US20130110195A1

Movatterモバイル変換

Info

Publication number: US20130110195A1
Application number: US13/722,185
Authority: US
Inventors: Kellie Fletcher; Patrick Hard; Anthony V. Caparso; Karen Tsuei
Original assignee: Autonomic Technologies Inc
Current assignee: Autonomic Technologies Inc
Priority date: 2009-01-15
Filing date: 2012-12-20
Publication date: 2013-05-02
Also published as: US20170072200A1; US20150321018A1; US10286213B2

Abstract

An apparatus (10) for applying stimulation therapy to a patient includes an implantable medical device (20) and a remote controller (50) for inductively powering the medical device and communicating with the medical device. The remote controller (50) includes a feedback portion (220) for helping to establish a communication link between the remote controller and the implantable medical device (20).

Description

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 61/578,415, filed Dec. 21, 2011. This application is also a continuation-in-part of U.S. patent application Ser. No. 12/688,524, filed Jan. 15, 2010, titled “APPROVAL PER USE IMPLANTED NEUROSTIMULATOR,” which claims the benefit of U.S. Provisional Application No. 61/145,003 filed Jan. 15, 2009. This application is also a continuation-in-part of U.S. patent application Ser. No. 12/765,712, filed Apr. 22, 2010, titled “IMPLANTABLE NEUROSTIMULATOR WITH INTEGRAL HERMETIC ELECTRONIC ENCLOSURE, CIRCUIT SUBSTRATE, MONOLYTHIC FEED-THROUGH, LEAD ASSEMBLY AND ANCHORING MECHANISM,” which claims the benefit of U.S. Provisional Application No. 61/171,749 filed Apr. 22, 2009, and U.S. Provisional Application No. 61/177,895 filed May 13, 2009. The full disclosures of these applications are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The invention relates generally to systems, devices, and methods for using an implantable medical device to deliver therapy to a patient. More specifically, according to one aspect of the invention, systems, devices, and methods according to the invention are used to deliver electrical stimulation to a peripheral, central or autonomic neural structure. In one particular aspect, the invention relates to neurostimulator systems, devices, and methods for treating primary headaches, such as migraines, cluster headaches, trigeminal autonomic cephalalgias and/or many other neurological disorders, such as atypical facial pain and/or trigeminal neuralgias.

BACKGROUND OF THE INVENTION

Primary headaches are debilitating ailments that afflict millions of individuals worldwide. The specific pathophysiology of primary headaches is not known. Known causes of headache pain include trauma, vascular defects, autoimmune deficiencies, degenerative conditions, infections, drug and medication-induced causes, inflammation, neoplastic conditions, metabolic-endocrine conditions, iatrogenic conditions, musculoskeletal conditions, and myofacial causes. In many situations, however, even though the underlying cause of the headache may be identified and treated, the headache pain itself may persist.

Recent clinical studies in treatment of headaches have targeted the manipulation of sphenopalatine (pterygopalatine) ganglion (SPG), a large, extra cranial parasympathetic ganglion. A ganglion is a mass of nervous tissue found in some peripheral and autonomic nerves. Ganglia are located on the roots of the spinal nerves and on the roots of the trigeminal nerve. Ganglia are also located on the facial, glossopharyngeal, vagus and vestibulochoclear nerves. The SPG is a complex neural ganglion with multiple connections, including autonomic, sensory, and motor connections. The SPG includes parasympathetic neurons that innervate, in part, the middle cerebral and anterior cerebral blood vessels, the facial blood vessels, and the lacrimal glands.

The maxillary branch of the trigeminal nerve and the nerve of the pterygoid canal (also known as the vidian nerve which is formed by the greater and deep petrosal nerves) send neural projections to the SPG. The fine branches from the maxillary nerve (pterygopalatine nerves) form the sensory component of the SPG. These nerve fibers pass through the SPG and do not synapse. The greater petrosal nerve carries the preganglionic parasympathetic axons from the superior salivary nucleus, located in the Pons, to the SPG. These fibers synapse onto the postganglionic neurons within the SPG. The deep petrosal nerve connects the superior cervical sympathetic ganglion to the SPG and carries postganglionic sympathetic axons that again pass through the SPG without any synapses.

The SPG is located within the pterygopalatine fossa. The pterygopalatine fossa is bounded anteriorly by the maxilla, posteriorly by the medial plate of the pterygoid process and greater wing of the sphenoid process, medially by the palatine bone, and superiorly by the body of the sphenoid process. The lateral border of the pterygopalatine fossa is the pterygomaxillary fissure, which opens to the infratemporal fossa.

Various clinical approaches have been used to modulate the function of the SPG in order to treat headaches, such as cluster headaches or chronic migraines. These approaches vary from lesser or minimally invasive procedures (e.g., transnasal anesthetic blocks) to procedures or greater invasiveness (e.g., surgical ganglionectomy). Other procedures of varying invasiveness include those such as surgical anesthetic injections, ablations, gamma knife procedures, and cryogenic surgery. Although most of these procedures can exhibit some short term efficacy in the order of days to months, the results are usually temporary and the headache pain eventually reoccurs.

SUMMARY OF THE INVENTION

The invention relates to systems, devices, and methods for using an implantable medical device (“IMD”) to deliver therapy to a patient. According to one aspect, the invention relates to an IMD for delivering electrical stimulation to a peripheral, central or autonomic neural structure. In this aspect, the IMD may comprise a neurostimulator for treating primary headaches, such as migraines, cluster headaches, trigeminal autonomic cephalalgias and/or many other neurological disorders, such as atypical facial pain and/or trigeminal neuralgias.

In one embodiment, an IMD and an associated handheld remote controller (“RC”) each may have an operating memory for storing a programmable operating instructions and data, both input and recorded, that govern the operation of each respective device. The IMD and RC each may also include processing hardware, associated with the operating memory, for executing the programmable operating instructions in accordance with the input and recorded data. According to one aspect, the IMD may receive from the RC operating instructions, data, or both operating instructions and data, that at least partially govern the therapies applied via the IMD. The governed therapies may include either or both therapies delivered within a clinical trial and a post-market usage.

The IMD administers therapy in accordance with stimulation parameters stored on the IMD. The stimulation parameters may be programmed into the IMD in a variety of manners. For example, the stimulation parameters may be programmed via a programming system, which can be either local to or remote from the device. Local programming of the IMD can be accomplished, for example, with the patient near a physician's workstation, which can communicate wirelessly with the device (e.g., via Bluetooth, long range induction, etc.) or with the RC acting as an interface or wand to the device. Remote programming of the IMD can be accomplished by establishing communication with the RC via one or more communication networks. For example, a remotely located physician's workstation can communicate with a patient's personal computer via an internet connection, which relays the stimulation parameters to the IMD via the RC acting as an interface.

