US20080300657A1 - Therapy system - Google Patents

Abstract

A therapy system for applying an electrical signal to an internal anatomical feature of a patient includes an implantable component and an external component. Initial values for the parameters of a therapy program can be incremented after a predetermined period of time by a predetermined amount to obtain a subsequent value of the parameter and therapy can be applied using the subsequent value. A sensor may be implanted within the patient to determine an activity level of the patient. Weight loss of the patient can be analyzed to determine whether the weight loss corresponds to the activity level of the patient.

Description

CROSS REFERENCE
• This application claims priority to U.S. Provisional Application Ser. No. 60/941,118, filed May 31, 2007, and entitled “IMPLANTABLE DEVICE,” the disclosure of which is hereby incorporated by reference herein.
• This application discloses and claims subject matter disclosed in commonly assigned U.S. application Ser. Nos. ______ and (attorney docket numbers 14283.0034USU1 and 14283.0034USU3, respectively), filed concurrently herewith and titled “Implantable Therapy System” and “Implantable Therapy System,” respectively. U.S. application Ser. No. ______ (having attorney docket number 14283.0034USU1) names Adrianus Donders, Mark Raymond Stultz, and Koen Jacob Weijand as inventors; and U.S. application Ser. No. ______ (having attorney docket number 14283.0034USU3) names Scott Anthony Lambert and Adrianus Donders as inventors.
I. BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention pertains to systems for applying electrical signals to an anatomical feature of a patient. While many of the disclosed concepts are applicable to a wide variety of therapies (e.g., cardiac pacing with electrodes applied to heart tissue), the invention is described in a preferred embodiment where the invention pertains to the treatment of gastro-intestinal disorders such as obesity, pancreatitis, irritable bowel syndrome and inflammatory disorders. In a most preferred embodiment, this invention pertains to the treatment of a gastrointestinal disorder by the application of a high frequency signal to a vagus nerve of a patient.
• 2. Description of the Prior Art
• A blocking therapy can be used alone or in combination with traditional electrical nerve stimulation in which impulses are created for propagation along a nerve. The disorders to be treated include, without limitation, functional gastrointestinal disorders (FGIDs) (such as functional dyspepsia (dysmotility-like) and irritable bowel syndrome (IBS)), gastroparesis, gastroesophageal reflux disease (GERD), inflammation, discomfort and other disorders.
• In a blocking therapy, an electrode (or multiple electrodes) is placed on or near a vagus nerve or nerves of a patient. By “near”, it is meant close enough that a field created by the electrode captures the nerve. As disclosed in the foregoing patent and applications, the electrode can be placed directly on a nerve, overlying tissue surrounding a nerve or on or in an organ near a nerve.
• Higher frequencies (e.g., 2,500 Hz-20,000 Hz) are believed to result in more consistent neural conduction block. Particularly, the nerve conduction block is applied with an electrical signal selected to block the entire cross-section of the nerve (e.g., both afferent and efferent signals on both myelinated and non-myelinated fibers) at the site of application of the blocking signal.
• In one embodiment of the electrodes a signal amplitude of 0.5 mA to 8 mA at the electrode-nerve interface has been found to be adequate for blocking. However, depending on electrode design, other amplitudes may suffice. Other signal parameters, as non-limiting examples, include an adjustable pulse width (e.g., 50 μsec to 500 μsec), and a frequency range of (by non-limiting example) 1000 Hz to 10,000 Hz. It must be recognized that the frequency sets certain limitations on the available pulse width; for example, the pulse width cannot exceed 50% of the cycle time for a symmetrical biphasic pulse.
• A typical duty cycle of therapy could consist of 5 minutes on and 10 minutes off. These are representative only. For example, a duty cycle could be 2 minutes on and 5 minutes off or be 30 minutes on per day. These examples are given to illustrate the wide latitude available in selecting particular signal parameters for a particular patient.
• A complete system for applying a signal to a nerve may include systems for addressing the potential for charge build-up, assuring good communication between implanted and external components, recharging implantable batteries, physician and patient controls and programming and communication with the system. These issues and selected prior art systems for addressing these issues will now be discussed.
II. SUMMARY OF THE INVENTION
• According to a preferred embodiment of the present invention, a therapy system is disclosed for applying therapy to an internal anatomical feature of a patient. The system includes at least one electrode for implantation within the patient and placement at the anatomical feature (e.g., a nerve) for applying the therapy signal to the feature upon application of a treatment signal to the electrode. An implantable component is placed in the patient's body beneath a skin layer and coupled to the electrode. The implantable component includes an implanted antenna. An external component has an external antenna for placement above the skin and adapted to be electrically coupled to the implanted antenna across the skin through radiofrequency transmission.
• According to aspects, the external component is adapted to be configured into multiple selectable operating modes including an operating room mode, a programming mode, and a charging mode.
• For example, communicatively coupling the external component to peripheral devices can automatically configure the external component into one of the operating modes.
• According to other aspects, the implantable component is adapted to be configured into multiple selectable operating modes including a training mode for simulating a therapy, and a therapy mode for providing therapy.
• According to other aspects, the implantable component may be configured to increment therapy settings automatically by a predetermined amount after a predetermined period of time.
III. BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic representation of a therapy system having features that are examples of inventive aspects of the principles of the present invention, the therapy system including a neuroregulator and an external charger;
• FIG. 2A is a plan view of an implantable neuroregulator for use in the therapy system ofFIG. 1 according to aspects of the present disclosure;
• FIG. 2B is a plan view of another implantable neuroregulator for use in the therapy system ofFIG. 1 according to aspects of the present disclosure.
• FIG. 3A is a block diagram of a representative circuit module for the neuroregulator ofFIG. 2A andFIG. 2B according to aspects of the present disclosure;
• FIG. 3B is a block diagram of another representative circuit module for the neuroregulator ofFIG. 2A andFIG. 2B according to aspects of the present disclosure;
• FIG. 4 is a block diagram of a circuit module for an external charger for use in the therapy system ofFIG. 1 according to aspects of the present disclosure;
• FIG. 5 is a plan schematic view of an example external charger for use in the therapy system ofFIG. 1 according to aspects of the present disclosure;
• FIG. 6 is a plan, schematic view of an external charger and schematic views of a patient transmit coil and a physician transmit coil configured to couple to the external charger according to aspects of the present disclosure;
• FIG. 7 is a side elevation, schematic view of an external coil in a desired alignment over an implanted coil according to aspects of the present disclosure;
• FIG. 8 illustrates the external coil and implanted coil ofFIG. 7 arranged in a misaligned position according to aspects of the present disclosure;
• FIG. 9 is a perspective view of a distal portion of a bipolar therapy lead according to aspects of the present disclosure;
• FIG. 10 is a schematic representation of an electrode placement for a blocking therapy according to aspects of the present disclosure;
• FIG. 11 is a schematic representation of a first electrode configuration according to aspects of the present disclosure;
• FIG. 12 is a schematic representation of a typical waveform according to aspects of the present disclosure;
• FIG. 13 is a schematic representation of a second electrode configuration according to aspects of the present disclosure;
• FIG. 14 is a schematic representation of a typical waveform according to aspects of the present disclosure;
• FIG. 15 is a schematic representation of a third electrode configuration according to aspects of the present disclosure;
• FIG. 16 is a schematic representation of a typical waveform according to aspects of the present disclosure;
• FIG. 17 is a schematic representation of a fourth electrode configuration according to aspects of the present disclosure;
• FIG. 18 is a schematic representation of a typical waveform according to aspects of the present disclosure;
• FIG. 19 is a graphical illustration of a treatment schedule according to aspects of the present disclosure;
• FIG. 20 is a schematic representation of a signal pulse illustrating charge balancing according to aspects of the present disclosure;
• FIG. 21 is a schematic representation of an alternative means of charge balancing according to aspects of the present disclosure;
• FIG. 22 is a schematic illustration of a charge balancing system shown in a shorting state according to aspects of the present disclosure;
• FIG. 23 is the view ofFIG. 22 in a non-shorting state according to aspects of the present disclosure; and
• FIG. 24 is a graphical illustration comparing waveforms in shorting and non-shorting states according to aspects of the present disclosure.
IV. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• With reference now to the various drawing figures in which identical elements are numbered identically throughout, a description of the preferred embodiments of the present invention will now be described. While the invention is applicable to treating a wide variety of gastro-intestinal disorders, the invention will be described in preferred embodiments for the treatment of obesity.
• FIG. 1 schematically illustrates atherapy system100 for treating obesity or other gastro-intestinal disorders. Thetherapy system100 includes aneuroregulator104, anelectrical lead arrangement108, and anexternal charger101. Theneuroregulator104 is adapted for implantation within a patient to be treated for obesity. As will be more fully described herein, theneuroregulator104 typically is implanted just beneath askin layer103.
• Theneuroregulator104 is configured to connect electrically to thelead arrangement108. In general, thelead arrangement108 includes two or moreelectrical lead assemblies106,106a. In the example shown, thelead arrangement108 includes two identical (bipolar)electrical lead assemblies106,106a. Theneuroregulator104 generates therapy signals and transmits the therapy signals to thelead assemblies106,106a.
• Thelead assemblies106,106aup-regulate and/or down-regulate nerves of a patient based on the therapy signals provided by theneuroregulator104. In an embodiment, thelead assemblies106,106aincludedistal electrodes212,212a, which are placed on one or more nerves of a patient. For example, theelectrodes212,212amay be individually placed on the anterior vagal nerve AVN and posterior vagal nerve PVN, respectively, of a patient. For example, thedistal electrodes212,212acan be placed just below the patient's diaphragm. In other embodiments, however, fewer or more electrodes can be placed on or near fewer or more nerves.
• Theexternal charger101 includes circuitry for communicating with the implantedneuroregulator104. In general, the communication is transmitted across theskin103 along a two-way signal path as indicated by arrows A. Example communication signals transmitted between theexternal charger101 and theneuroregulator104 include treatment instructions, patient data, and other signals as will be described herein. Energy also can be transmitted from theexternal charger101 to theneuroregulator104 as will be described herein.
• In the example shown, theexternal charger101 can communicate with the implantedneuroregulator104 via bidirectional telemetry (e.g. via radiofrequency (RF) signals). Theexternal charger101 shown inFIG. 1 includes acoil102, which can send and receive RF signals. Asimilar coil105 can be implanted within the patient and coupled to theneuroregulator104. In an embodiment, thecoil105 is integral with theneuroregulator104. Thecoil105 serves to receive and transmit signals from and to thecoil102 of theexternal charger101.
• For example, theexternal charger101 can encode the information as a bit stream by amplitude modulating or frequency modulating an RF carrier wave. The signals transmitted between thecoils102,105 preferably have a carrier frequency of about 6.78 MHz. For example, during an information communication phase, the value of a parameter can be transmitted by toggling a rectification level between half-wave rectification and no rectification. In other embodiments, however, higher or lower carrier wave frequencies may be used.
• In an embodiment, theneuroregulator104 communicates with theexternal charger101 using load shifting (e.g., modification of the load induced on the external charger101). This change in the load can be sensed by the inductively coupledexternal charger101. In other embodiments, however, theneuroregulator104 andexternal charger101 can communicate using other types of signals.
• In an embodiment, theneuroregulator104 receives power to generate the therapy signals from an implantable power source151 (seeFIG. 3A), such as a battery. In a preferred embodiment, the power source151 is a rechargeable battery. In some embodiments, the power source151 can provide power to the implantedneuroregulator104 when theexternal charger101 is not connected. In other embodiments, theexternal charger101 also can be configured to provide for periodic recharging of the internal power source151 of theneuroregulator104. In an alternative embodiment, however, theneuroregulator104 can entirely depend upon power received from an external source (seeFIG. 3B). For example, theexternal charger101 can transmit power to theneuroregulator104 via the RF link (e.g., betweencoils102,105).
• In some embodiments, theneuroregulator104 initiates the generation and transmission of therapy signals to thelead assemblies106,106a. In an embodiment, theneuroregulator104 initiates therapy when powered by the internal battery151. In other embodiments, however, theexternal charger101 triggers theneuroregulator104 to begin generating therapy signals. After receiving initiation signals from theexternal charger101, theneuroregulator104 generates the therapy signals (e.g., pacing signals) and transmits the therapy signals to thelead assemblies106,106a.
• In other embodiments, theexternal charger101 also can provide the instructions according to which the therapy signals are generated (e.g., pulse-width, amplitude, and other such parameters). In a preferred embodiment, theexternal charger101 includes memory in which several predetermined programs/therapy schedules can be stored for transmission to theneuroregulator104. Theexternal charger101 also can enable a user to select a program/therapy schedule stored in memory for transmission to theneuroregulator104. In another embodiment, theexternal charger101 can provide treatment instructions with each initiation signal.
• Typically, each of the programs/therapy schedules stored on theexternal charger101 can be adjusted by a physician to suit the individual needs of the patient. For example, a computing device (e.g., a notebook computer, a personal computer, etc.)107 can be communicatively connected to theexternal charger101. With such a connection established, a physician can use thecomputing device107 to program therapies into theexternal charger101 for either storage or transmission to theneuroregulator104.
• Theneuroregulator104 also may include memory152 (seeFIGS. 3A and 3B) in which treatment instructions and/or patient data can be stored. For example, theneuroregulator104 can store therapy programs indicating what therapy should be delivered to the patient. Theneuroregulator104 also can store patient data indicating how the patient utilized thetherapy system100 and/or reacted to the delivered therapy.
• In what follows, the focus of the detailed description is the preferred embodiment in which theneuroregulator104 contains a rechargeable battery151 from which theneuroregulator104 may draw power (FIG. 3A).
1. System Hardware Components
• a. Neuroreulator
• Different embodiments of theneuroregulator104,104′ are illustrated schematically inFIGS. 2A and 2B, respectively. Theneuroregulator104,104′ is configured to be implanted subcutaneously within the body of a patient. Preferably, theneuroregulator104,104′ is implanted subcutaneously on the thoracic sidewall in the area slightly anterior to the axial line and caudal to the arm pit. In other embodiments, alternative implantation locations may be determined by the implanting surgeon.
