communicating or otherwise activating IMD <NUM>. Thus, IMD <NUM> is operating in the exposure operating mode from the time at which the mode is manually enabled until the time at which the mode is manually disabled.

In the automatic exposure mode programming option, IMD <NUM> enables and disables the exposure operating mode of IMD <NUM> in response to one or more conditions, e.g., detection of disruptive energy field <NUM> with disruptive field detector <NUM> (e.g., detection of the static magnetic field, the gradient magnetic fields or the RF pulses of MRI scanner <NUM>), expiration of a timer, detection of some other signal, or other condition or a combination of conditions. The condition(s) for enabling and disabling the exposure operating mode may be the same for enabling and disabling the exposure operating mode or the condition(s) for enabling the exposure operating mode may be different than the condition(s) for disabling the exposure operating mode. For example, processor <NUM> may automatically configure IMD <NUM> to operate in accordance with the parameters of the exposure operating mode in response to disruptive field detector <NUM> detecting disruptive energy field <NUM> of MRI scanner <NUM> and automatically disable the exposure operating mode in response to disruptive field detector <NUM> no longer detecting disruptive energy field <NUM> of MRI scanner <NUM>. As another example, processor <NUM> may automatically configure IMD <NUM> to operate in accordance with the parameters of the exposure operating mode in response to disruptive field detector <NUM> detecting disruptive energy field <NUM> of MRI scanner <NUM> and automatically disable the exposure operating mode after a predetermined period of time (e.g., one hour).

Processor <NUM> may automatically configure IMD <NUM> to enable and/or disable the exposure operating mode upon satisfaction of multiple conditions. The multiple conditions may be concurrent conditions or conditions that occur in a specific order. For example, processor <NUM> may automatically configure IMD <NUM> to operate in accordance with the parameters of the exposure operating mode in response to disruptive field detector <NUM> detecting disruptive energy field <NUM> of MRI scanner <NUM> within a particular time period (e.g., on a specified day and/or time) and automatically disable the exposure operating mode after no longer detecting disruptive energy field <NUM> for a particular period of time. These are just a few examples of the automatic programming option. Any combination of one or more conditions may be required for automatically enabling or disabling the exposure operating mode of IMD <NUM>.

In the semi-automatic programming option, the user either manually enables the exposure operating mode of IMD <NUM> and processor <NUM> automatically disables the exposure operating mode of IMD <NUM> or processor <NUM> automatically enables the exposure operating mode of IMD <NUM> and the user manually disables the exposure operating mode of IMD <NUM>. As with the automatic programming option, IMD <NUM> automatically enables or automatically disables the exposure operating mode of IMD <NUM> in response to one or a combination of conditions, such as the ones described in detail above.

IMD <NUM> may additionally be capable of supporting different settings within each of the exposure mode programming options. As one example, the user may selectively configure IMD <NUM> to specify the condition or conditions required to automatically enable and/or disable the exposure operating mode. The user may, for example, selectively configure IMD <NUM> to enable and/or disable the exposure operating mode using a timer, one or more disruptive field detectors <NUM>, or a combination thereof. Additionally, the user may selectively configure thresholds for each of the selected conditions, e.g., threshold magnitudes of the detected fields, time periods for the timer or the like. As such, the exposure mode programming option of IMD <NUM> is not only selectively configurable, but so are settings within each of the exposure mode programming options.

Processor <NUM> of IMD <NUM> may receive a communication signal from programming device <NUM> or other external device indicating the programming option selected by a user, e.g., a physician. Processor <NUM> may store predetermined configuration settings for each of the programming options in memory <NUM> and select the configuration settings corresponding to the programming option indicated in the communication signal. The communication signal may, for example, indicate the programming option selected by the user in either the header or the body of the communication. Alternatively, the communication signal received by processor <NUM> may include the configuration settings for the programming option selected by the user.

Prior to enabling the exposure operating mode, e.g., either automatically or manually, processor <NUM> operates IMD <NUM> in accordance with settings programmed by a physician, clinician or other user, referred to herein as the normal operating mode. The normal operating mode may correspond with the operating mode that a physician or other user feels provides a most efficacious therapy for patient <NUM>. The normal operating mode may vary from patient to patient depending on the condition of patient <NUM> for which IMD <NUM> is providing therapy. In some instances, the normal operating mode may be adaptive in that the normal operating mode actually includes switching between more than one pacing mode based on the condition of the patient, such as described in <CIT>.

