Sensing system for implantable electrodes
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-01-28
- Publication Date
- 2026-08-13
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Figure IB2026050800_13082026_PF_FP_ABST
Abstract
Description
Docket No.: A0013098W001SENSING SYSTEM FOR IMPLANTABLE ELECTRODESCROSS RELATED REFERENCES
[0001] This application is a PCT application that claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 754,404, filed February 5, 2025, the entire contents of which is incorporated herein by reference.TECHNICAL FIELD
[0002] This disclosure generally relates to medical devices, and more specifically, sensing electrical signals using medical devices.BACKGROUND
[0003] Medical devices may be external or implanted and may be used to deliver electrical stimulation therapy to patients via various tissue sites to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson’s disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device may deliver electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Stimulation proximate the spinal cord, proximate the sacral nerve, within the brain, and proximate peripheral nerves are often referred to as spinal cord stimulation (SCS), sacral neuromodulation (SNM), deep brain stimulation (DBS), and peripheral nerve stimulation (PNS), respectively.
[0004] Patients afflicted with movement disorders or other neurodegenerative impairment, whether by disease or trauma, may experience muscle control and movement problems, such as rigidity, bradykinesia (i.e., slow physical movement), rhythmic hyperkinesia (e.g., tremor), nonrhythmic hyperkinesia (e.g., tics) or akinesia (i.e., a loss of physical movement). Movement disorders may be found in patients with Parkinson’s disease, multiple sclerosis, and cerebral palsy, among other conditions. Delivery of electrical stimulation and / or a fluid (e.g., a pharmaceutical drug) by a medical device to one or more sites in a patient, such as a brain, spinal cord, leg muscle or arm muscle, in a patient may help alleviate, and in some cases, eliminate symptoms associated with movement disorders.Docket No.: A0013098W001SUMMARY
[0005] In general, the disclosure is directed to devices, systems, and techniques for monitoring electrode measurements from one or more electrodes coupled to an implantable medical device (IMD). During implantation of the HMD, the clinician may receive measurements from electrodes coupled to the IMD, e.g., to determine a selection of electrodes for the delivery of the stimulation signal. Once the IMD is implanted, the IMD may deliver electrical stimulation signals to tissue of the patient via the selected electrodes.
[0006] Devices, systems, and techniques are described for determining electrical measurements for one or more electrodes based on two or more tripolar measurements from three or more electrodes. The two or more tripolar measurements may each be defined by measurements from each of the three or more electrodes, including the target electrodes. By altering the polarities of the non-target electrodes of the three or more electrodes, between the tripolar measurements, the system may isolate the measurements of the target electrode from the non-target electrodes. This process can then identify electrical contributions to the measurements for the target electrode, e.g., free from the influence of the any other electrodes.
[0007] In some examples, techniques to identify electrode measurements may require extensive post-processing and / or more measurements, which may increase a duration and / or a complexity of the procedure. The techniques described herein may reduce and / or eliminate an amount post-processing required to determine the electrode measurements, which may reduce a complexity and / or duration of the procedure and / or may increase an accuracy of the electrode measurements. In some examples, techniques to identify electrode measurements may require the use of electrodes on two or more implantable leads, e.g., on two or more contralateral leads. With some patients, the physiology of the patient may be incompatible with the use of two or more separate implantable leads (e.g., due to age, disease state, etc.). The techniques described herein may be performed using electrodes on a single implantable lead, which may allow the techniques to be performed on patients who may be limited to receiving only a single implantable lead and / or in an event where one or more implantable leads are damaged.
[0008] In some examples, this disclosure is directed to a medical device system comprising: processing circuitry configured to: control sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; control the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; sum the first measurement andDocket No.: A0013098W001the second measurement to generate electrical activity of a specific electrode of the three or more electrodes from the patient; and output a representation of the electrical activity of the specific electrode.
[0009] In some examples, this disclosure is directed to a method comprising: controlling, by processing circuitry of a medical device system, sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; controlling, by the processing circuitry, the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; summing, by the processing circuitry, the first measurement and the second measurement to generate electrode activity of a specific electrode of the three or more electrode from the patient; and outputting, by the processing circuitry, a representation of the electrical activity of the specific electrode.
[0010] In some examples, this disclosure is directed to a computer-readable medium comprising instructions that, when executed by processing circuitry of a medical device system, causes the processing circuitry to: control sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; control the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; sum the first measurement and the second measurement to generate electrode activity of a specific electrode of the three or more electrode from the patient; and output representation of the electrical activity of the specific electrode.
[0011] The summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the systems, device, and methods described in detail within the accompanying drawings and description below. Further details of one or more examples of this disclosure are set forth in the accompanying drawings and in the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGSDocket No.: A0013098W001
[0012] FIG. l is a conceptual diagram illustrating an example system for delivering electrical stimulation to a patient, in accordance with one or more techniques of this disclosure.
[0013] FIG. 2 is a functional block diagram illustrating components of the IMD of FIG. 1, in accordance with one or more techniques of this disclosure.
[0014] FIG. 3 is a conceptual block diagram of the programmer of FIG. 1, in accordance with one or more techniques of this disclosure.
[0015] FIG. 4A is a conceptual diagram illustrating an example electrode arrangement over an implantable lead of FIG. 1.
[0016] FIG. 4B is a conceptual diagram illustrating an example of the electrode arrangement of FIG. 4 A, the implantable lead has been longitudinally cut and laid flat.
[0017] FIG. 5A is a conceptual diagram illustrating an example operation performed with two measurements to isolate electrode measurements by a single electrode level of a plurality of electrode levels of the electrode arrangement of FIG. 4A.
[0018] FIG. 5B is a conceptual diagram illustrating an example operation performed with two measurements to isolate electrode measurements by a single electrode within an electrode level of the electrode arrangement of FIG. 4 A.
[0019] FIG. 5C is a conceptual diagram illustrating an example operation performed with two measurements to isolate electrode measurements by a single electrode of a plurality of electrodes across a plurality of electrode levels of the electrode arrangement of FIG. 4A.
[0020] FIG. 6A is a conceptual diagram illustrating an example user interface illustrating electrode activity of different electrode levels of the electrode arrangement of FIG. 4 A.
[0021] FIG 6B is a conceptual diagram illustrating an example user interface illustrating electrode activity of different electrodes within different electrode levels of the electrode arrangement of FIG. 4 A.
[0022] FIG. 7 is a flow chart illustrating an example technique for determining an electrode measurement of a specific electrode on an implantable lead of FIG. 1.
[0023] Like reference characters denote like elements throughout the description and figures.DETAILED DESCRIPTION
[0024] The disclosure describes examples of medical devices, systems, and techniques for sensing electrical signals from electrode combinations and isolating electrical activity for one or more electrodes using different electrode combinations. Elecrical signals can be sensed between two or more electrodes implanted within a patient. These electrical signals can be used to identify which electrodes can be used for further sensing and / or delivering electrical stimulation.Docket No.: A0013098W001However, the sensed electrical signals between multiple electrodes inherently includes contributions of electrical activity in tissue near each electrode. Since the sensed electrical signals, and resulting measurements thereof, include contributions from each electrode in the combination, it can be difficult to determine which one or more electrodes should be used for further sensing and / or delivering stimulation.
[0025] As described herein, a medical system can sense electrical signals and generate respective measurements of different electrode configurations that have polarity assignments for each electrode in order to isolate the measurement attributable to a single electrode. For example, different tripolar electrode configurations can assign the target electrode with the same polarity in two different electrode configurations, whereas two other electrodes of the electrode configurations switch polarities between the different electrode configurations. The system can then sum the resulting measurements from the different tripolar electrode configurations to generate the electrical activity from the target electrode because activity attributable to the electrodes switching polarity cancels out. The system can perform this process for some or all of the available electrodes and then use the resulting electrical activity from each electrode to compare and determine the desired electrode (or more than one) to use for subsequent sensing of electrical activity of the patient.
[0026] In some examples, the desired electrode (or two or more electrodes) can also be used for delivering electrical stimulation to the brain of a patient in order to suppress one or more bioelectric brain signals of the patient. As will be described further below, in some examples, a medical device (e.g., an implantable medical device (IMD)) may deliver electrical stimulation to the brain of the patient to manage or otherwise treat a patient disorder. Although DBS is used as one example, similar techniques may be used to sense signals in any anatomical location and / or delivery electrical stimulation to any target tissue within a patient.
[0027] FIG. 1 is a conceptual diagram illustrating an example system 100 for delivering electrical stimulation to a patient 102, in accordance with one or more techniques of this disclosure. System 100 may deliver electrical stimulation therapy to treat or otherwise manage a patient condition, such as, e.g., a movement disorder of patient 102. The electrical stimulation therapy may include, but is not limited to, deep brain stimulation (DBS), other nerve stimulation therapy, or the like. Patient 102 ordinarily will be a human patient. In some cases, however, system 100 may be applied to other mammalian or non-mammalian, non-human patients.