• Theneuroregulator104,104′ is generally sized for such implantation in the human body. By way of non-limiting example, an outer diameter D, D′ of theneuroregulator104,104′ is typically less than or equal to about sixty mm and a thickness of theneuroregulator104,104′ is less than or equal to about fifteen mm. In a preferred embodiment, theneuroregulator104,104′ has a maximum outer diameter D, D′ of about fifty-five mm and a maximum thickness of about nine mm. In one embodiment, theneuroregulator104,104′ weighs less than about one hundred twenty grams.
• Typically, theneuroregulator104,104′ is implanted parallel to the skin surface to maximize RF coupling efficiency with theexternal charger101. In an embodiment, to facilitate optimal information and power transfer between theinternal coil105,105′ of theneuroregulator104,104′ and theexternal coil102 of theexternal charger101, the patient can ascertain the position of theneuroregulator104,104′ (e.g., through palpation or with the help of a fixed marking on the skin). In an embodiment, theexternal charger101 can facilitate coil positioning as discussed herein with reference toFIGS. 7 and 8.
• As shown inFIGS. 2A and 2B, theneuroregulator104,104′ generally includes ahousing109,109′ overmolded with theinternal coil105,105′, respectively. Theovermold110,110′ of theneuroregulator104,104′ is formed from a bio-compatible material that is transmissive to RF signals (i.e., or other such communication signals). Some such bio-compatible materials are well known in the art. For example, theovermold110,110′ of theneuroregulator104,104′ may be formed from silicone rubber or other suitable materials. Theovermold110,110′ also can include suture tabs or holes119,119′ to facilitate placement within the patient's body.
• Thehousing109,109′ of theneuroregulator104,104′ also may contain a circuit module, such as circuit112 (seeFIG. 1,3A, and3B), to which thecoil105,105′ may be electrically connected along apath105a,105a′. The circuit module within thehousing109 may be electrically connected to thelead assemblies106,106a(FIG. 1) throughconductors114,114a. In the example shown inFIG. 2A, theconductors114,114aextend out of thehousing109 throughstrain reliefs118,118a.Such conductors114,114aare well known in the art.
• Theconductors114,114aterminate atconnectors122,122a, which are configured to receive or otherwise connect thelead assemblies106,106a(FIG. 1) to theconductors114,114a. By providingconnectors122,122abetween the neuroregulator104 and thelead assemblies106,106a, thelead assemblies106,106amay be implanted separately from theneuroregulator104. Also, following implantation, thelead assemblies106,106amay be left in place while the originally implantedneuroregulator104 is replaced by a different neuroregulator.
• As shown inFIG. 2A, theneuroregulator connectors122,122acan be configured to receiveconnectors126 of thelead assemblies106,106a. For example, theconnectors122,122aof theneuroregulator104 may be configured to receive pin connectors (not shown) of thelead assemblies106,106a. In another embodiment, theconnectors122,122amay be configured to secure to thelead assemblies106,106ausing set-screws123,123a, respectively, or other such fasteners. In a preferred embodiment, theconnectors122,122aare well-known IS-1 connectors. As used herein, the term “IS-1” refers to a connector standard used by the cardiac pacing industry, and is governed by the international standard ISO 5841-3.
• In the example shown inFIG. 2B,female connectors122′,122a′ configured to receive theleads106,106aare molded into a portion of theovermold110′ of the neuroregulator104′. Theleads connectors126 are inserted into these moldedconnectors122′,122a′ and secured viaset screws123′,123a′, seals (e.g., Bal Seals®), and/or another fastener.
• The circuit module112 (seeFIGS. 1,3A, and3B) is generally configured to generate therapy signals and to transmit the therapy signals to thelead assemblies106,106a. Thecircuit module112 also may be configured to receive power and/or data transmissions from theexternal charger101 via theinternal coil105. Theinternal coil105 may be configured to send the power received from the external charger to thecircuit module112 for use or to the internal power source (e.g., battery)151 of theneuroregulator104 to recharge the power source151.
• Block diagrams ofexample circuit modules112,112″ are shown inFIGS. 3A,3B, respectively. Eithercircuit module112,112″ can be utilized with any neuroregulator, such asneuroregulators104,104′ described above. Thecircuit modules112,112″ differ in that thecircuit module112 includes an internal power source151 and acharge control module153 and thecircuit module112″ does not. Accordingly, power for operation of thecircuit module112″ is provided entirely by theexternal charger101 via theinternal coil105. Power operation forcircuit module112 may be provided by theexternal charger101 or by the internal power source151. Eithercircuit module112,112″ may be used with eitherneuroregulator104,104′ shown inFIGS. 2A,2B. For ease in understanding, the following description will focus on thecircuit module112 shown inFIG. 3A.
• Thecircuit module112 includes anRF input157 including arectifier164. Therectifier164 converts the RF power received from theinternal coil105 into DC electric current. For example, theRF input157 may receive the RF power from theinternal coil105, rectify the RF power to a DC power, and transmit the DC current to the internal power source151 for storage. In one embodiment, theRF input157 and thecoil105 may be tuned such that the natural frequency maximizes the power transferred from theexternal charger101.
• In an embodiment, theRF input157 can first transmit the received power to acharge control module153. Thecharge control module153 receives power from theRF input157 and delivers the power where needed through apower regulator156. For example, theRF input157 may forward the power to the battery151 for charging or to circuitry for use in creating therapy signals as will be described below. When no power is received from thecoil105, thecharge control153 may draw power from the battery151 and transmit the power through thepower regulator160 for use. For example, a central processing unit (CPU)154 of theneuroregulator104 may manage thecharge control module153 to determine whether power obtained from thecoil105 should be used to recharge the power source151 or whether the power should be used to produce therapy signals. TheCPU154 also may determine when the power stored in the power source151 should be used to produce therapy signals.
• The transmission of energy and data via RF/inductive coupling is well known in the art. Further details describing recharging a battery via an RF/inductive coupling and controlling the proportion of energy obtained from the battery with energy obtained via inductive coupling can be found in the following references, all of which are hereby incorporated by reference herein: U.S. Pat. No. 3,727,616, issued Apr. 17, 1973, U.S. Pat. No. 4,612,934, issued Sep. 23, 1986, U.S. Pat. No. 4,793,353, issued Dec. 27, 1988, U.S. Pat. No. 5,279,292, issued Jan. 18, 1994, and U.S. Pat. No. 5,733,313, issued Mar. 31, 1998.
• In general, theinternal coil105 may be configured to pass data transmissions between theexternal charger101 and atelemetry module155 of theneuroregulator104. Thetelemetry module155 generally converts the modulated signals received from theexternal charger101 into data signals understandable to theCPU154 of theneuroregulator104. For example, thetelemetry module155 may demodulate an amplitude modulated carrier wave to obtain a data signal. In one embodiment, the signals received from theinternal coil105 are programming instructions from a physician (e.g., provided at the time of implant or on subsequent follow-up visits). Thetelemetry module155 also may receive signals (e.g., patient data signals) from theCPU154 and may send the data signals to theinternal coil105 for transmission to theexternal charger101.
• TheCPU154 may store operating parameters and data signals received at theneuroregulator104 in anoptional memory152 of theneuroregulator104. Typically, thememory152 includes non-volatile memory. In other embodiments, thememory152 also can store serial numbers and/or model numbers of theleads106; serial number, model number, and/or firmware revision number of theexternal charger101; and/or a serial number, model number, and/or firmware revision number of theneuroregulator104.
• TheCPU154 of theneuroregulator104 also may receive input signals and produce output signals to control asignal generation module159 of theneuroregulator104. Signal generation timing may be communicated to theCPU154 from theexternal charger101 via thecoil105 and thetelemetry module155. In other embodiments, the signal generation timing may be provided to theCPU154 from an oscillator module (not shown). TheCPU154 also may receive scheduling signals from a clock, such as 32 KHz real time clock (not shown).
• TheCPU154 forwards the timing signals to thesignal generation module159 when therapy signals are to be produced. TheCPU154 also may forward information about the configuration of theelectrode arrangement108 to thesignal generation module159. For example, theCPU154 can forward information obtained from theexternal charger101 via thecoil105 and thetelemetry module155.
• Thesignal generation module159 provides control signals to anoutput module161 to produce therapy signals. In an embodiment, the control signals are based at least in part on the timing signals received from theCPU154. The control signals also can be based on the electrode configuration information received from theCPU154.
• Theoutput module161 produces the therapy signals based on the control signals received from thesignal generation module159. In an embodiment, theoutput module161 produces the therapy signals by amplifying the control signals. Theoutput module161 then forwards the therapy signals to thelead arrangement108.
• In an embodiment, thesignal generation module159 receives power via afirst power regulator156. Thepower regulator156 regulates the voltage of the power to a predetermined voltage appropriate for driving thesignal generation module159. For example, thepower regulator156 can regulate the voltage to about 2.5 volts.
• In an embodiment, theoutput module161 receives power via asecond power regulator160. Thesecond power regulator160 may regulate the voltage of the power in response to instructions from theCPU154 to achieve specified constant current levels. Thesecond power regulator160 also may provide the voltage necessary to deliver constant current to theoutput module161.
• Theoutput module161 can measures the voltage of the therapy signals being outputted to thelead arrangement108 and reports the measured voltage to theCPU154. Acapacitive divider162 may be provided to scale the voltage measurement to a level compatible with theCPU154. In another embodiment, theoutput module161 can measure the impedance of thelead arrangement108 to determine whether theleads106,106aare in contact with tissue. This impedance measurement also may be reported to theCPU154.
• b. External Charger
• A block diagram view of an exampleexternal charger101 is shown inFIG. 4. The exampleexternal charger101 may cooperate with any of theneuroregulators104,104′ discussed above to provide therapy to a patient. Theexternal charger101 is configured to transmit to the neuroregulator104 (e.g., via an RF link) desired therapy parameters and treatment schedules and to receive data (e.g., patient data) from theneuroregulator104. Theexternal charger101 also is configured to transmit energy to theneuroregulator104 to power the generation of therapy signals and/or to recharge an internal battery151 of theneuroregulator104. Theexternal charger101 also can communicate with anexternal computer107.
• In general, theexternal charger101 includes power andcommunications circuitry170. The power andcommunications circuitry170 is configured to accept input from multiple sources, to process the input at a central processing unit (CPU)200, and to output data and/or energy (e.g., viacoil102,socket174, or display172). It will be appreciated that it is well within the skill of one of ordinary skill in the art (having the benefit of the teachings of the present invention) to create such circuit components with such function.
• For example, the circuit power andcommunications circuit170 can be electrically connected to theexternal coil102 for inductive electrical coupling to thecoil105 of theneuroregulator104. The power andcommunications circuit170 also can be coupled to interface components enabling input from the patient or an external computing device (e.g., a personal computer, a laptop, a personal digital assistant, etc.)107. For example, theexternal charger101 can communicate with thecomputing device107 via an electrically isolated Serial port.
• Theexternal charger101 also includes a memory ordata storage module181 in which data received from the neuroregulator104 (e.g., viacoil102 and socket input176), the external computer107 (e.g., via socket input174), and/or the patient (e.g. via select input178) can be stored. For example, thememory181 can store one or more predetermined therapy programs and/or therapy schedules provided from theexternal computer107. Thememory181 also can store software to operate the external charger101 (e.g., to connect to theexternal computer107, to program external operating parameters, to transmit data/energy to theneuroregulator104, and/or to upgrades the operations of the CPU200). Alternatively, theexternal charger101 can include firmware to provide these functions. Thememory181 also can store diagnostic information, e.g., software and hardware error conditions.
• An external computer orprogrammer107 may connect to thecommunications circuit170 through thefirst input174. In an embodiment, thefirst input174 is a port or socket into which a cable coupled to theexternal computer107 can be plugged. In other embodiments, however, thefirst input174 may include any connection mechanism capable of connecting theexternal computer107 to theexternal charger101. Theexternal computer107 provides an interface between theexternal charger101 and a physician (e.g., or other medical professional) to enable the physician to program therapies into theexternal charger101, to run diagnostic and system tests, and to retrieve data from theexternal charger101.
• Thesecond input176 permits theexternal charger101 to couple selectively to one of either anexternal power source180 or the external coil102 (seeFIG. 1). For example, thesecond input176 can define a socket or port into which thepower source180 orexternal coil102 can plug. In other embodiments, however, thesecond input176 can be configured to couple to a cable or other coupling device via any desired connection mechanism. In one embodiment, theexternal charger101 does not simultaneously connect to both thecoil102 and theexternal power source180. Accordingly, in such an embodiment, theexternal power source180 does not connect directly to the implantedneuroregulator104.
• Theexternal power source180 can provide power to theexternal charger101 via thesecond input176 when theexternal charger101 is not coupled to thecoil102. In an embodiment, theexternal power source180 enables theexternal charger101 to process therapy programs and schedules. In another embodiment, theexternal power source180 supplies power to enable theexternal charger101 to communicate with the external computer107 (seeFIG. 1).
• Theexternal charger101 optionally may include a battery, capacitor, or other storage device182 (FIG. 4) enclosed within theexternal charger101 that can supply power to the CPU200 (e.g., when theexternal charger101 is disconnected from the external power source180). The power andcommunications circuit170 can include apower regulator192 configured to receive power from thebattery182, to regulate the voltage, and to direct the voltage to theCPU200. In a preferred embodiment, thepower regulator192 sends a 2.5 volt signal to theCPU200.
• Thebattery182 also can supply power to operate theexternal coil102 when thecoil102 is coupled to theexternal charger101. Thebattery182 also can supply power to enable theexternal charger101 to communicate with theexternal computer107 when theexternal power source180 is disconnected from theexternal charger101. Anindicator190 may provide a visual or auditory indication of the remaining power in thebattery182 to the user.
• In an embodiment, thebattery182 of theexternal charger101 is rechargeable. For example, theexternal power source180 may couple to theexternal charger101 to supply a voltage to thebattery182. In such an embodiment, theexternal charger101 then can be disconnected from theexternal power source180 and connected to theexternal coil102 to transmit power and/or data to theneuroregulator104. Further details regarding example rechargeable systems include U.S. Pat. No. 6,516,227 to Meadows, issued Feb. 4, 2003; U.S. Pat. No. 6,895,280 to Meadows, issued May 17, 2005; and U.S. patent application Publication No. US 2005/0107841 to Meadows May 19, 2005, the disclosures of which are hereby incorporated herein by reference.
