Implantable devices and systems for connecting leads

Abstract

A header for an implantable medical device may include a header body defining an elongated bore that is configured to receive an elongated body. The elongated body may include a plurality of electrical contacts. The elongated bore may extend between a proximal bore opening and a. distal bore end. The header may further include a plurality' of header connectors positioned along the elongated bore. At least one header connector of the plurality- of header connector is configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body. The plurality of header connectors may include a first connector pair defining a first inter-connector spacing. 'The plurality' of header connectors may include a second connector pair defining a second inter-connector spacing greater than the first inter-connector spacing.

Description

Docket No.: A0013213WO01 / 1123-858WO01 IMPLANTABLE DEVICES AND SYSTEMS FOR CONNECTING LEADS

[0001] This application is a PCT application that claims the benefit of, and priority to, U.S. Provisional Application Serial No.63 / 691,162, filed September 5, 2024, which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0002] The present disclosure generally relates to headers for implantable devices, and in particular, headers for connecting leads and lead extensions. BACKGROUND

[0003] Medical devices may be external or implanted, and may be used to deliver electrical stimulation therapy to various tissue sites of a patient to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson’s disease, dystonia, other movement disorders, epilepsy, headache, psychiatric disorders, memory dysfunction, urinary or fecal incontinence, sexual dysfunction, obesity and eating disorders, 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. Hence, electrical stimulation may be used in different therapeutic applications, such as deep brain stimulation (DBS), occipital nerve stimulation (ONS), spinal cord stimulation (SCS), pelvic stimulation, sacral nerve stimulation, phrenic nerve stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS). SUMMARY

[0004] In general, this disclosure describes headers for implantable devices, for example, headers for connecting leads and lead extensions, and systems including headers.

[0005] In examples, an example header for an implantable medical device may include a header body defining an elongated bore that is configured to receive an elongated body. The elongated body includes a plurality of electrical contacts. The header may further include a plurality of header connectors positioned along the elongated bore. At least one header connector of the plurality of header connectors is configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body. The plurality of header connectors may include a first connector pair defining a first inter-connector spacing. The plurality of header connectors may include a second connector pair defining a second inter- connector spacing greater than the first inter-connector spacing.Docket No.: A0013213WO01 / 1123-858WO01

[0006] In examples, a system includes a header, and at least one elongated body including a plurality of electrical contacts electrically coupled to a plurality of electrodes. The header may include a header body defining an elongated bore that is configured to receive an elongated body. The elongated body includes a plurality of electrical contacts. The elongated bore may extend between a proximal bore opening and a distal bore end. The header may further include a plurality of header connectors positioned along the elongated bore. At least one header connector of the plurality of header connectors is configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body. The plurality of header connectors may include a first connector pair defining a first inter-connector spacing. The plurality of header connectors may include a second connector pair defining a second inter- connector spacing greater than the first inter-connector spacing. The at least one elongated body is receivable in the elongated bore of the header to electrically couple the plurality of electrodes of the at least one elongated body to the plurality of header connectors of the header by conductive contact between the plurality of header connectors of the header and the electrical contacts of the at least one elongated body.

[0007] The details of one or more examples of the techniques of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0008] FIG.1 is a conceptual diagram illustrating an example system that includes an implantable medical device (IMD) configured to deliver DBS to a patient according to an example of the techniques of the disclosure.

[0009] FIG.2A is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 including an elongated bore configured to receive an elongated body.

[0010] FIG.2B is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 in a first configuration 100A with a first elongated body received in the elongated bore.

[0011] FIG.2C is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 in a second configuration 100B with a second elongated body received in the elongated bore.

[0012] FIG.2D is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 in a third configuration 100C with the first elongated body received in a first elongated bore and a second elongated body received in a second elongated bore.Docket No.: A0013213WO01 / 1123-858WO01

[0013] FIG.3 is a conceptual diagram illustrating a cross-sectional view of a ring connector for a header.

[0014] FIG.4 is a conceptual diagram illustrating a cross-sectional view of a split connector for a header.

[0015] FIG.5A is a conceptual diagram illustrating a cross-sectional view of an elongated bore of a header defining an alignment channel.