[0028] System 100 includes a programmer 104, an implantable medical device (IMD) 106, a lead extension 108, and one or more leads 110A and HOB (collectively “leads 110”) with respective sets of electrodes 112, 114. Lead 110A may include set of electrodes 112, and leadDocket No.: A0013098W001HOB may include set of electrodes 114. Each of leads 110 may define an elongated body extending along a longitudinal axis. Electrodes of the corresponding set of electrodes (e.g., set of electrodes 112 for lead 110A, set of electrodes 114 for lead HOB) may be disposed over and / or around an outer surface of the elongated body. In some examples, as illustrated in FIG. 1, patient 102 may be physiologically suited to be implanted with at least two leads 110 (e.g., leads 110A, HOB). In some examples, patient 102 may be physiologically restricted (e.g., due to age, disease state, etc.) and only one lead 110 is implanted within patient 102.
[0029] IMD 106 may generate and deliver electrical stimulation therapy to one or more regions of brain 116 of patient 102 via a subset of one or more of sets of electrodes 112, 114 of leads 110A, 110B, respectively. Each of leads 110 may be a unilateral or bilateral lead. The subset of electrodes may be selected based on sensed measurements from electrodes of one or more of sets of electrodes 112, 114, e.g., as described in greater detail herein. In the example shown in FIG. 1, system 100 may be referred to as a DBS system because IMD 106 provides electrical stimulation therapy directly to tissue within brain 116, e.g., a tissue site under the dura mater of brain 116. In other examples, leads 110 may be positioned to deliver therapy to a surface of brain 116 (e.g., the cortical surface of brain 116).
[0030] In some examples, delivery of stimulation to one or more regions of brain 116, such as an anterior nucleus (AN), thalamus or cortex of brain 116, provides an effective treatment to manage a disorder of patient 102. In some examples, IMD 106 may provide cortical stimulation therapy to patient 102, e.g., by delivering electrical stimulation to one or more tissue sites in the cortex of brain 116. Target stimulation site(s) within brain 116 may include one or more basal ganglia sites, including, e.g., subthalamic nucleus (STN), globus pallidus interna (GPi), globus pallidus externa (GPe), pedunculopontine nucleus (PPN), thalamus, substantia nigra pars reticulata (SNr), internal capsule, and / or motor cortex.
[0031] IMD 106 may be implanted within a subcutaneous pocket above the clavicle of patient 102. In other examples, IMD 106 may be implanted within other regions of patient 102, such as a subcutaneous pocket in the abdomen or buttocks of patient 102 or proximate the cranium of patient 102. Lead extension 108 is coupled to IMD 106 via a connector block 118 (also referred to as “header 118”), which may include, for example, electrical contacts that electrically couple to respective electrical contacts on lead extension 108. The electrical contacts electrically couple the sets of electrodes 112, 114 carried by leads 110 to IMD 106. Lead extension 108 traverses from the implant site of IMD 106 within a chest cavity of patient 102, along the neck of patient 102 and through the cranium of patient 102 to access brain 116. IMDDocket No.: A0013098W001106 may be constructed of a biocompatible material that resists corrosion and degradation from bodily fluids.
[0032] Leads 110A and HOB may be implanted within the right and left hemispheres, respectively, of brain 116 in order deliver electrical stimulation to one or more regions of brain 116, which may be selected based on many factors, such as the type of patient condition for which system 100 is implemented to manage. Other implant sites for leads 110 and IMD 106 are contemplated. For example, IMD 106 may be implanted on or within a cranium 120 or leads 110 may be implanted within the same hemisphere or IMD 106 may be coupled to a single lead 110 that is implanted in one or both hemispheres of brain 116.
[0033] Leads 110 may be positioned to deliver electrical stimulation to one or more target tissue sites within brain 116 to manage patient symptoms associated with a disorder of patient 102. Leads 110 may be implanted to position the sets of electrodes 112, 114 at desired locations of brain 116 through respective holes in cranium 120. Leads 110 may be placed at any location within brain 116 such that the sets of electrodes 112, 114 are capable of providing electrical stimulation to target tissue sites within brain 116 during treatment. For example, in the case of Parkinson’s disease, for example, leads 110 may be implanted to deliver electrical stimulation to one or more basal ganglia sites, including, e.g., subthalamic nucleus (STN), globus pallidus interna (GPi), globus pallidus externa (GPe), pedunculopontine nucleus (PPN), thalamus, substantia nigra pars reticulata (SNr), internal capsule, and / or motor cortex.
[0034] Although leads 110 are shown in FIG. 1 as being coupled to lead extension 108, in some examples, leads 110 may be coupled to IMD 106 via separate lead extensions or directly coupled to IMD 106. Moreover, although FIG. 1 illustrates system 100 as including leads 110A and HOB coupled to IMD 106 via lead extension 108, in some examples, system 100 may include one lead 100 or more than two leads 110.
[0035] Leads 110 may deliver electrical stimulation to treat any number of neurological disorders or diseases in addition to movement disorders, such as seizure disorders or psychiatric disorders. Examples of movement disorders include a reduction in muscle control, motion impairment or other movement problems, such as rigidity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, dystonia, tremor, and akinesia. Movement disorders may be associated with patient disease states, such as Parkinson’s disease or Huntington’s disease. Examples of psychiatric disorders include MDD, bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and OCD. As described above, while examples of the disclosure are primarily described with regard to treating Parkinson’s disease, treatment ofDocket No.: A0013098W001other patient disorders via delivery of therapy to brain 116 or to other target tissue of patient 102 is contemplated.
[0036] Leads 110 may be implanted within a desired location of brain 116 via any suitable technique, such as through respective burr holes in a skull of patient 102 or through a common burr hole in cranium 120. Leads 110 may be placed at any location within brain 116 such that the sets of electrodes 112, 114 of leads 110 are capable of providing electrical stimulation to targeted tissue during treatment. Electrical stimulation generated from the stimulation generator (not shown) within the therapy module of IMD 106 may help prevent the onset of events associated with the patient’s disorder or mitigate symptoms of the disorder.
[0037] Sets of electrodes 112, 114 of leads 110 may include ring electrodes, electrode arrays, or the like. For example, the sets of electrodes 112, 114 of leads 110 may define an electrode array configured of producing shaped electrical fields. The electrode array may include multiple electrodes (e.g., partial ring or segmented electrodes) around the perimeter of each of leads 110. In this manner, electrical stimulation may be directed to a specific direction from leads 110 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue.
[0038] IMD 106 may receive the bioelectrical signals from the sets of electrodes 112, 114 or other electrodes positioned to monitored brain signals of patient 102. Sets of electrodes 112, 114 may deliver stimulation signals to and / or sense brain signals from tissue of brain 116. IMD 106 may use separate sensing electrodes to sense the bioelectric brain signals from brain 116. One or more electrodes of sets of electrodes 112, 114 may be used to sense bioelectric brain signals while one or more different electrodes of sets of electrodes 112, 114 may be used to deliver electrical stimulation.
[0039] Depending on the particular stimulation electrodes and sense electrodes used by IMD 106, IMD 106 may monitor brain signals and deliver electrical stimulation at the same region of brain 116 or at different regions of brain 116. In some examples, the electrodes used to sense bioelectric brain signals may be located on the same lead 110 used to deliver electrical stimulation, while in other examples, the electrodes used to sense bioelectric brain signals may be located on a different lead 110 than the electrodes used to deliver electrical stimulation. In some examples, a brain signal of patient 102 may be monitored with external electrodes, e.g., scalp electrodes.
[0040] The bioelectric brain signals monitored by the IMD 16 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue. Examples of the monitored bioelectric brain signals include, but are not limited to, anDocket No.: A0013098W001electroencephalogram (EEG) signal, an evoked resonant neural activity (ERNA) signal, an electrocorti cogram (ECoG) signal, a local field potential (LFP) sensed from within one or more regions of a patient’s brain and / or action potentials from single cells within the patient’s brain.
[0041] Programmer 104 wirelessly communicates with IMD 106 as needed to provide or retrieve therapy information. Programmer 104 is an external computing device that the user, e.g., the clinician and / or patient 102, may use to communicate with IMD 106. For example, programmer 104 may be a clinician programmer that the clinician uses to communicate with IMD 106 and program one or more therapy programs for IMD 106. Alternatively, programmer 104 may be a patient programmer that allows patient 102 to select programs and / or view and modify therapy parameters. The clinician programmer may include more programming features than the patient programmer. In other words, more complex or sensitive tasks may only be allowed by the clinician programmer to prevent an untrained patient from making undesired changes to IMD 106.