The normal operating mode of IMD <NUM> may be one or more of any of a number of pacing modes, including DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR, VOO, AOO, DOO, ODO and other modes of single and dual-chamber pacing or sensing. For example, the normal operating mode may be an atrial based pacing mode, such as AAI or ADI pacing mode, if IMD <NUM> is providing therapy to a patient experiencing bradycardia. As another example, the normal operating mode may be a dual-chamber pacing mode, such as a DDD pacing mode, if IMD <NUM> is providing therapy to a patient with unreliable A-V conduction.

In the aforementioned operating modes, the abbreviations of which conform to the NBG Pacemaker Code, the first letter in the pacing mode indicates the chamber or chambers paced and may take on the letter "D" indicating dual-chamber (i.e., atrial and ventricle both paced), "V" indicating a ventricle is paced, "A" indicating an atrium is paced, or "O" indicating no chamber is paced. The second letter indicates the chamber or chambers sensed and may take on the letter "D" indicating dual-chamber (i.e., atrial and ventricle both paced), "V" indicating a ventricle is paced, "A" indicating an atrium is paced, or "O" indicating no chamber is paced. The third letter indicates mode or modes of response to sensing and may take on the letter "T" indicating triggered pacing (i.e., pacing is provided in response to the sensing), "I" indicating inhibited pacing (i.e., pacing is stopped based in response to the sensing), "D" indicating dual response (i.e., triggered and inhibited) and "O" for no response. The fourth letter indicates programmable functions and may take on the letter "R" indicating rate modulated pacing, as well as other letters not explained here. Although not described here, a fifth letter may be provided in accordance with the NBG Pacemaker Code indicating anti-tachycardia functions.

When IMD <NUM> is configured to generate and deliver therapy to heart <NUM>, control processor <NUM> controls stimulation module <NUM> to deliver electrical stimulation therapy to heart <NUM> via one or more of electrodes <NUM>, <NUM>, <NUM>, <NUM> and/or the housing electrode. Stimulation module <NUM> is electrically coupled to electrodes <NUM>, <NUM>, <NUM> and <NUM>, e.g., via conductors of the respective lead <NUM> and <NUM>, or, in the case of the housing electrode, via an electrical conductor disposed within the housing of IMD <NUM>. Control processor <NUM> controls stimulation module <NUM> to generate and deliver electrical pacing pulses with the amplitudes, pulse widths, rates, electrode combinations or electrode polarities specified by a selected therapy program. For example, electrical stimulation module <NUM> may deliver bipolar pacing pulses via ring electrodes <NUM> and <NUM> and respective corresponding helical tip electrodes <NUM> and <NUM> of leads <NUM> and <NUM>, respectively. Stimulation module <NUM> may deliver one or more of these types of stimulation in the form of other signals besides pulses or shocks, such as sine waves, square waves, or other substantially continuous signals. In addition to pacing pulses, stimulation module <NUM> may, in some instances, deliver other types of electrical therapy, such as defibrillation therapy or cardioversion therapy.

Processor <NUM> may include a pacer timing and control module (not shown), which may be embodied as hardware, firmware, software, or any combination thereof. The pacer timing and control module may comprise a dedicated hardware circuit, such as an ASIC, separate from other components of control processor <NUM>, or comprise a software module executed by a component of control processor <NUM>, which may be a microprocessor or ASIC. In other instances, the pacer timing and control module may be part of stimulation module <NUM>.

The pacer timing and control module may include programmable counters which control the basic time intervals associated with various single and dual-chamber pacing modes. Intervals defined by the pacer timing and control module within control processor <NUM> may include, for example, atrial and ventricular pacing escape intervals and refractory periods during which sensed atrial and ventricular events are ineffective to restart timing of the escape intervals. As another example, the pace timing and control module may define a blanking period, and provide signals to sensing module <NUM> to blank one or more channels, e.g., amplifiers, for a period during and after delivery of electrical stimulation to heart <NUM>. The durations of these intervals may be determined by control processor <NUM> in response to parameters of the operating mode, which are stored in memory <NUM>. The pacer timing and control module of control processor <NUM> may also determine the amplitude and pulse width of the cardiac pacing pulses.

