Patent Application
20080183246
1. Field of the Invention
This invention relates generally to implantable medical device systems and, more particularly, a guided procedure function to an interactive forum for providing a navigated set of displays for implanting an implantable medical device (IMD) and/or performing a patient care management action during a follow-up visit to a physician to adjust parameter data for treating one or more disorders using an IMD.
2. Description of the Related Art
Many advancements have been made in treating diseases such as epilepsy. Therapies using electrical signals for treating these diseases have been found to effective. Implantable medical devices have been effectively used to deliver therapeutic stimulation to various portions of the human body (e.g., the vagus nerve) for treating these diseases. As used herein, “stimulation” or “stimulation signal” refers to the application of an electrical, mechanical, magnetic, electromagnetic, photonic, audio and/or chemical signal to a neural structure in the patient's body. The signal is an exogenous signal that is distinct from the endogenous electrical, mechanical, and chemical activity (e.g., afferent and/or efferent electrical action potentials) generated by the patient's body and environment. In other words, the stimulation signal (whether electrical, mechanical, magnetic, electromagnetic, photonic, audio or chemical in nature) applied to the nerve in the present invention is a signal applied from an artificial source, e.g., a neurostimulator.
A “therapeutic signal” refers to a stimulation signal delivered to a patient's body with the intent of treating a disorder by providing a modulating effect to neural tissue. The effect of a stimulation signal on neuronal activity is termed “modulation”; however, for simplicity, the terms “stimulating” and “modulating”, and variants thereof, are sometimes used interchangeably herein. In general, however, the delivery of an exogenous signal itself refers to “stimulation” of the neural structure, while the effects of that signal, if any, on the electrical activity of the neural structure are properly referred to as “modulation.” The modulating effect of the stimulation signal upon the neural tissue may be excitatory or inhibitory, and may potentiate acute and/or long-term changes in neuronal activity. For example, the “modulating” effect of the stimulation signal to the neural tissue may comprise one more of the following effects: (a) initiation of an action potential (afferent and/or efferent action potentials); (b) inhibition or blocking of the conduction of action potentials, whether endogenous or exogenously induced, including hyperpolarizing and/or collision blocking, (c) affecting changes in neurotransmitter/neuromodulator release or uptake, and (d) changes in neuro-plasticity or neurogenesis of brain tissue.
Electrical neurostimulation may be provided by implanting an electrical device underneath the skin of a patient and delivering an electrical signal to a nerve such as a cranial nerve. In one embodiment, the electrical neurostimulation involves sensing or detecting a body parameter, with the electrical signal being delivered in response to the sensed body parameter. This type of stimulation is generally referred to as “active,” “feedback,” or “triggered” stimulation. In another embodiment, the system may operate without sensing or detecting a body parameter once the patient has been diagnosed with a medical condition that may be treated by neurostimulation. In this case, the system may apply a series of electrical pulses to the nerve (e.g., a cranial nerve such as a vagus nerve) periodically, intermittently, or continuously throughout the day, or over another predetermined time interval. This type of stimulation is generally referred to as “passive,” “non-feedback,” or “prophylactic,” stimulation. The electrical signal may be applied by an IMD that is implanted within the patient's body. In another alternative embodiment, the signal may be generated by an external pulse generator outside the patient's body, coupled by an RF or wireless link to an implanted electrode.
Generally, neurostimulation signals that perform neuromodulation are delivered by the IMD via one or more leads. The leads generally terminate at their distal ends in one or more electrodes, and the electrodes, in turn, are electrically coupled to tissue in the patient's body. For example, a number of electrodes may be attached to various points of a nerve or other tissue inside a human body for delivery of a neurostimulation signal.
During a surgical operation to implant an IMD into a patient's body, various steps are performed to insure proper operation of the IMD throughout the implant surgery. Generally, these steps are performed as part of a manual list of tasks that have been developed to ensure proper functionality of the IMD. In some cases, a trouble-shooting, step-by-step guide may be consulted as part of the manual process of implanting and verifying proper operation of the IMD. When improper operation is detected, a further series of manual steps may be taken to correct any malfunction. One of the problems associated with the state-of-the-art methodology of implanting medical devices is that the series of manual steps may be excessively time consuming. For example, when improper operation of the device is detected during implantation of a medical device, various manual checks may be performed to correct any problems. Because these manual tasks may take considerable time to perform, the surgical implant procedure may require additional operating room time.
When employing state-of-the-art methodology of implanting medical devices using the manual system, some errors may be inadvertently overlooked. For example, some communication errors may not be recognized by a medical professional during the installation process. Further, interpretive errors may exist as a result of the manual process involving state-of-the-art implantation of medical devices. For example, if a communication error is detected, an incorrect step of checking the pin connections between a lead and the IMD may be performed, which may not shed light on the detected problem. Other interpretive errors may also be encountered using the state-of-the-art implantation devices. In addition, the surgeon may inadvertently omit one or more verification or troubleshooting steps in the surgical process.