[0042] Programmer 104 may be a hand-held computing device with a display viewable by the user and a user interface (UI) for providing input to programmer 104 (i.e., a user input mechanism). For example, programmer 104 may include a small display screen (e.g., a liquid crystal display (LCD) or a light emitting diode (LED) display) configured to present information to the user, a touch screen display, keypad, buttons, a peripheral pointing device or another input mechanism that allows the user to navigate through the user interface of programmer 104 and provide input. If programmer 104 includes buttons and a keypad, the buttons may be dedicated to performing a certain function, i.e., a power button, or the buttons and the keypad may be soft keys that change in function depending upon the section of the user interface currently viewed by the user.
[0043] In some examples, programmer 104 may be a larger workstation or a separate application within another multi -function device, rather than a dedicated computing device. For example, the multi -function device may be a notebook computer, tablet computer, workstation, cellular phone, personal digital assistant or another computing device that may run an application that enables the computing device to operate as a secure medical device programmer. A wireless adapter coupled to the computing device may enable secure communication between the computing device and IMD 106.
[0044] Programmer 104 may transmit initial programming information to IMD 106. This initial information may include hardware information, such as the type of the leads 110, the arrangement of the sets of electrodes 112, 114 on leads 110, the position of leads 110 within brain 116, initial programs defining therapy parameter values, and any other information that may beDocket No.: A0013098W001useful for programming into IMD 116. Programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance one or more electrodes of the sets of electrodes 112, 114 of the leads 110).
[0045] The clinician may also store therapy programs within IMD 106 with the aid of programmer 104. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to patient 102 to address symptoms associated with the seizure disorder (or another patient condition). For example, the clinician may select one or more electrode combinations with which stimulation is delivered to brain 116, e.g., as described in greater detail below. During the programming session, patient 102 may provide feedback to the clinician as to the efficacy of the specific program being evaluated or the clinician may evaluate the efficacy based on one or more physiological parameters of patient (e.g., heart rate, respiratory rate or muscle activity). Programmer 104 may assist the clinician in the creation / identification of therapy programs by providing a methodical system for identifying potentially beneficial therapy parameter values.
[0046] Programmer 104 may also be configured for use by patient 102. When configured as a patient programmer, programmer 104 may have limited functionality (compared to a clinician programmer) in order to prevent patient 102 from altering critical functions of IMD 106 or applications that may be detrimental to patient 102. In this manner, programmer 104 may only allow patient 102 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter.
[0047] Programmer 104 may be configured to communicate to IMD 106 and, optionally, another computing device, via wireless communication. Programmer 104, for example, may communicate via wireless communication with IMD 106 using radio frequency (RF) telemetry techniques known in the art. Programmer 104 may communicate with another programmer or computing device via a wired or wireless connection using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, infrared (IR) communication according to the IRDA specification set, or other standard or proprietary telemetry protocols. Programmer 104 may communicate with other programming or computing devices via exchange of removable media, such as magnetic or optical disks, memory cards or memory sticks. Programmer 104 may communicate with IMD 106 and another programmer via remote telemetry techniques known in the art, communicating via a local area network (LAN), wide area network (WAN), public switched telephone network (PSTN), or cellular telephone network, for example.Docket No.: A0013098W001
[0048] System 100 may be implemented to provide chronic stimulation therapy to patient 102 over the course of several months or years. However, system 100 may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, some components of system 100 may not be implanted within patient 102. For example, patient 102 may be fitted with an external medical device, such as a trial stimulator, rather than IMD 106. The external medical device may be coupled to percutaneous leads or to implanted leads via a percutaneous extension. If the trial stimulator indicates system 100 provides effective treatment to patient 102, the clinician may implant a chronic stimulator (e.g., IMD 106) within patient 102 for relatively long-term treatment.
[0049] FIG. 2 is a functional block diagram illustrating components of IMD 106 of FIG. 1, in accordance with one or more techniques of this disclosure. IMD 106 may include, but is not limited to, processing circuitry 202, memory 204, signal generation circuitry 206, sensing circuitry 208, telemetry circuitry 210, and power source 212. The processing circuitry 202 may include any one or more microprocessors, controllers, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), and discrete logic circuitry. The functions attributed to processors described herein, including the processing circuitry 202, may be provided by a hardware device and embodied as software, firmware, hardware, or any combination thereof.
[0050] In the example shown in FIG. 2, sensing circuitry 208 senses bioelectric brain signals of the patient 12 via select combinations of electrodes of sets of electrodes 112, 114. Sensing circuitry 208 may include circuitry that measures the electrical activity of a particular region, e.g., an anterior nucleus, thalamus or cortex of brain 116 via select electrodes of sets of electrodes 112, 114. For example, sensing circuitry 208 may be configured to measure the electrical activity of the subthalamic nucleus (STN), globus pallidus interna (GPi), globus pallidus externa (GPe), and / or other areas of the basal ganglia.
[0051] Sensing circuitry 208 may sample the bioelectric brain signal continuously or at regular intervals, such as, but not limited to, a frequency of about 1 Hz to about 1000 Hz, such as about 250 Hz to about 1000 Hz or about 500 Hz to about 1000 Hz. Sensing circuitry 208 may determine a voltage difference between two electrodes of the sets of electrodes 112, 114, which generally indicates the electrical activity within the particular region of brain 116. One electrode of the sets of electrodes 112, 114 may act as a reference electrode for sensing circuitry 208.
[0052] Processing circuitry 202 may receive the output of sensing circuitry 208. In some cases, processing circuitry 202 may apply additional processing to the bioelectrical signals, e.g., convert the output to digital values for processing and / or amplify the bioelectric brain signal. InDocket No.: A0013098W001some examples, sensing circuitry 208 and / or processing circuitry 202 may filter the signal from the selected electrodes of sets of electrodes 112, 114 in order to remove undesirable artifacts from the signal, such as noise from cardiac signals generated within the body of patient 102. In some examples, sensing circuitry 208 may sense brain signals substantially at the same time that IMD 106 delivers therapy to patient 102. In some examples, sensing circuitry 208 senses brain signals and IMD 106 may delivers therapy at different times.
[0053] Memory 204 may include any volatile or non-volatile media, such as a random access memory (RAM), read only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and the like. Memory 204 may store computer-readable instructions that, when executed by processing circuitry 202, cause IMD 106 to perform various functions described herein. Memory 204 may be considered, in some examples, a non-transitory computer-readable storage medium comprising instructions that cause one or more processors, such as, e.g., processing circuitry 202, to implement one or more of the example techniques described in this disclosure. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. However, the term “non-transitory” should not be interpreted to mean that memory 204 is non-movable. As one example, memory 204 may be removed from IMD 106, and moved to another device (e.g., to programmer 104).
[0054] Signal generation circuitry 206 may represent a single channel or multi-channel signal generator. For example, signal generation circuitry 206 may be capable of delivering a single stimulation pulse, multiple stimulation pulses or a continuous signal at a given time via a single electrode, via a single combination of electrodes, or via multiple combinations of electrodes. Signal generation circuitry 206 may include independent controllable sources and sinks for each electrode on sets of electrodes 112, 114.
[0055] In accordance with one or more examples of the disclosure, processing circuitry 202 and / or a processing circuitry of another device (e.g., processing circuitry of the programmer 104) may control signal generation circuitry 206 to generate and deliver electrical stimulation to one or more regions of brain 116.
[0056] Telemetry circuitry 210 may support wireless communication between IMD 106 and programmer 104 or another computing device under the control of the processing circuitry 202. Processing circuitry 202 of IMD 106 may, for example, transmit bioelectric brain signals and / or stimulation parameter values for the stimulation signal via telemetry circuitry 210 to a telemetry module within programmer 104 or another external device. Telemetry circuitry 210 in IMD 106, as well as telemetry modules in other devices and systems described herein, such as programmerDocket No.: A0013098W001104, may accomplish communication by radiofrequency (RF) communication techniques. In addition, telemetry circuitry 210 may communicate with programmer 104 via proximal inductive interaction of IMD 106 with programmer 104. Accordingly, telemetry circuitry 210 may send information to programmer 104 on a continuous basis, at periodic intervals, or upon request from IMD 106 or programmer 104.
[0057] Power source 204 may deliver operating power to various components of IMD 106. Power source 204 may include a small rechargeable or non-rechargeable battery and a power generation circuit to produce the operating power. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD 106. In some examples, power requirements may be small enough to allow IMD 106 to utilize patient motion and implement a kinetic energy-scavenging device to trickle charge a rechargeable battery. In other examples, traditional batteries may be used for a limited period of time.