According to another aspect of the invention, the RC is configured to prompt for and elicit from the patient subjective and objective data, which the patient enters via the RC. The RC records the patient input data, and also records data associated with the treatment applied by the IMD. The data can then be transmitted to the physician's workstation or possibly mobile device such as a PDA, cell phone, tablet, etc., so that the physician can use the data to verify the stimulation parameters for current therapy or to determine control or stimulation parameter adjustments for subsequent therapies or determine if the current stimulation parameters provide effective therapy to the patient.

Accordingly, the present invention relates to an apparatus for applying stimulation therapy to a patient includes an implantable medical device and a remote controller for inductively powering the medical device and communicating with the medical device. The remote controller includes a feedback portion for helping to establish a communication link between the remote controller and the implantable medical device, answering patient subjective and objective data, and other system alerts.

The invention also relates to a method for coupling a remote controller to an implantable medical device. The method includes the steps of positioning the remote controller relative to the medical device. The method also includes the step of adjusting the position of the remote controller relative to the medical device in response to an optimal communication feedback provided by the remote controller. The method includes the further step of maintaining the position of the remote controller in response to a communication maintenance feedback provided by the remote controller.

The invention also relates to an apparatus for applying stimulation therapy to a patient. The apparatus includes an implantable medical device storing at least one of stimulation parameters and therapy settings and a remote controller for inductively powering the medical device. The medical device is adapted to apply stimulation therapy to the patient according to the stimulation parameters and therapy settings.

The invention further relates to a method for applying stimulation therapy to a patient. The method includes the step of implanting an implantable medical device in the patient. The method also includes the step of storing at least one of stimulation parameters and therapy settings on the medical device. The method also includes the step of using a remote controller to inductively power the implanted medical device. The method includes the further step of applying via the implanted medical device stimulation therapy to the patient according to the stimulation parameters and therapy settings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of devices that form a portion of a system for delivering therapy using an implantable medical device, according to the invention;

FIGS. 2A and 2B illustrate a portion of the system implanted in a patient;

FIG. 3 is a schematic block diagram of the system for delivering therapy using an implantable medical device, according to the invention;

FIG. 4 is a schematic block diagram of a portion of the system ofFIG. 3, according to the invention; and

FIGS. 5-7B are functional block diagrams illustrating various steps in a process that can be performed by the medical device ofFIG. 1, according to the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention relates to systems, devices, and methods for imparting a therapy on a patient. More particularly, the invention relates to devices, systems, and methods for applying patient stimulation therapies a patient. According to one aspect of the invention, the devices, systems, and methods of the invention provide for feedback to the patient that helps to improve the effectiveness of the stimulation therapy.

FIG. 1 illustrates by way of example a medical device forming a portion of a system that can be implemented in accordance with the invention. Referring toFIG. 1, according to one aspect of the invention, amedical device10 includes an implantable medical device (“IMD”)20 and a handheld remote controller (“RC”)50 for interfacing with and controlling operation of the IMD. In this description, the term “implantable” is meant to describe that the medical device is configured for in vivo placement in the patient by surgical or other means. In the illustrated embodiment, theIMD20 is shown and described as an implantable neurostimulator. TheIMD20 may, for example, be a neurostimulator of the type shown and described in co-pending U.S. Patent Application Publication No. US 2010/027413 A1, the disclosure of which is hereby incorporated by reference in its entirety.

The neurostimulator embodying theIMD20 illustrated and described herein is an example of just one particular IMD that may be implemented in accordance with the systems, devices, and methods of the invention. Those skilled in the art will appreciate that the systems, devices, and methods of the invention can be applied to implantable stimulators other than the neurostimulator illustrated inFIG. 1 without departing from the spirit of the invention. Those skilled in the art will also appreciate that the systems, devices, and methods of the invention can be applied to IMDs other than stimulators, in general, and other than neurostimulators, more specifically.

TheIMD20 illustrated inFIG. 1 includes astimulator body22, astimulator lead24 including one or morestimulating electrodes26, and an anchoringportion28. TheIMD20 is an inductively powered system having stored programmed stimulation parameters and bi-directional telemetry to facilitate communication between the implanted device and theexternal RC50. Thebody22 comprises an electronics enclosure that can house, for example, an application-specific integrated circuit, various passive components, and an antenna/coil for radio frequency transfer of power and communication. Thelead24 provides an electrical connection between the electronics housed in thebody portion22 and the stimulatingelectrodes26. Each of the one ormore electrodes26 provides a site for electrical stimulation of the target anatomy.

TheIMD20 of the example embodiment ofFIG. 1 is powered inductively by theRC50 and has electronics, micro-electronic components, and integrated circuits necessary to store settings, parameters, and other data. During a therapy session, theIMD20, powered by theRC50, delivers electrical stimulation per the stimulation parameters stored on the IMD. Each of theelectrodes26 is controllable independently, which allows the physician to select which electrodes will serve as anodes and which electrodes will serve as cathodes in any combination. TheIMD20 can apply the stimulation therapy in accordance with the stimulation parameters stored on the IMD. Additionally, theIMD20 can acquire and transmit to theRC50 therapy session data gathered during a therapy session. TheIMD20 includes a non-volatile memory for storing the stimulation parameters and other clinical trial related information.

TheRC50 provides inductive power to theIMD20 and communicates (e.g., via radio frequency) with the IMD. Through this communication, theRC50 can access settings and parameters stored on theIMD20 and also record therapy session data (in real-time or at a predetermined time). For example, in an embodiment used in a clinical trial, theRC50 may record therapy session data in real time while also accessing clinical trial specific data (e.g., trial type, specific questions to be asked, therapy randomization strings, language settings, etc.) in real-time or at some predetermined time before, during, or after the therapy session. In another example, in an embodiment used in a post-market patient usage, theRC50 may record therapy session data in real time while also recording post-market specific data (e.g., specific questions to be asked) in real-time or at some predetermined time before, during, or after the therapy session.