State-of-the-art implantable medical systems utilize an external device (ED) to communicate with the IMD for programming the therapeutical electrical signal to be delivered by the implanted device, performing diagnostics and making adjustments to one or more parameters defining the therapeutic electrical signal. A physician may assess the progress of a particular therapy regimen given to a patient during office visits following surgical implant. The physician may examine the patient and make a determination as to the efficacy of the therapy being delivered and may use the ED to reprogram or adjust various stimulation parameters that will modify subsequent therapy delivered to the patient.
There are various problems associated with state-of-the-art implanted neurostimulators. For example, tedious record-keeping and study of charts are required to perform therapy management to treat patients. When the physician evaluates a patient, various settings for therapy delivered by the IMD are documented in the patient's chart at each visit. At subsequent visits, the physician may then examine previous entries into the chart (e.g., the physician may study the various parameters defining the therapeutic electrical signal, medications taken by the patient, etc.) to make adjustments to the therapy delivered by the IMD. The process of documenting the changes in the parameters, medication, and patient evaluation may become quite laborious, as well as time-consuming, with a corresponding risk that important information may not be collected or may not be incorporated into the adjustments made to the therapy to improve or maintain efficacy.
Further, during a follow-up visit with a medical professional, access to a patient's IMD may not be performed efficiently due to a lack of knowledge of the IMD's capabilities and/or due to a failure to collect data available from the IMD. State-of-the-art methods involve a medical professional manually checking various performance data relating to the IMD and making certain observations based upon the data thus obtained. However, the medical professional may not be aware of the various recommended steps and tests that may be performed to gain a more in-depth analysis of the performance of the IMD.
The present invention is directed to overcoming, or at least reducing, the effects of one or more of the problems set forth above.
In one aspect, the present invention provides a method for guiding a medical procedure relating to an implantable medical device (IMD) operatively coupled to a cranial nerve. Communications between the IMD and an external device (ED) are established. An implant procedure is performed for implanting the IMD. A first diagnostic process of the IMD is performed. Using the ED, a first signal is received from the IMD based on the first diagnostic process. A first instruction is displayed using the ED based upon the first signal received by the ED. The first instruction includes information relating to guiding the implant procedure.
In another aspect, the present invention provides a method for guiding a medical procedure relating to an IMD operatively coupled to a cranial nerve. Communications between the IMD and an ED is established. A diagnostic process is performed on the IMD. The ED receives a first signal from the IMD as a result of the diagnostic process. At least one selectable option is displayed using the ED based upon the signal received by the ED. The selectable option relates to an operational setting of the IMD.
In another aspect, the present invention provides a method for guiding a medical procedure relating to an IMD operatively coupled to a cranial nerve. Communications between the IMD and an ED is established. A first signal is transmitted from the ED to the IMD. Using the ED, a second signal is received from the IMD responsive to the first signal. A recommendation is determined using the ED, in response to the second signal. A display indicative of the recommendation is generated using the ED.
In another aspect, a graphical user interface (GUI) integrated into an ED is provided for guiding an operation relating to an IMD coupled to a cranial nerve. The GUI includes a display region adapted to display a visual indication of a graphical representation, confirming the establishment of communications between the IMD and the ED. The ED transmits a first signal to the IMD. The ED also receives a second signal from the IMD responsive to the first signal. Additionally, the ED determines a recommendation in response to the second signal. The display region also provides a display indicative of the recommendation.
In yet another aspect of the present invention, a system is provided for guiding an operation of an IMD operatively coupled to a cranial nerve. The system of the present invention includes an IMD capable of providing an electrical signal for treating a disease. The system also includes an external computing device (ECD) capable of communicating with the IMD. The ECD is capable of establishing communications with the IMD and transmitting a first signal from the ECD to the IMD. The ECD is also capable of receiving a second signal from the IMD responsive to the first signal, determining a recommendation in response to the second signal, and generating a display indicative of the recommendation using the ECD.
In yet another aspect of the present invention, a computer readable program storage device encoded with instructions is provided for guiding an operation of an IMD operatively coupled to a cranial nerve. The computer readable program storage device is encoded with instructions that, when executed by a computer, performs a method, which comprises: establishing communications between the IMD and an ED; performing a diagnostic process on the IMD; receiving with the ED a first signal from the IMD as a result of the diagnostic process; and displaying at least one selectable option using the ED based upon the signal received by the ED. The selectable option relates to an operational setting of the IMD.
The invention may be understood by reference to the following description taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and in which:
Illustrative embodiments of the invention are described herein. In the interest of clarity, not all features of an actual implementation are described in this specification. In the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the design-specific goals, which will vary from one implementation to another. It will be appreciated that such a development effort, while possibly complex and time-consuming, would nevertheless be a routine undertaking for persons of ordinary skill in the art having the benefit of this disclosure.
This document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms “including” and “includes” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to.” Also, the term “couple” or “couples” is intended to mean either a direct or an indirect electrical connection. “Direct contact,” “direct attachment,” or providing a “direct coupling” indicates that a surface of a first element contacts the surface of a second element with no substantial attenuating medium there between. The presence of substances, such as bodily fluids, that do not substantially attenuate electrical connections does not vitiate direct contact. The word “or” is used in the inclusive sense (i.e., “and/or”) unless a specific use to the contrary is explicitly stated.