• In an alternative embodiment, thebattery180 is a replaceable, rechargeable battery, which is recharged external to theexternal charger101 in its own recharging stand. In yet another embodiment, thebattery182 in theexternal charger101 can be a replaceable, non-rechargeable battery.
• In use, energy from theexternal power source180 flows through thesecond input176 to anenergy transfer module199 of the power andcommunications circuit170. Theenergy transfer module199 directs the energy either to theCPU200 to power the internal processing of theexternal charger101 or to thebattery182. In an embodiment, theenergy transfer module199 first directs the energy to apower regulator194, which can regulate the voltage of the energy signal before sending the energy to thebattery182.
• In some embodiments, theexternal coil102 of theexternal charger101 can supply energy from thebattery182 to theinternal coil105 of the neuroregulator104 (e.g., to recharge the internal power source151 (FIG. 3) of the neuroregulator104). In such embodiments, theenergy transfer module199 receives power from thebattery182 via thepower regulator194. For example, thepower regulator194 can provide a sufficient voltage to activate theenergy transfer module199. Theenergy transfer module199 also can receive instructions from theCPU200 regarding when to obtain power from thebattery182 and/or when to forward power to theexternal coil102. Theenergy transfer module199 delivers the energy received from thebattery182 to thecoil102 of theexternal charger101 in accordance with the instructions provided by theCPU200. The energy is sent from theexternal coil102 to theinternal coil105 of theneuroregulator104 via RF signals or any other desired power transfer signal. In an embodiment, therapy delivery at theneuroregulator104 is suspended and power is delivered from theexternal charger101 during recharging of the internal power source151.
• In some embodiments, theexternal charger101 controls when the internal battery151 of the implantedneuroregulator104 is recharged. For example, theexternal charger101 can determine when to recharge the battery151 using the processes described in U.S. Pat. No. 6,895,280 to Meadows issued May 17, the disclosure of which is hereby incorporated herein by reference. In other embodiments, however, the implantedneuroregulator104 controls when the battery151 is recharged. Details pertaining to controlling the battery recharging process can be found in U.S. Pat. No. 3,942,535 to Schulman, issued Mar. 9, 1976; U.S. Pat. No. 4,082,097 to Mann, issued Apr. 4, 1978; U.S. Pat. No. 5,279,292 to Baumann, issued Apr. 4, 1978; and U.S. Pat. No. 6,516,227 to Meadows, issued Feb. 4, 2003, the disclosures of which are hereby incorporated herein by reference. These details typically parallel the battery manufacturer's recommendations regarding how to charge the battery.
• As noted above, in addition to power transmissions, theexternal coil102 also can be configured to receive data from and to transmit programming instructions to the neuroregulator104 (e.g., via an RF link). Adata transfer module196 may receive and transmit data and instructions between theCPU200 and theinternal coil105. In an embodiment, the programming instructions include therapy schedules and parameter settings. Further examples of instructions and data transmitted between theexternal coil102 and the implantedcoil105 are discussed in greater detail herein.
• FIG. 5 shows a front view of an exampleexternal charger101. Theexternal charger101 includes ahousing171 defining a first input (e.g., socket input)174, a second input (e.g., socket input)176, and a third input (e.g., select input)178 coupled to thecommunications circuit170. In an embodiment, thehousing171 also may enclose abattery182 configured to supply power to theexternal charger101 via the power andcommunications circuit170. Alternatively, theexternal charger101 can receive power from an external source180 (FIG. 1).
• As shown inFIG. 5,visual display172 also is provided on thehousing171 for presenting human readable information processed by thecommunications circuit170. In an embodiment, thevisual display172 is a liquid crystal display (LCD) screen. In other embodiments, however, thevisual display172 can include any display mechanism (e.g., a light-emitting diode (LED) screen, vacuum fluorescent display (VFD) screen, etc.). Non-limiting examples of information that can be shown on thevisual display172 include the status of thebattery182 of theexternal charger101, the status of the battery151 in the implantedneuroregulator104, coil position (as will be described), impedances between theelectrodes212,212aand attached tissue, and error conditions.
• As shown inFIG. 5, thethird input178 of theexternal charger101 includes aselection input178 with which the user can interact with theexternal charger101. In an embodiment, theselection input178 can include a button, which sequentially selects menu options for various operations performed by theexternal charger101 when pressed successively. In other embodiments, however, thethird input178 includes another type of selection input (e.g., a touch screen, a toggle-switch, a microphone for accepting voice-activated commands, etc.).
• Example functions capable of selection by the user include device reset, interrogation of battery status, interrogation of coil position, and/or interrogation of lead/tissue impedance. In other embodiments, a user also can select measurement of tissue/lead impedance and/or initiation of a stomach contraction test. Typically, the measurement and testing operations are performed when the patient is located in an operating room, doctor's office, or is otherwise surrounded by medical personnel.
• In another embodiment, the user can select one or more programs and/or therapy schedules to submit to thememory152 of theneuroregulator104. For example, the user can cycle through available programs by repeatedly pressing theselection button178 on theexternal charger101. The user can indicate the user's choice by, e.g., depressing theselector button178 for a predetermined period of time or pressing theselector button178 in quick succession within a predetermined period of time.
• In use, in some embodiments, theexternal charger101 may be configured into one of multiple modes of operation. Each mode of operation can enable theexternal charger101 to perform different functions with different limitations. In an embodiment, theexternal charger101 can be configured into five modes of operation: an Operating Room mode; a Programming mode; a Therapy Delivery mode; a Charging mode; and a Diagnostic mode.
• When configured in the Operating Room mode, theexternal charger101 can be used to determine whether the implanted neuroregulator104 and/or the implantedlead arrangement108 are functioning appropriately. If any component of thetherapy system100 is not functioning as desired, then the medical personnel can trouble-shoot the problem while still in the operation room or can abandon the procedure, if necessary.
• For example, theexternal charger101 can be used to determine whether the impedance at theelectrodes212,212aof the lead arrangement108 (FIG. 1) is within a prescribed range. When the impedance is within the prescribed range, a gastric contraction test can be initiated to demonstrate that theelectrodes212,212aare appropriately positioned and can become active. If the impedance is outside an acceptable range, the system integrity can be checked (e.g. connections to the leads can be verified). Additionally, thetherapy electrodes212,212amay be repositioned to provide better electrode-tissue contact.
• In another embodiment, theexternal charger101 can be used to initiate a stomach contraction test in the operating room. The stomach contraction test enables medical personnel to confirm theelectrodes212,212aof the lead arrangement108 (FIG. 1) are in contact with the appropriate nerves and not with some other tissue. For example, theexternal charger101 can instruct theneuroregulator104 to generate a signal tailored to cause the stomach to contract if the signal reaches the appropriate nerves.
• Typically, theexternal charger101 is not connected to anexternal computer107 when configured in the Operating Room mode. In a preferred embodiment, the external charger is connected (e.g., via socket input176) to aphysician coil102′ (shown schematically inFIG. 6) instead of a patient coil102 (described above). Thephysician coil102′ can differ from thepatient coil102 in one or more respects.
• For example, as shown inFIG. 6, a length L′ of theconnection cable102a′ on thephysician coil102′ can be longer than a length L of thecable102aof thepatient coil102. In one example embodiment, the length L′ of theconnection cable102a′ of thephysician coil102′ can be about 300 cm and the length L of theconnection cable102aof thepatient coil102 can be about 60 cm. The longer length L′ allows theexternal charger101 to be located outside the sterile field in the operating room when thephysician coil102′ is connected.
• In another embodiment, thephysician coil102′ can include an indicator circuit to identify thecoil102′ as a physician coil to theexternal charger101. For example, thephysician coil102′ can contain asmall resistor102b′, which can be recognized by theexternal charger101 when thephysician coil102′ is plugged into thesocket176. When theexternal charger101 detects the presence of the indicator circuit, theexternal charger101 automatically configures itself into an Operating Room mode. This mode allows the physician to conduct various system and patient response tests, such as those described above, without the need for connection to aclinician computer107.
• When configured in the Programming mode, theexternal charger101 is connected with the external computer107 (FIG. 1) via which the physician manages the components of thetherapy system100. In general, the physician may select a therapy program and a therapy schedule stored on theexternal computer107 to transfer to theexternal charger101. In certain embodiments, theexternal charger101 forwards the programs and schedule to theneuroregulator104. In an embodiment, theexternal charger101 can be coupled to thephysician coil102′ during programming. In another embodiment, theexternal charger101 can be coupled to thepatient coil102. In addition, in different embodiments, theexternal computer107 also can assess the impedance of theelectrodes212,212a, initiate system and/or diagnostic tests, and take corrective action when theexternal charger101 is configured into the Programming mode.
• After theneuroregulator104 has been implanted and theexternal charger101 and/orneuroregulator104 have been programmed, theexternal charger101 can be configured into the Therapy Delivery mode. When configured in the Therapy Delivery mode, theexternal charger101 communicates with and/or powers theneuroregulator104 as described above. Typically, theexternal charger101 is coupled to thepatient coil102 and not to theexternal computer107 when configured in the Therapy Delivery mode.
• Theexternal charger101 also can interact with the user via the third input (e.g., the selector button)178 and thedisplay172 to select the therapy to be provided. In an embodiment, theexternal charger101 can send instructions indicating which program theneuroregulator104 should follow while administering therapy. In another embodiment, theexternal charger101 sends instructions in accordance with a selected program stored on theexternal charger101.
• If theneuroregulator104 includes an internal power source151, then theexternal charger101 can enter a Charging mode in which theexternal charger101 recharges the internal power source151 of theneuroregulator104 when theneuroregulator104 is not delivering therapy. Typically, theexternal charger101 enters the Charging mode at the request of theneuroregulator104. In a preferred embodiment, theneuroregulator104 controls how much power is sent by theexternal charger101.
• During follow-up visits between the patient and the physician, theexternal charger101 may be configured into a Diagnostic mode. In this mode, theexternal charger101 is coupled to theexternal computer107 to provide an interface for the physician to obtain data stored on theexternal charger101 and to download therapy and/or software updates. In an embodiment, thedisplay172 on theexternal charger101 is disabled and all information is conveyed to the physician via theexternal computer107 only. Theexternal charger101 may be coupled to eithercoil102,102′ when configured in the Diagnostic mode.
• In an embodiment, theexternal charger101 also can be configured into a Shipping mode, in which thebattery182 is disconnected from the rest of the circuitry. The Shipping mode avoids draining thebattery182 and enhances safety. In one such embodiment, pressing theselector button172 causes theexternal charger101 to change from this Shipping mode into another mode, such as the Therapy Delivery mode.
• c. Alignment of External and Implanted Coils
• Theexternal charger101 enables alignment of the relative positions of the external and implantedcoils102,105 and optimization of the signal strength. Optimizing the alignment of thecoils102,105 and the power of the transmission signal facilitates continuous, transcutaneous transmission of power and/or information.
• i. Positioning of External Coil
• In general, theexternal coil102 is adapted to be placed on the patient's skin (e.g., by adhesives) overlying the implantedinternal coil105. The position and orientation of thecoils102,105 can affect signal reliability. In addition, the strength of the transmission signals between theexternal coil102 and the implantedcoil105 also is affected by the distance between thecoils102,105. Implanting theneuroregulator104 very close to the surface of theskin103 typically results in a large and expanded range of signal strengths. Conversely, implanting theneuroregulator104 at a large distance beneath theskin103 yields a generally weak transmission link and a compressed range of signal strengths.
• FIG. 7 illustrates anexternal coil102 appropriately aligned with an implantedcoil105. Thecoil105 is implanted beneath theskin103 at a preferred depth D₁(e.g., about two centimeters to about three centimeters beneath the skin103). Preferably, a plane of thecoil105 extends parallel to the surface of theskin103. In an embodiment, eachcoil102,105 is a circular coil surrounding a central axis X-X, Y-Y, respectively. As shown inFIG. 7, in a preferred alignment configuration, the axes X-X, Y-Y are collinear so that there is no lateral offset of the axes X-X, Y-Y and the planes of thecoils102,105 are parallel to one another. Such an alignment configuration may be attained, e.g., when theexternal coil102 is applied to a patient'sskin103 when the patient is lying flat (e.g., on the patient's back).
• FIG. 8 illustrates misalignment between thecoils102,105 resulting from movement of the patient (e.g., a change in posture). For example, when the patient sits, excess fat may cause theskin103 to roll. This rolling may cause the spacing between thecoils102,105 to increase to a distance D2. Also, the orientation of theexternal coil102 may change so that the axes X-X and Y-Y of thecoils102,105, respectively, have a lateral offset T and an angular offset A. Such changes in spacing and orientation may be occurring constantly throughout the day.
• The relative position of thecoils102,105 may be optimized (e.g., for each use) when theexternal charger101 senses the transmission link is weakened (e.g., on initial power up or when the energy transfer to theimplantable neuroregulator104 has degraded). For example, theexternal charger101 can sound an alarm and invite the user to configure theexternal charger101 into a Locate mode. Alternatively, the user can decide independently to enter the Locate mode (e.g., through a menu selection).
• When configured in the Locate mode, theexternal charger101 prompts the user to adjust the orientation of theexternal coil102 to achieve an alignment (e.g., coaxial alignment) facilitating better coil interaction. Theexternal charger101 also provides feedback to the user indicating the current degree of alignment of thecoils102,105. Examples of such feedback include audio signals, lit LED's, bar graphs or other textual, graphical, and/or auditory signals provided to the user.
• In general, when theexternal charger101 is configured in the Locate mode, the user sweeps theexternal coil102 back and forth across the general location of the implantedneuroregulator104. During the sweep, theexternal charger101 sends a locator signal S₁to the implanted coil105 (seeFIG. 7). The implantedcoil105 responds with a feedback signal S₂(FIG. 7). Theexternal charger101 analyzes the feedback signal S₂to determine the strength of the transmission link between thecoils102,105.