Also, in this description, reference is made to stimulation parameters that may be programmed and/or stored on theIMD20 and accessed and transmitted to/from theRC50. The term “stimulation parameters,” as used herein, is meant to encompass the parameters that define the stimulation therapy applied to the patient by themedical device10. In a clinical trial setting, the stimulation parameters may include parameters for each of several therapy modes or configurations used during the clinical trial. The stimulation parameters include, but are not limited to, the parameters set forth below in Table 1:

TABLE 1

Stimulation Parameters

		Amplitude
		Frequency
		Pulse Width
		Pulse Interval
		Electrode Settings
		Patient Limits
		Amplitude Ramp Rates
		Pulse Width Ramp Rates
		Biphasic or Monophasic Stimulation
		Pulses

Additionally, in this description, reference will be made to therapy settings programmed and/or stored on theIMD20 and accessed and transmitted to/from theRC50. The term “therapy settings,” as used herein, is meant to refer to patient specific settings and data that customize themedical device10 according to patient needs/preferences and physician/clinician requirements. The therapy settings include, but are not limited to, the settings set forth below in Table 2:

TABLE 2

Therapy Settings

		Language Preference
		Screen Brightness, Color, etc.
		Screen Appearance/Fonts
		Text Size
		Patient Preferred Feedback
		Modes
		Volume
		Patient Diary Questions
		Diary Date/Time Schedule
		Patient Diary Entries
		Diary Dates/Times
		Hardware Identification/Ser.
		No.

Additionally, in this description, reference will be made to therapy session data that can be recorded, stored and transmitted by theRC50. The term “therapy session data,” as used herein, is meant to refer to data related to the therapy applied by themedical device10 during a session. The therapy session data includes, but is not limited to, the data set forth below in Table 3:

TABLE 3

Therapy Session Data

		Electrode Impedances
		Electrode Opens/Shorts
		Date/Time of Therapy Start
		Date/Time of Therapy End
		Therapy Session Duration
		Manual Patient Adjustments
		Patient Attempted djustments
		Ramp Times
		Maximum Amplitude
		Actual Amplitudes
		Time at Each Setting
		Patient Diary Entries
		Diary Dates/Times
		Software/Firmware Versions
		Serial Number Data
		Data Integrity Check Data
		IMD Register Values
		Tilt/Fault Data
		Communication Loss Data

Referring toFIG. 1, theRC50 includes abody portion52 and anantenna portion54. Thebody portion52 is ergonomically shaped/contoured and includes a graphical user interface (“GUI”)56 that includes adisplay60 and a user navigation/input controls62. Thedisplay60 may, for example, comprise an LED or LCD display, color or B&W, that displays the status, settings, and other data related to the operation of theRC50. TheRC50

interface

56 may be fully customizable, i.e., the color, brightness, font, text size, sound volume, etc. can be adjusted to suit the patient. The user navigation/input device62 illustrated inFIG. 1 comprises control buttons64 that are located at an ergonomic position on theRC50 so that they can be accessed with either right or left hand while the controller is held in the therapy position. The user navigation/input device62 could, however, comprise alternative devices, such as a touch screen, track ball, touch pad, thumb wheel, etc. The navigation/input device62 may also be customizable in that the buttons and other devices may have functions that are programmable or assignable by the user.

TheRC50 also includes apower button68 and I/O ports in the form of a USB/chargingport70. TheRC50 may include multiple ports and other connectivity features for providing flexibility in communications, data transfer, software/firmware uploading/downloading. Such additional ports may also be used to provide for connectivity and expandability with peripheral devices, such as a Bluetooth or other add-on communications module, or a remote inductive coil device.

TheRC50 includes a power source that includes batteries (disposable or rechargeable) and may also be powered externally via a cable connection (e.g., via AC outlet or USB). Theantenna portion54 includes a coil for inductively powering theIMD20 and for communicating with the IMD. TheRC50 is configured to power and communicate with theIMD20 when theRC50 is brought into a predefined proximity (e.g., within 5 centimeters) of the IMD.

TheRC50 is illustrative of one example controller that may be implemented in accordance with the systems, apparatuses, and methods of the invention. Those skilled in the art will appreciate that certain aspects of the systems, apparatuses, and methods of the invention can be applied to controllers other than theRC50 illustrated inFIG. 1 without departing from the spirit of the invention.

For example,FIG. 4 illustrates one possible internal configuration of theRC50. The configuration illustrated inFIG. 4 is an example configuration that shows certain components that may be employed by theRC50. Those skilled in the art will appreciate that the configuration illustrated inFIG. 4 is but one of many example configurations of components that may be implemented in theRC50. Components may be added, omitted or may be arranged differently than shown inFIG. 4 without departing from the spirit of the invention.

Referring toFIG. 4, theRC50 includes apower supply200 and acontroller logic portion202. Thecontroller logic portion202 includes one or more processors204 (e.g., microprocessors, ASICs, etc.) and a memory portion206 (e.g., non-volatile memory). Thelogic portion202 controls the operation of theRC50 according to programmed instructions and data or other parameters that are programmed onto or retrieved from theIMD20.

TheRC50 also includes a graphical user interface (“GUI”)210, which may comprise the input buttons62,64 anddisplay screen60 described above, along with any associated electronics, such as graphics drivers, input buffers, etc. TheRC50 also includes a power andcommunication antenna212 that, as the name implies, includes the antenna(s) necessary to power theIMD20 and communicate with the IMD.

Thepower supply200 may, for example, comprise a chargeable battery system with conventional AC wall power being available to charge the batteries or power the device directly. Thepower supply200 supplies power to thecontroller logic portion202, theGUI210, and the power/communication antenna212. Thepower supply200 may power these components directly or indirectly via another component.

TheRC50 may also include aremote antenna240, which may be an optional component that can be added as an accessory to the RC. Theremote antenna240 is a power/communication antenna that may be similar or identical to theantenna212. Theremote antenna240 can be connected to theRC50, for example, via a cable that plugs intosocket242. Theremote antenna240 would thus be powered by thepower supply200 of theRC50.

In use, to establish communication between theRC50 and theIMD20, theantenna portion54 of theRC50 needs to be positioned within a certain distance of the IMD (e.g., within 5 centimeters). Additionally, the position of theRC50 and, more particularly, the antenna portion54 (i.e., direction, angle, etc.) can also affect the strength of the communication between theRC50 and theIMD20.

According to the invention, theRC50 also includes afeedback portion220 that provides feedback to the user for establishing and maintaining the communication link between theRC50 andIMD20 when applying stimulation therapy using themedical device10. One particular feature of thefeedback portion220 is that it provides an indication to the patient that theRC50 is in the proper or optimal position relative to the implantedIMD20 for powering and communicating with the IMD. Thefeedback portion220 may have other uses, such as indicating that theRC50 is powered up, that a therapy session has ended, other alerts (for example that more therapy session need to be purchased or approved before using the RC again or contact your doctor) or to alert the patient of an error or loss of communication.