[0058] FIG. 3 is a conceptual block diagram of programmer 104 of FIG. 1, in accordance with one or more techniques of this disclosure. Programmer 104 may include processing circuitry 302, a memory 304, telemetry circuitry 306, a user interface (UI) 308, and a power source 310. Processing circuitry 104 may control UI 308 and telemetry circuitry 306, and stores and retrieves information and instructions to and from memory 304. Programmer 104 may be configured for use as a clinician programmer or a patient programmer. Processing circuitry 302 may comprise any combination of one or more processors including one or more microprocessors, DSPs, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry. Accordingly, processing circuitry 302 may include any suitable structure, whether in hardware, software, firmware, or any combination thereof, to perform the functions ascribed herein to processing circuitry 302.
[0059] A user, such as a clinician or patient 102, may interact with programmer 104 through UI 308. UI 308 may include a display (not shown), such as an LCD or LED display or other type of screen, to present information related to treatment of the seizure disorder of patient 102. UI 308 may also include an input mechanism to receive input from the user. The input mechanisms may include, for example, buttons, a keypad (e.g., an alphanumeric keypad), a peripheral pointing device or another input mechanism that allows the user to navigate through UI 308 presented by processing circuitry 302 of programmer 104 and provide input to processing circuitry 302 via UI 308.
[0060] Memory 304 may include instructions for operating UI 308 and telemetry circuitry 306, and for managing power source 310. Memory 304 may also store any therapy data retrieved from IMD 106 during the course of therapy, as well as sensed bioelectric brain signals. TheDocket No.: A0013098W001clinician may use this therapy data to determine the progression of the patient condition in order to plan future treatment. Memory 304 may include any volatile or nonvolatile memory, such as RAM, ROM, EEPROM or flash memory. Memory 304 may also include a removable memory portion that may be used to provide memory updates or increases in memory capacities. A removable memory 304 may also allow sensitive patient data to be removed before programmer 104 is used by a different patient.
[0061] Memory 304 may be considered, in some examples, a non-transitory computer-readable storage medium comprising instructions that cause one or more processors, such as, e.g., processing circuitry 302, to implement one or more of the example techniques described in this disclosure. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. However, the term “non-transitory” should not be interpreted to mean that memory 302 is non-movable. As one example, memory 302 may be removed from programmer 104, and moved to another device. In certain examples, a non-transitory storage medium may store data that can, over time, change (e.g., in RAM).
[0062] Wireless telemetry in programmer 104 may be accomplished by RF communication or proximal inductive interaction of programmer 104 with IMD 106. This wireless communication is possible through the use of telemetry circuitry 306. Accordingly, telemetry circuitry 306 may be similar to the telemetry module contained within IMD 106. In alternative examples, programmer 104 may be capable of infrared communication or direct communication through a wired connection. In this manner, other external devices may be capable of communicating with programmer 104 without needing to establish a secure wireless connection.
[0063] Power source 310 may deliver operating power to the components of programmer 104. Power source 310 may include a battery and a power generation circuit to produce the operating power. In some examples, the battery may be rechargeable to allow extended operation.
[0064] FIG. 4A is a conceptual diagram illustrating an example electrode arrangement over an implantable lead 400. Lead 400 may be one of leads 110 (e.g., lead 110A) of FIG. 1. FIG. 4B is a conceptual diagram illustrating an example of the electrode arrangement of FIG. 4A, wherein implantable lead 440 has been longitudinally cut and laid flat. While FIGS. 4 A and 4B are primarily described with reference to lead 400, the example lead illustrated in FIGS. 4 A - 4B may encompass any example leads described herein.
[0065] Lead 400 may extend longitudinally along longitudinal axis 401. Lead 400 may include set of electrodes 403. Set of electrodes 403 may be similar to set of electrodes 112.Within set 403, electrodes may define a plurality of electrode levels 402A-N (collectivelyDocket No.: A0013098W001referred to herein as “electrode levels 402”). Each of electrode levels 402 may be define by one or more corresponding electrodes extending around a full, or partial, outer perimeter of lead 400. For example, as illustrated in FIG. 4A, first electrode level 402A may be defined by one or more electrodes 404, second electrode level 402B may be defined by one or more electrodes 406, third electrode level 402C may be defined by one or more electrodes 408, fourth electrode level 402N may be defined by one or more electrodes 410, etc.
[0066] Each electrode level 402 may be defined by one or more electrodes (e.g., electrodes 404, 406, 408, 410). For example, electrode levels 402A, 402B, 402C, and 402N may be defined by electrodes 404A-N, electrodes 406A-N, electrodes 408 A-N, and electrodes 410A-N, respectively, where each electrode of a respective level is disposed at a different perimeter position (or circumferential position) and the same longitudinal position. While FIG. 4B illustrated each electrode level 402 as being defined by three electrodes, in some examples each electrode level 402 may be defines by one, two or four or more electrodes. For example, each electrode level 402 may be defined by a single ring electrode.
[0067] With each electrode level 402, each electrode may be assigned a unique identifier. For example, within first electrode level 402A, a first electrode 404A may be assigned an identifier “EOa”, a second electrode 404B may be assigned an identifier “EOb”, and a third electrode 404C may be assigned an identifier “EOc”. Similarly, within second electrode level 402B, a first electrode 406A may be assigned an identifier “El a”, a second electrode 406B may be assigned an identifier “Elb”, and a third electrode 406C may be assigned an identifier “Elc”. For each of electrodes 404-410, the identifier may denote an electrode level of electrode levels 402 and / or a position within the electrode level (e.g., around the outer perimeter of lead 400) for the particular electrode. Electrodes 404-410 may define an electrode array around lead 400. In such examples, the identifiers for each of electrodes 404-410 may indicate the position each electrode within the electrode array.
[0068] System 100 may select electrodes along lead 400, e.g., for the sensing of signals from and / or for delivery of signals to tissue of brain 116 using different combinations of electrodes. The selected electrodes may be on different electrode levels 402. For example, one or more of one electrode 404, one electrode 406, one electrode 408, and / or one electrode 410 may be selected for the sensing and / or delivery of signals. In some examples, the selected electrodes are on a same electrode level 402. For example, two or more of electrodes 404A - 404N may be selected for the sensing and / or delivery of signals. System 100 may determine the relative positions of each electrode (e.g., within an electrode array) of a combination of electrodes based on the identifiers of each electrode. When IMD 106 causes electrodes to deliver a stimulationDocket No.: A0013098W001signal to and / or obtain measurements (e.g., tripolar measurements) from the tissue, IMD 106, processor 104, and / or the user may identify the relative positions of the electrodes along lead 400 and / or relative to target tissue of patient 102, e.g., based at least in part on identifiers for the electrodes. The measurements may include, but are not limited to, electrical potential of tissue at or around a specific electrode.
[0069] System 100 may isolate measurements from each electrode within a selected combination of electrodes 404-410 via two or more measurements. By isolating measurements from each electrode, system 100 may determine an efficacy of each electrode for sensing of signals from and / or delivery of signals to tissue of patient 102. System 100 may select one or more electrodes for the sensing of signals and / or the delivery of signals based on the relative efficacies of a plurality of electrodes 404-410.
[0070] System 100 may receive a first measurement from a selected combination of electrodes 404-410 in a first configuration. In some examples, in the first configuration, system 100 may transmit an electrical signal (e.g., a test signal) from a first electrode and a second electrode of the selected combination to a third electrode of the selected combination. In such examples, the first and second electrodes may have a different polarity than the third electrode. System 100 may then receive the first measurement in response to the electrical signal. In some examples, system 100 may receive (e.g., passively sense) the first measurement from tissue of patient 102 in the first configuration. In such examples, the first measurement may include electrical signals from the tissue of patient 102, e.g., in response to or independent of any electrical signals delivered by system 100 to patient 102.
[0071] System 100 may then receive a second measurement from the selected combination of electrodes 404-410 in a second configuration different from the first configuration. In some examples, in the second configuration, system 100 may transmit an electrical signal (e.g., a test signal) from the first electrode and the third electrode to the second electrode. In some examples, at least two of the electrodes may have different polarities between the first and second configurations. System 100 may then receive the second measurement in response to the electrical signal. In some examples, system 100 may receive (e.g., passively sense) the first measurement from tissue of patient 102 in the first configuration. System 100 may receive the first and second measurements from a same selected combination of electrodes 404-410. System 100 may deliver electrical signals with the same parameters (e.g., same amplitude) or different magnitudes between the selected electrodes in the first and the second configuration.