• In an embodiment, theexternal charger101 keeps track of the strongest and weakest signals found during the sweep. The maximum signal strength and the minimum signal strength can be indicated to the user, e.g., via thevisual display172. These maximum and minimum values provide the user with context for judging the relative strength of a given signal at each location during the sweep. In an embodiment, the relative strength of the signal at a given position also can be displayed to the user as the user passes theexternal coil102 over the position.
• For example, in one embodiment, the first signal may be indicated initially as the maximum and minimum signal strength on thevisual display172. As theexternal coil102 is moved about, any subsequent signals having greater signal strength replace the maximum signal shown. The strength of any subsequent, weaker signal also can be tracked by theexternal charger101. The strength of the weakest signal can be indicated to the user as the minimum signal strength found. In one embodiment, if the strength of a subsequent signal falls between the currently established values for minimum and maximum, then an interpolated value representing the relative strength of the signal at the respective coil position can be displayed.
• Thus theexternal charger101 learns the maximum and minimum values for signal strength pertaining to external coil positions relative to the location of the implantedcoil105. By identifying the context of the signal strength measurements (i.e., the maximum and minimum signal strength found during a sweep), theexternal charger101 can provide consistent and context-sensitive measurements of signal strength to the user regardless of the distance of thecoil102 from the implantedcoil105. Such measurements facilitate identification of an optimum coil position.
• After the initial placement, theexternal coil102 may need to be repositioned with respect to the implantedcoil105 to maintain the signal integrity. Theexternal charger101 can monitor whether theneuroregulator104 is receiving signals having sufficient signal strength. If theexternal charger101 determines theneuroregulator104 is not receiving a sufficient signal, then theexternal charger101 may sound an alarm (e.g., auditory and/or visual) to alert the user that coil transmission effectiveness has been lost.
• In an embodiment, after indicating the loss of transmission effectiveness, theexternal charger101 may invite the user to configure theexternal charger101 into the Locate mode to reposition theexternal coil102. Alternatively, theexternal charger101 may invite the user to modify the position of theexternal coil102 without entering the Locate mode. In an embodiment, when the coil transmission effectiveness is re-established, the system automatically self-corrects and resumes therapy delivery.
• ii. Dynamic Signal Power Adiustment
• The amount of power received at theneuroregulator104 can vary due to relative movement of thecoils102,105 after the initial placement of theexternal coil102. For example, the signal strength may vary based on the distance betweencoils102,105, the lateral alignment of thecoils102,105, and/or the parallel alignment of thecoils102,105. In general, the greater the distance between thecoils102,105, the weaker the transmission signal will be. In extreme cases, the strength of the transmission signal may decrease sufficiently to inhibit the ability of theneuroregulator104 to provide therapy.
• Thecoils102,105 may move relative to one another when the patient moves (e.g., walks, stretches, etc.) to perform everyday activities. Furthermore, even when the patient is inactive, theexternal coil102 may be placed on tissue with substantial underlying fat layers. The surface contour of such tissue can vary in response to changes in patient posture (e.g., sitting, standing, or lying down). In the treatment of obesity, the distance from the top layer ofskin103 to the implantedcoil105 can vary from patient to patient. Moreover, the distance can be expected to vary with time as the patient progresses with anti-obesity therapy.
• In addition, the power consumption needs of theneuroregulator104 can change over time due to differences in activity. For example, theneuroregulator104 will require less power to transmit data to theexternal charger101 or to generate therapy signals than it will need to recharge the internal battery151.
• To overcome these and other difficulties, an embodiment of theexternal charger101 can change the amplification level of the transmission signal (e.g., of power and/or data) to facilitate effective transmission at different distances between, and for different relative orientations of, thecoils102,105. If the level of power received from theexternal charger101 varies, or if the power needs of theneuroregulator104 change, then theexternal charger101 can adjust the power level of the transmitted signal dynamically to meet the desired target level for the implantedneuroregulator104.
• Adjustments to the power amplification level can be made either manually or automatically. In an embodiment, theexternal charger101 may determine a target strength of the transmission signal (e.g., a predetermined strength selected to provide sufficient power to the neuroregulator104), assess the effectiveness of the transmission signals currently being sent to the implantedcoil105, and automatically adjust the amplification levels of the transmitted signals to enhance the effectiveness of the transmissions between theexternal coil102 and the implantedcoil105.
• For example, if theneuroregulator104 indicates it is recharging its battery151, then theexternal charger101 may establish a transmission link having a first power level appropriate for the task. At the conclusion of recharging, and when theneuroregulator104 subsequently indicates it will begin therapy delivery, then theexternal charger101 may change the power of the transmission link to a second power level sufficient to initiate therapy generation and delivery.
• Theexternal charger101 also may increase the power level of the signal if the signal is lost due to separation and/or misalignment of the coils. If theexternal charger101 is unable to sufficiently increase the power level of the transmitted signal, however, then theexternal charger101 may issue an alarm and/or an invitation to the user to reposition theexternal coil102 as described above.
• Theexternal charger101 also may decrease the strength of the signal (i.e., the amount of power) being sent to theneuroregulator104. For example, due to safety concerns, the amount of power that can be transmitted across skin via RF signals is limited. Receiving excessive amounts of power could cause theneuroregulator104 to heat up and potentially burn the patient.
• In an embodiment, theneuroregulator104 includes a temperature sensor (not shown) configured to monitor the temperature of theneuroregulator104. Theneuroregulator104 can communicate the temperature to theexternal charger101. Alternatively, theneuroregulator104 can issue a warning to theexternal charger101 if theneuroregulator104 becomes too warm. When the temperature of theneuroregulator104 is too high, theexternal charger101 may lower the power transmitted to the implantedcoil105 of theneuroregulator104 to bring the temperature down to an acceptable level. Alternatively, theneuroregulator104 may detune its receivingRF input circuit157 to reduce power and temperature.
• In a preferred embodiment, the temperature of theneuroregulator104 should not exceed the surface temperature of the surrounding skin by greater than about 2° C. (assuming a normal body temperature of 37° C.). Operational parameters, such as current, frequency, surface area, and duty cycle, also can be limited to ensure safe operation within the temperature limit. Further details regarding safety concerns pertaining to transdermal power transmission can be found, e.g., inThe Cenelec European Standard, EN 45502-1 (August 1997), page 18, paragraph 17.1, the disclosure of which is hereby incorporated by reference herein.
• In an embodiment, theexternal charger101 also can decrease the target power level based on a “split threshold” power delivery concept. In such an embodiment, theexternal charger101 initially provides a stronger signal than necessary to theneuroregulator104 to ensure sufficient power is available. Theexternal charger101 then reduces the strength of the transmissions to a level just above the necessary signal strength when the actual requirements have been established. This subsequent reduction in power saves drain on theexternal battery182 orpower source180.
• For example, theexternal charger101 can provide a low level of power capable of sustaining basic operation of theneuroregulator104 when theneuroregulator104 indicates it is not actively providing therapy or recharging its battery151. When theneuroregulator104 indicates it is about to initiate therapy, however, theexternal charger101 can increase the power level of the transmission signal to a first threshold level, which is comfortably in excess of the power required to provide basic operation of theneuroregulator104 as well as provide therapy. When the actual power requirements for therapy delivery become apparent, theexternal charger101 may decreases the power level of the signal to a second threshold level, which is closer to the minimum power level required to provide basic functionality and maintain therapy delivery.
• To perform this dynamic adjustment of signal strength, theexternal charger101 analyzes a feedback signal (e.g., signal S₂ofFIG. 7) received from the implantedneuroregulator104 indicating the amount of power required by theneuroregulator104. The signal S₂also may provide information to theexternal charger101 indicating the power level of the signal S₁being received by the implantedcoil105 of theneuroregulator104. Such signal analysis would be within the skill of one of ordinary skill in the art (having the benefit of the teachings of the present invention).
• In an embodiment, theexternal charger101 sets the signal power level based on a predetermined target power level for the transmission signal S₁. In response to the feedback signal S₂, theexternal charger101 modifies the power level of the transmission signal S₁to be within a tolerance range of the target power level. In an embodiment, theexternal charger101 iteratively modifies the power level of the transmission signal S₁until the feedback signal S₂indicates the power level is within the tolerance range.
• In addition to the dynamic adjustment of transmitted signal power described above, theneuroregulator104 can be configured to optimize the power received from theexternal charger101 when theneuroregulator104 is recharging its battery151. For example, theneuroregulator104 may tune (e.g., using a combination of hardware and software) the natural resonant frequency of a recharging circuit (not shown) to maximize the power delivered to a load resistance for a given set of input parameters such as voltage, current and impedance at the implantedcoil105.
• Transmission of power and/or information between theexternal charger101 and the implantedneuroregulator104 is typically performed using a carrier frequency of 6.78 MHz. Emission requirements of industrial, scientific and medical equipment are governed by Federal Communications Commission requirements described in FCC Title 47, Parts 15 and 18, and in EN 55011. The FCC requirements in the vicinity of this frequency are more restrictive than those of EN 55011.
• A preferred method for managing the temperature and carrier frequency of theneuroregulator104 during the recharging process includes passing a high power unmodulated transmission between theexternal charger101 and theimplantable neuroregulator104 for a finite time (e.g., from about half of a minute to about five minutes), during which time no informational communication takes place between theexternal charger101 and the implantable neuroregulator104 (i.e., no information is passed between thecharger101 and the neuroregulator104). At the conclusion of this finite time period, the unmodulated transmission ceases.
• An informational, modulated communicational transmission then is passed at low power (e.g., within the requirements of FCC Title 47 Part 15) during which the temperature of theimplantable neuroregulator104 is communicated periodically to theexternal charger101. If the temperature rises within certain restrictions (e.g., within the restrictions ofThe Cenelec European Standard, EN 45502-1 (August 1997), page 18, paragraph 17.1), then the communications transmission may be terminated, and the whole cycle may be repeated beginning with the initiation of the high power, unmodulated, recharging transmission.
• In an additional preferred embodiment, when the informational, modulated communicational transmission is performed, the requisite signal power is reduced by using only externally transmitted power for the telemetered communications, and by simultaneously using internal battery power to operate the rest of the implanted circuitry112 (FIGS. 3A and 3B), such as a microcontroller and/or peripherals. In such embodiments, the transmitted power may be less than if implant components (microcontroller and/or peripherals) also were receiving power from the RF transmission. Accordingly, the transmitted power may be limited to the power required for communications at short distances of six centimeters or less. Advantageously, such a power reduction reduces the total power required to below FCC Part 15 limits for telemetry communications.
• During the phase in which the battery151 of theimplantable neuromodulator104 is being recharged by a high powered, unmodulated transmission (e.g., under the requirements of FCC Title 47 Part 18), the temperature of the implantedneuroregulator104 may be monitored and, if necessary, steps taken to inhibit the temperature from exceeding certain requirements (e.g., the requirements ofThe Cenelec European Standard, EN 45502-1 (August 1997), page 18, paragraph 17.1). For example, the temperature may be reduced by terminating the high powered, unmodulated transmission. In an alternative embodiment, the power level of the high powered, unmodulated transmission may be reduced in later cycles to limit the increase in temperature. In another embodiment, a control loop is established between the temperature rise and the power level of the unmodulated transmission to ensure the increase in temperature always remains within the identified requirements.
• d. Implanted Leads
• FIG. 9 shows an example distal end of a bipolar lead, such as lead106 (seeFIG. 1). Thelead106 includes alead body210 curved to receive a nerve (e.g., a vagus nerve). Thelead body210 contains an exposedtip electrode212 configured to contact with the nerve received within thelead body210. Thetip electrode212 is capable of delivering an electrical charge to nerves having a diameter ranging from about one millimeter to about four millimeters.
• Thelead body210 also can have asuture tab214 to attach thelead body210 to the patient's anatomy to stabilize the position of thelead body210. A first end of aflexible lead extension216, which encloses a conductor from theelectrode212, couples with thelead body210. A second, opposite end of thelead extension216 terminates at a pin connector (not shown) for attachment to a connector (e.g., an IS-1 connector)122 (shown inFIG. 1).
• Thelead106 shown inFIG. 9 also includes aring electrode218 surrounding thelead extension216 at a position spaced from thetip electrode212. In an embodiment, the surface area of eachelectrode212,218 is greater than or equal to about thirteen square millimeters. Asuture tab220 may be provided for placement of thering electrode218 on the patient's anatomy in general proximity to the placement of thetip electrode212 on the nerve.
• In an alternative embodiment, a monopolar lead (not shown) may be implanted instead of thebipolar lead106. Typically, the monopolar lead is the same as thebipolar lead106, except the monopolar lead lacks aring electrode218. Such a monopolar lead is described in commonly assigned and co-pending U.S. patent application Ser. No. 11/205,962, to Foster et al, filed Aug. 17, 2005, the disclosure of which is hereby incorporated by reference.
• Further details pertaining to example electrode placement and application of treatment can be found, e.g., in U.S. Pat. No. 4,979,511 to Terry, Jr., issued Dec. 25, 1990; U.S. Pat. No. 5,215,089 to Baker, Jr., issued Jun. 1, 1993; U.S. Pat. No. 5,251,634 to Weinberg, issued Oct. 12, 1993; U.S. Pat. No. 5,531,778 to Maschino et al., issued Jul. 2, 1996; and U.S. Pat. No. 6,600,956 to Maschino et al., issued Jul. 29, 2003, the disclosures of which are hereby incorporated by reference herein.
2. Placement of Electrodes and Electrode Configuration Options
• FIG. 10 shows a posterior vagus nerve PVN and an anterior vagus nerve AVN extending along a length of a patient's esophagus E. The posterior nerve PVN and the anterior AVN are generally on diametrically opposite sides of the esophagus E just below the patient's diaphragm (not shown). Afirst tip electrode212 of a lead arrangement108 (FIG. 1) is placed on the anterior vagus nerve AVN. Asecond electrode212aof thelead arrangement108 is placed on the posterior vagus nerve PVN. Theelectrodes212,212aare connected byleads106,106ato a neuroregulator104 (FIG. 1).