Thefeedback portion220 may incorporate one or more modes for providing feedback to the patient. For example, as shown inFIG. 4, thefeedback portion220 may includevibratory feedback222,visual feedback226,audible feedback230, shape/pressure feedback224,thermal feedback228, andgyroscopic feedback232. The feedback provided by the various feedback modes are perceptible to the patient via one or more senses (e.g., sight, touch, hearing). Each feedback mode has one or more characteristics that change or adjust in response to conditions (e.g., communication signal strength, RC/IMD relative positions, etc.) that are indicated by the feedback. For example, in providing the feedback, the feedback mode characteristic(s) can be changed in response to the amount of data exchanged between theRC50 and theIMD20, which can be associated with the communication signal strength between the RC and the IMD. Additionally, or alternatively, parameters such as receiving antenna coil voltage at theRC50 orIMD20 can be measured, and the RC can adjust the feedback mode characteristic(s) in response to this measurement. Also, the feedback modes can be used in an “alarm clock” or “alert” mode to alert the patient of occurrences, such as software/firmware updates, stimulation parameter/therapy setting updates, diary entries/requirements, scheduled therapy, or even appointments, scheduling, etc. These feedback mode features may be available at any time theRC50 is in communication with the network170, either wired or wirelessly.

Thevibratory feedback222 may comprise a vibration motor that has either a fixed or a variable speed configuration. Thevibratory feedback222 can be throttled in response to the sensed relative position of theRC50 and theIMD20 by adjusting the speed of the vibration motor, e.g., by throttling motor voltage or via pulse width modulation. This throttling results in a corresponding change in the frequency of the vibration that can be sensed by the patient by touch, e.g., with the hand that is holding theRC50 in the position ofFIG. 2B. For example, in providing the vibratory feedback, the speed of the vibration motor can be changed in response to the communication signal strength between theRC50 and theIMD20, which can be determined as a function of the amount of data exchanged between the RC and the IMD, or as a function of the receiving antenna coil voltage of the RC or IMD.

Thevisual feedback226 may comprise one or more light indicators (e.g., LEDs) on theRC50 or a portion of thedisplay screen60. Thevisual feedback226 can be throttled in response to the sensed relative position of theRC50 and theIMD20 by adjusting the intensity of the light indicators, the number of lights illuminated, or via a graphical display on thescreen60. Thevisual feedback226, of course, requires sight by the patient while the RC is held in the patient's hand as shown inFIG. 2B. For example, in providing the visual feedback, LED brightness, LED numbers, and/or a visual display on thescreen60 can be changed in response to the communication signal strength between theRC50 and theIMD20, which can be determined as a function of the amount of data exchanged between the RC and the IMD, or as a function of the receiving antenna coil voltage of the RC or IMD.

Theaudible feedback230 may comprise one or more audible indicators (e.g., speakers) on theRC50. Theaudible feedback230 can be throttled in response to the sensed relative position of theRC50 and theIMD20 by adjusting the volume, tone, pitch, etc. of the audible indicator. Theaudible feedback230 can also incorporate recorded verbal feedback or instructions for achieving the optimal relative positions of theEC50 andIMD20. Theaudible feedback230 does not require sight by the patient while the RC is held in the patient's hand as shown inFIG. 2B. For example, in providing the audible feedback, the volume, tone, pitch, etc. of the audible indicator can be changed in response to the communication signal strength between theRC50 and theIMD20, which can be determined as a function of the amount of data exchanged between the RC and the IMD, or as a function of the receiving antenna coil voltage of the RC or IMD.

The shape/pressure feedback224 may comprise one or more piezoelectric, dielectric, shape memory alloy, or slow actuators that can change or alter their shape. The shape/pressure feedback224 can be throttled, or the position of the pressure/shape change can be moved in response to the sensed relative position of theRC50 and theIMD20. The shape/pressure feedback224 does not require sight by the patient while the RC is held in the patient's hand as shown inFIG. 2B. For example, in providing the shape/pressure feedback, the shape/pressure feedback224 can be adjusted in magnitude or location in response to the communication signal strength between theRC50 and theIMD20, which can be determined as a function of the amount of data exchanged between the RC and the IMD, or as a function of the receiving antenna coil voltage of the RC or IMD.

Thethermal feedback228 may comprise one or more thermoelectric elements, such as peltier elements, that can change temperature. Thethermal feedback228 can be throttled in response to the sensed relative position of theRC50 and theIMD20 by adjusting the applied current/voltage. Thetemperature feedback228 does not require sight by the patient while the RC is held in the patient's hand as shown inFIG. 2B. For example, in providing the thermal feedback, the temperature can be changed in response to the communication signal strength between theRC50 and theIMD20, which can be determined as a function of the amount of data exchanged between the RC and the IMD, or as a function of the receiving antenna coil voltage of the RC or IMD.

Thegyroscopic feedback232 may comprise one or more electronic gyroscopes that can stabilize the position and position of theRC50 once the communication is achieved. Thegyroscopic feedback232 can be used to help maintain the optimal relative positioning between theRC50 andIMD20 once achieved. For example, thegyroscopic feedback232 can be tied to the audible or

visual feedbacks

230,226 and can use them to provide instruction for maintaining the achieved optimal position. While thegyroscopic feedback232 does not require sight by the patient while the RC is held in the patient's hand as shown inFIG. 2B, the other feedbacks used in conjunction may require sight. Thegyroscopic feedback232 could have additional uses. For example, thegyroscopic feedback232 could be used to “memorize” an optimal position relative to theIMD20 and could be used in conjunction with another of the feedback modes (e.g., audible, vibration, visual, etc.) to help guide the user to the optimal communication position.

One of the primary functions of thefeedback portion220 is to provide feedback on the proper positioning of the power/communication antenna212 relative to theIMD20. To do this, each of the feedback modes has one or more characteristics that adjust or change in magnitude in response to the position of theRC50 relative to theIMD20. In addition to this, each of the feedback modes may employ an additional indicator that signals when the optimal positioning of theRC50 andIMD20 are achieved, and when that optimal positioning is lost. The feedback modes may be employed individually or in combination with each other, and may be selectable and configurable to a patient/physician preference.

The primary feedback modes for establishing optimal communication between theRC50 andIMD20 are thevibratory feedback22, thevisual feedback226, and theaudible feedback230. Once the optimal communication feedback is established, the feedback modes can provide feedback indicating whether the optimal communication is maintained and how to position/reposition theRC50 to maintain the optimal communication. This communication maintenance feedback can be provided by any of the feedback modes. The optimal communication feedback and the communication maintenance feedback can be communicated using the same or different feedback modes. For the purpose of providing clarity to the patient, those skilled in the art will appreciate that it may be desirable to use different feedback modes for these functions.