During pacing, escape interval counters within the pacer timing and control module of control processor <NUM> may be reset upon sensing of R-waves and P-waves with detection channels of sensing module <NUM>. Additionally, the value of the count present in the escape interval counters when reset by sensed R-waves and P-waves may be used by control processor <NUM> to measure the durations of R-R intervals, P-P intervals, P-R intervals and R-P intervals, which are measurements that may be stored in memory <NUM>. Control processor <NUM> may analyze these various intervals to determine conditions of heart <NUM>, such as to detect a tachyarrhythmia event. When IMD <NUM> is capable of providing defibrillation therapy, the R-R intervals may be used to increment a VF counter to control delivery of cardioversion or defibrillation shocks. For example, the VF counter may be incremented in response to detection of short R-R intervals, and possibly in response to other events such as R-R interval variance. The VF counter triggers delivery of a defibrillation shock when the counter reaches a number of intervals for detection (NID) threshold. Additionally, control processor <NUM> may begin an anti-tachyarrhythmia pacing regimen prior to delivery of the defibrillation shock.

Sensing module <NUM> is configured to receive signals from one or more sensors. In one example, sensing module <NUM> is configured to receive signals sensed by one or more of electrodes <NUM>, <NUM>, <NUM>, <NUM> and the housing electrode. In this manner, electrodes <NUM>, <NUM>, <NUM>, <NUM>, and the housing electrode may operate as sense electrodes in addition to or instead of being used for delivering electrical stimulation therapy. In other instances, leads <NUM> and <NUM> may include one or more electrodes dedicated for sensing. In further examples, sensing module <NUM> is coupled to one or more sensors that are not included on leads <NUM> and <NUM>, e.g., via a wired or wireless coupling. Such sensors may include, but are not limited to, pressure sensors, accelerometers, flow sensors, blood chemistry sensors, activity sensors or other type of physiological sensor. Signals monitored by sensing module <NUM> may be stored in memory <NUM>.

Sensing module <NUM> may receive signals sensed by any number of sensing configurations defined by various combinations of one or more of electrodes <NUM>, <NUM>, <NUM> and <NUM>. Control processor <NUM> may select the electrodes that function as sense electrodes, sometimes referred to as a sensing configuration or sensing vector, in order to monitor electrical activity of heart <NUM>. In one example, sensing module <NUM> may include a switch module (not shown) to select which of the available electrodes are used to sense the heart activity. Control processor <NUM> may select the electrodes that function as sense electrodes, or the sensing electrode configuration, via the switch module within sensing module <NUM>, e.g., by providing signals via a data/address bus.

Sensing module <NUM> may store the sensed signals in memory <NUM>. In some instances, sensing module <NUM> may store the sensed signals in raw form. In other instances, sensing module <NUM> may process the sensed signals and store the processed signals in memory <NUM>. Sensing module <NUM> may, for example, include multiple detection channels configured to detect different cardiac events, such as intrinsic or paced atrial events, intrinsic or paced ventricular events, repolarization of the ventricles, and the like. Each of the detection channels may comprise an amplifier, filter or other components. Sensing module <NUM> may amplify and filter the sensed signal and store the filtered signal in memory <NUM>. The signals stored by sensing module <NUM> may, in some cases, be retrieved and further processed by control unit <NUM>. In some instances, stimulation module <NUM> may be controlled by processor <NUM> based on the signals sensed by sensing module <NUM>.

As described above, the normal operating mode of IMD <NUM> may be susceptible to undesirable operation when IMD <NUM> is placed within environment <NUM> with disruptive energy field <NUM>. In some instances, sensing module <NUM> inappropriately detects the induced energy on the leads as physiological signals (e.g., intrinsic cardiac events). In other words, IMD <NUM> senses a physiological signal when one is not actually present. At the very least, the detection of the induced energy caused by disruptive energy field <NUM> results in the stored data not accurately representing the actual function and condition of heart <NUM>. Moreover, the detection of the induced energy caused by disruptive energy field <NUM> may in turn cause undesirable operation of IMD <NUM>.

For example, when the current or normal operating mode is a pacing mode with inhibit response to sensing, processor <NUM> may not deliver (i.e., withhold) a desired pacing pulse in response to sensing the induced energy from disruptive energy field <NUM> as a physiological signal. For example, processor <NUM> may identify the induced energy as a ventricular event. This may result in control processor <NUM> resetting the ventricular escape interval counter, thereby inhibiting delivery of a desired pacing pulse. In other instances when the normal operating mode is a dual chamber pacing mode with inhibit and trigger response to sensing, processor <NUM> may also deliver an undesirable pacing pulse in addition to withholding a desired pacing pulse in response to sensing the induced energy from disruptive energy field <NUM> as a physiological signal. In particular, sensing the induced energy from the disruptive energy field as a physiological signal may inappropriately start an escape interval after which an undesired pacing pulse is delivered. This may result in dangerously fast heart rhythms and may lead to tachyarrhythmia or fibrillation.