The term “electrode” or “electrodes” described herein may refer to one or more stimulation electrodes (i.e., electrodes for delivering an electrical signal generated by an IMD to a tissue), sensing electrodes (i.e., electrodes for sensing a physiological indication of a patient's body), and/or electrodes that are capable of delivering a stimulation signal, as well as performing a sensing function.
Cranial nerve stimulation has been proposed to treat a number of disorders pertaining to or mediated by one or more structures of the nervous system of the body, including epilepsy and other movement disorders, depression, anxiety disorders and other neuropsychiatric disorders, dementia, head trauma, coma, migraine headache, obesity, eating disorders, sleep disorders, cardiac disorders (such as congestive heart failure and atrial fibrillation), hypertension, endocrine disorders (such as diabetes and hypoglycemia), and pain, among others. See, e.g., U.S. Pats. Nos. 4,867,164; 5,299,569; 5,269,303; 5,571,150; 5,215,086; 5,188,104; 5,263,480; 6,587,719; 6,609,025; 5,335,657; 6,622,041; 5,916,239; 5,707,400; 5,231,988; and 5,330,515. Despite the numerous disorders for which cranial nerve stimulation has been proposed or suggested as a treatment option, the fact that detailed neural pathways for many (if not all) cranial nerves remain relatively unknown, makes predictions of efficacy for any given disorder difficult or impossible. Moreover, even if such pathways were known, the precise stimulation parameters that would modulate particular pathways relevant to a particular disorder generally cannot be predicted.
Despite the difficulties of predicting efficacy for particular disorders, the use of vagus nerve stimulation as a therapy for treating epilepsy and/or depression is an established therapy option. Although many patients respond well to the therapy, a significant number of patients require periodic follow-up visits to have the therapeutic electrical signal adjusted periodically to cause and/or maintain a positive therapeutic response. Further, implanting the IMD into a patient's body may be a time-consuming process that involves precise steps for trouble-shooting to ensure proper installation of the IMD. The present invention provides guided procedure functions for guiding a user during a surgical operation for implanting an IMD into a patient's body and/or for performing a guided process during a post-implant follow-up visit to a physician's office to verify or improve the efficacy of the stimulation provided by the IMD. The guided procedure function of the present invention may refer to a series of interactions between an IMD, an ED (e.g., a computer, a hand-held device, etc.) communicatively coupled to the IMD, and a user (e.g., a medical professional). Guided procedure function may refer to various recommendations made to the user, via a display (e.g., a graphical user interface display) that is connected to the ED. The ED may communicate with the IMD, and based upon this communication, the ED may provide a series of recommended or suggested steps/procedures to the user based upon inputs from the IMD and/or the user. The guided procedure function may guide a medical professional through procedures, such as a surgical procedure for implanting a medical device, a follow-up visit to evaluate the efficacy of the therapy and other operating parameters relating to the IMD, and/or implementing changes to the operation of the IMD by adjusting one or more operating parameters.
The implantable medical system of the present invention provides for software module(s) that are capable of acquiring, storing, and processing various forms of data, such as patient data/parameters (e.g., physiological data, side-effects data, such as effects on heart rate and breathing, brain-activity parameters, disease progression or regression data, self-evaluation data, seizure characteristic data, quality of life data, etc.) and therapy parameter data. The guided procedure function of embodiments of the present invention provides for various tasks, such as guiding a surgical implantation procedure, guiding a follow-up evaluation process, guiding the adjustment of various therapy parameters, etc. Therapy parameters may include, but are not limited to, electrical signal parameters that define the therapeutic electrical signals delivered by the IMD, medication parameters (e.g., dosages, frequency of medication provided to the patient, etc.) and/or any other therapeutic treatment parameter. In an alternative embodiment, the term “therapy parameters” may refer to electrical signal parameters defining the therapeutic electrical signals delivered by the IMD. Therapy parameters for a therapeutic electrical signal may also include, but are not limited to, a current amplitude, a voltage amplitude, a rate of change of said current amplitude, a rate of change of said voltage amplitude, a time period of a rate of change of said current amplitude, a time period of a rate of change of said voltage amplitude, a pulse width, a rate of change of the pulse width, a time period of a rate of change of the pulse width, a frequency, a rate of change of the frequency, a time period of a rate of change of the frequency, a signal on-time, a signal off-time, and/or a duty cycle.
In one embodiment, the guided procedure function of the present invention also provides for a plurality of graphical user interfaces (GUI) that may be interactive. The GUIs of the guided procedure function may facilitate the entry of various physicians' inputs, such as the selection of a mode of operation for a guided procedure. Once a certain mode, such as a surgical implant mode, a follow-up visit mode, a user preferences mode, etc., is initiated by a user (e.g., a physician, a nurse, or a medical technician), the guided procedure function may provide, for example, an interactive interface to perform trouble-shooting and installation procedures during a surgical implant process, or to perform adjustments to the operations of the IMD during a follow-up office visit and/or adjust various operation parameters of the IMD.