• At the time of placement of theleads106,106a, it may be advantageous for thetip electrodes212,212ato be individually energized with a stimulation signal selected to impart a neural impulse to cause a detectable physiological response (e.g., the generation of antropyloric waves). The absence of a physiological response may indicate the absence of an overlying relation of the testedelectrode212,212ato a vagus nerve PVN, AVN. Conversely, the presence of a physiological response may indicate an overlying relation (e.g., correct placement) of the testedelectrode212,212ato a vagus nerve. After determining theleads106,106acreate a physiologic response, theelectrodes212,212acan be attached to the nerves PVN, AVN.
• A preferred embodiment of theleads106,106afor treating obesity is shown inFIG. 10. Thelead arrangement108 includes bipolar leads106,106a. The bipolar leads106,106aeach include one tip (i.e., or cathode)electrode212,212athat can be placed directly on the nerve PVN, AVN and one ring (i.e., or anode)electrode218,218athat is not placed on the nerve PVN, AVN, but rather may be attached to another structure (e.g., the stomach). In other embodiments, however, thelead arrangement108 may include monopolar leads (i.e., each lead106,106ahaving only atip electrode212,212a).
• Electrical connection between the neuroregulator104 and the therapy leads106,106ais made through bipolar IS-1 compatiblelead adapters122,122aattached to theneuroregulator104. If the bipolar lead design is used, two bipolar electrode pairs—one for the anterior vagus and one for the posterior vagus—are provided. One bipolar lead feeds a bipolar electrode pair. If the monopolar lead design is used, only the conductor connected to the distal tip electrode of each bipolar IS-1 connector is used.
• The therapies as previously described could be employed by using blocking electrodes or stimulation electrodes or both in order to down-regulate and/or up-regulate the vagus nerve. A blocking signal down-regulates a level of vagal activity and simulates, at least partially, a reversible vagotomy.
• Referring toFIGS. 11-18, the pacing signals to theelectrodes212,212acan be selected to create different types of signals and signal paths (referred to herein as “configurations”).FIGS. 11-18 illustrate four different electrode configurations.
• a. Blocking Electrode Configuration (1)
• A first blocking electrode configuration is shown inFIG. 11. This configuration creates a current path (seearrow1 inFIG. 11) with current flowing between the anterior and posterior nerves AVN, PVN. Thetip electrodes212,212a, which are located directly on the anterior and posterior vagal nerves AVN, PVN, respectively, are electrically active. Theanodic ring electrodes218,218aare not energized.
• A continuous waveform (e.g., the square waveform W₁₀shown inFIG. 12) propagates along the current path (see arrow1) extending across the esophagus E. Such an electrode configuration is generally monopolar (i.e., only one location on each nerve PVN, AVN is subject to the treatment) and could be accomplished with monopolar leads (i.e., leads withoutring electrodes218,218a).
• b. Blocking Electrode Configuration (2)
• FIG. 13 illustrates a second blocking electrode configuration in which each of thetip electrodes212,212ais associated with ananode electrode218,218a, respectively. Therapy signals are applied only to the anterior vagus nerve AVN between thedistal electrode212 and theanode electrode218. Advantageously, current (seearrow2 inFIG. 13) does not flow through the esophagus E, thereby decreasing the likelihood of the patient sensing the treatment (e.g., feeling discomfort or pain).
• In general, theanode electrodes218,218acan be positioned on any anatomical structure. In a preferred embodiment, theanode electrodes218,218aare placed on structures in generally close proximity (e.g., within about five centimeters) of thetip electrodes212,212a. For example, theanode electrodes218,218acan be placed on the same vagal nerve PVN, AVN as the anode electrode's associatedelectrode212,212a.
• In other embodiments, however, theanode electrodes218,218acan be placed on the stomach, the esophagus, or other anatomical structure in the general vicinity of theelectrodes212,212a. In an embodiment, theanode electrodes218,218acan be placed on the stomach to permit monitoring of stomach contractions (e.g., by strain receptors associated with theanode electrodes218,218a). The arrangement ofFIG. 13 results in a pacing waveform W₁₁(FIG. 14).
• c. Blocking Electrode Configuration (3)
• FIG. 15 illustrates the same electrode configuration shown inFIG. 13, except the signals are applied only to the posterior vagus nerve PVN between thetip electrode212aand theanode electrode218a. The corresponding current path is shown byarrow3 inFIG. 15. In an embodiment, the example signal waveform W₁₂(seeFIG. 16) propagating across the current path is the same as the waveform W₁₁inFIG. 14. In other embodiments, however, any desired waveform can be utilized.
• d. Blocking Electrode Configuration (4)
• The electrode configuration ofFIG. 17 is generally the same as the electrode configurations ofFIGS. 11,13 and15. InFIG. 17, however, an electrically active anode (e.g.,ring electrode218,218a) and cathode (e.g.,tip electrode212,212a) are associated with each nerve PVN, AVN to provide a dual channel system. Such an electrode arrangement routes current flow through both nerves PVN, AVN as indicated byarrows4.
• In an embodiment, a first electrode (e.g., thetip electrode212,212a) is placed directly on each of the nerve trunks and a second electrode (e.g.,ring electrode218,218a) is located in proximity to the first electrode. Two waveforms (e.g., an anterior nerve waveform W_12Aand a posterior nerve waveform W_12Pshown inFIG. 18) are generated. In the example shown, the pulses of one of the waveforms occur during no-pulse periods of the other waveform. In such a configuration, a complete charging and rebalancing cycle can occur on one channel before the second channel is charged and rebalanced. Accordingly, only one channel is electrically paced at a time. Typically, the electrodes on the nerve are energized cathodically first.
3. Post-Operative Testing of Electrodes
• After completing implantation, assembly, and positioning of theneuroregulator104 and theelectrode arrangement108, a physician can determine the lead integrity by measuring the lead impedance and assessing whether the lead impedance is within an acceptable range. If the lead impedance is within range, the physician can connect an external computer107 (e.g., a clinician computer) to the external charger101 (seeFIG. 1).
• Theclinician computer107 can transmit treatment therapy settings and treatment data to theneuroregulator104 via theexternal charger101. Theclinician computer107 also can retrieve data from theexternal charger101 orneuroregulator104. For example, in one embodiment, theclinician computer107 detects serial numbers of theexternal charger101 andneuroregulator104 automatically. After adjustment of blocking parameters and retrieval of data, theclinician computer107 may be disconnected from theexternal charger101.
• After the patient has adequately recovered from the surgery (e.g., approximately fourteen days after the implantation surgery), the physician may program initial treatment parameters into theexternal charger101. For example, the physician can couple theclinician computer107 to theexternal charger101 and follow menu commands on thecomputer107 to upload select therapy programs to theexternal charger101. In certain embodiments, the uploaded programs can then be transferred to the implantedneuroregulator104.
• Additionally, the physician can use theclinician computer107 to select treatment start times for the patient. In an embodiment, treatment start times are selected based on the individual patient's anticipated waking and initial meal times. The start times can be set differently for each day of the week. Further details regarding scheduling treatment will be discussed herein with respect toFIG. 19.
4. System Software
• Theexternal charger101 and theneuroregulator104 contain software to permit use of thetherapy system100 in a variety of treatment schedules, operational modes, system monitoring and interfaces as will be described herein.
• a. Treatment Schedule
• To initiate the treatment regimen, the clinician downloads a treatment specification and a therapy schedule from anexternal computer107 to theexternal charger101. In general, the treatment specification indicates configuration values for theneuroregulator104. For example, in the case of vagal nerve treatment for obesity, the treatment specification may define the amplitude, frequency, and pulse width for the electrical signals emitted by the implantedneuroregulator104. In another embodiment, “ramp up” time (i.e., the time period during which the electrical signals builds up to a target amplitude) and “ramp down” time (i.e., the time period during which the signals decrease from the target amplitude to about zero) can be specified.
• In general, the therapy schedule indicates an episode start time and an episode duration for at least one day of the week. An episode refers to the administration of therapy over a discrete period of time. Preferably, the clinician programs an episode start time and duration for each day of the week. In an embodiment, multiple episodes can be scheduled within a single day. Therapy also can be withheld for one or more days at the determination of the clinician.
• During a therapy episode, theneuroregulator104 completes one or more treatment cycles in which theneuroregulator104 sequences between an “on” state and an “off” state. For the purposes of this disclosure, a treatment cycle includes a time period during which theneuroregulator104 continuously emits treatment (i.e., the “on” state) and a time period during which theneuroregulator104 does not emit treatment (i.e., the “off” state). Typically, each therapy episode includes multiple treatment cycles. The clinician can program the duration of each treatment cycle (e.g., via the clinician computer107).
• When configured in the “on” state, theneuroregulator104 continuously applies treatment (e.g., emits an electrical signal). Theneuroregulator104 is cycled to an “off” state, in which no signal is emitted by theneuroregulator104, at intermittent periods to mitigate the chances of triggering a compensatory mechanism by the body. For example, if a continuous signal is applied to a patient's nerve for a sufficient duration, the patient's digestive system eventually can learn to operate autonomously.
• An exampledaily treatment schedule1900 is schematically shown inFIG. 19. Thedaily schedule1900 includes a timeline indicating the times during the day when the treatment is scheduled to be applied to a patient. Duty cycle lines (dashed lines) extend along the time periods during which treatment is scheduled. For example, a first episode is scheduled between 8 AM and 9 AM. In certain embodiments, thetreatment schedules1900 address other details as well. For example, thedaily schedule1900 ofFIG. 19 indicates details of the waveform (e.g., ramp-up/ramp-down characteristics) and details of the treatment cycles.
• b. System Operational Modes
• Thetherapy system100 can be configured into two basic operational modes—a training mode and a treatment mode—as will be described herein. In an embodiment, thetherapy system100 also can be configured into a placebo mode for use in clinical trials.
• i. Training Mode
• The training mode is used post-operatively to train the patient on using thetherapy system100. In this mode, electrical signals are not delivered to the nerves for the purpose of creating blocking action potentials. In a preferred embodiment, theneuroregulator104 does not generate any electrical signals. In some embodiments, the training therapy setting can be preset by the therapy system manufacturer and are unavailable to the treating physician.
• The training mode allows the physician to familiarize the patient with the positioning of theexternal charger101 relative to the implantedneuroregulator104. The physician also instructs the patient in how to respond to the feedback parameters within thetherapy system100. Training also can cover information and menus which can be displayed on theexternal charger101, for example: the status of thebattery182 of theexternal charger101, the status of the battery151 of the implantedneuroregulator104, coil position, lead/tissue impedances, and error conditions.
• The physician also can train the patient in how to interact with theexternal charger101. In an embodiment, the patient interacts with theexternal charger101 using theselection input button174. For example, by successively pressing thebutton174, the patient can select one of multiple device operations, such as: device reset, selective interrogation of battery status, and coil position status.
• ii. Treatment Mode
• The treatment mode is the normal operating mode of theneuroregulator104 in which theneuroregulator104 applies a blocking signal to the nerves using blocking therapy settings. In general, the therapy settings are specified by the physician based on the specific needs of the patient and timing of the patient's meals. In some embodiments, theneuroregulator104 controls the therapy being provided according to therapy programs and schedules stored on theneuroregulator104. In other embodiments, theneuroregulator104 follows the instructions of theexternal charger101 to deliver therapy.
• iii. Placebo Mode
• This mode may be used for patients randomized to a placebo treatment in a randomized, double-blind clinical trial. In this mode, theneuroregulator104 does not apply therapy signals to thelead arrangement108. Rather, in different embodiments, therapy signals can be supplied to a dummy resistor to drain the internal power source151 (FIG. 3) of theneuroregulator104.
• Theexternal charger101 interacts with the patient and the physician as if therapy was being applied. For example, the patient and/or physician can view system status messages and a battery drain rate of theexternal charger101 andneuroregulator104. Because theexternal charger101 functions as normal, the physician and the patient are blind to the fact that no significant therapy is being applied.
• To give the patient the sensation that therapy is being applied, current pulses may be applied to the vagal nerve trunks during impedance measurements at the start of therapy. However, no therapy is delivered during the remainder of the blocking cycle. These sensations are felt by the patient and provide a misleading indication of activity. These sensations, therefore, help in maintaining the double blindness of the study.
• c. Treatment Therapy Settings
• Theneuroregulator104 is configured to provide therapy signals to theelectrode arrangement108. In general, the therapy signals can induce stimulation of the nerves, blocking of nerve impulses, or some combination of the two.
• i. Blocking Treatment
• During treatment, theneuroregulator104 provides blocking signals to the nerves of a patient. Blocking signals include high frequency waveforms that inhibit the transmission of signals along the nerves. In general, the physician selects and sets therapy settings (e.g., waveform characteristics and treatment schedule) based on meal times and a patient's eating pattern. In an embodiment, thetherapy system100 can provide a choice of at least three unique blocking therapy settings which can be applied as part of a daily treatment schedule.
• ii. Low Frequency Mode
• The low frequency mode provides low frequency stimulating signals along the patient's nerves to create a brief, potentially observable, physiological response as an intra-operative screen. Such a physiologic response could be, for example, the twitching of a muscle or organ, such as the stomach.
• This therapy setting may be used by the physician to confirm correct electrode placement. The system operates in this mode for short time periods and, typically, only when the patient is under physician care. This mode may be accessed through the programmer interface. In an embodiment, this mode can be enabled/disabled (e.g., by the manufacturer) through the programming interface.
• iii. Temporary Test Therapy Setting Mode
• Thetherapy system100 has the ability to program special treatment/testing therapy settings to support “one-time” physiological evaluations. Special testing therapy parameters can be preset (e.g., by the manufacturer) to be made available for use by the physician.
• d. System Monitoring
• Thetherapy system100 facilitates monitoring the operation of thetherapy system100 and its components. By monitoring the operation of thetherapy system100, faults and malfunctions can be caught early and dealt with before becoming problematic. Thetherapy system100 can record the operation and/or the fault conditions for later analysis. Thetherapy system100 also can notify the patient and/or physician of the system operating status and non-compliant conditions. For example, an error message can be displayed on screen172 (seeFIG. 5) of theexternal charger101 or on a display screen (not shown) of the external computing device107 (seeFIG. 1).