For example, thevibratory feedback222 may be used to provide the optimal communication feedback and theaudible feedback230 may be used to provide the communication maintenance feedback. In this configuration, thevibration feedback222 may increase or decrease in frequency as the relative positions are adjusted, with a higher frequency being indicative of better features that help guide the patient toward the optimal RC position. When the optimal relative positions are achieved, theaudible feedback230 may provide an audible indication. Thereafter, theaudible feedback230 may provide additional audible indication for maintaining the optimal communication position.

As another example, theaudible feedback230 and/or thevisual feedback226 may be used to provide the optimal communication feedback and the communication maintenance feedback. In this configuration, theaudible feedback230 may increase or decrease in tone, volume, frequency, etc. as the relative positions are adjusted, and thevisual feedback226 may increase in intensity, brightness, number of lights as the relative positions are adjusted. When the optimal relative positions are achieved, theaudible feedback230 may provide an audible indication. Thereafter, theaudible feedback230 and/or thevisual feedback226 may provide additional audible indication for maintaining the optimal communication position.

As a further example, any of thevibratory feedback222, theaudible feedback230, and thevisual feedback226 may be used to provide the optimal communication feedback and thegyroscopic feedback232, in combination with theaudible feedback230, may be used to provide the communication maintenance feedback. Once the optimal relative positions are achieved and the optimal communication feedback indication is issued, thegyroscopic feedback230 may store or “memorize” the position or position of theRC50. Thereafter, thegyroscopic feedback230 may, via theaudible feedback230, provide the communication maintenance feedback. In doing so, theaudible feedback230 may be in the form of an audible beep or tone, or even can be voice commands instructing the patient on where to move theRC50.

Additionally, during use of the remote antenna, thefeedback portion220, particularly thevisual feedback226, can become advantageous. This is because theantenna240, being remote from theRC50 allows the patient to clearly view thedisplay screen60 while holding the remote antenna in against the his/her head.

Advantageously, thefeedback portion220 of theRC50 helps guide the patient to the optimal communication position of theRC50 relative to theIMD20. According to the invention, thevibratory feedback222 can be of a particular advantage in the embodiment illustrated inFIGS. 2A and 2B since, in use, theRC50 is held by the patient in a position where visual feedback may be difficult or impossible. Additionally, since the feedback may include both optimal communication feedback and communication maintenance feedback, it is advantageous that theRC50 includes two feedback modes (e.g., vibratory and audible) that can be used to differentiate between the two types of feedback.

Thefeedback portion220 of theRC50 may provide additional enhancements to either or both the optimal communication feedback and communication maintenance feedback. For example, thefeedback portion220 may include surface texturing, vibrations, or thermal feedback that is distributed to different locations on theRC50. These distributed feedback modes can provide direction to the patient on how or in which direction to adjust the position of theRC50 in order to achieve optimal communication. For instance, the feedback modes could be distributed to locations where the patient would normally rest their palms or fingers on theRC50 or, additionally or alternatively, where the RC rests on the patient's face during use. These distributed feedback modes can serve as the optimal communication feedback and/or the communication maintenance feedback in order to help direct the patient to and maintain the optimal communication position.

In operation, theRC50 transfers energy to theIMD20 via near field electromagnetic induction. TheRC50 transmits power signals via the power antenna, located in theantenna portion54, at a specific frequency. TheIMD20 includes a power coil/antenna that is tuned to resonate close to the frequency at which theRC50 transmits the power signal and thereby generates, through induction, power for the IMD.

TheRC50 also communicates with theIMD20 to provide, for example, stimulation parameters, software/firmware upgrades, and other operating instructions and data prior to or subsequent to IMD implantation. TheRC50 may also receive from theIMD20 therapy session data, handshaking communications, and current stimulation parameter settings.

The antenna(s) employed in theantenna portion54 of theRC50 may have various designs. For example, theantenna portion54 may include a first antenna for inductively powering theIMD20 and for transmitting communications to the IMD. Theantenna portion54 may also include a second antenna for receiving communication transmissions from theIMD20.

FIGS. 2A and 2B illustrate, by way of example, an implementation of thesystem10 in which theIMD20 is implanted in a patient in order to treat primary headaches, such as migraines, or other neurological disorders. As illustrated inFIG. 2A, theIMD20 is implantable in a patient'shead30. In this particular implementation, theIMD20 is implanted such that thestimulator body22 is positioned medial to thezygoma32 on the lateral/posterior maxilla34 within the buccal fat pad of the cheek, and theintegral fixation apparatus28 is anchored to the zygomaticomaxillary buttress36, such as by using standard craniomaxillofacial bone screws, for example. Thestimulation lead26 can be placed within the pterygopalatine fossa or, more specifically, in very close proximity to the sphenopalatine (pterygopalatine) ganglion (SPG)ganglion38.

Referring toFIG. 2B, to operate theIMD20, the patient manually positions theRC50 adjacent his/herhead30 so that theantenna portion54 is positioned in the proximity of theIMD20. The patient can manipulate the position of theRC50 in response to the indications provided by thefeedback portion220 to achieve a strong inductive link between the controller and theIMD20.

Once a communication and power link is established via a feedback method, theIMD20 administers the therapy in accordance with the instructions of theRC50 and the stimulation parameters stored on the IMD. During use, the patient may be able to adjust certain stimulation parameters (amplitude, pulse width, frequency, combination thereof, or specific protocols with autonomic preset adjustment in two or more parameters at once) or parameters (ramp time, etc.) via the input device62, e.g., by manipulating the control buttons64. These adjustments are physician/clinician approved & configurable.

TheRC50 andIMD20 are components of a system for applying stimulation therapy to a patient. Referring toFIG. 3, an example of asystem100 in which theRC50 andIMD20 are implemented includes multiple computer platforms, each of which may have a different remote location. These multiple platforms can be networked for communication with each other via a variety of wired (indicated in solid lines) and wireless (indicated in dashed lines) connections. The example system ofFIG. 3 includes the medical device10 (i.e., theIMD20 and the RC50), a physician workstation (“physician WS”)110, a patient personal computer/docking station (“patient PC”)120, and a remote database (“remote DB”)140.

The wireless communication/power connection between theRC50 and theIMD20 is illustrated in dashed lines at102. Thisconnection102 may, for example, employ a medical implant specific communication protocol, such as a medical implant communication system (MICS) protocol. This specialized protocol helps institute a degree of safety and reliability in communications between theRC50 and theIMD20, especially while the IMD is implanted in the patient.