Embodiments of the present invention provide for a method, apparatus and system for providing communications with an IMD using an ED. The embodiments of the present invention provide for communications between the ED and the IMD to provide guided installation instructions during a pre-operation, operation and/or a post-operation procedure relating to implantation of the IMD. Further, embodiments of the present invention provide for an instructional or navigated set of screens for providing instructions on performing various post-surgical follow-up interactions with the IMD. These interactions may include various tasks, such as inquiry of IMD performance data, programming of various operational parameters, i.e., details regarding the type of stimulation data and the frequency of stimulation delivery, etc.
Embodiments of the present invention provide for a navigated set of instructional screens on an ED that may be useful during pre-operation, operation and post-operation procedures for implanting an IMD in a patient's body. For example, during implant, various problems, such as communications errors between the external device and the IMD, may exist. Various trouble-shooting instructional text, graphics, animation, etc., may be provided via the ED to inform the surgeon how to resolve the various implant problems as they occur. For example, if communication between the ED and the IMD occurs during implantation of the IMD into a patient's body, various trouble-shooting steps may be automatically provided by the ED in embodiments of the present invention. This may include instructions, such as repositioning the hand-held device or the wand (a communication device typically coupled to the ED for placing externally over the patient's skin in close proximity to the implanted IMD, to establish and permit communications between the ED and the IMD) for better communication; changing or charging the batteries associated with the ED; adjusting the depth of the position of the IMD, etc. The term “wand” may in alternative embodiments refer to a hand-held device that is capable of performing the various computational processes described herein. The term “wand” may also refer to a device that is an extension of a data interface device that is coupled operatively to a stand-alone computer device and/or a hand-held device. In embodiments of the present invention, the wand (where present) is considered to be part of the ED system for communicating with the IMD. In one embodiment, the wand may be the entire ED. In an alternative embodiment, the wand may be a portion of an ED.
Various instructions to assist in the step-by-step procedure of implantation of the IMD may be provided by the ED. For example, the ED may instruct a medical professional (e.g., a physician) to perform a lead impedance test. The result of the lead impedance test may be detection of a high lead impedance in the operating room (during the implantation process). The implant procedure may include a pre-operation phase, an operation phase, and a post-operation phase. Various tasks or steps may be suggested by the ED during the implantation process. A high lead impedance during an installation process may be caused by various factors, such as the lead being improperly interfaced with a target nerve in the patient's body, one or more electrodes being improperly interfaced with a target nerve, a lead pin associated with the lead being improperly inserted into the IMD, a break in the lead, etc.
In response to the detection of a high lead impedance during an implant procedure, the ED of the embodiments of the present invention may provide various instructions or recommendations to the surgeon, such as pulling the pin out of the IMD, checking inside the header of the IMD to insure that the set screw associated with the header is not obstructing the lead insertion, and/or other troubleshooting steps. For example, if in response to a recommendation to check the set screw inside the header of the IMD, the surgeon observes that the set screw inside the header of an IMD is, indeed, obstructing the lead insertion, the ED may then provide instructions to back-up the setscrew(s), fully insert the lead and tighten the set screw in the header. In some cases, different or additional instructions such as disconnecting the lead from the IMD and using a test resistor to check the lead impedance may be provided in order to ensure that the IMD itself is not causing such a problem. These various actions and proposed solutions may be automatically provided by the ED through interactive prompts displayed to, and responses provided by, the surgeon. This may reduce interpretive errors and the possibility of overlooking various errors since they may be automatically flagged utilizing embodiments of the present invention. Various methods may be used to convey instructions to a medical professional, such as a series of instructive screens providing text and/or graphics to prompt a sequence of steps to be performed by a user. In this manner, a navigated set of screens may be useful for problem-solving/trouble-shooting during a surgical implant procedure, as well as for a guided follow-up procedure during, e.g., a post-implant office visit.
The guided follow-up procedure may involve a post-operation visit to a medical professional at various pre-determined and/or random intervals to check the operation of the IMD. Various instructional guidance screens may be provided by the external device to prompt a user to perform various tests and/or adjustments of parameters associated with the operation of the IMD. The guided navigated set of screens provided by the embodiments of the present invention for pre-operation, post-operation, and/or follow-up visits are described in further details in various drawings and the accompanying descriptions below.
Although not so limited, a system capable of implementing embodiments of the present invention is described below.
A nerve electrode assembly 125, preferably comprising a plurality of electrodes having at least an electrode pair, is conductively connected to the distal end of the lead assembly 122, which preferably comprises a plurality of lead wires (one wire for each electrode). Each electrode in the electrode assembly 125 may operate independently or alternatively, may operate in conjunction with the other electrodes.