In other instances, the induced energy on the leads may result in IMD <NUM> not sensing actual physiological signals that are present. Processor <NUM> may, for example, initiate a blanking period in response to the induced energy on the leads. During the blanking period, sensing module <NUM> may power down one or more sense amplifiers. As such, sensing module <NUM> will fail to detect any intrinsic physiological event that occurs during the blanking period. Failure to detect this actual physiological event may again result in IMD <NUM> delivering undesired therapy or withholding desired therapy.

In further instances, the induced energy on one or more of leads <NUM> and <NUM> may result in inadvertent stimulation or heating of the tissue and/or nerve site adjacent to any of electrodes <NUM>, <NUM>, <NUM> and <NUM> of respective leads <NUM> and <NUM>. Such heating may result in thermal damage to the tissue adjacent the electrodes. This may in turn possibly compromise pacing and sensing thresholds at the site.

To reduce the adverse effects of disruptive energy field <NUM>, control processor <NUM> may be configured to operate IMD <NUM> in the exposure operating mode in accordance with the selected exposure mode programming option as described in detail above. The exposure operating mode is typically less susceptible to undesirable operation in disruptive energy field <NUM> than the normal operating mode. In other words, operating IMD <NUM> in the exposure mode may reduce if not eliminate some or all of the adverse effects that disruptive energy field <NUM> have on therapy delivery to patient <NUM>. When operating in the exposure operating mode, control processor <NUM> is configured to operate with different functionality compared to the normal operating mode. Processor <NUM> may, in some instances, be configured to operate with reduced functionality. For example, processor <NUM> may not provide sensing, not deliver therapy, delivery only a subset of possible therapies, not log collected data or the like. In other instances, processor <NUM> may be operating with approximately the same functionality or even increased functionality in the exposure mode. For example, processor <NUM> may use a different sensor or algorithm to detect cardiac activity of the heart of patient <NUM>, such as pressure sensor measurements rather than electrical activity of the heart.

Processor <NUM> may receive the parameters of the exposure operating mode from a user via programming device <NUM>. In other words, the exposure operating mode parameters may be manually configured by the user. In another example, at least a portion, and in some cases all, of the parameters of the exposure operating mode may be automatically determined. One example technique for automatically determining one or more parameters of the exposure operating mode is described in co-pending patent application number <CIT>. Whether the parameters were manually entered or automatically determined or both, processor <NUM> may store the parameters of the exposure operating mode in memory <NUM>.

Control processor <NUM> may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or integrated circuitry, including analog circuitry, digital circuitry, or logic circuitry. The functions attributed to control processor <NUM> herein may be embodied as software, firmware, hardware or any combination thereof.

Memory <NUM> may include computer-readable instructions that, when executed by control processor <NUM> or other component of IMD <NUM>, cause one or more components of IMD <NUM> to perform various functions attributed to those components in this disclosure. Memory <NUM> may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), static non-volatile RAM (SRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other computer-readable storage media.

The various components of IMD <NUM> are coupled to power source <NUM>, which may include a rechargeable or non-rechargeable battery. A non-rechargeable battery may be capable of holding a charge for several years, while a rechargeable battery may be inductively charged from an external device, e.g., on a daily or weekly basis. Power source <NUM> also may include power supply circuitry for providing regulated voltages and/or current levels to power the various components of IMD <NUM>.

Under the control of processor <NUM>, telemetry module <NUM> may receive downlink telemetry from and send uplink telemetry to programming device <NUM> with the aid of an antenna <NUM>, which may be internal and/or external to IMD <NUM>. Telemetry module <NUM> includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as programming device <NUM>. For example, telemetry module <NUM> may include appropriate modulation, demodulation, encoding, decoding, frequency conversion, filtering, and amplifier components for transmission and reception of data.

The various modules of IMD <NUM> may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), programmable logic circuitry, or the like, that may perform various functions and operations, such as those described herein.

<FIG> is a block diagram illustrating an example programming device <NUM> in further detail. Programming device <NUM> may correspond to a programming device, a monitoring device or other external device located on or in the vicinity of patient <NUM>. As illustrated in the example of <FIG>, programming device <NUM> includes a telemetry module <NUM>, user interface <NUM>, control processor <NUM>, memory <NUM> and power source <NUM>, all of which are interconnected by a data bus <NUM>.