• Embodiments of thetherapy system100 can confirm proper functioning of and communication between the components of thetherapy system100. For example, thetherapy system100 can monitor the link strength between theexternal charger101 and theneuroregulator104. In an embodiment, immediate feedback indicating the link strength can be provided to the patient (e.g., through thedisplay172 of the external charger101) and/or to the physician (e.g., through the external computing device107).
• Thetherapy system100 also can determine one or both of thecoils102,105 are broken, shorted, or disconnected. In an embodiment, thetherapy system100 determines whether thecoils102,105 are operational by measuring the impedance between the coils and determining whether the measured impedance falls within an acceptable range.
• Thetherapy system100 also can measure the impedance between theelectrodes212,212aof thelead arrangement108 and determine whether the impedance is out of range (e.g., due to inadequate electrode-nerve contact, or shorted electrodes). Details regarding the measurement of lead impedance are discussed later herein. Impedance measurements also can be used to verify proper lead placement, verify nerve capture, and monitor stomach contraction during the implant procedure.
• Thetherapy system100 also can communicate other types of system errors, component failures, and software malfunctions to the patient and/or physician. For example, thetherapy system100 can monitor the battery status (e.g., low battery, no charge, battery disconnected, etc.) of theneuroregulator104 and/or theexternal charger101 and warn the patient and/or physician when the battery should be recharged and/or replaced.
• Thetherapy system100 can indicate an inability to deliver a signal having the specified current (e.g., due to the impedance being out of range or due to internal component failure) to thelead arrangement108 during treatment delivery. Thetherapy system100 also can indicate whether theexternal charger101 and/or theneuroregulator104 have sufficient power to transmit and/or receive signals (e.g., based on antenna alignment, battery power, etc.).
• i. Lead Impedance Measurement
• Embodiments of thetherapy system100 have the ability to independently measure and record lead impedance values. Lead impedance values outside a predefined range may indicate problems or malfunctions within thetherapy system100. High impedance, for example, could mean that theelectrodes212,212aare not properly coupled to the nerves of the patient. Low impedance could mean inappropriate shorting of theelectrodes212,212a.
• These embodiments of thetherapy system100 allow the physician to measure lead impedance on-demand. Thetherapy system100 also can enables the physician to periodically measure impedance (e.g., during the Training Mode) without initiating a blocking therapy setting. Generally, impedance is measured and stored separately for each channel of each electrode configuration. These measurements may be used to establish a nominal impedance value for each patient by calculating a moving average. The nominal impedance and impedance tolerance range can be used for system non-compliance monitoring, as will be described below.
• e. External Computer Interface
• Programmer software, with which the physician can program treatment configurations and schedules, resides on and is compatible with an external computing device107 (FIG. 1) that communicates with theexternal charger101. In general, application software for thecomputing device107 is capable of generating treatment programs stored in a commonly accepted data file format upon demand.
• The programming interface of thecomputing device107 is designed to enable the physician to interact with the components of thetherapy system100. For example, the programming interface can enable the physician to modify the operational modes (e.g., training mode, treatment mode) of theexternal charger101. The programming interface also can facilitate downloading treatment parameters to theexternal charger101. The programming interface enables the physician to alter the treatment parameters of theneuroregulator104, and to schedule treatment episodes via theexternal charger101.
• The programming interface also enables the physician to conduct intra-operative testing amongst the components of thetherapy system100. For example, the physician can initiate a lead impedance test via the programming interface. The physician also can program temporary treatment settings for special physiologic testing. The programming interface also can facilitate conducting diagnostic stimulation at follow-up visits between the patient and the physician.
• The programming interface of thecomputing device107 also enables the physician to access patient data (e.g., treatments delivered and noted physiological effects of the treatment). For example, the programming interface can enable the physician to access and analyze patient data recorded by the therapy system100 (e.g., stored in thememory152 of theneuroregulator104 and/or thememory181 of the external charger101). The physician also can upload the patient data to theexternal computing device107 for storage and analysis.
• The programming interface also can enable the physician to view system operation information such as non-compliant conditions, system faults, and other operational information (e.g., lead impedance) of thetherapy system100. This operational data also can be uploaded to theexternal computing device107 for storage and analysis.
• i. Programming Access Level
• In certain embodiments, the programming interface defines at least two levels of access, one for the physician and one for the system manufacturer. The programming interface can provide different types of information to a requestor depending on what level of access the requestor has. For example, the programming interface may enable the system manufacturer to program system settings (e.g., default values for treatment parameters, acceptable ranges for treatment parameters and/or system settings, system tolerances, etc.) that cannot be adjusted by the physician.
• In an embodiment, a user with a high level of access can select, for each system setting, the level of access required before the programming interface will enable a user to modify the system setting. For example, the system manufacturer may wish to prevent treating physicians from modifying default treatment settings. It will be appreciated that generating software implementing the above-described features of the programming interface is within the skill of one of ordinary skill in the art having the benefits of the teachings of the present application.
5. Charge Balancing
• Nerves may be damaged when exposed to direct current (e.g., net current from electrical stimulation) over extended periods of time. Such damage may result from very small net currents acting over a long time, e.g. microamperes of current over minutes. For example, direct current can be caused by a voltage buildup at theelectrodes212,212a(FIG. 1) due to inherent differences in electrode component values.
• Charge-balancing advantageously mitigates (and may eliminate) damage to the nerve due to charge build-up during treatment. However, conventional processes for achieving a current/charge balance to within (for example) 1 μA in a current of about 6 mA place inordinate requirements on the implantable device of providing consistent power at a consistent frequency. Below are descriptions of two processes for balancing charge, a timing process and a shorting process, that do not require such inordinate consistency.
• a. Timing Correction
• Referring toFIGS. 20-24, charge or current on the patient's nerves can be balanced by applying a correction to a pulse-width PW of a treatment signal pulse2000 over a number of cycles (seeFIG. 20). A cycle refers to a single iteration of the pulse. The correction includes adding or subtracting a “timer tick” to the pulse-width PW of at least one phase of the treatment signal pulse2000 to increase or decrease the pulse-width for a period of time. In an embodiment, an example timer tick can equate to the minimum resolution of the applied clock frequency (e.g., about 560 nanoseconds).
• Typically, the treatment signal pulse2000 is a bi-phasic (e.g., having a negative phase and a positive phase) pulse signal having a pulse-width PW. In general, the negative charge provided by the first phase of the signal pulse2000 is balanced by the positive charge provided by the second phase of the signal pulse2000. One or more timer ticks can be added to one or both phases of the pulse2000 to correct a charge imbalance.
• In the example shown inFIG. 20, the first phase of the signal pulse2000 has a first pulse-width PW1 and the second phase of the signal pulse2000 has a second pulse-width PW2. One or more timer ticks can be added to the pulse-width PW1, PW2 of one or both phases of the signal pulse2000. For example, the pulse-width PW1 of the first phase can be increased by two timer ticks to a pulse-width of PW1′. Alternatively, the pulse-width PW2 of the second phase can be decreased by two timer tick to a pulse-width of PW2′.
• To determine the number of timer ticks to add or subtract from each pulse-width, theneuroregulator104 periodically can measure the voltage of the signal applied to eachlead electrode212,212aoflead arrangement108. The combination of charge buildup sensing and pulse width control creates a feedback loop to minimize the resulting voltage offset. Advantageously, this sense and control process is effective in the presence of physiologic variations, circuit tolerances, differences in electrode size, and temperature changes.
• For example, as shown inFIGS. 3A and 3B, the electrodes of each lead (e.g., thetip electrodes212,212ain contact with the anterior and posterior vagal nerves AVN, PVN, respectively) are coupled to theCPU154 of theneuroregulator104 via acapacitive divider162. TheCPU154 provides timed instructions to theoutput module161 for controlling the voltage measurements V_A, V_Bof the signals applied by theelectrodes212,212a(FIG. 1).
• Between pulses, themicroprocessor CPU154 can zero thecapacitive divider162, release thecapacitive divider162 at a predetermined time relative to the signal cycle, and measure the voltages V_A, V_Bof theelectrodes212,212a. For example, theCPU154 can zero thecapacitive divider162, release thecapacitive divider162 approximately ten microseconds into a negative phase of the pulse, and measure the voltages V_A, V_B(seeFIG. 20). TheCPU154 can subsequently measure the voltages V_A, V_Bat approximately 10 microseconds into a positive phase of the pulse. If the voltage measurement V_Aof theelectrode212 is greater than the voltage measurement V_Bof thesecond electrode212a, then theCPU154 delivers instructions to decrease the pulse width (e.g., by about 560 nanoseconds) of the negative phase of the pulse of the next/subsequent cycle.
• The above process may be repeated at a sampling frequency (e.g., typically about 40 Hz). Gradually, the number of pulse width corrective increments (“timer ticks”) applied to the signal can be adjusted. For example, the pulse width PW1 of the positive phase of the pulse can be increased or decreased every sample period until the voltage measurement V_Aof thefirst electrode212 is less than the voltage measurement V_Bof thesecond electrode212a. In such a case, the pulse width PW2 of the negative pulse then can be increased to achieve balance. When the maximum pulse width PW2 of the negative phase of the pulse is reached, then the pulse width PW1 of the positive phase of the biphasic pulse may be decreased to maintain balance. In a preferred embodiment, the corrective increment is applied to a series of signals until the net offset current is well below a target current (e.g., about 1 μA).
• In an embodiment, the amplitudes of the positive and negative phases of the pulse are compared very early in the cycle, and a relatively large correction is initially applied to the pulse width of the signal. Subsequently, the balancing correction is refined by changing the pulse width by only the one or two ticks as described above.
• Advantageously, the charge-balancing goal can be achieved over a number of these cycles using the above described processes without requiring a high clock frequency. Because the charge buildup tends to be a slow process, correcting the charge buildup can be done less frequently than delivering therapy signals. For example, in an embodiment, therapy signals can be delivered at about 5 kHz and correction pulses can be delivered at about 40 Hertz.
• FIG. 21 illustrates an example application of charge balancing through timing corrections.FIG. 21 illustrates a blocking waveform222 (e.g., a biphasic, symmetric current waveform), which results in avoltage waveform224 at the electrode-tissue interface. Thevoltage waveform224 includes anexponential voltage component226 which reflects the fact that the electrode-tissue interface has capacitive elements, resulting in charging and discharging of this capacitance.
• In one cycle of thecurrent waveform222, the charge applied to the electrode-tissue interface is balanced when the voltages V_Cand V_Dare equal. Accordingly, in such a case, the net potential of the electrode-tissue interface is zero. As described above, however, there are a number of reasons why, in practice, voltages V_Cand V_Dmay not be equal, resulting in a charge imbalance.
• Typically, in practical operation, the voltage values of V_Cand V_Dare measured periodically (e.g., about every 25 milliseconds). If the voltage V_Cis greater than the voltage V_D, then thepulse width228 of the first phase of thecurrent waveform222 is reduced by one “timer tick,” and applied for about 1 millisecond. At the end of subsequent measurement periods (e.g., about every 25 milliseconds), the values of voltages V_Cand V_Dare measured again. When the voltage V_Cis greater than the voltage V_D, thepulse width228 of the first phase is reduced by an additional timer tick. Thecurrent waveform222 having the phase with the reduced pulse-width228 is applied for an additional 1 millisecond.
• When the value of the voltage V_Cis eventually less than the value of the voltage V_D, then thepulse width228 of the first phase can be increased by one timer tick for 1 millisecond for each measurement period. In this situation, it may be that the maximum pulse width (as determined by the applied frequency of the therapy)228, is reached while the voltage V_Cis still less than the voltage V_D. If this occurs, then thepulse width230 of the second phase of thecurrent pulse222 is decreased one timer tick at a time, as described above, until equilibrium is established (i.e., V_C=V_D).
• Additionally, in the methods represented byFIGS. 20 and 21, themicroprocessor CPU154 can short out theelectrodes212,212aat the beginning, midpoint and/or end of the biphasic, square-wave, current pulse, as described in more detail herein. Over a series of such sampling cycles, it has been demonstrated that the net offset current is well below the design goal of 1 μA.
• During a feedback cycle, software stored in themicroprocessor CPU154 can initiate a therapy shut down if the sensed voltage offset exceeds safe values. This is an advantageous feature in actual use, where electrode configurations and other parameters could vary.
• By using a combination of both hardware (i.e., electrode shorting) and closed-loop software techniques, the average charge imbalance may be lower than with either method individually.
• At the end of therapy delivery, it is useful to have the hardware briefly drain any residual charge. Subsequently, the circuitry may be made safe until the next therapy delivery and the software loop turned off.
• b. Shorting Correction
• Some processing for achieving charge balance have involved the use of biphasic pulses in which, for example, the negative charge provided by the first part of the waveform is balanced by the positive charge provided by the second part of the waveform. Further details describing the use of electrode shorting to achieve charge balancing can be found in U.S. Pat. No. 4,498,478 to Bourgeois, issued Feb. 12, 1985; U.S. Pat. No. 4,592,359 to Galbraith, issued Jun. 3, 1986; and U.S. Pat. No. 5,755,747 to Daly et al, issued May 26, 1998, the disclosures of which are hereby incorporated by reference herein.
• FIGS. 22-24 illustrate a preferred charge balancing process.FIGS. 22 and 23 schematically illustrate an implantedcircuit112 of aneuroregulator104 connected tonerve electrodes212,212a. Thecircuit112 has components schematically illustrated as aswitch150 for selectively creating an electrical short between theelectrodes212,212a. InFIG. 22, theswitch150 is arranged in a short state to create an electrical short betweenelectrodes212,212a. InFIG. 23, theswitch150 is arranged in a non-short state with no short being created between theelectrodes212,212a.