[0072] System 100 may combine (e.g., sum) the first and second measurements to isolate measurements for a specific electrode (e.g., the first electrode) of the selected combination ofDocket No.: A0013098W001electrodes 404-410. The first and second measurements may include measurements from each of two or more electrodes of the selected combination of electrodes 404-410 at opposite polarities. For example, second electrode may act as an anode in the first configuration and as a cathode in the second configuration, e.g., thereby causing the measurements from the second electrode in the first and second measurements to have opposite polarities. The specific electrode may define a same polarity across both the first and second configurations and may define a same polarity within the first and second measurements. When the first and second measurements are combined, the measurements for each of the two or more electrodes would cancel out (e.g., due to the opposing polarities between the measurements for each of the two or more electrodes), e.g., thereby isolating the measurements for the specific electrode. System 100 may then determine the measurements for the specific electrode for each of the first and second measurements based on the isolated measurements for the specific electrode (e.g., by dividing the isolated measurement by 1.5 or 2). In some examples, other post-processing techniques may be performed to determine the measurements for the specific electrode. Uniform post-processing techniques (e.g., the same post-processing techniques) may be performed for each of a plurality of electrodes monitored by system 100, e.g., to allow system 100 to compare the relative efficacies of the electrodes.
[0073] By using two measurements from the same selection of electrodes on lead 400 to determine measurements for a single electrode on lead 400, system 100 may determine the measurements for the single electrode without requiring another lead (e.g., one of leads 110) to be within the tissue of patient 102 (e.g., within brain 116). Additionally, the technique performed by the system 100 significantly reduces and / or eliminates any required post-processing of the measurements obtained by system 100, which may reduce a complexity and / or duration of techniques used to determine measurements for the single electrode. System 100 may perform the techniques described above via programmer 104, IMD 106, and / or one or more other computing devices, computing systems, and / or cloud computing environments in communication with programmer 104 and / or IMD 106.
[0074] FIG. 5A is a conceptual diagram illustrating an example operation 500 performed with two measurements to isolate electrode measurements by a single electrode level of a plurality of electrode levels 402 of the electrode arrangement of FIG. 4A. While FIG. 5 A primarily illustrates operation 500 performed by system 100 to isolate measurements from a first electrode level (e.g., first electrode level 402A) on lead 400, system 100 may perform operation 500 to isolate measurements from any other electrode level 402 on lead 400.Docket No.: A0013098W001
[0075] System 100 may receive a first measurement 502 A and a second measurement 502B from electrodes on lead 110A. Each of measurements 502A, 502B (collectively referred to as “measurements 502”) may be a combination of three or more measurements from three or more different electrode levels 402. For example, as illustrated in FIG. 5A, first measurement 502A may be a combination of measurements 504A-N (collectively referred to herein as "measurements 504”), each of measurements 504 being from one or more electrodes on a different electrode level 402 when electrode levels 402 are in a first configuration. Second measurement 502B may be a combination of measurements 506A-N (collectively referred to herein as “measurements 506”), each of measurements 506 being from one or more electrodes on a different electrode level 402 when electrode levels 402 are in a second configuration.
[0076] In the first configuration, system 100 may receive first measurement 502A from electrode levels 402A-N. First measurement 502A may be a tripolar measurement formed from three separate measurements 504A, 504B, and 504N, corresponding to electrode levels 402A, 402B, and 402N, respectively. Within first measurement 502A, measurements 504A, 504N may have a positive polarity while measurement 504B may have a negative polarity. Measurements 504A, 504N may have a positive polarity due to electrode levels 402A, 402N being cathodes within the first configuration. Measurement 504B may have a negative polarity due to electrode level 402B being an anode within the first configuration.
[0077] In the second configuration, system 100 may receive second measurement 502B from electrode levels 402A-N. Second measurement 502B may be a tripolar measurement formed from three separate measurements 506A, 506B, and 506N, corresponding to electrode levels 402A, 402B, and 402N, respectively. Within second measurement 502A, measurements 504A, 504B may have a positive polarity while measurement 504N may have a negative polarity. Measurements 504A, 504B may have a positive polarity due to electrode levels 402A, 402B being cathodes within the second configuration. Measurement 504N may have a negative polarity due to electrode level 402N being an anode within the second configuration.
[0078] System 100 may combine (e.g., sum) first measurement 502A and second measurement 502B to determine output 508. Output 508 may be an isolated measurement from first electrode level 402A, e.g., resulting from the combination of measurements 502. When system 100 combines first and second measurements 502A, 502B, measurements from the same electrode level (e.g., from second electrode level 402B, from third electrode level 402N) with opposite polarities may cancel out, leaving measurements from the same electrode level (e.g., from first electrode level 402A) with the same polarity. For example, as illustrated in FIG. 5A, measurement 504B may cancel out measurement 506B and measurement 504N may cancel outDocket No.: A0013098W001measurement 506N, leaving a sum of measurements 504A and 506A as output 508. Output 508 may correspond to isolated measurements for a specific electrode level (i.e., first electrode level 402A) from both first measurement 502A and second measurement 502B. System 100 may determine the measurement for the specific electrode level for one of first measurement 502A or second measurement 502B (e.g., measurement 504A, measurement 506A) based on output 508. For example, system 100 may divide output 508 by 1.5 or by 2 to determine measurement 504A and / or measurement 506A. In other examples, other post-processing techniques may be applied to output 508 to determine measurement 504A and / or measurement 506A.
[0079] FIG. 5B is a conceptual diagram illustrating an example operation 509 performed with two measurements to isolate electrode measurements by a single electrode within an electrode level 204 of the electrode arrangement of FIG. 4A. Operation 509 may be substantially similar to operation 500, aside from the elements described below.
[0080] System 100 may receive a first measurement 510A and a second measurement 510B from electrodes on lead 110 A. Each of measurements 510A, 510B (collectively referred to herein as “measurements 510”) may be a combination of three or more measurements from three or more different electrodes within a same electrode level 402. For example, as illustrated in FIG.5B, first measurement 510A may be a combination of measurements 512A-N (collectively referred to herein as “measurements 512”), each of measurements 512 being from a different electrode on a same electrode level 402 when the electrodes are in a first configuration. Second measurement 510B may be a combination of measurements 514A-N (collectively referred to herein as “measurements 514”), each of measurements 514 being from a different electrode on a same electrode level 402 when the electrodes are in a second configuration. Measurements 512 and 514 may be from a same selection of electrodes. For example, measurements 512A, 514A may be from first electrode 404A on first electrode level 402A, measurements 512B, 512B may be from second electrode 404B on first electrode level 402A, and measurements 512N, 514N may be from third electrode 404N on first electrode level 402A.
[0081] In the first configuration, system 100 may receive first measurement 510A from electrodes 404A-N after delivery of the electrical signal in the first configuration. First measurement 510A may be a tripolar measurement formed from three separate measurements 512A, 512B, and 512N, corresponding to electrode levels 404A, 404B, and 404N, respectively. Within first measurement 510A, measurements 512A, 512N may have a positive polarity while measurement 512B may have a negative polarity.
[0082] In the second configuration, system 100 may receive second measurement 510B from electrodes 404 A-N. Second measurement 510B may be a tripolar measurement formed fromDocket No.: A0013098W001three separate measurements 514A, 514B, and 512N, corresponding to electrode levels 404A, 404B, and 404N, respectively. Within second measurement 510B, measurements 514A, 514B may have a positive polarity while measurement 514N may have a negative polarity.
[0083] System 100 may combine (e.g., sum) first measurement 510A and second measurement 51 OB to determine output 516. Output 516 may be an isolated measurement from first electrode 404A of first electrode level 402A, e.g., resulting from the combination of measurements 510. When system 100 combines measurements 510, measurements from the same electrode (e.g., from second electrode 404B, from third electrode 404N) with opposite polarities may cancel out, leaving measurements from the same electrode (e.g., from first electrode 404A) with the same polarity. System 100 may then determine one or more of measurements 512A, 514A based on output 516, e.g., as described above with respect to FIG. 5A.
[0084] FIG. 5C is a conceptual diagram illustrating an example operation 519 performed with two tripolar measurements to isolate electrode measurements by a single electrode of a plurality of electrodes across a plurality of electrode levels of the electrode arrangement of FIG.4A. Operation 519 may be substantially similar to one or more of operations 500, 509, aside from the elements described below.
[0085] System 100 may receive a first measurement 520 A and a second measurement 520B from electrodes on lead 110 A. Each of measurements 520 A, 520B (collectively referred to herein as “measurements 520”) may be a combination of three or more measurements from three or more different electrodes within different electrode levels 402. For example, as illustrated in FIG.5B, first measurement 520A may be a combination of measurements 522A-N (collectively referred to herein as “measurements 522”), each of measurements 522 being from a different electrode on a different electrode level 402 when the electrodes are in a first configuration. In some examples, up to two electrodes may be on a same electrode level 402. Second measurement 520B may be a combination of measurements 524A-N (collectively referred to herein as “measurements 524”), each of measurements 524 being from a different electrode on a different electrode level 402 when the electrodes are in a second configuration. In such examples, the different electrodes may be longitudinally and circumferentially offset from each other.Measurements 522 and 524 may be from a same selection of electrodes. For example, measurements 522A, 524A may be from first electrode 404A on first electrode level 402A, measurements 522B, 524B may be from second electrode 406B on second electrode level 402B, and measurements 522N, 524N may be from third electrode 410N on first electrode level 402N.Docket No.: A0013098W001In other example, any other three electrodes on the electrode array illustrated in FIGS. 4A-B may be selected.