Thephysician WS110, patient PC120 (or cell phone, PDA, etc.), andremote DB140 can be interconnected via a communication network170 that includes wired connections (e.g., a wired internet connection), indicated generally with solid lines and wireless connections (e.g., a WiFi internet connection, a Bluetooth connection, or a GSM/CDMA/LTE mobile network connection), indicated generally with dashed lines. In the embodiment illustrated inFIG. 3, thephysician WS110 is has a wiredconnection116 and awireless connection118 with theremote database140. Thepatient PC120 has a connectedwired connection126 and awireless connection128 with theremote database140. Thephysician WS110 and thepatient PC120 have a wiredconnection146 and awireless connection148 with each other. Thephysician WS110 and the database WS can also communicate with each other via a wired162 or awireless164 connection. Thephysician WS110,patient PC120,remote DB140, anddatabase WS150 can communicate with each other via the network170 using any combination of the wired and wireless network connections.

TheRC50 can be connected to thephysician WS110 via a direct wired connection112 (e.g., via a USB port or docking station), or via a wireless connection114 (e.g., a WiFi connection, a Bluetooth connection, or a GSM/CDMA/LTE mobile network connection). Connected with the physician'sWS110, theRC50 may act in a pass-through mode, allowing the physician to access theIMD20 for programming or data retrieval via the physician WS. TheRC50 may indicate the occurrence of these events via thefeedback portion220. Thefeedback portion220 may alert the patient to other occurrences, such as software updates, required diary entries, stimulation parameter changes, etc.

TheRC50 can also be connected to the patientpersonal computer120 via a direct wired connection122 (e.g., via the USB port or docking station), or via a wireless connection124 (e.g., a WiFi connection, a Bluetooth connection, or a GSM/CDMA/LTE mobile network connection). TheRC50 may indicate this occurrence via thefeedback portion220, for example, by displaying a “PC Control” message on thedisplay screen60. TheRC50 can also communicate with theremote DB140 via the network170. Additionally, theRC50 can be connected directly to theremote DB140 via a wireless connection142 (e.g., a GSM/CDMA/LTE mobile network connection).

From the above, those skilled in the art will appreciate that thesystem100 has a highly selectable configuration, and that the communication between theRC50,physician WS110,patient PC120, andremote DB140 may be configured to occur in various combinations. In this configuration, the network170 allows for the omission of certain portions or components of thesystem100 and also for redundancy in various communication channels through the network.

For example, referring toFIG. 4A, in one communication configuration or mode, theRC50 may communicate with thepatient PC120 viawireless connection124, with thephysician WS110 viawired connection112, and with theremote DB140 via the wireless connection with the patient PC and either the wired126 orwireless128 connection between the patient PC and the remote DB.

In another example communication configuration or mode, referring toFIG. 4B, theRC50 may communicate with thephysician WS110 and with thepatient PC120 via

wired connections

112 and122, respectively, and with theremote DB140 via thewired connection122 and either thewired connection126 orwireless connection128.

In yet another example communication configuration or mode, referring to

FIG. 4C, theRC50 may communicate with thephysician WS110 via thewired connection112 and with theremote DB140 directly via thewireless connection142. In this configuration, the patient PC is not necessary to establish the necessary communication channels.

In a further example communication configuration or mode, referring toFIG. 4D, theRC50 may communicate with thephysician WS110 via thewireless connection114 and with theremote DB140 directly via thewireless connection142. Again, in this configuration, the patient PC is not necessary to establish the necessary communication channels.

Referring toFIG. 3, thesystem100 also includes a database maintenance and reporting workstation (“database WS”)150 that is operatively connected to theremote DB140 and/or thephysician WS110 via wired152 orwireless154 connections. The architecture in which thedatabase WS150 and theremote DB140 are implemented can vary. For example, thedatabase WS150 may comprise a workstation on a local area network, and theremote DB140 may be is stored on a server in that local area network. Alternatively, theremote DB140 may be a cloud-based database that theRC50,patient PC120,physician WS110, anddatabase WS150 access via the internet.

Thesystem100 also includes apatient diary160 in which the patient records data associated with the treatments administered via theIMD20. The data can be in the form of responses to questions asked by the system, and the questions can be either subjective or objective in nature. The questions can be prompted and answered both prior to, during, and/or after the therapy is applied. In this manner, answering the questions may serve as a gate to patient therapy by which therapy is denied until certain diary questions are answered. Post therapy diary questions can be answered immediately after the stimulation therapy is applied or sometime thereafter. The timing and content of the questions asked both pre and post therapy can be physician/clinician selected. Post therapy diary questions can be answered via theRC50 directly or via thepatient PC120. The patient diary can be considered a portion of the therapy/clinical trial settings & data (Table 2).

Thepatient diary160 is illustrated inFIG. 3 as being part of theRC50 because this is where the data included in the diary is entered into thesystem100 by the patient. Thepatient diary160 may reside in a remote location or combination of locations. For example, thepatient diary160, while collected and entered at theRC50, may be accumulated and stored at theremote DB140 or at thephysician WS110. As another alternative, thepatient diary160 may comprise an internet based diary stored on a remote server and accessible via the internet. As a further alternative, thepatient diary160 may comprise a cloud based system in which the diary is accessible via the internet.

Once entered, when theRC50 is operatively connected for communication with the system100 (wired or wirelessly), the data from thepatient diary160 can be transmitted to theremote DB140, to thephysicians WS120, to thepatient PC110, or to a cloud based storage system. Thereafter, the physician can access the data via theworkstation110. Additionally, the patient may also be able to access certain data from thepatient diary160, such as previously answered diary questions, unanswered diary questions or additional questions, via thepatient PC120. In an internet or cloud-based implementation, the patient can access thepatient diary160 online via web access. Thefeedback portion220 may serve to provide feedback or indication (visual, audible, vibratory, etc.) regarding the diary entries. Such indications may, for example, include indications that questions require answering, questions are complete, etc.