A user (e.g., a physician) may interact with a programming device <NUM> to select the manner in which the exposure operating mode of IMD <NUM> is enabled or disabled. The user may, for example, interact with programming device <NUM> via user interface <NUM> to select one of a plurality of exposure mode programming options supported by IMD <NUM>. User interface <NUM> may include an output mechanism and an input mechanism via which the user interacts. The output mechanism may, for example, include an electronic display, e.g., a cathode ray tube (CRT) display, a liquid crystal display (LCD) or light emitting diode (LED) display, and/or a speaker. The input mechanism may be a keypad, a peripheral pointing device, such as a mouse, and/or a microphone via which a user may interact with the user interface. In some embodiments, the display of programming device <NUM> may include a touch screen display, and a user may interact with programming device <NUM> via the display.

Programming device <NUM> may include an electronic display via which programming device <NUM> presents the user with one or more graphical user interfaces for use in selecting the desired exposure mode programming option for IMD <NUM>. For example, programming device <NUM> may present a graphical user interface on the display that presents the programming options supported by IMD <NUM> for enabling and disabling the exposure operating mode. The graphical user interface may include one or more text-based hyperlinks and/or graphical or visual indicators, e.g., windows, menus, buttons, radio buttons, check boxes, text boxes, drop-down lists, icons, or the like that represent the exposure mode programming options supported by IMD <NUM>. One such graphical user interface is illustrated and described in more detail in <FIG>. In other instances, the user interface presented to the user may be a text-based interface, such as a command-line interface (CLI), in which text commands are used for interaction. In yet other instances, the user interface <NUM> may present the programming options audibly, e.g., via a speaker.

In one instance, programming device <NUM> may receive a communication from IMD <NUM> and determine the exposure mode programming options supported by IMD <NUM> based on the communication from IMD <NUM>. For example, programming device <NUM> may maintain a mapping, e.g., in memory <NUM>, that associates each type of IMD with corresponding exposure mode programming options supported by the IMD. In this manner, programming device <NUM> may determine the exposure mode programming options supported by IMD <NUM> based a device type, a device serial number or other information contained in a header of the communication from IMD <NUM>. Alternatively, the sent communication from IMD <NUM> may include the exposure mode programming options supported by IMD <NUM>. As such, programming device <NUM> may query IMD <NUM> to retrieve the exposure mode programming options supported by IMD <NUM>.

The user selects, e.g., via the input mechanism, the desired programming option for enabling and disabling the exposure operating mode from the list on the graphical user interface. The desired programming option selected by the user may be based on user preference, patient preference, resource availability, experience scanning patients with IMDs, clinical practice within or across geographies, or other factor.

In some instances, programming device <NUM> may present a series of one or more additional graphical user interfaces via the display in response to the user selecting the desired exposure mode programming option. The series of additional graphical user interfaces may, for example, include a graphical user interface that presents a list of settings within the selected exposure mode programming option that the user may also configure. One example series of graphical user interfaces is illustrated in <FIG>. As another example, a second graphical user interface may present the user with the option to select conditions for enablement of the exposure operating mode or the option to select conditions for disablement of the exposure operating mode for the automatic exposure mode programming option. Within each of these options, another graphical user interface may be presented to provide the user with the ability to select the type of condition(s) (e.g., detection of disruptive energy field <NUM> with disruptive field detector <NUM>, expiration of a timer, detection of some other signal, or other condition or a combination of conditions,) as well as specify thresholds for each of the conditions (e.g., threshold magnitudes of the detected fields, time periods for the timer or the like). The selected exposure programming option and/or the settings of the selected programming option may be stored within memory <NUM>.

Programming device <NUM> transmits a communication to IMD <NUM> to configure IMD <NUM> into the selected exposure mode programming option and, in some instances, settings for the selected exposure programming option. Processor <NUM> controls telemetry module <NUM> to transmit the communication to telemetry module <NUM> of IMD <NUM>. Telemetry module <NUM> communicates wirelessly with IMD <NUM> and, more specifically, with telemetry module <NUM> of IMD <NUM>. Telemetry module <NUM>, like telemetry module <NUM> of IMD <NUM>, may include any suitable hardware, firmware, software or any combination thereof for communicating with IMD <NUM>. For example, telemetry module <NUM> may include appropriate modulation, demodulation, frequency conversion, filtering, and amplifier components for transmission and reception of data, including radio frequency (RF) components and antenna <NUM>, as applicable. In some instances, telemetry module <NUM> may include two or more sets of RF components, e.g., one for communication with IMD <NUM> and one for communication with another computing device (e.g., remote server).

The various modules of programming device <NUM> may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), programmable logic circuitry, or the like, that may perform various functions and operations, such as those described herein.