[0016] FIG.5B is a conceptual diagram illustrating a cross-sectional view of an elongated body defining an alignment boss configured to be received in the alignment channel of the elongated more of FIG.5A.

[0017] FIG.6 is a flowchart illustrating an example technique for detecting electrical coupling between at least one header connector of a header and at least one electrode of an elongated body.

[0018] FIG.7 is a functional block diagram illustrating components of the IMD of FIG.1, in accordance with one or more techniques of this disclosure. DETAILED DESCRIPTION

[0019] The present disclosure describes headers and systems for implantable medical devices, for example, for electrically coupling electrodes of leads to implantable medical devices.

[0020] Stimulation therapies may utilize multiple electrodes on a lead for delivering therapy or for sensing a parameter. The lead may be received within a header of an implantable medical device to electrically couple the implantable medical device to one or more electrodes of the lead. In some examples, multiple types of leads different in lead length or electrode configuration may be used with the same header. In certain examples, an adapter may be used to connect different types of headers to various types of leads or lead extensions, for example, that may be previously implanted in a patient. However, such adapters may add bulk to an implant site, or may prevents the device from utilizing a full MRI compatibility as adapter may change the MRI characteristics.

[0021] Headers according to the present disclosure may be configured to receive and electrically couple different types (e.g., differing in size, geometry, connector configuration, or other aspects) of elongated bodies. An elongated body may include any structure insertable into an elongated bore of a header. For example, the elongated body may include a portion of a lead or a lead extension including electrical contacts. Elongated bodies may differ in header connection length, or carry different electrical contacts along the lead for connecting different electrode configurations. For example, electrical contacts along different elongated bodies, or even along the same elongated body, may differ in inter-connector spacing or distribution. In some examples, a detent is used to receive an appropriate connection length of a lead within anDocket No.: A0013213WO01 / 1123-858WO01 elongated bore of a header, such that respective electrical contacts of the lead are electrically coupled to corresponding header connectors of the header, even for different lead lengths or configurations received by the same header. For example, the detent may provide the user tactile feedback and resist or prevent over-insertion of a lead beyond an appropriate electrical connection length into a bore of a header. For example, over-insertion may affect the integrity of the lead or lead extension as the softer part of the lead would need to be pushed into the bore and scrape across the newer contacts that may not be in use. The same bore may thus alternatively receive a first elongated body including twelve electrical contacts or a second elongated body including eight electrical contacts, and electrically couple corresponding electrical contacts of the different elongated bodies to appropriate or complementary header connectors of the header.

[0022] In some examples, header connectors along a bore include at least one split connector, thus provide twice (or a greater number) of connections with respective electrical contacts of an elongated body in a similar length or geometry of the bore or header. In some such examples, the inter-connector spacing between respective connector pairs of the plurality of header connectors may be substantially the same in an axial direction along the bore. In other examples, the header connectors including at least one split connector may differ in inter-connector spacing along the bore.

[0023] In some examples, one or more adapters may be used to couple (e.g., electrically and / or mechanically) an elongated body to a header. For example, an adapter may include a first adapter portion configured to be coupled to the elongated body, and a second adapter portion configured to be coupled to the header. For example, the elongated body may be receivable in the first adapter portion, and the second adapter portion may be receivable in the header. The first adapter portion and the second adapter portion may be electrically coupled using any appropriate configuration. In some examples, there is a 1:1 correspondence between respective connectors of the adapter, header connectors of the header, and electrical contacts of the elongated body. In other examples, the adapter may be configured to electrically couple different numbers or types of electrical contacts of the elongated body with header connectors of the header (e.g., one-to-many connections, many-to-one connections, or other differences such as different diameters, axial widths, arrangements, orientations, or spacings of electrical contacts of the elongated body with header connectors of the header).