The questions queried to the patient for entry in thepatient diary160 can be subjective questions or objective questions. Subjective questions can serve to help describe or categorize the headache episode in terms of symptoms, severity, duration, lasting effects, etc. The data from the subjective questions in the patient diary thus give patient specific details and sensory perceptions that can be used to evaluate and adjust the therapy regimen for that particular patient. Objective questions elicit from the patient factual details not subject to the patients perception, and thus generate data that can collected along with objective data from other patients and used to evaluate efficacy for the group as a whole. The subjective and objective data collected in the patient diary includes, but is not limited to, the data set forth below in Table 4:

TABLE 4

Patient Diary Data

	Subjective Data	Objective Data

	Headache Pain Level	Headache Occurrence
	Sensitivity to Light	Headache Start/End Time
	Sensitivity to Sound	Acute Medication Usage
	Aura Before	Rescue Medication Usage
	Nausea/Vomiting	Medication Start Time
	Throbbing/Pulsating Pain	Foods/Beverages Ingested
		Prior
	Location (Side)—Left/Right/Both	Sleep Pattern
	Activity/Movement Aleve Pain	Location—Work, Home, etc.
	Stress Level	Activity—Reading, Computer,
		etc.
	Tiredness
	Autonomic Symptoms

The questions for obtaining the patient diary data can be queried by theRC50 at specific times or according to a predetermined schedule. For example, when theRC50 is initially powered on, the patient may be prompted via any of the feedback modes to answer questions regarding headache pain levels, location (side) of the headache pain, acute medications taken, sensitivity to light/sound, the presence of nausea or vomiting, and the presence of autonomic symptoms (e.g., red/tearing eyes, blocked nose, eyelid swelling, etc.). When therapy is stopped, the patient may be prompted to answer questions regarding headache pain. At a predetermined time after therapy stops, such as one hour after therapy, the patient may be prompted to answer questions regarding headache pain levels, rescue medications taken, sensitivity to light/sound, the presence of nausea or vomiting, and the presence of autonomic symptoms.

Additionally, the therapy applied by themedical device10 may be controlled or otherwise limited or scheduled according to a therapy cycle of a predetermined duration and which includes predetermined intervals according to which therapy is applied. As an example, a therapy cycle may be a 90 minute cycle during which therapy can be applied only during the first 15 minutes. Additionally, prior to beginning therapy, the therapy cycle may require that the headache diary questions be answered. The example therapy cycle may permit continuous or intermittent use during the initial 15 minutes of the 90 minute cycle, and theRC50 will display the remaining therapy time during the initial 15 minutes of the therapy cycle. Once the 15 minute therapy time expires, no additional therapy is permitted for the remaining 75 minutes of the 90 minute therapy cycle. In applying scheduled therapy, any of the feedback modes can be used to alert the patient.

According to the invention, thesystem100 can facilitate administering stimulation therapy as a part of an ongoing regimen in combating disorders, such as migraine headaches. At the patient level, the physician can program theIMD20 via theworkstation110 to set the, individualized stimulation parameters, the individualized settings for the RC50 (e.g., language, diary questions, screen settings, etc.), and any software/firmware updates that may be necessary. TheRC50 then can upload these items to theIMD20. At home, the patient self-administers, within physician prescribed limits, the stimulation therapy on an as-needed basis, or in accordance with a schedule assigned by a physician/clinician.

Thephysician WS110 is outfitted with software that allows the workstation to communicate with theRC50 when connected thereto via either thewired connection112 or thewireless connection114. Thephysician WS110 also may communicate with theRC50 connected remotely to thepatient PC120, via the

internet connection

146,148. Thephysician WS110, being additionally connected with theremote database140, can also access the remote database as a central repository for information relating to patient data, stimulation settings, therapy settings, manufacturer notices, software/firmware updates, and other bulletins. Through theremote database140, physicians/clinicians may receive stimulation parameters for loading onto anRC50, which can then be downloaded to theIMD20 via theRC50.

Thephysician WS110 can be a PC based system used by the physician to configure theIMDs20 prior to implantation or post implantation. The programmer (physician) can interface with theRC50 wirelessly or through the USB connection. In an embodiment, theRC50 communicates with thephysician WS110 through thewired connection112, and the controller may enter a pass-through mode in which all or some of the controls are disabled, leaving the controller to simply serves as a communication bridge between thephysician WS110 and theIMD20. TheRC50 may also communicate with the physician WS wirelessly via thewireless connection114. Through this communication, the programmer can instruct theRC50 to communicate with theIMD20, transmitting and receiving data via their built-in bi-directional telemetry capabilities. This allows the programming physician to, for example, install or update software/firmware and to set and adjust the stimulation parameters and therapy settings in theIMD20.

Thepatient PC110 can be a PC based system with installed proprietary software that provides for communicating with theRC50 and relaying data to theremote DB140. Thepatient PC110 is not, however, limited to a PC based system. Thesystem100 can be adapted to provide for charging and communicating with theRC50 in a variety of manners. For example, thesystem100 may include a standalone charging/docking station with wireless internet communication capabilities for transmitting data to theremote DB140. In this configuration, a PC is not necessary. As another example, theRC50 could be fitted with a simple AC power cord for charging and short-range wireless communication capabilities (e.g., Bluetooth) for transmitting data to theremote DB140 via an external device, such as a Bluetooth enabled PC or cell phone, or a PDA type device.

Theremote DB140 may be built on any platform that allows information to be stored, read, and updated. For example, the remote database can be an industry standard such as Oracle, Microsoft SQL Server, etc., that permits standard SQL (Structured Query Language) commands and queries to store, access, and manipulate the data contained therein. Theremote DB140 may also be an internet or web based (e.g., cloud based) platform for storing stimulation parameters (Table 1), Therapy Settings (Table 2), Therapy Session Data (Table 3) and patient diary data (Table 4). Theremote DB140 can additionally serve as a central repository for storing and distributing manufacturer notices/bulletins, instruction manuals and other materials, and software/firmware updates. Theremote DB140 can further serve as a central platform for administering a clinical trial. Theremote DB140 can include a table or tables that contain the serial numbers of allIMDs20 that have been implanted in patients, and can also contain the therapy status of those patients.

For example, the database may include all the results of the clinical trial for all patients enrolled in the trial including, but not limited to, the patients' histories, therapy protocol for the patients, therapy efficacy, and treatment regimens for the patients and results to-date. To address privacy concerns, the data stored on theremote DB140 may be blind to the identity of the patients. Theremote DB140 may, however, may store non-identifying clinically relevant patient data, such as height, weight, blood pressure, sex, and age of the clinical trial participants.

According to one aspect of the invention, the stimulation parameters and therapy settings programmed onto theIMD20 can include all of the patient and device specific information necessary to perform the stimulation therapy on the patient. It is not necessary to include any patient or therapy specific data (e.g., stimulation parameters/therapy settings) on theRC50 itself. Due to this, theRC50 is necessary only to inductively power theIMD20. This offers a great advantage in that anyRC50, whether it is the patient's personal unit, a physician's unit, or a replacement unit can be used to apply stimulation therapy via theIMD20 without any pre-programming or set up. TheRC50 may thus be a turn-key unit ready to operate right out of the box.

As another advantage, theRC50 can also perform its querying and recording functions without any preprogramming either. TheRC50 reads the patient diary questions and schedule from theIMD20, administers the diary questions, and records the patient diary data accordingly. TheRC50 also reads and records the therapy session data and clinical trial data in real time during the therapy session. TheRC50 thus additionally initiate and administers the patient diary questions, records the therapy session data, and records the patient diary data without pre-programming any patient or trial specific parameters, settings, or data into the RC.