• FIG. 24 schematically illustrates signal waveforms W₁, W₂, W_1A, W_2Aproduced at theelectrodes212,212aunder various conditions of operation of theswitch150. The waveforms W₁and W₂show the signals produced atelectrodes212,212a, respectively, when theswitch150 is arranged in the non-short state. Each waveform W₁and W₂has a negative pulse and a positive pulse of equal pulse width PW. The waveforms W₁, W₂are out of phase so that the negative pulses of the waveform W₁occur during the positive pulses of the waveform W₂.
• It will be appreciated, these waveforms are illustrative only. Any other waveform (e.g., the time offset waveform W_12AofFIG. 18 could be used). In addition, while the short is shown betweenelectrodes212,212a, the short alternatively or additionally could be created between cathode and anode pairs212,218 and212a,218a, previously described.
• In the example shown, theswitch150 is operated to create a short betweenelectrodes212,212aat the start of each pulse and for a duration Ds. The waveforms atelectrodes212,212aresulting from such shorting are shown inFIG. 24 as W_1A, W_2A. As a result of the short, any charge build-up at an electrode (e.g., electrode212) is distributed to the oppositely charged electrode (e.g.,electrode212a). The pulse width PW of each pulse is reduced to a pulse width PW_A. Advantageously, repeating this process throughout the therapy maintains any net charge build-up below tolerable levels.
• The example given shows the short state occurring at the beginning of each signal pulse. This is illustrative only. The short state can occur at the beginning, end or any intermediate time of a signal pulse. Furthermore, the short state need not be applied to every pulse, but rather can occur intermittently throughout the pulse cycles or even during time delays between pulses. When applied during a pulse cycle, the duration Ds of the short is preferable not greater than about 10% of the pulse width PW. For example, the duration Ds can range from about 10 μs to about 20 μs.
6. Therapy Calibration and Safety Limits
• The design of the neuroregulator104 (FIG. 3) includes acapacitive divider162 and anoutput module161 to measure the voltage present at the lead arrangement108 (e.g., thetip electrodes212,212aand/orring electrodes218 and218aof both anterior and posterior leads106,106a). Theoutput module161 can measure the current flow through the electrodes arranged in any of the four electrode configurations (seeFIGS. 11,13,15, and17). A programmable current source (not shown) can enable a physician to select how current is delivered through theelectrodes212,212a,218, and218ato the nerve.
• Before therapy is delivered, the physician can calibrate theneuroregulator104 to ensure the desired current can be delivered to the nerves. For example, this calibration can be accomplished by connecting the programmable current source from a power source to ground and adjusting the current to the desired level. Current does not flow through theleads106 during this calibration procedure. If the desired current cannot be delivered, or if the DC voltage offset is greater than a programmed limit, then the therapy can be terminated (e.g., such conditions trigger a flag or error alert).
• Advantageously, calibrating thetherapy system100 significantly reduces the effect of component tolerance, drift, and aging on the amount of current delivered. Temperature effects are not likely to be significant since theneuroregulator104 is at body temperature when implanted. In addition, thecapacitive divider162 can be calibrated before therapy is delivered. Advantageously, calibrating thedivider162 can enhance the accuracy of the safety checks from a 20% worst case value to approximately 2%.
• During therapy, the current between the active electrodes is measured during each signal pulse to ensure that the delivered current is within the programmed tolerance (e.g., +/−about 5%).
• Additionally, in order to determine the state of charge balance, thetherapy system100 can determine a peak-to-peak voltage quantity for each signal pulse. The peak-to-peak voltage quantity is divided by two and compared to the peak voltage measurement of each phase of the waveform. If the deviation exceeds a predetermined value, the therapy can be shut down.
• The normal shutdown of theoutput module161 shorts the electrodes together and connects them to ground through one of the current sources. Normally, this is a desirable and safe condition. However, certain failures could cause current to flow after shutdown, resulting in damage to the nerve. To eliminate this problem, an additional check can be made after normal shutdown has been completed. If current flow is detected, the leads are disconnected from each other (allowed to float) and the current sources are programmed to zero current.
7. Auto-Increment Therapy Delivery
• For blocking therapy to be effective, energy delivery may need to be increased beyond the level that a patient perceives as acceptable at the initiation of therapy. The power of the therapy signals can be increased in small increments to enable the patient to acclimate to the more powerful therapy signals.
• For example, the current of the therapy signal can be increased in steps of about 1 mA at weekly follow-up visits. Over time, patients may willingly accept multiple increments of 1 mA/week through periodic follow-up visits and programming sessions. For example, an initial setting of 3 mA may rise to at least 6 mA as a result of such follow-up sessions.
• In certain embodiments of thetherapy system100, energy (i.e., power) delivery can be incrementally increased or decreased automatically over a pre-determined period of time. Advantageously, this automatic incremental increase can mitigate the need for frequent doctor office visits. This flexibility is especially convenient for patients who are located remote from the implanting bariatric center.
• In an embodiment, thetherapy system100 automatically increases the current of the therapy signal by, for example, 0.25 mA every other day, cumulatively achieving the 1 mA/week incremental increase. In another embodiment, thetherapy system100 increases the current by about 0.125 mA per day. Initial studies have demonstrated such increment levels as acceptable.
• The patient can retain the ability to turn therapy off at any time and return to the physician for re-evaluation. Alternatively, the patient can revert to previously acceptable therapy delivery levels (e.g., the therapy level of the previous day). For example, the patient can interact with theexternal charger101 to issue such an instruction.
• The physician can choose whether to activate the auto-increment therapy capability. The physician also can specify the date and/or time of therapy initiation and therapy parameters (e.g., including the starting and ending therapy parameters). The physician also may specify safety limits or tolerances for the therapy parameters. Additionally, the physician can specify the rate at which the therapy parameters are incremented over various time periods (e.g., about 0.5 mA/day for the first 7 days, then 0.125 mA/day over the following 24 days).
8. Predetermined Programs
• One or more therapy programs can be stored in the memory of theexternal computer107. The therapy programs include predetermined parameters and therapy delivery schedules. For example, each therapy program can specify an output voltage, a frequency, a pulse width, ramp-up rates, ramp-down rates, and an on-off cycle period. In an embodiment, the ramp-up rates and ramp-down rates can be individually and separately programmed.
• In use, the physician may select any one of these therapy programs and transmit the selected therapy program to the implanted neuroregulator104 (e.g., via the external charger101) for storage in the memory of theneuroregulator104. The stored therapy program then can control the parameters of the therapy signal delivered to the patient via theneuroregulator104.
• Typically, the parameter settings of the predetermined programs are set at the factory, prior to shipment. However, each of these parameters can be adjusted over a certain range, by the physician, using thecomputer100 to produce selectable, customized, predetermined therapy programs. Using these selectable, customized therapy programs, the physician can manage the patient's care in an appropriate manner.
• For example, when patients require more varied therapies, theneuroregulator104 can store a therapy program including one or more combinations of multiple therapy modes sequenced throughout the day.
• For example, referring to electrode configuration shown inFIG. 10, a single therapy program can include instructions to apply a blocking signal between electrode tips212 (anterior vagal nerve) and212a(posterior vagal nerve) from 8 a.m. to noon at 6 mA and kHz; alternating between applying a blocking signal toposterior tip212ato ring218aand applying a blocking signal toanterior tip212 to ring218 from noon to 2 p.m. at 3 mA and 2.5 kHz; and applying a blocking signal fromelectrode tip212 toelectrode tip212afrom 2 p.m. from 2 p.m. to midnight at 6 mA and 5 kHz.
9. Operation Logs
• In general, theneuroregulator104 can have a time base to facilitate the delivery of therapy according to the treatment schedule. To determine this time base, theneuroregulator104 can maintain one or more operating logs indicating the operations of thetherapy system100.
• For example, theneuroregulator104 maintains a time-and-date-stamped delivery log of the actual delivery of therapy. For example, the delivery log can include the time and date of initiation of each therapy episode, the time and date of completion of the therapy episode, the therapy parameters associated with the therapy episode. Both scheduled therapy and automatically-initiated therapy can be logged. The delivery log also can include a parameter to indicate whether the therapy episode was scheduled or automatically initiated.
• Additionally, theneuroregulator104 can maintain a time-and-date-stamped error log of all conditions that interfered with the delivery of therapy. For example, the error log can record all impedances measured, temperatures measured by the on-board temperature sensor, each instance in which the battery was charged by theexternal charger101, each instance in which the battery reached its low-charge threshold, and each instance in which the battery reached its depleted threshold.
• The delivery log and the error log are readable by the external computer107 (e.g., a clinician programmer). In an embodiment, the delivery log and the error log each can accommodate up to about 3 months of data.
• 10. Detection of Food Passage through the Esophagus
• Neural blocking therapy can affect the rate at which the stomach empties and the level of intestinal motility. When applying neural blocking therapy for obesity control, it is desirable to determine the approximate times at which the patient ingests food (i.e., mealtimes) and the approximate quantity of food being consumed at each meal. Advantageously, with this information, the duty cycle of thetherapy system100 can be synchronized with the mealtimes. Additionally, the nature of the therapy can be adjusted in accordance with the quantity of food being consumed. For example, food detection is described in U.S. Pat. No. 5,263,480 to Wernicke et al, issued Nov. 23, 1993, the disclosure of which is hereby incorporated herein by reference.
• In certain embodiments of thetherapy system100, the anterior and posteriorvagal nerve electrodes212,212acan be positioned on the esophagus E adjacent to the junction between the esophagus E and the stomach. An impedance measurement between the anterior and posteriorvagal nerve electrodes212,212aprovides a measure of the presence of food in the esophagus E between theelectrodes212,212a(e.g., seeFIG. 11). The time integration of this impedance value provides a measure of the quantity of food consumed.
• The impedance value between theelectrodes212,212acan be measured by passing a low amplitude, sinusoidal signal (e.g., having a frequency of about 500-1000 Hz) between theelectrodes212,212a. In an alternative embodiment, the impedance can be measured by passing the signal between thering electrodes218,218a. In other embodiments, the dual bipolar lead/electrode configuration can operate as a quadripolar array.
• In a quadripolar electrode array, two pairs of electrodes are typically secured in generally the same plane and normal to the length of the esophagus E. In such a configuration, a small signal applied across one pair of the electrodes (e.g.,tip electrode212, ring electrode218) can be detected across the other pair (e.g.,tip electrode212a,ring electrode218a). In general, changes in relative amplitude of the detected signal are proportional to changes in resistance of the signal path.
• The impedance of the signal changes when food progresses down the esophagus E. This impedance change causes the amplitude of the detected signal to change, thereby providing an indication of the fact that food has passed, and giving an indication of the quantity of food. While a bipolar electrode pair may be used for both signal application and sensing across the esophagus E, it has the disadvantage of some interference as a result of polarization potentials.
• More generally, this technology can be used to detect changes in the nature of the fluid within a vessel or lumen of the body. Such technology can be utilized in multiple applications. For example, this impedance measurement technology can be used to detect the presence of liquid/food in the distal esophagus to ascertain the presence of esophageal reflux. In another embodiment, this impedance measurement technology can be used in diagnosing eating abnormalities, such as bulimia.
• In one embodiment, the time history of the transesophageal impedance measurement is recorded in the memory of the implanted module (e.g., in an operating log), for later telemetry to the external module, for review and analysis by the physician. With this information, the physician can preferentially choose the operating parameters of the system to best suit the eating habits of an individual patient.
• In an alternative embodiment, the output of the transesophageal impedance measurement becomes a control input intoCPU154 ofcircuit112 in neuroregulator104 (FIG. 3). The therapy signal output of theneuroregulator104 can be timed automatically to correspond to the timing and quantity of food consumed via a suitable algorithm.
11. Activity Monitoring System
• The weight reduction resulting from the application of therapy described in this patent application is expected to produce an increased feeling of well-being in the patient, and possibly an increase in the amount of activity in which the patient is comfortable becoming involved.
• In certain embodiments, thetherapy system100 monitors the activity of the patient. Generally, thetherapy system100 records the change in activity over the course of treatment. The therapy is applied to accomplish a goal (e.g., obesity reduction), and the activity level as a consequence of achieving the goal (e.g., weight loss) is then measured.
• In an embodiment, this change in activity then can be mapped to the affects of the treatment. This mapping of the change in activity to the results of treatment can be personally advantageous to patients as well as advantageous to the medical community. For example, knowledge of the likely change, both in weight and in activity level, could be useful information for patients who are contemplating the implant and associated therapy.
• In addition, such mapping would advantageously provide documented evidence of the positive effect of the weight control system to reimbursement groups. Additionally, from a medical/scientific perspective, it is known that weight loss is generally related to caloric intake, activity level, and metabolic rate. Increased quantification in the area of activity level would aid in developing a robust relationship among these factors.
• There are a variety of methods which can be used for measuring activity level. Some of these models have been used as the basis for determining the preferred rate of implantable pacemakers and defibrillators. For example, a sensor of movement or acceleration (e.g., a gyroscope-based sensor), can provide an instantaneous measurement of activity level. Suitable hardware, software, and/or algorithm systems can then derive from these measurements the activity level averaged over a period of time (e.g., a 24 hr period).
• An accelerometer also can be used to track patient activity. Other examples of activity sensing options include tracking the respiratory rate of the patient, by monitoring bio-impedance measurements (e.g., intrathoracic impedance), measuring a minute volume of, e.g., a compendium of respiratory rate and tidal volume, and monitoring blood pH, blood oxygen level, and blood pressure. In each case, the instantaneous value of the measurement can be integrated over a suitable time period.
• With the foregoing detailed description of the present invention, it has been shown how the objects of the invention have been attained in a preferred manner. Modifications and equivalents of disclosed concepts such as those which might readily occur to one skilled in the art are intended to be included in the scope of the claims which are appended hereto.