Lead assembly 122 is attached at its proximal end to connectors on the header 116 of generator 110. The electrode assembly 125 may be surgically coupled to a vagus nerve 127 in the patient's neck or at another location, e.g., near the patient's diaphragm or at the esophagus/stomach junction. Other (or additional) cranial nerves such as the trigeminal and/or glossopharyngeal nerves may also be used to deliver the electrical signal in particular alternative embodiments. In one embodiment, the electrode assembly 125 comprises a bipolar stimulating electrode pair 126, 128. Suitable electrode assemblies are available from Cyberonics, Inc., Houston, Tex., USA as the Model 302 electrode assembly. However, persons of skill in the art will appreciate that many electrode designs could be used in the present invention. In one embodiment, the two electrodes are wrapped about the vagus nerve, and the electrode assembly 125 may be secured to the nerve 127 by a spiral anchoring tether 130 such as that disclosed in U.S. Pat. No. 4,979,511 issued Dec. 25, 1990 to Reese S. Terry, Jr. and assigned to the same assignee as the instant application. Lead assembly 122 is secured, while retaining the ability to flex with movement of the chest and neck, by a suture connection to nearby tissue (not shown).
In alternative embodiments, the electrode assembly 125 may comprise temperature sensing elements and/or heart rate sensor elements. Other sensors for other body parameters may also be employed to trigger active stimulation. Both passive and active stimulation may be combined or delivered by a single IMD according to the present invention. Either or both modes may be appropriate to treat a specific patient under observation.
The electrical pulse generator 110 may be programmed with an ED such as computer 150 using programming software based on the description herein. A programming wand 155 may be coupled to the computer 150 as part of the ED to facilitate radio frequency (RF) communication between the computer 150 and the pulse generator 110. The programming wand 155 and computer 150 permit non-invasive communication with the generator 110 after the latter is implanted. In systems where the computer 150 uses one or more channels in the Medical Implant Communications Service (MICS) bandwidths, the programming wand 155 may be omitted to permit more convenient communication directly between the computer 150 and the pulse generator 110.
Turning now to
The controller 210 may comprise various components, such as a processor 215, a memory 217, etc. The processor 215 may comprise one or more microcontrollers, microprocessors, etc., capable of performing various executions of software components. The memory 217 may comprise various memory portions where a number of types of data (e.g., internal data, external data instructions, software codes, status data, diagnostic data, etc.) may be stored. The memory 217 may comprise one or more of random access memory (RAM) dynamic random access memory (DRAM), electrically erasable programmable read-only memory (EEPROM), flash memory, etc.
The IMD 200 may also comprise a stimulation unit 220 capable of generating and delivering electrical signals to one or more electrodes via leads. A lead assembly such as lead assembly 122 (
The IMD 200 may also comprise a power supply 230. The power supply 230 may comprise a battery, voltage regulators, capacitors, etc., to provide power for the operation of the IMD 200, including delivering the therapeutic electrical signal. The power supply 230 comprises a power source that in some embodiments may be rechargeable. In other embodiments, a non-rechargeable power source may be used. The power supply 230 provides power for the operation of the IMD 200, including electronic operations and the electrical signal generation and delivery functions. The power supply 230 may comprise a lithium/thionyl chloride cell or a lithium/carbon monofluoride (LiCFx) cell. Other battery types known in the art of implantable medical devices may also be used.
The IMD 200 may also comprise a communication unit 260 capable of facilitating communications between the IMD 200 and various devices. In particular, the communication unit 260 is capable of providing transmission and reception of electronic signals to and from an external unit 270, such as computer 150 and wand 155 that may comprise an ED (
The IMD 200 also comprises a detection unit 295 that is capable of detecting various patient parameters. For example, the detection unit 295 may comprise hardware, software, or firmware that is capable of obtaining and/or analyzing data relating to one or more body parameters of the patient relevant to the patient's disorder, (e.g., epilepsy or depression.) Based upon the data obtained by the detection unit 295, the IMD 200 may deliver the electrical signal to a portion of the vagus nerve to treat epilepsy, depression or other disorders. In one embodiment, the detection unit 295 may be capable of detecting a feedback response from the patient. The feedback response may include a magnetic signal input, a tap input, a wireless data input to the IMD 200, etc. The feedback may be indicative of a pain and/or noxious threshold, wherein the threshold may be the limit of tolerance of discomfort for a particular patient. The term “patient parameters” may refer to, but is not limited to, various body parameters, which may in some embodiments involve sensors coupled to the IMD 200.
The IMD 200 may also comprise a diagnostic unit 290. The diagnostic unit 290 may provide for performing various diagnostics, such as lead impedance tests, tests associated with the stimulation signals, system diagnostic tests, etc., which are described in further detail below. Upon receiving instructions from the external unit 270, the IMD 200 may perform various diagnostics tests as directed by the diagnostics unit 290 and the controller 210. In one embodiment, examples of the lead impedance test may include verifying the impedance of the lead to determine whether there is a problem in the electrical path defined by the path from the IMD 200, through the leads, through the electrodes, and onto the portion of the patient's body targeted for stimulation. Further tests performed by the diagnostic unit 290 may include verifying automatic capture of various patient data, verifying proper reception of data via sensing electrodes, verifying nerve activity, verifying the integrity and characteristics of stimulation signals, verifying whether particular portions of a nerve (e.g., the A-fiber, the B-fibers and/or the C-fiber) are being adequately targeted. This determination may be made by examining the data detected by one or more sensors, (e.g., a sensor electrode in communication with the IMD 200).