[0086] In the first configuration, system 100 may receive first measurement 520 A from electrodes 404 A, 406B, and 410N. First measurement 520 A may be a tripolar measurement formed from three separate measurements 522A, 522B, and 522N, corresponding to electrodes 404A, 406B, and 410N, respectively. Within first measurement 520A, measurements 522A, 522N may have a positive polarity while measurement 522B may have a negative polarity.
[0087] In the second configuration, system 100 may receive second measurement 520B from electrodes 404 A, 406B, and 410N. Second measurement 520B may be a tripolar measurement formed from three separate measurements 524A, 524B, and 524N, corresponding to electrodes 404A, 406B, and 410N, respectively. Within second measurement 520B, measurements 524A, 524B may have a positive polarity while measurement 524N may have a negative polarity.
[0088] System 100 may combine (e.g., sum) first measurement 520A and second measurement 520B to determine output 526. Output 526 may be an isolated measurement from first electrode 404A, e.g., resulting from the combination of measurements 510. When system 100 combines measurements 510, measurements from the same electrode (e.g., from second electrode 406B, from third electrode 410N) with opposite polarities may cancel out, leaving measurements from the same electrode (e.g., from first electrode 404A) with the same polarity. System 100 may then determine one or more of measurements 522 A, 524 A based on output 526, e.g., as described above with respect to FIG. 5 A.
[0089] FIG. 6A is a conceptual diagram illustrating an example display 600 illustrating electrode activity of different electrode levels 402 of the electrode arrangement of FIG. 4A. FIG 6B is a conceptual diagram illustrating an example display 620 illustrating electrode activity of different electrodes 404-410 within different electrode levels 402 of the electrode arrangement of FIG. 4A. Displays 600, 620 may be outputted on UI 308. The user may interact with displays 600, 620 via input controls on UI 308.
[0090] Display 600 may include a plurality of tiles 602A-N (collectively referred to herein as “tiles 602”). Each of tiles 602 may correspond to a different electrode level 402 on lead 400. For example, as illustrated in FIG. 6A, tiles 602A-N may correspond to electrode levels 402A-N, respectively. Tiles 602 may include electrode activity indicators 604A-N (collectively referred to herein as “indicators 604”) and electrode identifiers 606A-N (collectively referred to herein as “identifiers 606”).
[0091] For each electrode, the respective indicator 604 may indicate an electrode activity level of the electrode, e.g., a level of electrical potential of tissue around the electrode. Each ofDocket No.: A0013098W001indicators 604 may represent the electrode activity level of the electrode as a value (e.g., in volts (v)), as a boolean, as a percentage, as a rating (e.g., out of three, as illustrated in FIG. 6 A), or the like. Indicators 604 may indicate the electrode activity level, e.g., compared to a threshold value, compared to electrode activity levels of other electrodes and / or other electrode levels 402. In some examples, system 100 determines, based on the electrode activity levels (e.g., measurements) of different electrodes and / or electrode levels 402, recommended electrodes and / or electrode levels 402 for sensing of signals from and / or delivery of signals to patient 102. In such examples, system 100 may indicate on display 600 tiles 602 corresponding to the recommended electrodes and / or electrode levels 402. For example, as illustrated in FIG. 6A, system 100 may determine second electrode level 402B (i.e., electrode level “El”) to be the recommended electrode level 402. System 100 may generate output tile 604B on display 600 with different features (e.g., different colors, different patterns, different colors and / or patterns on indicators 604) to denote the recommended tiles 602 to the user.
[0092] Identifiers 606 may indicate electrodes and / or electrode levels 402 associated with each of tiles 602. For example, as illustrated in display 600, identifiers 606A-N indicate that tiles 602A-N are associated with electrode levels 402A-N, respectively. In some examples, identifiers 606 indicate electrode(s) associated within each of tiles 602.
[0093] The user may interact with display 600 to select one or more tiles 602, e.g., to select electrode(s) and / or electrode level(s) 402 for sensing of signals from and / or delivery of signals to patient 102. The user may select the one or more tiles 602 by directly interacting with tiles 602 (e.g., via a touch display of UI 308) and / or via one or more control elements (e.g., buttons, knobs, levers) of UI 308. Once the user selects the one or more tiles 602, programmer 104 may transmit instructions to IMD 106 to cause IMD 106 to sense signals from tissue patient 102 and / or deliver signals to tissue of patient 102 via the selected electrode(s) and / or electrode level(s) 402.
[0094] Display 620 may include a plurality of tiles 622A-N (collectively referred to herein as “tiles 622”) and a plurality of tiles 624A-N (collectively referred to herein as “tiles 624”). Each of tiles 622, 624 may be substantially similar to tiles 602. For example, tiles 622 may be tiles 602. Tiles 622 may define one set of tiles and tiles 624 may define another set of tiles. Each set of tiles may correspond to electrodes on a different electrode level 402. For example, as illustrated in FIG. 6B, tiles 622A-N may correspond to electrodes 406A-N on electrode level 402B, respectively. In another example, as illustrated in FIG. 6B, tiles 624A-N may correspond to electrodes 408A-N on electrode level 402C, respectively. Display 620 may display (e.g., via tiles 622, 624) electrode activity levels of electrodes on different electrode levels 402Docket No.: A0013098W001simultaneously, e.g., thereby allowing the user to compare electrode activity levels of different electrodes across different electrode levels 402 for selection of an optimal sensing and / or stimulation electrode. While FIG. 6B illustrates display 620 as including two sets of tiles (e.g., tiles 622, 624), other examples of display 620 may include three or more sets of tiles.
[0095] FIG. 7 is a flow chart illustrating an example technique for determining an electrode measurement of a specific electrode on an implantable lead 110A of FIG. 1. While FIG. 7 is primarily described herein with reference to system 100 illustrated in FIGS. 1-6B, the example technique may be applied by any medical device system described herein. While FIG. 7 illustrates the steps of the example technique in one order, system 100 may perform the steps of the technique in one or more other orders.
[0096] System 100 may receive a first measurement from patient tissue via three or more electrodes of an implantable medical device (IMD) in a first configuration (702). The three or more electrodes may be three or more of electrodes of electrodes 404, 406, 408, 410, or the like. In some examples, each of the three or more electrodes may include one or more electrodes of a different electrode level 402. In such examples, each of the three or more electrodes may correspond to a different electrode level 402. For example, the three or more electrodes may correspond to electrode levels 402A, 402B, and 402N. In some examples, each of the three or more electrodes may include a different electrode on a same electrode level 402. For example, the three or more electrodes may correspond to electrodes 404A-N on first electrode level 402A. In some examples, each of the three or more electrodes may be disposed on a different electrode level 402. For example, the three or more electrodes may include electrodes 404A, 406B, and 408N on electrode levels 402A, 402B, and 402N, respectively.
[0097] The first measurement (e.g., first measurement 502A, 510A, 520A) may correspond to a combination of measurements from each of the three or more electrodes. The first measurement may correspond to electrical signals within the body of patient 102 and / or in response to a first electrical signal delivered by system 100 (e.g., an evoked signal such as, but is not limited to, an evoked compound action potential (ECAP) signal). For example, first measurement 502A may be a combination of measurements 504A-N, first measurement 510A may be a combination of measurements 512A-N, and first measurement 520A may be a combination of measurements 520A-N. Each measurement from an electrode of the three or more electrodes may indicate an electrical activity of the electrode and / or of tissue surrounding the electrode (. For example, each measurement may indicate an electrical potential of tissue surrounding the respective electrode.Docket No.: A0013098W001
[0098] System 100 may receive a second measurement from patient tissue with the three or more electrodes in a second configuration (704). The second measurement (e.g., second measurement 502B, 510B, 520B) may correspond to measurements from each of the three or more electrodes, e.g., corresponding to electrical signals of tissue of patient 102 and / or in response to the second electrical signal. System 100 may simultaneously alternatively receive the first and second measurements from the three or more electrodes. In some examples, system 100 cause the three or more electrodes to deliver the first and second electrical signals in the first and second configurations simultaneously or alternatively and receive the first and second measurements simultaneously or alternatively, respectively.