[0024] FIG.1 is a conceptual diagram illustrating an example system 10 that includes an implantable medical device (IMD) 106 configured to deliver DBS to a patient 112 according to an example of the techniques of the disclosure. As shown in the example of FIG.1, system 10 includes a medical device programmer 104, implantable medical device (IMD) 106, a lead extension 110, and leads 114A and 114B with respective sets of electrodes 116, 118. In theDocket No.: A0013213WO01 / 1123-858WO01 example shown in FIG.1, electrodes 116, 118 of leads 114A, 114B are positioned to deliver electrical stimulation to a tissue site within brain 120, such as a deep brain site under the dura mater of brain 120 of patient 112. In some examples, delivery of stimulation to one or more regions of brain 120, such as the subthalamic nucleus, globus pallidus or thalamus, may be an effective treatment to manage movement disorders, such as Parkinson’s disease. Some or all of electrodes 116, 118 also may be positioned to sense or record neurological brain signals within a brain 120 of patient 112. In some examples, some of electrodes 116, 118 may be configured to sense or record neurological brain signals and others of electrodes 116, 118 may be configured to deliver adaptive electrical stimulation to brain 120. In other examples, all of electrodes 116, 118 are configured to both sense or record neurological brain signals and deliver adaptive electrical stimulation to brain 120.

[0025] IMD 106 includes a therapy module (e.g., which may include processing circuitry, signal generation circuitry or other electrical circuitry configured to perform the functions attributed to IMD 106) that includes a stimulation generator configured to generate and deliver electrical stimulation therapy to patient 112 via a subset of electrodes 116, 118 of leads 114A and 114B, respectively. The subset of electrodes 116, 118 that are used to deliver electrical stimulation to patient 112, and, in some cases, the polarity of the subset of electrodes 116, 118, may be referred to as a stimulation electrode combination or configuration. The group of electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes. In some examples, the plurality of electrodes 116 and / or 118 may have a complex electrode geometry such that two or more electrodes of the lead are located at different positions around the perimeter of the respective lead (e.g., different positions around a longitudinal axis or shaft of the lead). In some examples, at least one electrode includes at least two electrodes disposed at different axial positions along the lead in the patient. In some examples, at least one electrode includes at least two electrodes disposed at different axial positions along the lead, and may be disposed at a same or different circumferential position around a perimeter of the lead.

[0026] In some examples, the neurological signals (e.g., an example type of electrical signals) sensed or recorded within brain 120 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue. Examples of neurological brain signals include, but are not limited to, electrical signals generated from local field potentials (LFP) sensed within one or more regions of brain 120, such as an electroencephalogram (EEG) signal, or an electrocorticogram (ECoG) signal. Local field potentials, however, may include a broader genus of electrical signals within brain 120 of patient 112 (e.g., which signify brain state, disease state or symptom state).Docket No.: A0013213WO01 / 1123-858WO01

[0027] In some examples, the neurological brain signals that are used to select a stimulation electrode combination may be sensed within the same region of brain 120 as the target tissue site for the electrical stimulation. As previously indicated, these tissue sites may include tissue sites within anatomical structures such as the thalamus, subthalamic nucleus or globus pallidus of brain 120, as well as other target tissue sites. The specific target tissue sites and / or regions within brain 120 may be selected based on the patient condition. Thus, due to these differences in target locations, in some examples, the electrodes used for delivering electrical stimulation may be different than the electrodes used for sensing neurological brain signals. In other examples, the same electrodes may be used to deliver electrical stimulation and sense brain signals.

[0028] Electrical stimulation generated by IMD 106 may be configured to manage a variety of disorders and conditions. In some examples, the stimulation generator of IMD 106 is configured to generate and deliver electrical stimulation pulses to patient 112 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generator of IMD 106 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, a stimulation generator within IMD 106 may generate the electrical stimulation therapy for DBS according to a therapy program that is selected at that given time in therapy. In examples in which IMD 106 delivers electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., stimulation parameters), such as a stimulation electrode combination for delivering stimulation to patient 112, waveform pattern, pulse frequency, pulse width, and a current or voltage amplitude of the pulses. As previously indicated, the electrode combination may indicate the specific electrodes 116, 118 that are selected to deliver stimulation signals to tissue of patient 112 and the respective polarities of the selected electrodes. IMD 106 may deliver electrical stimulation intended to contribute to a therapeutic effect. In some examples, IMD 106 may also, or alternatively, deliver electrical stimulation intended to be sensed or recorded by other electrode and / or elicit a physiological response, such as an evoked compound action potential (ECAP) or resonant response, that can be sensed or recorded by electrodes.

[0029] IMD 106 may be implanted within a subcutaneous pocket below the clavicle, or, alternatively, on or within cranium 122 or at any other suitable site within patient 112. Generally, IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from body fluids. IMD 106 may include a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory.

[0030] As shown in FIG.1, implanted lead extension 110 is coupled to IMD 106 via a header 100 (also referred to as a connector or a connector block of IMD 106). In the example of FIG.1,Docket No.: A0013213WO01 / 1123-858WO01 lead extension 110 traverses from the implant site of IMD 106 and along the neck of patient 112 to cranium 122 of patient 112 to access brain 120. In the example shown in FIG.1, leads 114A and 114B (collectively “leads 114”) are implanted within the right and left hemispheres, respectively, of patient 112 in order deliver electrical stimulation to and / or sense or record from one or more regions of brain 120, which may be selected based on the patient condition or disorder controlled by therapy system 10. The specific target tissue site and the stimulation electrodes used to deliver stimulation to the target tissue site, however, may be selected, e.g., according to the identified patient behaviors associated with one or more brain disorders and / or other sensed patient signals. Other lead 114 and IMD 106 implant sites are contemplated. For example, IMD 106 may be implanted on or within cranium 122, in some examples. Alternatively, leads 114 may be implanted within the same hemisphere or IMD 106 may be coupled to a single lead implanted in a single hemisphere. Although leads 114 may have ring or omnidirectional electrodes at different longitudinal positions as shown in FIG.1, leads 114 may have electrodes disposed at different positions around the perimeter of the lead (e.g., different circumferential positions for a cylindrical shaped lead in a low resolution or high resolution segmented directional configuration for fractionalization of stimulation) as shown in the examples of FIGS.3 and 4.

[0031] Leads 114 illustrate an example lead set that include axial leads carrying ring or omnidirectional electrodes disposed at different axial positions (or longitudinal positions). In other examples, leads may be referred to as “paddle” leads carrying planar arrays of electrodes on one side of the lead structure. In addition, as described herein, complex lead array geometries may be used in which electrodes are disposed at different respective longitudinal positions and different positions around the perimeter of the lead.

[0032] Although leads 114 are shown in FIG.1 as being coupled to a common lead extension 110, in other examples, leads 114 may be coupled to IMD 106 via separate lead extensions or directly to header 100. Leads 114 may be positioned to deliver electrical stimulation to and / or sense or record from one or more target tissue sites within brain 120 to manage patient symptoms. Leads 114 may be implanted to position electrodes 116, 118 at desired locations of brain 120 through respective burr holes in cranium 122. Leads 114 may be placed at any location within brain 120 such that electrodes 116, 118 are capable of providing electrical stimulation to and / or sense or record from target tissue sites within brain 120 during treatment. For example, electrodes 116, 118 may be surgically implanted under the dura mater of brain 120 or within the cerebral cortex of brain 120 via a burr hole in cranium 122 of patient 112, and electrically coupled to IMD 106 via one or more leads 114.Docket No.: A0013213WO01 / 1123-858WO01

[0033] In the example shown in FIG.1, electrodes 116, 118 of leads 114 are shown as ring electrodes. Ring electrodes (annular having cylindrical symmetric design) may be used in DBS applications because they are relatively simple to program and are capable of delivering an omnidirectional electrical field to any tissue adjacent to electrodes 116, 118. In other examples, electrodes 116, 118 may have different configurations. For example, in some examples, at least some of the electrodes 116, 118 of leads 114 may have a complex electrode array geometry that is capable of producing shaped electrical fields. The complex electrode array geometry may include multiple electrodes (e.g., partial ring or segmented electrodes) around the outer perimeter of each lead 114, rather than one ring electrode. In this manner, electrical stimulation may be fractionalized and directed in a specific direction from leads 114 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue and / or sense or record from target tissue. In some examples, a housing of IMD 106 may include one or more stimulation and / or sensing electrodes. In alternative examples, leads 114 may have shapes other than elongated cylinders as shown in FIG.1. For example, leads 114 may be paddle leads, spherical leads, bendable leads, or any other type of shape effective in treating patient 112 and / or minimizing invasiveness of leads 114.

[0034] In the example shown in FIG.1, IMD 106 includes a memory to store a plurality of therapy programs that each define a set of therapy parameter values. In some examples, IMD 106 may select a therapy program from the memory based on various parameters, such as sensed patient signals and the identified patient behaviors e.g., as patient behaviors associated with one or more brain disorders, and / or other sensed patient signals.

[0035] External 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., a clinician and / or patient 112, 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 112 to select programs or groups and / or view and modify allowable therapy parameters within a preset range in addition to triggering capture of a tagged / untagged sensing event. 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 undesirable changes to IMD 106. Programmer 104 may enter a new programming session for the user to select new stimulation parameters for subsequent therapy.

[0036] When programmer 104 is configured for use by the clinician, programmer 104 may be used to transmit initial programming information to IMD 106. This initial information mayDocket No.: A0013213WO01 / 1123-858WO01 include hardware information, such as the type of leads 114 and the electrode arrangement, the position of leads 114 within brain 120, the configuration of electrode array 116, 118, initial programs defining therapy parameter values, a known electrode orientation from a previous session if available and any other information the clinician desires to program into IMD 106. Programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of electrodes 116, 118 of leads 114). In some examples, programmer 104 may receive sensed signals or representative information and perform the same techniques and functions attributed to IMD 106 herein. In other examples, a remote server (e.g., a standalone server or part of a cloud service) may perform the functions attributed to IMD 106, programmer 104, or any other devices described herein.

[0037] 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 112 to address symptoms associated with the patient condition, and, in some cases, specific to one or more different patient states, such as a sleep state, movement state or rest state. For example, the clinician may select one or more stimulation electrode combination with which stimulation is delivered to brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by patient 112 or based on one or more physiological parameters of patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.) and / or sensed or recorded signals. Alternatively, identified patient behavior from video information may be used as feedback during the initial and subsequent programming sessions. 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.

[0038] Programmer 104 may also be configured for use by patient 112. When configured as a patient programmer, programmer 104 may have limited functionality (compared to a clinician programmer) in order to prevent patient 112 from altering critical functions of IMD 106 or applications that may be detrimental to patient 112. In this manner, programmer 104 may only allow patient 112 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter and / or triggering capture of a sensing event.

[0039] Programmer 104 may also provide an indication to patient 112 when therapy is being delivered, when patient input has triggered a change in therapy or when the power source within programmer 104 or IMD 106 needs to be replaced or recharged. For example, programmer 104 may include an alert LED, may flash a message to patient 112 via a programmer display, generate an audible sound or somatosensory cue to confirm patient input was received, e.g., to indicate a patient state or to manually modify a therapy parameter. Programmer 104, such as theDocket No.: A0013213WO01 / 1123-858WO01 patient programmer, may be used to trigger sensing / recording of events through physician configured electrodes for varying lengths of time.

[0040] Therapy system 10 may be implemented to provide chronic stimulation therapy to and / or sense or record from patient 112 over the course of several months or years. However, system 10 may also be employed on a trial basis to evaluate therapy before committing to full implantation. If implemented temporarily, some components of system 10 may not be implanted within patient 112. For example, patient 112 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 DBS system 10 provides effective treatment to patient 112, the clinician may implant a chronic stimulator within patient 112 for relatively long-term treatment.

[0041] Although IMD 106 is described as delivering electrical stimulation therapy to brain 120, IMD 106 may be configured to direct electrical stimulation to other anatomical regions of patient 112 in other examples. In other examples, system 10 may include an implantable drug pump in addition to, or in place of, IMD 106. Further, an IMD may provide other electrical stimulation such as spinal cord stimulation, or tissue stimulation at other sites.

[0042] The architecture of system 10 illustrated in FIG.1 is shown as an example. The techniques as set forth in this disclosure may be implemented in the example system 10 of FIG. 1, as well as other types of systems not described specifically herein. Nothing in this disclosure should be construed so as to limit the techniques of this disclosure to the example architecture illustrated by FIG.1.

[0043] In the example shown in FIG.1, the set of electrodes 116 includes eight electrodes, and the set of electrodes 118 includes four electrodes. However, the set of electrodes 116 and the set of electrodes 118 may independently include any number of electrodes. Electrodes 116, 118 on respective leads 114 may be constructed of a variety of different designs. For example, one or both of leads 114 may include two or more electrodes at each longitudinal location along the length of the lead, such as multiple electrodes at different perimeter locations around the perimeter of the lead.

[0044] Lead 110 may be substantially rigid to prevent the implanted lead from varying from the expected lead shape. Lead 110 may be substantially cylindrical in shape. In other embodiments, lead 110 may be shaped differently than a cylinder. For example, lead 110 may include one or more curves to reach target anatomical regions of brain 120. In some embodiments, lead 110 may be similar to a flat paddle lead or a conformable lead shaped for patient 112. Also, in other embodiments, lead 110 may be any of a variety of different polygonalDocket No.: A0013213WO01 / 1123-858WO01 cross sections (e.g., triangle, square, rectangle, octagonal, etc.) taken transverse to the longitudinal axis of the lead.

[0045] Electrodes, for example, electrodes 116 and / or 118, may be coupled to IMD 106 via an elongated body (e.g., a portion of lead extension 110 and / or leads 114). The elongated body may include a plurality of connectors (described with reference to FIG.2) configured to electrically couple IMD 106 (e.g., circuitry of IMD 106) with electrodes 116 and / or 118.

[0046] FIG.2A is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 including an elongated bore 130A configured to receive an elongated body 132A. For example, elongated body 132A may include any portion of lead extension 110 and / or leads 114A or 114B electrically coupled to electrodes 116 and / or 118. Header 100 may include a header body 134 defining elongated bore 130A. Elongated bore 130A is configured to receive elongated body 132A. Elongated bore 130A may extend between a proximal 136 bore opening and a distal bore end 138. Header 100 may further include a plurality of header connectors 140 positioned along the elongated bore. Each header connector of plurality of header connectors 140 is configured to receive a signal from, or send a signal to, IMD 106. The signal may be a signal configured to be transmitted to, or received from, an electrode (e.g., of plurality of electrodes 114 and / or 116).

[0047] System 10 includes at least one elongated body 132A comprising a plurality of electrical contacts 142A electrically coupled to plurality of electrodes 114 and / or 116. For example, each electrical contact of plurality of electrical contacts 142A is coupled to at least one respective electrode of plurality of electrodes 114 and / or 116. In some examples, there is a 1:1 correspondence between electrical contacts 142A and electrodes (e.g., individual electrodes of plurality of electrodes 114 and / or 116). In other examples, more than one electrical contact 142A may be coupled to a respective electrode (e.g., an individual electrode of plurality of electrodes 114 and / or 116). In still further examples, more than one electrode (e.g., a subset of plurality of electrodes 114 and / or 116) may be coupled to a respective electrical contact 142A. For example, multiple sensing electrodes may be electrically coupled to the respective electrical contact 142A.

[0048] System 10 (e.g., IMD 106) may include processing circuitry configured to generate at least one signal configured to be transmitted to plurality of electrodes 114 and / or 116 of at least one elongated body 132A via plurality of header connectors 140 of header 100. In addition, or alternatively, the processing circuitry may be configured to receive at least one signal transmitted from plurality of electrodes 114 and / or 116 of at least one elongated body 132A via plurality of header connectors 140 of header 100.

[0049] Plurality of header connectors 140 may include a first connector pair 140A and 140B defining a first inter-connector spacing D1. Plurality of header connectors 140 may include aDocket No.: A0013213WO01 / 1123-858WO01 second connector pair 140C and 140D defining a second inter-connector spacing D2 greater than first inter-connector spacing D1. In some examples, D1 and D2 are respectively inter-connector spacings, for example, a spacing between opposing surfaces of neighboring header connectors 140. In some examples, second inter-connector spacing D2 is 0.110 inches (2.794 mm), and the first inter-connector spacing D1 is 0.085 inches (2.159 mm), or 0.055 inches 1.397 mm). In the example shown in FIG.2, the inter-connector spacing refers to an end-to-end distance between immediately adjacent connectors in an axial direction along elongated bore 130A. In other examples, the inter-connector spacing may refer to a midpoint-to-midpoint minimum distance between immediately adjacent connectors in an axial direction along elongated bore 130A. The difference in first inter-connector spacing D1 and second inter-connector spacing D2 allows header 100 to electrically couple different types of elongated bodies 132A, for example, elongated bodies carrying different numbers of electrodes (and thus, different numbers of electrical contacts for electrically coupling the electrodes of elongated body 132A with electrodes) or carrying different spacings of electrical contacts 142A (for example, different spacings along a length of elongated body 132A). Thus, header 100 may be compatible with different types of elongated bodies 132A.