The external unit 270 may be an ED that is capable of programming various modules and electrical signal parameters of the IMD 200. In one embodiment, the external unit 270 is a computer system capable of executing a data-acquisition program. The external unit 270 may be controlled by a healthcare provider, such as a physician, at a base station in, for example, a doctor's office. In alternative embodiments, the external unit 270 may be controlled by a patient in a system providing less control over the operation of the IMD 200 than another external unit 270 controlled by a healthcare provider. Whether controlled by the patient or by a healthcare provider, the external unit 270 may be a computer, preferably a handheld computer or PDA, but may alternatively comprise any other device that is capable of electronic communications and programming, e.g., hand-held computer system, a PC computer system, a laptop computer system, a server, a personal digital assistant (PDA), an Apple-based computer system, etc. The external unit 270 may download various parameters and program software into the IMD 200 for programming the operation of the IMD, and may also receive and upload various status conditions and other data from the IMD 200. Communications between the external unit 270 and the communication unit 260 in the IMD 200 may occur via a wireless or other type of communication, represented generally by line 277 in
The external unit 270 may comprise a procedure guidance unit 275. The procedure guidance unit 275 is capable of performing various instruction generating processes described herein. The procedure guidance unit 275 is capable of acquiring, storing and/or processing data relating to pre-operation, operating room, post-operation and follow-up office visits for prompting a medical professional to perform various tasks. The procedure guidance unit 275 is capable of providing guidance to a medical professional to perform various tests and/or trouble-shooting steps during pre-operation and operation/implantation of the IMD 200. Further, various information resulting from the analysis performed by the procedure guidance unit 275 may be provided in a text or in a graphical format. Display of the overall data relating to the analysis performed by the procedure guidance unit 275 may be provided to a user to prompt the user to perform various tasks. Based upon performance or non-performance of the task by the user, further analysis and instructions may be provided to the user. This cycle of instructions may be provided until the proper conclusion of the procedure, (i.e., implantation, or follow-up analysis of the operation of the IMD 200 is performed). In other words, the procedure guidance unit 275 is capable of generating data for displaying a series of navigational displays for guiding an operation relating to the IMD 200. A more detailed description of the procedure guidance unit 275 is provided in
In one embodiment, the external unit 270 comprises a graphical user interface (GUI) unit 240. It will be appreciated that the GUI unit 240 may also be a separate unit from the external unit 270. Regardless of whether the GUI unit 240 is part of, or separate from, the external unit 270, the external unit 270 is capable of driving various displays on the GUI unit 240. In one embodiment, the GUI unit 240 is capable not only of receiving data from the external unit 270 for driving one or more displays, but also of receiving inputs from a user, such as a physician or patient, and transmitting the data to the procedure guidance unit 275. The GUI unit 240 may be comprised of a variety of devices, including, but not limited to, a computer terminal, a cathode ray tube (CRT) device, a liquid crystal device (LCD) module, a plasma-display device, etc. The GUI unit 240 may include a touch sensitive screen monitor that is capable of detecting an external input from the user. It may also be a hand-held device, such as a personal digital assistant (PDA), a pen input device, a portable computer device, etc.
In one embodiment, the external unit 270 also comprises a remote unit interface 285. The remote unit interface 285 may contain circuitry for facilitating communications with a remote device 292 via a communication link 297. In one embodiment, the remote device 292 may be a computer system. The communications link 297 may be a wireless or wired communications line, (e.g., a network connection, a wireless connection, a local area network connection (LAN), a wide-area network connection (WAN), a “hotspot” connection, an intranet connection, an Internet connection, a Bluetooth™ link, etc.). A display provided by the GUI unit 240 may be synchronized with a corresponding display on the remote device 292. Using this feature, a remote user may view and/or interact with the GUI displays of the external device. Therefore, using the remote device 292, a remote user may provide additional guidance/feedback to the user of the IMD 200.
In one embodiment, the external unit 270 may comprise a local database unit 255 from which the procedure guidance unit 275 may receive data. Optionally or alternatively, the external unit 270 may also be coupled to a database unit 250, which may be separate from external unit 270 (e.g., a centralized database wirelessly linked to a handheld external unit 270). The database unit 250 and/or the local database unit 255 are capable of storing various patient data. This data may comprise patient parameter data acquired from a patient's body and/or therapy parameter data. The database unit 250 and/or the local database unit 255 may comprise data for a plurality of patients, and may be organized and stored in a variety of manners, such as in date format, severity of disease format, etc. The database unit 250 and/or the local database unit 255 may be relational databases in one embodiment. A physician may perform various patient management functions described below using the GUI unit 240, which may display data from the IMD 200 and/or data from the database unit 250 and/or the local database unit 255. The database unit 250 and/or the local database unit 255 may store various patient data such as seizure types, etc. Inputs into the GUI unit 240 may be sent to the IMD 200 to modify various parameters for the therapeutic electrical signal.
