Patent Grant
9597507
The disclosure is directed to electrical stimulation therapy.
Medical devices, including implantable medical devices (IMDs), may be used to treat a variety of medical conditions. Medical electrical stimulation devices, for example, may deliver electrical stimulation therapy to a patient via external or implanted electrodes. Electrical stimulation therapy may include stimulation of nerve, muscle, the brain, or other tissue within a patient. In some examples, an electrical stimulation device is fully implanted within the patient. For example, an implantable electrical stimulation device may include an implantable electrical stimulation generator and one or more implantable leads carrying electrodes. Alternatively, the electrical stimulation device may comprise a leadless stimulator in which electrodes are carried on housing of the device. In other examples, implantable electrodes may be coupled to an external electrical stimulation generator via one or more percutaneous leads and/or lead extensions.
Medical electrical stimulation devices have been proposed for use to relieve a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, depression, epilepsy, migraines, urinary or fecal incontinence, pelvic pain, sexual dysfunction, obesity, and gastroparesis. An electrical stimulation device may be configured to deliver electrical stimulation therapy via leads that include electrodes implantable proximate to the spinal cord, pelvic nerves, gastrointestinal organs, peripheral nerves, or within the brain of a patient. Stimulation proximate the spinal cord, within the brain, and proximate peripheral nerves are often referred to as spinal cord stimulation (SCS), deep brain stimulation (DBS), and peripheral nerve stimulation (PNS), respectively.
This disclosure describes delivery of electrical stimulation therapy to patient using paired electrical stimulation pulses, and adjusting one or more parameters of the paired pulses based on a sensed compound action potential (CAP). The paired pulses of the electrical stimulation therapy may include a first electrical stimulation pulse delivered to a patient at a first tissue location via a first electrode, and a second electrical stimulation pulse delivered at a second tissue location via a second electrode. The combination of the first and second electrical stimulation pulses may evoke a CAP within the patient when delivered to the patient. The evoked CAP may be sensed via one or more electrodes, e.g., at a third tissue location, and one or more parameters of the paired pulses may be adjusted based on the sensed CAP.
In one example, the disclosure is directed to a method comprising delivering an electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a first electrical stimulation pulse delivered to the patient via a first electrode and a second electrical stimulation pulse delivered to the patient via a second electrode, wherein the first electrical stimulation pulse and second electrical stimulation pulse are delivered as paired pulses with respect to each other and a combination of the first electrical stimulation pulse and the second electrical stimulation pulse evoke a compound action potential within the patient. The method further comprises sensing the compound action potential evoked by the combination of the first electrical stimulation pulse and the second electrical stimulation pulse, and adjusting one or more parameters of the electrical stimulation therapy based on the sensed compound action potential.
In another example, the disclosure is directed to an electrical stimulation device comprising a stimulation pulse generator configured to deliver an electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a first electrical stimulation pulse delivered to the patient via a first electrode and a second electrical stimulation pulse delivered to the patient via a second electrode, wherein the first electrical stimulation pulse and second electrical stimulation pulse are delivered as paired pulses with respect to each other and a combination of the first electrical stimulation pulse and the second electrical stimulation pulse evoke a compound action potential within the patient. The electrical stimulation device further comprising a sensor configured to sense the compound action potential evoked by the combination of the first electrical stimulation pulse and the second electrical stimulation pulse, and a processor configured to adjust one or more parameters of the electrical stimulation therapy based on the sensed compound action potential.
In an additional example, the disclosure is directed to a system comprising means for delivering an electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a first electrical stimulation pulse delivered to the patient via a first electrode and a second electrical stimulation pulse delivered to the patient via a second electrode, wherein the first electrical stimulation pulse and second electrical stimulation pulse are delivered as paired pulses with respect to each other and a combination of the first electrical stimulation pulse and the second electrical stimulation pulse evoke a compound action potential within the patient; means for sensing the compound action potential evoked by the combination of the first electrical stimulation pulse and the second electrical stimulation pulse; and means for adjusting one or more parameters of the electrical stimulation therapy based on the sensed compound action potential.
In a further example, the disclosure is directed to a computer-readable storage medium that includes instructions that, when executed by at least one processor, cause the at least one processor to control delivery of an electrical stimulation therapy to a patient, the electrical stimulation therapy comprising a first electrical stimulation pulse delivered to the patient via a first electrode and a second electrical stimulation pulse delivered to the patient via a second electrode, wherein the first electrical stimulation pulse and second electrical stimulation pulse are delivered as paired pulses with respect to each other and a combination of the first electrical stimulation pulse and the second electrical stimulation pulse evoke a compound action potential within the patient; sense the compound action potential evoked by the combination of the first electrical stimulation pulse and the second electrical stimulation pulse; and adjust one or more parameters of the electrical stimulation therapy based on the sensed compound action potential.
The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.
This disclosure describes systems, devices and methods for delivering electrical stimulation therapy to a patient. The electrical stimulation therapy may include paired pulses which, in combination, evoke a compound action potential in tissue of the patient. The electrical stimulation therapy may be adjusted according to the sensed CAP evoked in response to the delivered electrical stimulation therapy. The electrical stimulation therapy may relieve any of a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, depression, epilepsy, migraines, urinary or fecal incontinence, pelvic pain, sexual dysfunction, obesity, and gastroparesis. In various examples, the electrical stimulation therapy may be delivered via electrodes implantable proximate to the spinal cord, pelvic nerves, gastrointestinal organs, peripheral nerves, or within the brain of a patient. For ease of illustration, examples of the present disclosure are describe primarily in which the electrical stimulation takes the form of spinal cord stimulation (SCS) therapy. However, examples are not limited as such. For example, in some examples, the therapy may be delivered in the form of deep brain stimulation (DBS) therapy, peripheral nerve stimulation (PNS), peripheral nerve field stimulation (PNFS) therapy, or other therapy which may suitably employ one or more of the example systems, device, and/or techniques described herein.
An IMD may deliver SCS to a patient via one more electrodes located on lead(s) implanted adjacent the spinal cord of a patient. Various parameters of the electrical stimulation therapy delivered the IMD may be selected to provide for efficacious treatment of one or more patient conditions, such as, e.g., patient pain. For electrical stimulation delivered in the form of a plurality of electrical pulses, example stimulation parameters may include electrode configuration (including electrode combination, polarity, and whether the stimulation is unipolar, bipolar, or multipolar), pulse frequency, pulse width, amplitude (either current or voltage), duty cycle, and the like.
In some examples, an IMD may deliver electrical stimulation therapy including paired pulses to treat one or more patient conditions. As will be described further below, the delivery of paired pulses may include delivery of first and second pulses in coordination with one another. The first pulse may be delivered to the patient via a first electrode at a first location and the second pulse via a second electrode at a second location. In some examples, the second pulse may be delivered at substantially the same time the first pulse ends. In other examples, there may be some period of time delay between the end of the first pulse and delivery of the second pulse. When delivered in combination, the first and second pulses of the paired pulse may evoke a CAP in tissue of the patient. The evoked CAP may treat one or more aspects of a patient condition, e.g., by providing relief from patient pain.
However, it may be difficult to identify the parameter values for such pulse pairs which provide for effective therapy. For example, the efficacy of stimulation therapy may depend on the magnitude of the CAP evoked by the paired pulses and/or the particular tissue location in which the CAP is evoked. During a programming session to select desirable therapy parameters, a clinician may rely on patient feedback and perception of paresthesia area, e.g., using a trial and error approach, which may be relatively time consuming. The patient feedback may include feedback relating to efficacy of the stimulation in providing pain relief, as well as possible side effects which could undermine efficacy. In some cases, a patient may be partially sedated during this process, which may influence the reliability of the feedback elicited from the patient.
Even after a particular therapy parameter values have been found to deliver effective therapy, the therapeutic efficacy of the stimulation may vary over time. For example, lead migration and/or the posture state occupied by a patient may change the position of the one or more electrodes relative to the spinal cord and, thus, change the magnitude of the evoked CAP and/or the location of the tissue in which the CAP is evoked. Additionally, even if the position of the one or more electrodes relative to the spinal cord may stay substantially the same over time, physiological factors may cause a particular set of therapy parameter values to no longer define desirable stimulation therapy. In each case, the therapeutic efficacy of the paired pulse electrical stimulation delivered to the spinal of the patient may be negatively influenced.
In accordance with some example of this disclosure, an IMD may be configured to deliver electrical stimulation therapy to a patient using paired electrical stimulation pulses. The IMD may be configured to sense the CAP evoked by the paired pulses and adjust one or more parameters of the electrical stimulation therapy based on the sensed CAP. By adjusting one or more therapy parameters, the location of the CAP evoked in the tissue of the patient and/or magnitude of the evoked CAP as a result of the paired pulses may be changed. Such a process may be used to identify values for the therapy parameters which provide for a desired therapy. For example, the process may identify values for the therapy parameters which provide the largest possible CAP over, e.g., the anatomical midline of the spinal cord or other tissue location that maintains comfortable and/or tolerable paresthesia for the patient. In another example, the process may identify values for the therapy parameters during an initial calibration period where CAP amplitudes may be matched with desirable pain relief as indicated by the patient. In one example, a CAP maximum threshold may be identified by the patient, e.g., based on the CAP amplitude that results in uncomfortable sensation experienced by the patient. In such examples, during or after the calibration period, a processor may use an algorithm to reference the programming and recorded CAPs to make a prediction on how the one or more parameters should be adjusted according to the CAP threshold identified by the patient.
In still other examples, a desired magnitude and location of an evoked CAP may be identified. The IMD may be configured to sense an evoked CAP while delivering therapy according to multiple different parameter sets. The IMD may thereby determine which one or more parameter sets approximately produce the desired CAP. If multiple different parameter sets approximately produce the desired CAP, the IMD may select the one of these multiple parameter sets that is the most energy efficient as the parameter set used to deliver therapy. For instance, the IMD may select the therapy parameter set that will deplete the energy stored by a power source of the IMD at the slowest rate.
As will be described further below, paired pulses of the electrical stimulation therapy may include a first electrical stimulation pulse delivered to a patient at a first tissue location via a first electrode in coordination with the delivery a second electrical stimulation pulse delivered at a second tissue location via a second electrode. IMD may sense the evoked CAP via one or more electrodes, e.g., at a third tissue location, and one or more parameters of the paired pulses may be adjusted based on the sensed CAP.
The combination of the first and second electrical stimulation pulses may evoke a CAP within the patient when delivered to the patient. For example, even if both the first pulse and second pulse are individually sub-action threshold pulses (e.g., when delivered individually, each pulse does not activate tissue of the patient), the delivery of the first pulse and second pules may be coordinated in a manner that evokes a CAP in the tissue of the patient. Alternatively, one or both of the first and second electrical stimulation pulses may individually define stimulation at or above the activation threshold such that the individual pulse evokes an action potential in tissue of the patient. However, the combination of the first and second pulses delivered as paired pulses evokes an even greater compound action potential and/or activates a tissue region that would not otherwise be activated by the individual pulses.
As described herein, paired electrical stimulation pulses may be used to evoke an action potential including a CAP. In terms of an individual cell, an action potential may be produced across a cell membrane when a neuron is activated electrically, and the action potential travels at a speed according to the properties of the membrane. A compound action potential (described herein as “CAP”) may be the sum of action potentials of a population of neurons in an area of tissue (e.g., spinal cord, brain, nerve tissue, or the like). Detection of a CAP may be an indication that an activation threshold has been reached for the corresponding population of neurons. Slow CAPs may indicate the activation of small and/or unmyelinated fibers. Fast CAPs may indicate the activation of large myelinated fibers. The characteristics of each CAP may be indicative of how many fibers have been activated as well as the type of fiber.
Various aspects of some example paired electrical stimulation pulses may include one or more of the examples described in U.S. Pat. No. 7,689,289, to King, entitled “TECHNIQUE FOR ADJUSTING THE LOCUS OF EXCITATION OF ELECTRICALLY EXCITABLE TISSUE WITH PAIRED PULSES,” filed Mar. 22, 2006, the entire content of which is incorporated by reference herein.
In some examples, the first and second electrical stimulation pulses may be delivered via different electrodes in a paired pulse manner. The IMD may deliver the pulses as unipolar (e.g., with an electrode on the housing of the IMD defining the reference electrode) or multipolar (e.g., bipolar) electrical stimulation. The stimulation electrodes could be on same or different leads. The CAP evoked by the paired pulses may be sensed, e.g., by an electrode on a common lead with one or both of stimulation electrodes, an electrode on a separate lead, or a combination of electrodes on the common lead and the separate lead.
In some examples, one or more parameters of the electrical stimulation therapy may be adjusted. The one or more parameters adjusted may be the parameters of the first and second electrical stimulation pulses delivered as paired pulses. The one or more parameters of the electrical stimulation therapy may include, but not limited to, an amplitude (voltage or current), pulse rate, or pulse width of at least one of the first or second electrical stimulation pulses, an electrode configuration defined to deliver the at least one of the first or second electrical stimulation pulses (including electrode combination and/or polarity), or an interpulse interval between the end of the first electrical stimulation pulse and beginning of the second electrical stimulation pulse.
Adjusting one or more parameters of the electrical stimulation therapy including the paired pulses may influence the CAP evoked by the electrical stimulation. For example, the adjusted parameters of the electrical stimulation therapy may modify the magnitude of CAP evoked by the electrical stimulation therapy at a given sensing location. The adjusted parameters of the electrical stimulation therapy may also move the region of tissue in which the CAP is evoked. For example, in the case of SCS, one or more or the therapy parameters defining the paired pulses may be adjusted such that the region of tissue in which a CAP is evoked by the paired pulses may be shifted to either side of the spinal cord midline and/or move the region of tissue up or down relative the spinal cord.
One or more of the example technique described herein may be used to define one or more programs used by an IMD to control the delivery of electrical stimulation including paired pulses to a patient. For example, the adjustment of one or more parameters of the paired pulse therapy based on sensed, evoked CAP to identify desirable therapy parameter values may be used, e.g., by a clinician during a therapy programming session with a patient. Additionally or alternatively, electrical stimulation therapy may be delivered in a closed loop manner to make closed loop adjustments to the therapy, e.g., because the parameters that result in efficacious therapy may change over time. The closed loop adjustment may be continuous or periodic (e.g., based on some preprogrammed schedule and/or based on a triggering event such as a change in patient posture or at the direction of the patient). The triggering event may be a change in the sensed CAP and/or a signal from an accelerometer, which may be indicative of a change in patient posture. The closed loop adjustment may be based on the level of CAP sensed following the electrical stimulation (e.g., compared to some threshold), or even a binary decision such as whether or not any CAP is sensed.
In some examples, electrical stimulation therapy may include sensing the CAP evoked by the delivery of the paired pulses at a plurality of sensing locations. In such examples, one or more parameters of the electrical stimulation therapy may be adjusted based on the CAP sensed at each location relative to each other. In these examples, the sensed CAP at the plurality of location may be used to steer the region of tissue in which the CAP is evoked in the patient, e.g., by moving the region of tissue in which the CAP is evoked to tissue being targeted for activation. Sensing the evoked CAP at multiple regions may help track or gauge the movement of the region of tissue in which the CAP is evoked while adjusting the one or more therapy parameter settings.
In some examples, one or both of the paired electrical stimulation pulses may be delivered below perception threshold but the paired nature of the pulses results in activation of tissue which could be sensed as a CAP. The sub-perception threshold pulses may be used in order to set up a therapy program, where contact configurations and parameters are scanned at a sub-perception threshold amplitude in order to find the pulses that evoked a CAP above a target threshold. After determining the one or more parameters, the amplitude of the pulses of the paired electrical stimulation pulse may be increased to provide increased paresthesia coverage. Sub-perception threshold pulses may also be used with increasing the amplitude of the pulses if acceptable paresthesia coverage has been obtained over the pain region.
For example, the individual pulses can either be sub activation threshold or supra activation threshold (e.g., each individual pulse may evoke a CAP in a tissue). If a CAP is evoked by a combination of the paired pulses, then the combination of the paired pulse stimulation may be at or above an activation threshold (e.g., supra-activation threshold). However, if no CAP is evoked by the combination of paired pulses, the paired pulse stimulation may be below the activation threshold (e.g., sub-activation threshold). The activation threshold may be lower than a perception threshold for the stimulation, e.g., because the activation threshold may generally correspond to when neurons fire and the perception threshold is when the patient perceives activation of the neurons.
As shown in
IMD 14 may be constructed of any polymer, metal, or composite material sufficient to house the components of IMD 14 (e.g., components illustrated in
In some examples, the electrical stimulation energy may be constant current or constant voltage pulses, which are delivered from IMD 14 to one or more targeted locations within patient 12 via one or more electrodes (not shown in
Leads 16A-16C may comprise, as examples, a substantially cylindrical lead with ring electrodes, a paddle lead, or a lead with a more complex, three-dimensional electrode array geometry, such as a cylindrical lead with electrodes disposed at various circumferential positions around the cylinder (e.g., with the aid of partial ring electrodes or segmented electrodes disposed at various circumferential positions around a lead having a generally round cross-section). In some examples, leads 16A-16C may include electrodes, such as pad electrodes or segmented electrodes, on more than one surface. For example, leads 16A-16C may be a paddle-type lead with electrodes on multiple surfaces, or a multiple level lead. In general, the disclosure may be used with any type of lead, and is not limited to the leads described herein, or any particular type of implantable lead.
For the delivery of SCS therapy, leads 16A-16C may be implanted within patient 12 adjacent the spinal cord of patient 12 (not shown). Leads 16A-16C may tunnel through tissue of patient 12 from along the spinal cord to a subcutaneous tissue pocket or other internal location where IMD 14 is implanted. Although leads 16A-16C may include a lead extension or other segments that may aid in implantation or positioning of leads 16A-16C. In addition, proximal ends of leads 16A-16C may include a connector (not shown) that electrically couples to a header of IMD 14, either directly or indirectly (e.g., via a lead extension).
Leads 16A-16C may carry one or more electrodes (not shown in
Electrodes of leads 16A-16C transfer electrical stimulation generated by an electrical stimulation generator in IMD 14 to tissue of patient 12. The electrodes may be electrode pads on a paddle lead, circular (e.g., ring) electrodes surrounding the body of the lead, conformable electrodes, cuff electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), or any other type of electrodes capable of forming unipolar, bipolar or multipolar electrode configurations for therapy. As described herein, the electrode configurations used in delivering the paired electrical stimulation pulses are delivered by a combination of at least one anode and at least one cathode. In other words, the electrode combinations may be unipolar (e.g., a cathode on a lead and an anode on a case of the stimulator), or multipolar, such as, e.g., bipolar (e.g., a cathode on the lead and an anode on the same lead or a different lead).
In addition or alternatively to delivering electrical stimulation from IMD 14 to patient 12, one or more electrodes on leads 16A-16C may be used by IMD 14 to sense electrical signals in patient 12. For example, an electrode on one of leads 16A-16C may be used by IMD 14 to deliver electrical stimulation, sense electrical activity, or both.
In accordance with some examples of the disclosure, electrodes on leads 16A-16C may be used to deliver paired electrical stimulation pulses from IMD 14 to patient 12 and sense the compound action potential evoked by the delivery of the paired pulses. For example, an electrode on lead 16A may deliver a first electrical stimulation pulse (e.g., in a unipolar or bipolar configuration) and an electrode on lead 16B may deliver a second electrical stimulation pulse (e.g., in a unipolar or bipolar configuration), where the delivery of the first and second pulses is coordinated such that the pulses define paired pulses and combine to evoke a compound action potential in tissue of the patient. A third electrode on lead 16C may be used to sense the compound action potential evoked by the delivery of the paired pulses. As described herein, IMD 14 may make one or more adjustments to the electrical stimulation delivered to patient 12 based on the sensed compound action potential evoked by the paired pulses delivered to patient 12. Alternatively, each individual pulse of the paired pulses may be delivered via electrodes on a common lead. Likewise, the electrode used to sense the compound action potential evoked by the delivery of the paired pulses may be on the same lead as one or both of the stimulation electrodes or may be on a different lead entirely.
As one example, an electrode on lead 16A may deliver a first electrical stimulation pulse, which results in the activation of tissue within region 26A, and an electrode on lead 16B may deliver a second electrical stimulation pulse, which results in the activation of tissue within region 26B. To form a paired pulse the second pulse may, e.g., be delivered at substantially the same time the first pulse ends or after some time delay following the end of the first pulse. In either case, the combination of the first and second electrical stimulation pulses may result in a CAP in the tissue within region 28. For example, the magnitude of the evoke potential within region 28 may be greater than either regions 26A and 26B. As another example, both the first pulse and second pulse may be below the activation threshold such that no action potential is evoked in regions 26A or 26B. However, the combination of the first and second pulses as paired pulses may evoke a CAP in region 28.
As described herein, the combination of paired electrical stimulation pulses may activate the tissue of patient 12 to evoke a compound action potential (CAP) within region 28. While an individual pulse with a charge that activates a group of neuron may evoke a CAP substantially close to the active electrode(s), the combination of paired pulses may define a charge that activates a group of neurons to evoke a CAP remotely from the active electrode(s). In some examples, the combination of paired pulses with a charge that activates a group of neurons may evoke a CAP near the active electrode(s). However, the paired pulses may build up a charge (e.g., “combine”) at a remote location, such that there is an area of activation remote from the location of the electrode(s). By adjusting one or more stimulation parameters of the individual pulses and/or electrode(s) location, the locus of activation, may be moved. As the locus of activation is moved, the CAP may also be moved. Various aspects of some example action potentials may include one or more of the examples described in U.S. Pat. No. 7,689,289, to King, entitled “TECHNIQUE FOR ADJUSTING THE LOCUS OF EXCITATION OF ELECTRICALLY EXCITABLE TISSUE WITH PAIRED PULSES,” filed Mar. 22, 2006. As described by King, action potentials may be an all-or-none, nonlinear phenomenon, caused by opening of sodium gates, inrush of sodium ions, and a delayed opening of potassium gates and a restoration of the membrane potential. A certain amount of charge must be passed at the electrodes (amplitude [Volts]/resistance [Ohms]×pulse width [time]) in order to cause enough depolarization for an action potential to begin. There is a reciprocal relationship between amplitude and pulse width: the product must reach a certain value before the transmembrane potential threshold is reached. This relationship does not reach the Volts=O axis. There is a certain minimum voltage needed, called rhea base, before an action potential can happen.
A user, such as a clinician or patient 12, may interact with a user interface of an external programmer 20 to program IMD 14. Programming of IMD 14 may refer generally to the generation and transfer of commands, programs, or other information to control the operation of IMD 14. In this manner, IMD 14 may receive the transferred commands and programs from programmer 20 to control stimulation therapy. For example, external programmer 20 may transmit programs, parameter adjustments, program selections, group selections, user input, or other information to control the operation of IMD 14, e.g., by wireless telemetry or wired connection.
In some cases, external programmer 20 may be characterized as a clinician (or physician) programmer if it is primarily intended for use by a clinician. In other cases, external programmer 20 may be characterized as a patient programmer if it is primarily intended for use by a patient. A patient programmer may be generally accessible to patient 12 and, in many cases, may be a portable device that may accompany patient 12 throughout the patient's daily routine. For example, a patient programmer may receive input from patient 12 when the patient wishes to terminate or change stimulation therapy when the stimulation is undesirable (e.g., uncomfortable). In general, a physician or clinician programmer may support selection and generation of programs by a clinician for use by IMD 14, whereas a patient programmer may support adjustment and selection of such programs by a patient during ordinary use. In other examples, external programmer 20 may be included in, or part of, an external charging device that recharges a power source of IMD 14. In this manner, a user may program and charge IMD 14 using one device or multiple devices.
Information may be transmitted between external programmer 20 and IMD 14. IMD 14 and programmer 20 may communicate via wireless communication using any techniques known in the art. An example communication technique includes, for example, radiofrequency (RF) telemetry, but other techniques are also contemplated. In some examples, programmer 20 may include a communication head that may be placed proximate to the patient's body near the IMD 14 implant site in order to improve the quality or security of communication between IMD 14 and programmer 20. Communication between programmer 20 and IMD 14 may occur during power transmission or separate from power transmission.
In some examples, IMD 14 may be configured to generate and deliver a stimulation therapy chronically, e.g., substantially continuously for a period of time, such as days, weeks, months, or years. In other examples, IMD 14 may be configured to generate and deliver a stimulation therapy intermittently, e.g., periodically or aperiodically at scheduled times or in response to an instruction received from a user, such as patient 12, via external programmer 20.
In general, IMD 14 may comprise any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the various techniques described herein attributed to IMD 14 and processor 30. In various examples, IMD 14 may include one or more processors 30, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. IMD 14 also, in various examples, may include a memory 32, such as random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), or flash memory, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processor 30, therapy module 34, and telemetry module 36 are described as separate modules, in some examples, processor 30, therapy module 34, and telemetry module 36 may be functionally integrated. In some examples, processor 30, therapy module 34, and telemetry module 36 may correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.
Memory 32 may store therapy programs or other instructions that specify therapy parameters for the therapy provided by therapy module 34 and IMD 14, including the first and second stimulation therapies. In some examples, memory 32 may also store instructions for communication between IMD 14 and programmer 20, or any other instructions required to perform tasks attributed to IMD 14. In some examples, memory 32 stores a duplicate of the data stored in memory 52 of external programmer 20 (
Therapy module 34 may include a stimulation generator and a sensor. The stimulation generator of therapy module 34 may be configured to generate and deliver electrical stimulation under the control of processor 30. In some examples, processor 30 controls therapy module 34 by accessing memory 32 to selectively access and load at least one of the stimulation therapy programs to therapy module 34. In such examples, relevant stimulation parameters of the loaded therapy program may include a voltage amplitude, a current amplitude, a pulse frequency, a pulse width, an interpulse interval for paired pulses, a duty cycle, or the combination of electrodes 17A, 17B, 17C, and 17D (e.g., carried by leads 16A-16C of
An example range of electrical stimulation parameters that may be used to deliver effective treatment for chronic pain, e.g., when applied in SCS to spinal cord 22 (
Pulse Frequency: between approximately 0.5 Hz and 10,000 Hz. In one example, pulse frequency may be between approximately 5 Hz and 250 Hz or between approximately 30 Hz and 130 Hz. In other examples, pulse frequency may be greater than 250 Hz or even greater than 1,000 Hz.
Amplitude: between approximately 0.1 volts and 50 volts, such as between approximately 0.5 volts and 20 volts, or between approximately 1 volt and 10 volts. In other embodiments, a current amplitude may be defined as the biological load in the voltage that is delivered. For example, the range of current amplitude may be between approximately 0.1 milliamps (mA) and 50 mA.
Pulse Width: between about 10 microseconds and 5000 microseconds. In some examples, the pulse width may be between approximately 100 microseconds and 1000 microseconds or between approximately 180 microseconds and 450 microseconds.
Memory 32 may store at least two stimulation therapy programs, e.g., at least a first stimulation therapy program and a second stimulation therapy program. Each of the therapy programs may specify one or more stimulation therapy parameters, which may include, for example, an electrode configuration, a current or voltage amplitude, a pulse width, a pulse frequency (rate), a duty cycle, a target CAP threshold value, or a range of target CAP values, or the like. IMD also includes components to receive power from programmer 20 or a separate charging device to recharge power source 38. Power source 38 may include one or more capacitors, batteries, or other energy storage devices. IMD 14 may thus also include an inductive coil and a recharge module (both not shown) configured to manage the recharging session for power source 38. Although inductive coupling may be used to recharge power source 38, other wireless energy transfer techniques may alternatively be used. Alternatively, power source 38 may not be rechargeable.
Processor 30 may also control the exchange of information with programmer 20 and/or an external programmer using telemetry module 36. Telemetry module 36 may be configured for wireless communication using radio frequency protocols or inductive communication protocols. Telemetry module 36 may include one or more antennas configured to communicate with programmer 20, for example. Processor 30 may transmit operational information and receive therapy programs or therapy parameter adjustments via telemetry module 36. Also, in some examples, IMD 14 may communicate with other implanted devices, such as stimulators, control devices, or sensors, via telemetry module 36. For example, telemetry module 36 may receive user input or other commands from programmer 20.
In general, programmer 20 comprises any suitable arrangement of hardware, alone or in combination with software and/or firmware, to perform the techniques attributed to programmer 20, and processor 50, user interface 54, and telemetry module 56 of programmer 20. In various examples, processor 50 may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. Programmer 20 also, in various examples, may include a memory 52, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although processor 50 and telemetry module 56 are described as separate modules, in some examples, processor 50 and telemetry module 56 are functionally integrated. In some examples, processor 50 and telemetry module 56 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units.
Telemetry module 56 may support wireless communication between IMD 14 and programmer 20 under the control of processor 50. Telemetry module 56 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, telemetry module 56 may be substantially similar to telemetry module 36 of IMD 14 described herein, providing wireless communication via an RF or proximal inductive medium. In some examples, telemetry module 56 may include an antenna, which may take on a variety of forms, such as an internal or external antenna.
Examples of local wireless communication techniques that may be employed to facilitate communication between programmer 20 and other computing devices include RF communication according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with programmer 20 without needing to establish a secure wireless connection.
User interface 54 may include, for example, a user input mechanism (e.g., a button or keypad); lights; a speaker and microphone for transmitting and receiving voice commands; and a display, such as a liquid crystal (LCD), light-emitting diode (LED), or cathode ray tube (CRT). In some examples the display may be a presence-sensitive screen. User interface 54 may be configured to display any information related to the delivery of stimulation therapy, such as currently selected stimulation parameters or any other therapy information. Processor 50 may also receive user input via user interface 54. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen. Memory 52 may store instructions that, when executed by processor 50, cause processor 50 and programmer 20 to provide the functionality ascribed to programmer 20 throughout this disclosure. For example, memory 52 may include instructions that cause processor 50 to obtain a first and/or second stimulation therapy program from memory 52, receive a user input and send a corresponding command to IMD 14, or instructions for any other functionality. In addition, memory 52 may include a plurality of stimulation therapy programs, where each stimulation therapy program includes a parameter set that defines stimulation therapy. In some examples, programmer 30 may select a stimulation therapy program when a user, such as patient 12 or a clinician, provides input to start stimulation. In other examples, IMD 14 may request that programmer 30 selects a stimulation therapy program and transmit the stimulation therapy program, or at least one aspect of the stimulation therapy program, back to IMD 14 for delivery of corresponding electrical stimulation.
For first paired pulse 60, IMD 14 may deliver first pulse 64 via a first electrode and deliver second pulse 66 via a second electrode different from the first using a common or different lead. First pulse 64 and second pulse 66 of first paired pulse 60 may each have one or more parameters including, but not limited to, pulse width (PW), pulse amplitude (A) (e.g., current or voltage), pulse polarity, and pulse shape. In the example of
The pulse width and/or amplitude of first pulse 64 may be substantially the same or different than second pulse 66. In some examples, first pulse 64 and second pulse 66 may each have an individual pulse width between 10 and 5000 microseconds (μs), such as, e.g., between 40 and 1000 microseconds. In some examples, first pulse 64 and second pulse 66 may each have an individual amplitude between 0.1 and 50, such as, e.g., between 0.5 and 10 volts.
As show in
IMD 14 may deliver first pulse 64 via a first electrode, such as, e.g., electrode 17A, to a first tissue location of patient 12. IMD 14 may also deliver second pulse 66 via a second electrode, such as, e.g., electrode 17B, to a second tissue location of patient 12. A CAP may be evoked at a third tissue location of patient 12 (e.g., within region 28) and at a particular level in response to the delivery of paired pulse 60. As explained in King, paired pulses, such as, e.g., paired pulses 60 and 62 may have a benefit of utilizing the neurophysiological principle of “electrotonus” in that the area of suprathreshold potential can be controlled by varying the time delay between application of the two pulses to each respective driven electrode for creating the areas of subthreshold potential. Because of the memory effect of electrotonus, the transmembrane potential created within a nerve cell by a pulse starts to decay at the end of the excitation pulse, and this transmembrane potential is a function of time. By taking advantage of this time variation of the transmembrane potential, the area of suprathreshold potential can be adjusted by correspondingly varying the time delay between the pulses that are applied to two electrodes that each produce a subthreshold area. These individual subthreshold areas by themselves do not have sufficient potential changes to induce an action potential. However, a superposition of the subthreshold potential areas creates an area of suprathreshold potential that is greater than the transmembrane potential threshold such that nerve cells within that area have an action potential induced therein.
As noted above, IMD 14 may sense the CAP evoked by pulse pair 60, e.g., at the third tissue location via a third electrode, such as, e.g., electrode 17C. Following first paired pulse 60, IMD 14 may deliver second paired pulse 62. Based on the sensed CAP, IMD 14 may adjust one or more parameters from that first paired pulse 60 to define second paired pulse 62. In some examples, IMD 14 may wait a period of time between paired pulses to provide for a passive and/active discharge of the stimulation and prevent an accumulation of charge in the tissue.
In some examples, each individual pulse of paired pulses 60 or 62 may be at a sub-activation threshold such that the individual pulse by itself does not evoke a physiological response from the tissue of patient 12. However, the combination of the pulses of paired pulse 60 or 62 may be at a supra-threshold such that the combination evokes a physiological response from the tissue of patient 12 (e.g., evokes a CAP within region 28 as shown in
In some examples, each individual pulse of paired pulses 60 or 62 may be at a sub-perception threshold (such that the individual pulse by itself may not be perceived by patient 12.) However, the combination of the pulses of paired pulses 60 and 62 may be at a supra-perception threshold such that the combination of the pulses is perceived by patient 12. Conversely, the combination of the pulses of paired pulses 60 and 62 may result in therapy that is at the sub-perception threshold. In either case, IMD 14 may be configured to sense a CAP evoked in response to delivery of paired pulse 60 or 62, and adjust the stimulation therapy based upon the sensed CAP. In some examples, IMD 14 may automatically utilize the sensed CAP to continually adjust parameters of the paired electrical stimulation pulses.
As shown in
Processor 30 may control the delivery of the first and second stimulation pulses according to one or more therapy programs stored in memory 32 of IMD 14. As described above, each of the first pulse and the second pulse may be sub-activation threshold or supra-activation threshold pulses. Additionally, each of the first pulse and the second pulse may be sub-perception threshold or supra-perception threshold pulses. In each case, the combination of the first and second pulses delivered as paired pulses may evoke a CAP in tissue of patient 12.
Processor 30 may sense the evoked CAP using one or more of electrodes 17A-17D as a sense electrode (506). The electrode used to sense the evoked CAP may be the same or different as one of the electrodes used to deliver the first and/or second electrical stimulation pulse, and may be on the same or different lead from the electrodes used to deliver the electrical stimulation pulses. In some examples, the electrode(s) used to sense the CAP evoked by the delivery of the paired pulses may be implanted in a tissue near a tissue targeted for activation as part of the SCS therapy. Processor 30 may analyze the sensed signal to evaluate various parameters of the sensed CAP, such as, e.g., the amplitude, latency, shape, width, and number of peaks, and adjust the stimulation based on the sensed CAP. For instance, changes in the shape of the CAP may indicate that other and/or new fiber is being activated. Processor 30 may adjust one or more parameters of the therapy including the paired pulse based on the sensed CAP evoked by the paired pulses (508). For example, processor 30 may adjust at least one of the pulse width, amplitude, electrode combination, and/or polarity for one or both of the first and second stimulation pulses, and/or the interpulse interval of the paired pulses based on the sensed CAP. In some examples, processor 30 may adjust one or more of the parameters defining the paired pulse stimulation to increase or decrease the magnitude of the CAP evoked by the delivery of the paired pulses. In some examples, processor 30 may adjust the amplitude of each pulse, the interpulse interval between the pulses, and/or the electrode location of each pulse to increase or decrease the CAP evoked by the delivery of the paired pulses.
In some examples, processor 30 may adjust the one or more parameters of therapy during a calibration period, e.g., where the one or more parameters are given in a sequential order along the length of a lead and subsequent CAPs are recorded. In these examples, an algorithm may reference the programming and recorded CAPs to make a prediction on how the one or more parameters should be adjusted. Based on the calibration period observations, processor 30 may “learn” how different parameter adjustments change the CAP evoked by the stimulation. Alternatively or additionally, processor 30 may make parameter adjustment on a substantially trial and error basis.