<FIG> is a block diagram illustrating an example system that includes IMD <NUM>, a programming device <NUM>, an access point <NUM>, a network <NUM>, a server <NUM> and one or more computing devices 26A-26N. In the example of <FIG>, programming device <NUM>, access point <NUM>, server <NUM> and computing devices <NUM> are interconnected, and able to communicate with each other, through network <NUM>. Programming device <NUM>, access point <NUM>, server <NUM>, and computing devices 26A-26N may each include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, programmable logic circuitry, or the like, that may perform various functions and operations, such as those described herein.

IMD <NUM> may communicate with programming device <NUM> via a first wireless connection and communicate with access point <NUM> via a second wireless connection. Programming device <NUM> and/or access point <NUM> may connect to network <NUM> via any of a variety of wired or wireless connections, such as telephone dial-up, digital subscriber line (DSL), cable modem connection, Infrared Data Association (IrDA), Bluetooth, IEEE <NUM>, General Packet Radio Service (GPRS) or the like. As such, programming device <NUM> and access point <NUM> may forward data from IMD <NUM> to any other device connected to network <NUM>.

In some embodiments, access point <NUM> may be co-located with patient <NUM> and may comprise one or more programming units and/or computing devices (e.g., one or more monitoring units) that may perform various functions and operations described herein. For example, access point <NUM> may include a home-monitoring unit that is co-located with patient <NUM> and that may monitor the activity of IMD <NUM>. In some embodiments, server <NUM> or computing devices <NUM> may control or perform any of the various functions or operations described herein, e.g., allow a user to manually select the exposure mode programming option of IMD <NUM>. In other words, the various user interfaces described above with respect to programming device <NUM> may alternatively be presented to a user remotely via one or more computing devices <NUM>. In other words, the user (e.g., a physician) may select the exposure mode programming option to be used remotely via computing device <NUM> in the same manner described above in <FIG> with respect to programming device <NUM>.

In some cases, server <NUM> may be configured to provide a secure storage site for archival of sensing integrity information that has been collected from IMD <NUM> and/or programming device <NUM>. In some cases, programming device <NUM> or server <NUM> may assemble information, such as the automatically determined parameters of the exposure operating mode, in web pages or other documents for viewing by trained professionals, such as clinicians, via viewing terminals associated with computing devices <NUM>. The system of <FIG> may be implemented, in some aspects, with general network technology and functionality similar to that provided by the Medtronic CareLink® Network developed by Medtronic, Inc. , of Minneapolis, MN.

<FIG> is a flow diagram illustrating example operation of an IMD, such as IMD <NUM> or <NUM>, in accordance with one aspect of this disclosure. Processor <NUM> of IMD <NUM> receives a communication indicating an exposure mode programming option selected by a user, e.g., a physician (<NUM>). The communication may be a wireless telemetry communication received via any of a number of wireless communication protocols as described in detail above. The selected exposure mode programming option may be indicated in the header or payload of the communication.

Processor <NUM> obtains the settings of the selected exposure mode programming option (<NUM>). Processor <NUM> may store predetermined configuration settings for each of the programming options in memory <NUM> and obtain the configuration settings corresponding to the selected programming option from memory <NUM>. Alternatively, the communication signal received by processor <NUM> may include the configuration settings for the programming option selected by the user. Thus, processor <NUM> may obtain the configuration settings for the programming options from the communication signal itself. The configuration settings of the programming option may include, for example, conditions to monitor for (e.g., detection of disruptive energy field <NUM> or expiration of a time period) as well as thresholds to use in monitoring for the conditions. The configuration settings of the programming option may, however, include a number of other settings for the programming option.

Processor <NUM> configures IMD <NUM> in accordance with the settings of the selected exposure mode programming option (<NUM>). For the manual exposure mode programming option, processor <NUM> may be configured to disregard the output of disruptive field detector <NUM> and the timer (not shown) since the manual programming option requires that the exposure operating mode be manually enabled and manually disabled, e.g., via interaction with programming device <NUM>.

For the automatic exposure mode programming option, processor <NUM> may be configured to monitor disruptive field detector <NUM>, a timer, or the output of some other sensor or detector in determining whether to enable and disable the exposure operating mode. In this manner, processor <NUM> is configured to automatically enable and automatically disable the exposure operating mode in response to one or more conditions, e.g., detection of disruptive energy field <NUM> with disruptive field detector <NUM> (e.g., detection of the static magnetic field, the gradient magnetic fields or the RF pulses of MRI scanner <NUM>), expiration of a timer, detection of some other signal, or other condition or a combination of conditions. As described above, processor <NUM> may be configured to monitor for the same condition(s) for enabling and disabling the exposure operating mode or monitor for different condition(s) for enabling the exposure operating mode than the condition(s) for disabling the exposure operating mode.