[0099] System 100 may combine (e.g., sum) the first measurement and the second measurement to determine electrode activity for a specific electrode (e.g., the first electrode) of the three or more electrodes (706). The measurements from the first electrode in the first and second measurements (e.g., measurements 504A and 506A, measurements 512A and 514A, or measurements 522A and 524A) may have a same polarity. The measurement from the second electrode in the first and second measurements (e.g., measurements 504B and 506B, measurements 512B and 514B, or measurements 522B and 524B) may have opposite polarities. The measurement from the third electrode in the first and second measurements (e.g., measurements 504N and 506N, measurements 512N and 514N, or measurements 522N and 524N) may have opposite polarities. When system 100 combines the first and second measurements, the measurements from the second electrode may cancel out and the measurements from the third electrode may cancel out, leaving an output (e.g., output 508, 516, 526) only containing measurements from the first electrode (i.e., from the specific electrode). System 100 may determine the electrode activity for the first electrode based on the output. For example, system 100 may divide the output by 1.5 or 2 to determine the measurement by the first electrode for the first measurement or the second measurement (e.g., one or more of measurements 504A, 506A, 512A, 514A, 522A, or 524A). In other examples, system 100 may apply one or more post-processing techniques to determine the measurement by the first electrode for the first or the second measurement.
[0100] System 100 may perform the techniques described above with respect to FIG. 7 to each electrode of a plurality of electrodes on lead 400 (e.g., of set of electrodes 403 on lead 400) to determine electrode activity levels for each electrode. In some examples wherein system 100 includes two or more leads 400, system 100 may perform the techniques described above for each electrode within each set of electrodes on leads 400. Based on the determined electrode activity levels, system 100 may select and / or present to a user for selection one or moreDocket No.: A0013098W001electrodes for the sensing of signals from and / or delivery of signals to patient tissue. System 100 may adjust the first and second configurations and / or the electrodes within the three or more electrodes to determine electrode activity levels for different electrodes on each of one or more leads 400. System 100 may perform the techniques described herein as a part of a closed-loop stimulation technique.
[0101] System 100 may select the one or more electrodes based on the relative activity levels of electrodes within one or more sets of electrodes. For example, system 100 may select one or more electrodes of electrodes 404, 406, 408, or 410 based on the relative electrode activity levels of electrodes within set of electrodes 403. The electrode activity levels may be indicative of efficacy of the respective electrodes in the sensing of signals and / or in the delivery of electrical stimulation signals to patient 102. In some examples, system 100 presents the electrode activity levels of different electrodes to the user via indicators 604 on tiles (e.g., tiles 602, 622, 624) within a display (e.g., display 600, 620) outputted by UI 308 of programmer 104. In such examples, system 100 may receive, via UI 308, a selection of electrodes from the user. System 100 may then sense signals from and / or deliver signals to patient 102 via the selected electrodes. In some examples, each selected electrode may be a single electrode. In some examples, each selected electrode may include a single ring electrode defining one electrode level 402 or a plurality of electrodes (e.g., electrodes 402A-N) defining one electrode level 402.
[0102] In some examples, system 100 may output (e.g., via display 600, display 620, or any other display on UI 308), recommendations for electrodes on lead 400 to the user. System 100 may determine the recommendations based at least in part on measurements for the electrodes. In some examples, system 100 may recommend an electrode with a measurement indicating a strongest sensed signal. In some examples, system 100 ranks a plurality of electrodes on lead 400 based on the strength of the signals of the respective measurements. In some examples, system 100 may recommend one or more electrodes (e.g., one or more longitudinally and / or circumferentially adjacent electrodes, one or more longitudinally and / or circumferentially offset electrodes) for sensing of signals (e.g., monopolar sensing, bipolar sensing) from the tissue of patient 102 and / or for delivery of stimulation signals to the tissue of patient 102.
[0103] The technique illustrated and described herein may provide several technical advantages over other techniques used to determine electrode activity level for an electrode. The technique described herein may be implemented with electrodes on a single lead 110, which may allow for the use of the technique without implanting a second lead 110 in patient 102 or in situations where patient physiology does not allow for the implantation of more than one lead 110. The techniques described herein may also require reduced post-processing of measurementsDocket No.: A0013098W001from electrodes to determine electrode activity level for electrodes, which may reduce a complexity and / or a duration of the procedure. The techniques described herein also isolate electrode activity of each electrode during the determination of the electrode activity level, which may eliminate the effects of other factors (e.g., the effects of signals delivered by other electrodes) and increase an accuracy of the determination made by system 100.
[0104] The following examples are example systems, devices, and methods described herein.
[0105] Example 1: a medical device system comprising: processing circuitry configured to: control sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; control the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; sum the first measurement and the second measurement to generate electrical activity of a specific electrode of the three or more electrodes from the patient; and output a representation of the electrical activity of the specific electrode.
[0106] Example 2: the medical device system of example 1, further comprising an implantable lead coupled to the sensing circuitry, wherein the implantable lead comprises a plurality of electrodes comprising the three or more electrodes, wherein the plurality of electrodes are arranged around a perimeter of the elongated lead and along a longitudinal axis of the elongated body, and wherein the plurality of electrodes comprises: two or more electrodes disposed at a same longitudinal position along the elongated body and at different positions around the perimeter of the elongated body; and two or more electrode levels, wherein each electrode level of the two or more electrode levels is longitudinally offset from every other electrode level of the two or more electrode levels, and wherein each electrode level of the two or more electrode levels is defined by at least two electrodes disposed at the different positions around the perimeter.
[0107] Example 3: the medical device system of example 2, wherein the three or more electrodes are disposed at the different positions and at a same longitudinal position.
[0108] Example 4: the medical device system of example 2, wherein the three or more electrodes are disposed on at least two different electrode levels of the two or more electrode levels.
[0109] Example 5: the medical device system of any of examples 1-4, wherein the specific electrode comprises a first electrode of the three or more electrodes, wherein the first electrode configuration comprises the first electrode having a first polarity, a second electrode of the threeDocket No.: A0013098W001or more electrodes having the first polarity, and a third electrode of the three or more electrodes having a second polarity opposite the first polarity, and wherein the second electrode configuration comprises the first electrode having the first polarity, the second electrode having the second polarity, and the third electrode having the first polarity.
[0110] Example 6: the medical device system of any of examples 1-5, wherein the three or more electrodes comprises the specific electrode and at least two electrodes, wherein each of the first measurement and the second measurement comprises a combination of sensed electrical activities from each electrode of the three or more electrodes, and wherein each electrode of the at least two electrodes exhibit offsetting electrical activities in the first measurement and the second measurement.
[0111] Example 7: the medical device system of example 6, wherein a summation of the first measurement and the second measurement isolates the electrode activity of the specific electrode from electrode activity of any of the at least two electrodes.
[0112] Example 8: the medical device system of any of examples 1-7, wherein the processing circuitry is configured to: determine, for each electrode of the three or more electrodes, an electrode activity of the respective electrode based on respective first and second measurements for the electrode with the electrode being the specific electrode; select, based at least in part on the determined electrode activity for each electrode of the three or more electrodes, one electrode of the three or more electrodes for subsequent electrical stimulation; and control signal generation circuitry of the IMD to deliver, via the selected electrode of the three or more electrodes, the subsequent electrical stimulation signal to the patient.
[0113] Example 9: the medical device system of example 8, further comprising a user interface (UI) coupled to the processing circuitry, and wherein the processing circuitry is configured to control the UI to display one or more of an indication of the selected electrode of the three or more electrodes; or the electrode activity for each electrode of the three or more electrodes.
[0114] Example 10: the medical device system of any of examples 1-9, wherein the IMD comprises: the signal generator; an implantable lead electrically coupled to the signal generator, the implantable lead comprising: an elongated body; and the three or more electrodes disposed over the outer surface of the elongated body.
[0115] Example 11 : a method comprising: controlling, by processing circuitry of a medical device system, sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; controlling, by the processing circuitry, the sensing circuitry to sense, via the three or moreDocket No.: A0013098W001electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; summing, by the processing circuitry, the first measurement and the second measurement to generate electrode activity of a specific electrode of the three or more electrode from the patient; and outputting, by the processing circuitry, a representation of the electrical activity of the specific electrode.
[0116] Example 12: the method of example 11, wherein the three or more electrodes are disposed on an implantable lead coupled to the sensing circuitry, wherein the implantable lead comprises a plurality of electrodes comprising the three or more electrodes, wherein the plurality of electrodes are arranged around a perimeter of the elongated lead and along a longitudinal axis of the elongated body, and wherein the plurality of electrodes comprises: two or more electrodes disposed at a same longitudinal position along the elongated body and at different positions around the perimeter of the elongated body; and two or more electrode levels, wherein each electrode level of the two or more electrode levels is longitudinally offset from every other electrode level of the two or more electrode levels, and wherein each electrode level of the two or more electrode levels is defined by at least two electrodes disposed at the different positions around the perimeter.