Claims (6)

1. A method for providing therapy to a patient, comprising:

selecting initial values for the parameters of a therapy program;

programming an internal component implanted within a body of the patient to apply therapy to the patient according to the therapy program;

programming the internal component to increment the initial value of at least one of the parameters after a predetermined period of time by a predetermined amount to obtain a subsequent value of the parameter; and

programming the internal component to apply therapy to the patient using the subsequent value of the parameter after the initial value has been incremented.

2. The method ofclaim 1, wherein the parameter is a parameter selected from the group consisting of: voltage, current, pulse width, duty cycle, frequency, and rate of change.

3. The method ofclaim 1, wherein selecting initial values comprises:

programming the initial values for the parameters of the therapy program into an external component; and

transmitting the therapy program including the initial values for the parameters to the internal component.

4. The method ofclaim 1, further comprising:

receiving instructions to override automatic incrementation of the parameter at an external component; and

transmitting the instructions to override from the external component to the internal component, wherein the internal component does not increment the initial value of the parameter if instructions to override are received.

5. A method comprising:

implanting at least one electrode within a body of a patient including implanting the electrode adjacent an anatomical feature of the patient to enable the electrode to provide therapy to the anatomical feature;

implanting an internal component within the patient including communicatively coupling the internal component to the electrode, the internal component being programmed to generate treatment signals according to a treatment program and to transmit the treatment signals to the electrode according to a treatment schedule;

implanting an internal antenna within the patient including communicatively coupling the internal antenna to the internal component, the internal antenna being configured to send and receive RF transmissions;

implanting a sensor within the patient including communicatively coupling the sensor to the internal component, the sensor being configured to determine an activity level of the patient and to forward an indication of the activity level to the internal component;

aligning an external antenna with the internal antenna sufficient to enable RF transmission between the external antenna and the internal antenna;

receiving RF transmissions at the external antenna from the internal antenna, the RF transmissions including the indication of the activity level of the patient, the RF transmissions also including an indication of whether therapy was provided to the patient in accordance with the therapy program and the therapy schedule; and

analyzing whether weight loss of the patient corresponds to the activity level of the patient.

6. The method ofclaim 6, further comprising analyzing whether the weight loss of the patient corresponds to the therapy provided to the patient.

Images