For the semi-automatic exposure mode programming option, processor <NUM> may be configured to disregard the output of disruptive field detector <NUM>, timer, or other sensor/detector for enabling the exposure operating mode and be configured to monitor disruptive field detector <NUM>, a timer, and/or an output of some other sensor/detector for disabling the exposure operating mode. Alternatively, processor <NUM> may be configured to monitor the output of disruptive field detector <NUM>, timer, or other sensor/detector for enabling the exposure operating mode and be configured to disregard the output of disruptive field detector <NUM>, the timer, and/or an output of some other sensor/detector for disabling the exposure operating mode.

Processor <NUM> of IMD <NUM> enables the exposure operating mode in accordance with the settings of the programming option (<NUM>). Processor <NUM> may, for example, enable the exposure operating mode in response to receiving a communication from programming device <NUM> when configured in the manual programming option or enable the exposure operating mode in response to detecting one or more conditions when configured in the automatic programming option.

Processor <NUM> of IMD <NUM> disables the exposure operating mode in accordance with the settings of the programming option (<NUM>). Processor <NUM> may, for example, disable the exposure operating mode in response to receiving a communication from programming device <NUM> when configured in the manual programming option or disable the exposure operating mode in response to detecting one or more conditions when configured in the automatic programming option.

<FIG> is a flow diagram illustrating example operation of an IMD, such as IMD <NUM> or <NUM>, in accordance with one aspect of this disclosure. Processor <NUM> of programming device <NUM> presents the programming options supported by IMD <NUM> for enabling and disabling the exposure operating mode via an output mechanism of user interface <NUM> (<NUM>). As described above, the output mechanism may be a electronic display via which processor <NUM> presents a graphical user interface that may include one or more text-based hyperlinks, graphical icons and/or or visual indicators that present the exposure mode programming options supported by IMD <NUM>. As another example, the output mechanism may be a speaker that audibly presents the programming options supported by IMD <NUM>.

Processor <NUM> receives input from the user selecting the desired programming option for enabling and disabling the exposure operating mode (<NUM>). Processor <NUM> may receive input from the user via the input mechanism, which may be a keypad, peripheral device, touch screen or microphone. Processor <NUM> may determine whether the selected programming option has any programmable settings (<NUM>). When the selected programming option has programmable settings ("YES" branch of <NUM>), processor <NUM> may present one or more additional graphical user interfaces to the user indicating settings for the selected programming option (<NUM>). When the selected programming option is the automatic programming option or the semi-automatic programming option, for example, processor <NUM> may present one or more graphical user interfaces to allow the user to set the types and/or number of conditions to automatically enable and/or automatically disable the exposure operating mode, select particular threshold values for each of the selected condition or conditions, or the like.

Processor <NUM> receives input from the user via user interface <NUM> (which includes a key pad, peripheral pointing device or touch screen) selecting programmable settings for the selected programming option (<NUM>). The selected programming option and the settings selected by the user may be stored within memory <NUM> of programming device <NUM>.

After receiving the input from the user programming the settings for the selected programming option or when the selected programming option does not have any programmable settings, or the user does not want to program the settings ("NO" branch of <NUM>), programming device <NUM> transmits a communication to IMD <NUM> to configure IMD <NUM> into the selected exposure mode programming option and, in some instances, configuring the settings for the selected exposure programming option (<NUM>). In this manner, the user may interact with programming device <NUM> to selectively configure the exposure mode programming option of IMD <NUM>. As such, an exposure mode programming option may be selectable by a user, e.g., a physician, based on physician preference, patient preference, resource availability, experience scanning patients with IMDs, clinical practice within or across geographies, or other factor.

<FIG> are conceptual diagrams illustrating example graphical user interfaces on a display <NUM> that allow a user to interact with programming device <NUM> to select the exposure mode programming option and, in some instances, settings within the selected exposure mode programming option. The graphical user interfaces of <FIG> are one example of a series of graphical user interfaces presented to the user. In particular, the graphical user interface of <FIG> may initially be presented to the user, the graphical user interface of <FIG> may be presented to the user in response to the user selecting the semi-automatic programming option of the graphical user interface of <FIG>, and the graphical user interface of <FIG> may be presented to the user in response to the user selecting the enable manually and disable automatically setting of the graphical user interface of <FIG>.