As a further advantage, storing the stimulation parameters and therapy settings on theIMD20 helps ensure that the therapy will be applied according to the correct patient specific parameters and settings. This also helps ensure that the correct therapy type, patient language, and diary questions are applied/queried to the patient. All of these features advantageously improve the reliability and accuracy of themedical device10 over a device that includes patient specific settings or parameters on the remote unit.

According to one aspect of the invention, thesystem100, and the devices and methods implemented therein, enable a patient to respond to a therapy regimen. The stimulation therapy is applied as an ongoing treatment regimen tailored by the physician to treat the patient's specific medical condition. Thesystem100, themedical device10, and the methods by which the stimulation therapy is applied enable the evaluation of the patient's response by the physician so that the efficacy of that particular patient's treatment regimen can be monitored, adjusted, and improved.

FIG. 5 illustrates a flowchart diagram of aprocess300 by which therapy is applied using themedical device10. Theprocess300 illustrated inFIG. 5 is an example of one process that may be used to apply therapy using themedical device10. Those skilled in the art will appreciate that certain steps in the process may be adjusted, added, omitted, or performed in different order than that illustrated in the figures and described herein without departing from the spirit of the invention. For example, certain steps illustrated and described as being performed in a certain order may be performed simultaneously or in a different order, and certain steps illustrated and described as a single step may comprise multiple steps.

For example, an additional step could be implemented in which the application of therapy described inFIG. 5 may be predicated on gaining approval for using themedical device10 to apply the therapy. Such approval requirements may be similar or identical to those described in U.S. patent application Ser. No. 12/688,524, filed Jan. 15, 2010, titled “APPROVAL PER USE IMPLANTED NEUROSTIMULATOR,” the disclosure of which is hereby incorporated by reference in its entirety. As another example, in an initial use of anRC50 with anIMD20 where the RC has not previously communicated with that particular IMD, the RC may enter an initial mode where the RC prompts the patient (via any of the feedback modes) with an initial set of predetermined diary questions (e.g., a subset of those set forth in Table 4). Thereafter, theRC50 will use the patient/clinical trial appropriate questions programmed on theIMD20.

Referring toFIG. 5, when a patient senses the onset of an event, such as a migraine headache, the patient activates theRC50, atstep302. Theprocess300 then proceeds to step304, where the patient couples theRC50 to theIMD30. During couplingstep304, theRC50 may provide feedback—audible, tactile, or both, that assists the patient in achieving the proper positioning of theRC50 relative to theIMD30. Once theRC50 andIMD30 are coupled, theprocess300 proceeds to step306, where the RC can retrieve stimulation parameters (Table 1) or therapy settings (Table 2). For example, atstep306, theRC50 may retrieve patient diary questions to query the patient.

Theprocess300 then proceeds to step310, where theRC50 prompts, via any of the feedback modes, the patient for answers to any pre-treatment questions. These questions can be designed to elicit from the patient the patient diary data set forth in Table 4. Thisstep310 may be optional, as it is conditioned on whether the supervising physician/clinician has opted to require pre-treatment questions as a gateway to therapy. Theprocess300 then proceeds to step312, where the patient initiates and conducts the therapy session. During the therapy session, if permitted by the supervising physician/clinician, the patient can adjust any adjustable parameters within the physician defined limits. The therapy session ends at step314 due to either expiration of a timeout period or due to cessation by the patient.

Theprocess300 proceeds to step320, where theRC50 records the therapy session data (Table 3) and/or any necessary therapy settings (Table 2). Theprocess300 then proceeds to step322, where theRC50 prompts the patient for answers to any post-treatment questions, if the prompting for answers to such questions is enabled by the supervising physician/clinician. Atstep342, theIMD30 records the therapy session data. Theprocess300 proceeds to step324, where theRC50 transmits the recorded data, if this function is enabled. Alternatively, the recorded data may be stored until such a time that transmission of the data is convenient to the patient.

When theRC50 transmits the recorded data to the remote database, the remote database updates its records and analyzes the data. The database can be utilized to compare the data to pre-programmed data and determines whether an appropriate party, e.g., the patient's physician or an administrator of the clinical trial, should be contacted. If so, the party is contacted and can take the appropriate action, as needed.

Referring toFIG. 6, according to the invention, thestep304 of coupling theRC50 to theIMD20 includes theinitial step330 of positioning theRC50 relative to theIMD20. In this step, the patient initially moves theRC50 toward the position illustrated inFIG. 2B. Alternatively, the patient could bring theremote antenna coil240 into the same or similar position. Atstep332, the patient adjusts the position of the RC50 (or remote coil240) in response to the optimal communication feedback. As discussed above, the optimal communication feedback may comprise any of the various feedback modes of thefeedback portion220, alone or in combination. Atstep334, the patient maintains the position of theRC50 relative to theIMD20 in response to the communication maintenance feedback. The communication maintenance feedback may comprise any of the various feedback modes of thefeedback portion220, alone or in combination.

Referring toFIG. 7A, according to the invention, the

steps

306,312 include theinitial step340 of storing the stimulation parameters and therapy settings on theIMD20. This can be done, as discussed above, via thephysician WS110. Atstep342, theRC50 provides inductive power to theIMD20. Atstep344, theIMD20 applies stimulation therapy to the patient according to the stimulation parameters and therapy settings.

Advantageously, according tostep340, the stimulation parameters and therapy settings programmed onto theIMD20 can include all of the patient and device specific information necessary to perform the stimulation therapy on the patient. TheRC50 does not require any patient or therapy specific data and is required only to inductively power theIMD20.

Referring toFIG. 7B, according to the invention, thestep310 includes thestep350 that theRC50 retrieves questions from theIMD20. Atstep352, theRC50 prompts the patient to answer the questions retrieved from theIMD20. Advantageously, theRC50 can thus perform its querying and recording functions without any patient specific preprogramming. TheRC50 reads the patient diary questions and schedule from theIMD20, administers the diary questions, and records the patient diary data accordingly.

The processes illustrated inFIGS. 6,7A, and7B therefore offer the advantage in that as a further advantage, storing the stimulation parameters and therapy settings on theIMD20 helps ensure that the therapy will be applied according to the correct patient specific parameters and settings. This also helps ensure that the correct therapy type, patient language, and diary questions are applied/queried to the patient. All of these features advantageously improve the reliability and accuracy of themedical device10 over a device that includes patient specific settings or parameters on the remote unit.

From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims.