Current Source for Neurostimulation

Abstract

An implantable neurostimulator has an implantable electrode array comprising a plurality of stimulus electrodes. Each stimulus electrode is configured to deliver electrical stimuli to neural tissue. An implantable control module is configured to produce the electrical stimuli delivered by the stimulus electrodes, and is configured to effect current steering. The control module has a plurality of related current sources, each current source configured to deliver a respective stimulus current which is defined in a first part by a shared current control signal which is shared by each of the related current sources, and which is defined in a second part by a respective unique current control signal which is not shared by all of the related current sources.

Claims

1. An implantable neurostimulator comprising: an implantable electrode array comprising a plurality of stimulus electrodes, each stimulus electrode configured to deliver electrical stimuli to neural tissue; an implantable control module configured to produce the electrical stimuli delivered by the stimulus electrodes, the control module configured to effect current steering and comprising a plurality of related current sources, each current source configured to deliver a respective stimulus current which is defined in a first part by a shared current control signal which is shared by each of the related current sources, and which is defined in a second part by a respective unique current control signal which is not shared by all of the related current sources.

2. The implantable neurostimulator of claim 1 wherein the control module is configured to use the shared current control signal as a single control parameter to effect adjustments in net stimulation intensity.

3. The implantable neurostimulator of claim 1, wherein the control module is further configured to measure a neural response evoked by the stimulus, and to use the measurement for automated feedback control of an intensity of a subsequent stimulus.

4. The implantable neurostimulator of claim 1 wherein a majority of the operation of each current source is controlled by the shared current control signal.

5. The implantable neurostimulator of claim 4 wherein the current sources are digitally controlled current sources, and wherein a majority of a set of control bits used to control each current source is defined by the shared current control signal.

6. The implantable neurostimulator of claim 5 wherein at least the most significant half of the control bits are defined by the shared current control signal, with the remaining least significant bits being defined by the respective unique current control signal.

7. The implantable neurostimulator of claim 6 wherein at least two thirds of the control bits are defined by the shared current control signal, with the remaining least significant bits being defined by the respective unique current control signal.

8. The implantable neurostimulator of claim 7 wherein at least three quarters of the control bits are defined by the shared current control signal, with the remaining least significant bits being defined by the respective unique current control signal.

9. The implantable neurostimulator of claim 5 wherein 4 least significant bits are defined by the respective unique current control signal.

10. The implantable neurostimulator of claim 9 wherein the 4 least significant bits are defined by the respective unique current control signal in a manner to effect current steering by the plurality of related current sources.

11. The implantable neurostimulator of claim 1 wherein four or more related current sources are provided, to effect the use of current steering to position an apparent location of stimulation between electrodes in both a caudorostral direction and also between electrodes in a mediolateral direction.

12. The implantable neurostimulator of claim 1 further configured to connect a single return electrode to return current from more than one stimulus electrode.

13. The implantable neurostimulator of claim 12 wherein the return electrode is connected directly to a supply rail when in use.

14. The implantable neurostimulator of claim 1 [[to 11] further configured to connect a respective distinct return electrode for each of the plurality of stimulus electrodes.

15. The implantable neurostimulator of claim 14 wherein each return electrode is provided with an associated return current source configured to effect return current steering.

16. A method of current steering, comprising: generating a plurality of contemporaneous stimuli by controlling a respective plurality of current sources, each current source configured to deliver a respective stimulus current which is defined in a first part by a shared current control signal which is shared by each of the related current sources, and which is defined in a second part by a respective unique current control signal which is not shared by all of the related current sources; and delivering the contemporaneous stimuli to neural tissue via an implantable electrode array comprising a plurality of stimulus electrodes.

17. An implantable neurostimulator comprising: an implantable electrode array comprising at least one stimulus electrode and at least one return electrode, each electrode configured to deliver electrical stimuli to neural tissue; an implantable control module configured to produce the electrical stimuli delivered by the stimulus electrodes, the control module comprising at least one current injection current source configured to, in a first stimulus phase, pass a first current from a first supply rail to the stimulus electrode, and the control module further configured to connect the return electrode to a second supply rail during the first phase; and the control module further comprising at least one current extraction current source configured to, in a second phase, pass a second current from the stimulus electrode to the second supply rail, and the control module further configured to connect the return electrode to the first supply rail during the second phase.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] An example of the invention will now be described with reference to the accompanying drawings, in which:

[0033] FIG. 1 schematically illustrates an implanted spinal cord stimulator;

[0034] FIG. 2 is a block diagram of the implanted neurostimulator;

[0035] FIG. 3 is a schematic illustrating interaction of the implanted stimulator with a nerve;

[0036] FIG. 4 is a detailed view of a plurality of current sources provided within the pulse generator of the present embodiment;

[0037] FIGS. 5A and 5B illustrate typical switch connections during stimulation, when using a normal passive ground return electrode (FIG. 5A) or when using a virtual ground configuration (FIG. 5B);

[0038] FIG. 6 illustrates the control arrangement of each current source of FIG. 4;

[0039] FIG. 7 provides a key to symbols and terminology;

[0040] FIGS. 8A to 8E show implementation of a virtual electrode; and

[0041] FIGS. 9A to 9E illustrate implementation of a virtual electrode, together with the use of a virtual ground, in accordance with another embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] FIG. 1 schematically illustrates an implanted spinal cord stimulator 100. Stimulator 100 comprises an electronics module 110 implanted at a suitable location in the patient's lower abdominal area or posterior superior gluteal region, and an electrode assembly 150 implanted within the epidural space and connected to the module 110 by a suitable lead. Numerous aspects of operation of implanted neural device 100 are reconfigurable by an external control device 192. Moreover, implanted neural device 100 serves a data gathering role, with gathered data being communicated to external device 192.

[0043] FIG. 2 is a block diagram of the implanted neurostimulator 100. Module 110 contains a battery 112 and a telemetry module 114. In embodiments of the present invention, any suitable type of transcutaneous communication 190, such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used by telemetry module 114 to transfer power and/or data between an external device 192 and the electronics module 110.

[0044] Module controller 116 has an associated memory 118 storing patient settings 120, control programs 122 and the like. Controller 116 controls a pulse generator 124 to generate stimuli in the form of current pulses in accordance with the patient settings 120 and control programs 122. Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode(s). For simplicity FIGS. 2 and 3 show a single pulse generator 124 delivering a bipolar stimulus via electrodes 2 and 4, however as such electrodes are typically positioned at about 7 mm intervals the present invention further provides for current steering to be effected by use of additional pulse generators and additional stimulus electrodes, as described more fully in the following in relation to FIG. 4 et seq. Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126.

[0045] FIG. 3 is a schematic illustrating interaction of the implanted stimulator 100 with a nerve 180, in this case the spinal cord however alternative embodiments may be positioned adjacent any desired neural tissue including a peripheral nerve, visceral nerve, parasympathetic nerve or a brain structure. Electrode selection module 126 selects one or more stimulation electrode(s) 2 of electrode array 150 to deliver a triphasic electrical current pulse to surrounding tissue including nerve 180, although other embodiments may additionally or alternatively deliver a biphasic tripolar stimulus. Electrode selection module 126 also selects one or more return electrode(s) 4 of the array 150 for stimulus current recovery to maintain a zero net charge transfer.

[0046] Delivery of an appropriate stimulus to the nerve 180 evokes a neural response comprising a compound action potential which will propagate along the nerve 180 as illustrated, for therapeutic purposes which in the case of a spinal cord stimulator for chronic pain might be to create paraesthesia at a desired location. To this end the stimulus electrodes are used to deliver stimuli at 30 Hz. To fit the device, a clinician applies stimuli which produce a sensation that is experienced by the user as a paraesthesia. Current steering, described in more detail in the following, is used to identify an optimal location at which to apply such stimuli. When the paraesthesia is in a location and of a size which is congruent with the area of the user's body affected by pain, the clinician nominates that configuration for ongoing use.

[0047] The device 100 is further configured to sense the existence and electrical profile of compound action potentials (CAPs) propagating along nerve 180, whether such CAPs are evoked by the stimulus from electrodes 2 and 4, or otherwise evoked. To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8. The stimulator case may also be used as a measurement electrode or reference electrode, or as a stimulation electrode or return electrode. Signals sensed by the measurement electrodes 6 and 8 are passed to measurement circuitry 128, which for example may operate in accordance with the teachings of International Patent Application Publication No. WO2012155183 by the present applicant, the content of which is incorporated herein by reference. The present invention recognises that in circumstances such as shown in FIG. 3 where the recording electrodes are close to the site of stimulation, stimulus artefact presents a significant obstacle to obtaining accurate recordings of compound action potentials, but that reliable accurate CAP recordings are a key enabler for a range of neuromodulation techniques.

[0048] FIG. 4 provides a detailed view of a plurality of current sources provided within the pulse generator 124 and configured to effect current steering. As noted above, FIGS. 2 and 3 give a simplified view showing a single pulse generator 124 delivering a bipolar stimulus via electrodes 2 and 4. However as such electrodes are typically positioned at about 7 mm intervals, the present invention further provides for current steering to be effected by use of additional pulse generators and additional stimulus electrodes, as shown in more detail in FIG. 4. Current sources 412, 414, 416, 418, also referred to as anodic drivers, are each referenced to a supply rail VDDH.

[0049] An additional set of return current sources 422, 424, 426, 428, also referred to as cathodic drivers, are referenced to a ground rail GND.

[0050] Current sources 412, 414, 416, 418, 422, 424, 426, 428 may each be selectably connected to any one respective electrode of the electrode array 150, by appropriately configuring each switch within the switch array 430 within electrode selection module 126.

[0051] In one embodiment the implant 100 has 24 epidural electrodes, of which only 3 are shown in FIG. 4, and one indifferent (case) electrode. The epidural electrodes are mounted on two electrode leads, with 12 electrodes on each lead, whereby the two leads are implanted alongside each other and substantially parallel to each other alongside the dorsal column, thus forming a 2×12 array of electrodes. The provision of four stimulus current sources 412, 414, 416, 418 and four current sources 422, 424, 426, 428 thus permits current steering to be effected in two dimensions, both axially (caudorostrally) along the lead between two selected stimulus electrodes, as well as laterally between the leads.

[0052] As further shown in FIG. 4, a virtual ground amplifier 440 is also provided. Amplifier 440 can be selectably connected to any two respective electrodes of the electrode array 150, by appropriately configuring each switch within the switch array 430 within electrode selection module 126. Amplifier 440 operates in accordance with the teachings of International Patent Publication No. WO2014071445 by the present Applicant, the content of which is incorporated herein by reference.

[0053] Another aspect of the invention is illustrated in FIGS. 4-6. In particular, during a first phase of a stimulus the current sources 412-418 inject current to respective stimulus electrodes, while the return current sources 422-428 are disconnected, and a single return electrode is connected directly to the ground rail. Then, in a second phase of the stimulus, the return current sources 422-428 extract current from the stimulus electrodes in the same proportions as was injected in the first phase in order to ensure balanced net charge at each electrode. In this second phase the single return electrode is connected directly to the VDDH supply rail, and current sources 412-418 are disconnected. By positioning only one current source between the supply rails VDDH and GND in each phase, losses are reduced in this embodiment as compared to the use of a larger number of current sources. However, alternative embodiments may utilise one or more or all of the current sources 422-428 during the first phase, and/or may utilise one or more or all of current sources 412-418 during the second phase, for example to effect intra-phase charge balancing and/or to control the tissue voltage to a predictable value by current ratio control.

[0054] FIGS. 5A and 5B illustrate typical switch connections during stimulation, either when using a normal passive ground return electrode (FIG. 5A) or when using a virtual ground configuration (FIG. 5B). As will be understood, suitable switch sequences allow for delivery of a biphasic stimulus between each pair of stimulus electrodes, to ensure a zero net charge transfer and to also ensure that electrochemical effects at each electrode-tissue interface are reversed and/or generally to ensure that the stimulus regime meets safety requirements.

[0055] FIG. 6 illustrates the control arrangement of each current source of FIG. 4, in accordance with the described embodiment. The current control consists of one global digital to analog converter (GDAC) 610, which controls four local DACs (LDACs) 620, of which only one is shown in FIG. 6.

[0056] The GDAC 610 has 12-bit control, of which 9 bits are monotonic. Each LDAC 620 has 4-bit control with 16 steps. There is one GDAC 610 for all four current source pairs, and four LDACs, one LDAC for each current source pair. The resolution of the LDAC is chosen as a small value, namely 4 bits, in order to simplify the design and cost. The present invention recognises that 4 bits of local control is adequate for field shaping, despite not being adequate for control of the current for general use. In this regard the currents from the electrodes therefore depend on the GDAC value to provide useful general function, such as for amplitude control in response to posture changes. The GDAC 610 and the LDAC multipliers go from 2.sup.−n to 1.0. The arrangement of FIG. 4 thus nominally has 18 bits of DAC control: 12 bits for the GDAC, 4 bits for each respective LDAC and 4 current sources (2 bits).

[0057] When there is a single stimulating electrode or fewer than four stimulating electrodes, either an individual current source may be used for the or each stimulating electrode, or multiple current sources may be used to drive a single stimulating electrode by switching each such current source output to that electrode's rail in the switch array 430. Such embodiments may be particularly advantageous in patients for whom the desired currents are high (6.25 mA to 50 mA), as in such cases it is preferable to use multiple current sources to reduce loss of compliance voltage. When currents are low, it is preferable to use a single current source. Tables 1˜4 below show the range of currents and recommended number of current sources in each case, in accordance with a preferred embodiment of the invention.

TABLE-US-00001 TABLE 1 DAC Resolution - single stimulating electrode Number of monotonic steps 512 Resolution per current source (uA) 24.41 Patient's Maximum Number Current of Worst Minimum Maximum Current Resolution case (mA) (mA) Sources (uA) step size 1.56 3.13 1 24.4 1.6% 3.13 6.25 2 48.8 1.6% 6.25 12.50 4 97.7 1.6% 12.50 25.00 4 97.7 0.8% 25.00 50.00 4 97.7 0.4%

TABLE-US-00002 TABLE 2 DAC Resolution - two stimulating electrodes Number of monotonic steps 512 Resolution per current source (uA) 24.41 Patient's Maximum Number Current of Worst Minimum Maximum Current src Current Resolution case (mA) (mA) arrangement Sources (uA) step size 1.56 3.13 1 + 1 2 48.8 3.1% 3.13 6.25 1 + 1 2 48.8 1.6% 6.25 12.50 2 + 2 4 97.7 1.6% 12.50 25.00 2 + 2 4 97.7 0.8% 25.00 50.00 2 + 2 4 97.7 0.4%

TABLE-US-00003 TABLE 1 DAC Resolution - three stimulating electrodes Number of monotonic steps 512 Resolution per current source (uA) 24.41 Patient's Maximum Number Current of Worst Minimum Maximum Current src Current Resolution case (mA) (mA) arrangement Sources (uA) step size 1.56 3.13 1 + 1 + 1 3 73.2 4.7% 3.13 6.25 1 + 1 + 1 3 73.2 2.3% 6.25 12.50 1 + 1 + 1 3 73.2 1.2% 12.50 25.00 1 + 1 + 1 3 73.2 0.6% 25.00 50.00 1 + 2 + 1 4 97.7 0.4%

TABLE-US-00004 TABLE 2 DAC Resolution - four stimulating electrodes Number of monotonic steps 512 Resolution per current source (uA) 24.41 Patient's Maximum Number Current of Worst Minimum Maximum Current src Current Resolution case (mA) (mA) arrangement Sources (uA) step size 1.56 3.13 1 + 1 + 1 + 1 4 97.7 6.3% 3.13 6.25 1 + 1 + 1 + 1 4 97.7 3.1% 6.25 12.50 1 + 1 + 1 + 1 4 97.7 1.6% 12.50 25.00 1 + 1 + 1 + 1 4 97.7 0.8% 25.00 50.00 1 + 1 + 1 + 1 4 97.7 0.4%

[0058] In accordance with the present invention, more than one stimulus electrode can be utilised to simultaneously deliver respective stimuli components, so that the plurality of stimulus electrodes collectively form what is referred to herein as a virtual electrode. The DACs are organized so that the implant can provide virtual electrodes of any arrangement permitted by configuring the switch array 430, with each such virtual electrode consisting of the combined effect of up to four independent stimulating electrodes. When creating a virtual electrode, the current delivered to each physical electrode can be selected to 4-bit accuracy by controlling the respective LDAC 620 for each electrode. The present invention recognises that 4 bit accuracy permits the virtual electrode to be selectively located at a virtual location which may be between the actual electrodes, and may be so located to a sufficient degree of accuracy under 4-bit control.

[0059] Moreover, by providing the GDAC in the described manner, the present invention advantageously also permits the GDAC to be used as a single feedback control variable in a feedback loop. The feedback loop may be based on measurements of evoked compound action potentials, and may for example operate in accordance with the teachings of one or more of International Patent Publication WO2012155188, International Patent Publication WO2016090436 and International Patent Publication WO2017173493, by the present Applicant, the contents of each being incorporated herein by reference. In such a feedback loop, the controlled variable drives the global DAC 610 and the local DACs can each remain static, significantly simplifying the implementation of such a feedback loop.

[0060] The implant fitting process, as for example may be saved into firmware, should specify a single LDAC setting as part of a therapy map suitable for the patient concerned.

[0061] FIGS. 7 to 9 further illustrate the spatiotemporal nature of stimulation options made possible by the present invention.

[0062] FIG. 7 provides a key to the symbols and terminology utilised in FIGS. 8 & 9. These diagrams show a 4×2 array (or a 4×2 portion of an array) of electrodes. An electrode connected to a supply is shown with a solid line, with the sign of the supply written inside. Current sources are shown with a sign and the proportion of current borne by that respective electrode. When more than one current source is used, individual units are marked with the letter (A-D). Stimulus phases are numbered 1 . . . n, measurement and charge recovery phases are marked “M” and “C”. Time travels from left to right, whereby a first stimulus phase is portrayed in FIG. 8A, a second stimulus phase is portrayed in FIG. 8B, a third stimulus phase is portrayed in FIG. 8D, a measurement phase is portrayed in FIG. 8D and a shorting phase is portrayed in FIG. 8E. The stimulus electrode is usually cathodic, with other electrodes referred to as the anodic or return electrode. The values a,b,c,d are LDAC values to effect a virtual electrode, and are set for the patient's map as required for a desired therapeutic outcome.

[0063] FIGS. 8A to 8E thus show implementation of a virtual electrode interposed between actual electrodes A-D, in a tri-phasic stimulation configuration (FIGS. 8A-8C), followed by a measurement phase (FIG. 8D) and finally an electrode shorting phase (FIG. 8E).

[0064] FIGS. 9A-9E illustrate implementation of a virtual electrode, together with the use of a virtual ground in accordance with WO2014071445 noted previously herein, in a tri-phasic stimulation arrangement.

[0065] The GDAC value is a single value for each stimulus. Upon completion of each measurement phase (e.g FIG. 8D, 9D) the GDAC value can be changed via feedback based on the measurement result, to thus effect feedback controlled neural stimulation via a virtual electrode.

[0066] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not limiting or restrictive.