One or more of the blocks illustrated in the block diagram of the IMD 200 in
Turning now to
Turning now to
The interface unit 280 also comprises a data controller 310. The data controller 310 is capable of controlling the various functions performed by the interface unit 280, such as receiving and processing information from the external unit 270, as well as providing various parametric data to various portions of the IMD 200. The interface unit 280 may also comprise a data processing unit 330. The data processing unit 330 is capable of processing various patient parameter data and stimulation-related data. For example, upon a command from the external unit 270, the data processing unit 330 may process and correlate patient data with certain therapeutic electrical signal parameters that were used within a pre-determined time period in which the patient data was acquired. For example, after the delivery of a particular therapeutic stimulation cycle, within a predetermined time period, various patient parameters may be collected by the IMD 200. This data may then be correlated and organized in such a fashion that trends relating to the relationship between patient data and various electrical signal parameters may be determined. Statistical and/or other types of data manipulation may also be performed by the data processing unit 330.
Further, the interface unit 280 may also comprise an input unit 340, which is capable of receiving data from the external unit 270 via the communication unit 260. Further, the interface unit 280 may also comprise an output unit 350, which is capable of driving data from the interface unit 280 to the external unit 270. The input unit 340 may comprise various registers, buffers and/or amplifiers to process and streamline data, (e.g., convert data from serial to parallel, or vice versa). The output unit 350 is also capable of registering, buffering and/or amplifying data for transmission from the interface unit 280 to the external unit 270. The interface unit 280 is capable of receiving instructions and providing for various responsive actions in the IMD 200, as well as collecting, processing, and/or storing data. The interface unit 280 provides the ability for using a graphical user interface to provide interactivity between an external user (e.g., a physician), and the IMD 200.
The procedure guidance unit 275 may also comprise an external input interface 440. The external input interface 440 is capable of receiving data from a user, (e.g., a physician). Input from a user, via the external input interface 440, may prompt the procedure guidance unit 275 to perform calculations for providing various recommended steps for performing a surgical implantation of the IMD 200, defining therapeutic electrical signals during a follow-up visit, etc. The external input interface 440 may receive technical data relating to specific therapy parameters that are entered by a user/physician. For example, the particular charge required for a therapeutical electrical signal may be input by a physician and received by the external input interface 440.
The procedure guidance unit 275 is capable of interrogating an IMD 200. In one embodiment, interrogating an IMD 200 may refer to communicating with the IMD 200 and receiving various responsive data from the IMD 200. The responsive data from the IMD 200 may include, but is not limited to, various status data, diagnostic and/or test results, parameter value data, etc. The responsive data from the IMD 200 may be referred to as “interrogative signal.” As a result of the interrogation performed by the procedure guidance unit 275, the IMD data interface 420 and the database interface 430 may receive various external data sets that may be used to generate the instructions for the user. The external data received may include data relating to various diagnostic steps performed on the IMD 200, therapy parameter settings used in previous therapeutic electrical signals, type of disease being treated, etc.
The user guidance controller 415 is capable of determining the steps in which a series of procedures relating to implanting or preparing to implant (i.e., pre-operation procedure) an IMD 200 into a patient. The user guidance controller 415 is capable of analyzing input from the external user, (e.g., from a medical professional), to determine various instructions that may be provided to the user to perform a subsequent step. This may include extracting data from a local database unit 255 and/or the database unit 250 to provide guidance to the external user via text, graphics, video, etc. Data may be received via the GUI unit 240, while instructional displays may be sent to the GUI unit 240.
The procedure guidance unit 275 also comprises a surgical implant instruction unit 450, a patient management controller 410, and a follow-up visit instruction unit 460. The user guidance controller 415 is capable of receiving data from a surgical implant instruction unit 450. The surgical implant instruction unit 450 is capable of determining a series of steps that may be performed during a pre-operation, operation and/or a post-operation procedure. The surgical implant instruction unit 450 is capable of determining the consequence of various inputs from the user and/or data from test results, (e.g., impedance test, system test, etc.) and providing an appropriate, responsive instruction(s).
Further, the user guidance controller 415 is capable of providing instructions relating to follow-up visits to an external user. For example, during a follow-up visit with a medical professional, the follow-up visit instruction unit 460 may receive various inputs from an external unit 270 and/or from the IMD 200 and determine an appropriate responsive step that should be taken. For example, the follow-up visit instruction unit 460 may instruct a user, via the external unit 275, to check the stimulation signal parameters and perform an extraction of stimulation data results to determine whether the efficacy of the current parameters is acceptable. Other instructions may be provided by the follow-up visit instruction unit 460 based upon test results, performance test data from the IMD 200, and/or instructions or questions or inquiries from the external user. The user guidance controller 415 may provide the ability to perform a patient management of the IMD 200 and the patient and then prompt the external user to do so. The patient management controller 410 is capable of performing various patient management functions, as described in U.S. patent application Ser. No. 11/495,471, entitled “Patient Management System For Treating Depression Using An Implantable Medical Device,” in U.S. patent application Ser. No. 11/588,702, entitled Patient Management System For Treating Epilepsy Using An Implantable Device,” and in U.S. patent application Ser. No. 11/588,700, entitled “Patient Management System For Providing Parameter Data For An Implantable Medical Device,” wherein all three patent application are hereby incorporated by reference in full.