Additionally or alternatively, processor 30 may adjust one or more of the parameters defining the paired pulse stimulation to shift the region of tissue in which the CAP is evoked by delivery of the paired pulses. In some examples, processor 30 may adjust the pulse width of each pulse and/or the electrode location of each pulse to move the region of the CAP evoked by the delivery of the paired pulses.
In some examples, processor 30 may sense the evoked CAP at a plurality of locations, e.g., using a plurality of electrodes 17A-17D. In such an example, processor 30 may adjust one or more parameters of the electrical stimulation therapy based on the CAP sensed at each location relative to each other. In these examples, the sensed CAP at each of the plurality of location may be used to steer the region of tissue in which the CAP is evoked in the patient, e.g., by moving the region of tissue in which the CAP is evoked to tissue being targeted for activation. In these examples, the sensed CAP at each of the plurality of location may be used to steer the region of tissue in which the CAP is evoked in the patient, e.g., by moving the region of tissue in which the CAP is evoked to prevent stimulation in an unwanted location or locations. In other words, if the CAP is detected in an undesirable area or areas, the stimulation may be modulated to steer the region of tissue to target tissue for activation and/or prevent stimulation in tissue not targeted for activation.
Processor 30 may then compare the magnitude of the sensed CAP to a target threshold magnitude (606). In the example of
As shown in
In this manner, processor 30 may adjust values (e.g., semi-automatically or automatically) of paired pulse stimulation therapy delivered to patient 12 such that the paired pulse stimulation therapy evokes a sensed CAP with a magnitude above the target threshold value. In other examples, such a process may be used to adjust values of paired pulse therapy delivered to patient 12 such that the paired pulse stimulation therapy evokes a sensed CAP with a magnitude below a target threshold value or within some range of target values, which may be stored in memory 32. In each case, processor 30 may adjust one or more parameters of the paired pulse stimulation based on the sensed CAP evoked by deliver of paired pulse stimulation.
A similar process may also be used to shift or maintain the region of tissue in which a CAP is evoked by paired pulse stimulation therapy. For example, processor 30 may sense for the CAP evoked by the delivery of paired pulse stimulation at a plurality of locations (e.g., using at least one different sensing electrode at each location). Processor 30 may iteratively adjust one or more parameters of the paired pulse stimulation until the sensed CAP evoked by the paired pulse stimulation at the plurality of locations is consistent with the desired region of tissue in which the CAP is evoked by the paired pulse stimulation.
The example technique of
Alternatively, processor 30 may initiate the technique periodically, e.g., based on some preprogrammed time period (e.g., hourly, daily, weekly, and the like), continuously, or based on some triggering action. As one example of triggering action, processor 30 may receive an indication from patient 12, e.g., via programmer 20, which initiates the process described in
The delivery of first pulse 126A and second pulse 126B as paired pulses evokes CAP 130A sensed by an electrode on lead 19. Again, circle 130A may generally represents the magnitude of CAP 130A and location of the sensing electrode on lead 19. Processor 30 may determine that the magnitude of the sensed CAP evoked by the paired pulse stimulation in
As shown in
However, unlike that of
As shown in
However,
Further, as shown in 7A and 7B, to account for the shift in the target region of activation, processor 30 may adjust one or more parameters of paired electrical stimulation pulses 326A and 326B to create paired electrical stimulation pulses 326C and 326D. In the example of
However, in
As illustrated between
In any of the examples discussed above, multiple different sets of parameters of paired electrical stimulation pulses may be identified that result in approximately the same or a similar evoked CAP. Such parameter sets may be identified using a scan of different parameter sets while monitoring the evoked CAP, for instance. This could be performed as part of a calibration procedure, at regular intervals, or upon request by a user. In one example, the various parameter sets may be reported to a user along with information indicating a degree of energy efficiency of each parameter set. For instance, the amount of energy per unit time that would be consumed by IMD 14 to deliver stimulation according to each parameter set may be displayed for the user, as on user interface 54 of programmer 20. The user may program the IMD to employ the parameters of paired electrical stimulation that evoke the desired CAP and are the most energy efficient. For instance, the parameter set that will result in use the least energy per unit time may be selected. This may improve the longevity of the power source and, and in the case of rechargeable power sources, lengthen the time between recharge sessions. In other examples, IMD 14 and/or external programmer 20 may operate automatically or semi-automatically to select the set of the parameters of paired electrical stimulation pulses that are the most energy efficient.
The techniques described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. In particular, the techniques may be implemented in a hardware device, such as a wireless communication device or network device, either of which may include software and/or firmware to support the implementation. For portions implemented in software, the techniques may be realized in part by a computer-readable medium comprising program code containing instructions that, when executed, performs one or more of the methods described above. In this case, the computer readable medium may comprise RAM (e.g., synchronous dynamic random access memory (SDRAM)), ROM, NVRAM, EEPROM, FLASH memory, magnetic or optical data storage media, and the like. In some examples, computer-readable storage media may comprise non-transitory media. The term “non-transitory” may indicate that the storage medium is tangible and is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium may store data that can, over time, change (e.g., in RAM or cache).
The program code may be executed by one or more processors, such as one or more DSPs, general purpose microprocessors, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. In this sense, the techniques are implemented in hardware, whether implemented entirely in hardware or in hardware such as a processor executing computer-readable code. Accordingly, the term “processor,” as used herein may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein.
Various examples have been described. These and other examples are within the scope of the following claims.
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