[0117] Example 13: the method of any of examples 11 and 12, wherein the specific electrode comprises a first electrode of the three or more electrodes, wherein the first electrode configuration comprises the first electrode having a first polarity, a second electrode of the three or more electrodes having the first polarity, and a third electrode of the three or more electrodes having a second polarity opposite the first polarity, and wherein the second electrode configuration comprises the first electrode having the first polarity, the second electrode having the second polarity, and the third electrode having the first polarity.
[0118] Example 14: the method of any of claims 11-13, further comprising: determining, by the processing circuitry and for each electrode of the three or more electrodes, an electrode activity of the respective electrode based on respective first and second measurements for the electrode with the electrode being the specific electrode; selecting, by the processing circuitry and based at least in part on the determined electrode activity for each electrode of the three or more electrodes, one electrode of the three or more electrodes for subsequent electrical stimulation; and controlling, by the processing circuitry, signal generation circuitry of the IMD to deliver, via the selected electrode of the three or more electrodes, the subsequent electrical stimulation signal to the patient.Docket No.: A0013098W001
[0119] Example 15: the method of example 14, further comprising: controlling, by the processing circuitry, a user interface (UI) to display one or more of: an indication of the selected electrode of the three or more electrodes; or the electrode activity for each electrode of the three or more electrodes.
[0120] Example 16: a computer-readable medium comprising instructions that, when executed by processing circuitry of a medical device system, causes the processing circuitry to: control sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient; control the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration; sum the first measurement and the second measurement to generate electrode activity of a specific electrode of the three or more electrode from the patient; and output representation of the electrical activity of the specific electrode.
[0121] Example 17: the computer-readable medium of claim 16, wherein the specific electrode comprises a first electrode of the three or more electrodes, wherein the first electrode configuration comprises the first electrode having a first polarity, a second electrode of the three or more electrodes having the first polarity, and a third electrode of the three or more electrodes having a second polarity opposite the first polarity, and wherein the second electrode configuration comprises the first electrode having the first polarity, the second electrode having the second polarity, and the third electrode having the first polarity.
[0122] Example 18: the computer-readable medium of any of examples 16 and 17, further comprising instructions that causes the processing circuitry to: determine, for each electrode of the three or more electrodes, an electrode activity of the respective electrode based on respective first and second measurements for the electrode with the electrode being the specific electrode; select, based at least in part on the determined electrode activity for each electrode of the three or more electrodes, one electrode of the three or more electrodes for subsequent electrical stimulation; and control signal generation circuitry of the IMD to deliver, via the selected electrode of the three or more electrodes, the subsequent electrical stimulation signal to the patient.
[0123] Example 19: the computer-readable medium of any of examples 16-18, wherein the three or more electrodes comprises the specific electrode and at least two electrodes, wherein each of the first measurement and the second measurement comprises a combination of sensed electrical activities from each electrode of the three or more electrodes, and wherein eachDocket No.: A0013098W001electrode of the at least two electrodes exhibit offsetting electrical activities in the first measurement and the second measurement.
[0124] Example 20: the computer-readable medium of any of examples 16-19, further comprising instructions that causes the processing circuitry to: control a user interface (UI) to display one or more of: an indication of the selected electrode of the three or more electrodes; or the electrode activity for each electrode of the three or more electrodes.
[0125] For aspects implemented in software, at least some of the functionality ascribed to the systems and devices described in this disclosure may be embodied as instructions on a computer-readable storage medium such as RAM, DRAM, SRAM, FRAM, magnetic discs, optical discs, flash memory, or forms of EPROM or EEPROM. The instructions may be executed to support one or more aspects of the functionality described in this disclosure.
[0126] In addition, in some aspects, the functionality described herein may be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements. The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including an IMD, an external programmer, a combination of an IMD and external programmer, an integrated circuit (IC) or a set of ICs, and / or discrete electrical circuitry, residing in an IMD and / or external programmer.
Claims
Docket No.: A0013098W001WHAT IS CLAIMED IS:
1. A medical device system comprising:processing circuitry configured to:control sensing circuitry of an implantable medical device (IMD) to sense, via three or more electrodes in a first electrode configuration, a first measurement from the patient;control the sensing circuitry to sense, via the three or more electrodes in a second electrode configuration, a second measurement from the patient, wherein a polarity of at least one electrode of the three or more electrodes is different between the first electrode configuration and the second electrode configuration;sum the first measurement and the second measurement to generate electrical activity of a specific electrode of the three or more electrodes from the patient; and output a representation of the electrical activity of the specific electrode.
2. The medical device system of claim 1, further comprising an implantable lead coupled to the sensing circuitry, wherein the implantable lead comprises a plurality of electrodes comprising the three or more electrodes, wherein the plurality of electrodes are arranged around a perimeter of the elongated lead and along a longitudinal axis of the elongated body, and wherein the plurality of electrodes comprises:two or more electrodes disposed at a same longitudinal position along the elongated body and at different positions around the perimeter of the elongated body; andtwo or more electrode levels, wherein each electrode level of the two or more electrode levels is longitudinally offset from every other electrode level of the two or more electrode levels, and wherein each electrode level of the two or more electrode levels is defined by at least two electrodes disposed at the different positions around the perimeter.
3. The medical device system of claim 2, wherein the three or more electrodes are disposed at the different positions and at a same longitudinal position.
4. The medical device system of claim 2, wherein the three or more electrodes are disposed on at least two different electrode levels of the two or more electrode levels.
5. The medical device system of any of claims 1-4,Docket No.: A0013098W001wherein the specific electrode comprises a first electrode of the three or more electrodes, wherein the first electrode configuration comprises the first electrode having a first polarity, a second electrode of the three or more electrodes having the first polarity, and a third electrode of the three or more electrodes having a second polarity opposite the first polarity, and wherein the second electrode configuration comprises the first electrode having the first polarity, the second electrode having the second polarity, and the third electrode having the first polarity.
6. The medical device system of any of claims 1-5,wherein the three or more electrodes comprises the specific electrode and at least two electrodes,wherein each of the first measurement and the second measurement comprises a combination of sensed electrical activities from each electrode of the three or more electrodes, andwherein each electrode of the at least two electrodes exhibit offsetting electrical activities in the first measurement and the second measurement.
7. The medical device system of claim 6,wherein a summation of the first measurement and the second measurement isolates the electrode activity of the specific electrode from electrode activity of any of the at least two electrodes.
8. The medical device system of any of claims 1-7, wherein the processing circuitry is configured to:determine, for each electrode of the three or more electrodes, an electrode activity of the respective electrode based on respective first and second measurements for the electrode with the electrode being the specific electrode;select, based at least in part on the determined electrode activity for each electrode of the three or more electrodes, one electrode of the three or more electrodes for subsequent electrical stimulation; andcontrol signal generation circuitry of the IMD to deliver, via the selected electrode of the three or more electrodes, the subsequent electrical stimulation signal to the patient.Docket No.: A0013098W0019. The medical device system of claim 8, further comprising a user interface (UI) coupled to the processing circuitry, and wherein the processing circuitry is configured to control the UI to display one or more of:an indication of the selected electrode of the three or more electrodes; or the electrode activity for each electrode of the three or more electrodes.
10. The medical device system of any of claims 1-9, wherein the IMD comprises: the signal generator;an implantable lead electrically coupled to the signal generator, the implantable lead comprising:an elongated body; andthe three or more electrodes disposed over the outer surface of the elongated body.
11. The medical device system of any of claims 1-10, wherein the first measurement comprises a first electrical potential of patient tissue at or around the three or more electrodes, and wherein the second measurement comprises a second electrical potential of patient tissue at or around the three or more electrodes.
12. The medical device system of any of claims 1-11, wherein the processing circuitry is configured to cause a first electrode of the three or more electrodes to act as a cathode in the first electrode configuration and to act as an anode in the second electrode configuration.
13. The medical device system of any of claims 1-12, wherein the processing circuitry is further configured to sum the first measurement and the second measurement to generate electrical activity of the specific electrode of the three or more electrodes from the patient by:determining a sum of the first measurement and the second measurement; and applying a pot-processing technique to the sum of the first measurement and the second measurement to determine the electrical activity of the specific electrode.
14. The medical device system of any of claims 1-13, wherein the representation comprises an electrode activity level for the specific electrode of the three or more electrodes.Docket No.: A0013098W00115. The medical device system of claim 14, wherein the electrode activity level for the specific electrode indicates a relative electrode activity level for the specific electrode compared to electrode activity levels of one or more other electrodes.