Turning now to
Also, upon receiving input to begin the guidance process of block 520, the external unit 270 may also determine (block 530) that the follow-up visit guidance process has been selected. Upon such a determination, the external unit 270 may perform a patient follow-up guidance process (block 580). The patient follow-up guidance process is described herein, including exemplary GUI displays and accompanying description. Upon completion of the patient follow-up guidance process, the guidance process may then be terminated (block 560).
Similarly, referring back to blocks 520 and 530, based upon the input received by the external unit 270, a determination is made that the input relates to a request to initiate a user preference process. The selections represented by the input to the external unit 270 (block 520) and the process determinations (blocks 530) are exemplified in a sample GUI display in
In one embodiment, each of the GUI displays described in
When the guidance system provided by the embodiments of the present invention is activated, an initial GUI display screen may be launched to allow the user to select one of several choices, such as a surgical implant procedure selection, a follow-up office visit selection, or a user preference selection. As exemplified in the GUI display screen illustrated in
Upon selection of the “Start Interrogation” GUI button in
Continuing with the pre-operation process,
Turning now to
The GUI screen of
In one embodiment, the external unit 270 may store the initial lead impedance value for later comparison. Further, periodic impedance tests may be performed and recorded and an analysis of the percent change from a particular threshold impedance value may be calculated to determine the change in lead impedance over time. Additionally, the system diagnostics test may include various other types of tests to check the integrity of the implantable medical system. These tests may include, but are not limited to, normal mode test, magnet mode test, pre-implantation test, such as diagnostics relating to the IMD 200 itself, testing sense electrodes, etc. Upon selection of the system diagnostics button of
A message in the GUI display screen of
Continuing referring to
Upon the selection of the “System Diagnostics” GUI button of
Upon accepting the instruction to perform the second system diagnostics test by depressing the “OK” button of
Upon completion of the second system diagnostic test, an exemplary GUI screen, as illustrated in
The activation of the “Start Interrogation” GUI button provides for yet another interrogation of the IMD 200. This interrogation may be intended to prompt the user to check that the output current are set to zero milliamp before the patient is released after implantation of the IMD 200. Upon starting the interrogation, an exemplary GUI display screen illustrated in
Upon the selection of the “Return To Main Menu” GUI button of
Referring back to
Upon activation of the “Next” GUI button of
As shown in
Upon verifying the lead connector pins, more specific instructions, such as prompting the user to ensure that the end of the connector ring is inside the lead receptacle for a particular model of the IMD 200, (e.g., Cyberonics VNS Model 102) is provided. Further, for initial implantation of an IMD 200, if the nerve site is dry, the user is prompted to irrigate the nerve and remove pooled fluid. As illustrated in
The user is then asked to perform a generator diagnostics on the pulse generator, (e.g., the IMD 200) in isolation of the lead. The user may select this process by activating the “Next” GUI button to perform the generator diagnostics test. Upon selection of the “Next” button illustrated in
Upon performance of a successful generator diagnostics, the GUI screen of
Subsequently, the user is prompted, as indicated in
Turning now to
The display screens described in
Referring simultaneously to
Further, additional interrogation may be made to ensure that the parameters defining the stimulation signal are programmed into the IMD 200 based upon various factors, such as titration, efficacy and/or side effects. Based upon the follow-up visit screen, if the user activates the “Review of Change Settings” GUI button illustrated in
Upon completion of the interrogation, the parameter entry screen illustrated in
Upon successful completion of a normal mode diagnostics test, a message prompting the user to perform a system diagnostics upon test is provided to the user, as illustrated in
Utilizing embodiments of the present invention, guided and/or automated feedback to the user may be provided based upon input from the user and/or the IMD 200. The external device may provide various instructions to the user in performing surgical implants, follow-up visits, and/or parameter adjustments.
All of the methods and apparatuses disclosed and claimed herein may be made and executed without undue experimentation in light of the present disclosure. While the methods and apparatus of this invention have been described in terms of particular embodiments, it will be apparent to those skilled in the art that variations may be applied to the methods and apparatus and in the steps, or in the sequence of steps, of the method described herein without departing from the concept, spirit, and scope of the invention, as defined by the appended claims. It should be especially apparent that the principles of the invention may be applied to selected cranial nerves other than, or in addition to, the vagus nerve to achieve particular results in treating patients having epilepsy, depression, or other medical conditions.
The particular embodiments disclosed above are illustrative only as the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations are intended to the details of construction or design herein shown other than as described in the claims below. It is, therefore, evident that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention. Accordingly, the protection sought herein is as set forth in the claims below.