<FIG> is a conceptual diagram of an example graphical user interface on a display <NUM> that may be presented by programming device <NUM> to the user in accordance with the techniques of this disclosure. The graphical user interface includes a window <NUM> and buttons 124A-124C within window <NUM> that presents the user with the exposure mode programming options supported by IMD <NUM>. In the example illustrated in <FIG>, button 124A represents the automatic exposure mode programming option, button 124B represents the semi-automatic exposure mode programming option, and button 124C represents the manual exposure mode programming option.

The user may interact with the graphical user interface via user interface <NUM> (e.g., keypad, peripheral pointing device or touch screen display) to select one of the buttons 124A-124C and thereby choose the desired exposure mode programming option. For purposes of discussion, it will be assumed that the user selected button 124B corresponding to the semi-automatic programming option. In response to selecting button 124B, processor <NUM> presents the graphical user interface illustrated in <FIG>.

The graphical user interface of <FIG> includes a window <NUM> and buttons 128A and 128B. Button 128A corresponds with the semi-automatic programming option in which the exposure operating mode is automatically enabled (e.g., in response to detecting disruptive energy field <NUM>) and manually disabled (e.g., in response to a communication from programming device <NUM>). Button 128B corresponds with the semi-automatic programming option in which the exposure operating mode is manually enabled and automatically disabled. The user may interact with the graphical user interface via user interface <NUM> (e.g., keypad, peripheral pointing device or touch screen display) to select one of the buttons 128A and 128B and thereby choose the desired semi-automatic programming option for IMD <NUM>. For purposes of discussion, it will be assumed that the user selected button 128B corresponding to the semi-automatic programming option in which the exposure operating mode is manually enabled and automatically disabled. In response to selecting button 128B, processor <NUM> presents the graphical user interface illustrated in <FIG> indicating settings for the selected programming option.

The graphical user interface of <FIG> includes a window <NUM>, check boxes 132A and 132B, and text boxes 134A and 134B. Each of check boxes 132A and 132B corresponds with a condition for automatically disabling the exposure operating mode. In the example illustrated in <FIG>, check box 132A corresponds with the condition of detecting disruptive energy field <NUM> (e.g., using disruptive field detector <NUM>) and check box 132B corresponds with the condition of expiration of a timer. Other check boxes may be included for other conditions. For each of the conditions, the graphical user interface may include one or more text boxes, such as text boxes 134A and 134B, for entering threshold values for the respective conditions. In the example illustrated in <FIG>, text boxes 134A and 134B provide the user the capability to enter a threshold period of time for the timer by specifying the amount of time in hours and minutes, respectively. Window <NUM> may also include one or more notes, such as the note indicating to the user that if both conditions are selected, the exposure operating mode will be disabled when the disruptive field is no longer detected for the specified period of time. In the example illustrated in FIG. <NUM>, the user has selected only one disable condition, i.e., the disruptive energy field no longer being detected. However, the user may select more than one disable condition.

The graphical user interfaces of <FIG> are provided for purposes of illustration and should not be considered limiting of the type, number or layout of graphical user interfaces that may be used in accordance with the techniques of this disclosure. Moreover, the series of graphical user interfaces is only one example of the order of graphical user interfaces that may be presented to the user. A different series of graphical user interfaces may be presented to the user in the case of the manual programming option or the automatic programming option. Although shown as taking up a large portion of the display, the graphical user interfaces may be located within smaller portions of the display, e.g., along the side or in the corner of the display, and other information and data may be displayed concurrently with the illustrated graphical user interfaces.

The techniques described in this disclosure, including those attributed to IMD <NUM> and/or <NUM>, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as physician or patient programmers, stimulators, or other devices. The term "processor" may generally refer to any of the foregoing circuitry, alone or in combination with other circuitry, or any other equivalent circuitry.

Such hardware, software, or firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure.

When implemented in software, the functionality ascribed to the systems, devices and techniques described in this disclosure may be embodied as instructions on a computer-readable medium such as RAM, ROM, NVRAM, SRAM, EEPROM, flash memory, magnetic data storage media, optical data storage media, or the like. The instructions may be executed to support one or more aspects of the functionality described in this disclosure.

Claim 1:
A device comprising:
means (<NUM>) for presenting a plurality of exposure mode programming options supported by an implantable medical device for enabling and disabling an exposure operating mode of the implantable medical device;
means (<NUM>) for receiving input from the user to select one of the plurality of exposure mode programming options; and
means (<NUM>, <NUM>) for transmitting a communication to the implantable medical device that identifies the selected one of the plurality of exposure mode programming options.