[0050] FIG.2B is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 in a first configuration 100A with a first elongated body 132A received in elongated bore 130A. When at least one elongated body 132A is received and seated within bore 130A, electrical connections may be established between corresponding members of plurality of header connectors 140 of header 100 and plurality of electrical contacts 142A of elongated body 132A. Thus, at least one elongated body 132A is receivable in elongated bore 130A of header 100 to electrically couple plurality of electrodes (e.g., electrodes 114 and / or 116) of at least one elongated body 132A to plurality of header connectors 140 of header 100 by conductive contact between plurality of header connectors 140 of header 100 and electrical contacts 142A of at least one elongated body 132A. Accordingly, IMD 106 may send signals to, or receive signals from, electrodes 114 and / or 116 via electrical communication between corresponding members of header connectors 140 and electrical contacts 142A.

[0051] In some examples, elongated body 132A is a first elongated body defining a first connection length, and elongated bore 130A is dimensioned to receive a first connection length of the first elongated body or a second connection length defined by a second elongated body 132B. The second connection length may be different from the first connection length. In some examples, the second connection length is less than the first connection length.

[0052] FIG.2C is a conceptual diagram illustrating a partial view of a header of the IMD of FIG.1 in a second configuration 100B with a second elongated body 132B received in elongatedDocket No.: A0013213WO01 / 1123-858WO01 bore 130A. For example, first elongated body 132A may be removed from elongated bore 130A, and second elongated body 132B may be introduced in elongated bore 130A to receive the second connection length of second elongated body 132B within elongated bore 130A. Thus, elongated bore 130A may be configured to receive elongated bodies having different connection lengths.

[0053] In some examples, plurality of header connectors 140 includes a first subset of header connectors 140F configured to electrically couple a first plurality of electrical contacts 142A along the first connection length of elongated body 132A, and plurality of header connectors 140 includes a second subset of header connectors 140G configured to electrically couple a second plurality of electrical contacts 142B along the second connection length of second elongated body 132B. For example, as shown in FIG.2A, first elongated body 132A includes a greater number (twelve) of electrical contacts 142A than a number of electrical contacts (eight) 142B of second elongated body 132A. Thus, the total count of first plurality of electrical contacts 142A may be twelve, and the total count of second plurality of electrical contacts 142B may be eight. Correspondingly, the total count of first subset of header connectors 140F may be twelve, and the total count of second subset of header connectors 140G may be eight. In some examples, the second subset of header connectors 140G is a subset of first subset of header connectors 140F, as shown in FIG.2A. For example, one, more than one, or all, header connectors of second subset of header connectors 140G may be a part of first subset of header connectors 140F. In some examples, the first subset of header connectors 140F includes an entirety of plurality of header connectors 140, and the second subset of header connectors 140G includes less than the entirety of plurality of header connectors 140. However, first plurality of electrical contacts 142A or second plurality of electrical contacts 142B may independently include any suitable number of electrical contacts.

[0054] First subset of header connectors 140F is configured to receive all electrical contacts 142A of first elongated body 132A. First subset of header connectors 140F comprises a third subset of header connectors 140H. Third subset of header connectors 140H is configured to only receive additional electrical contacts 142A of first elongated body 132A (that are not present in second elongated body 132B). For example, first elongated body 132A may have a total count of twelve electrical contacts 142A, while second elongated body 132B may have a total count of eight electrical contacts 142B. Thus, first elongated body 132A may include additional electrical contacts (e.g., four additional electrical contacts) that are not present in second elongated body 132B. In such examples, first subset of header connectors 140F is configured to receive all electrical contacts 142A of first elongated body 132A, while third subset of header connectors 140H is configured to receive additional electrical contacts 142A of first elongated body 132ADocket No.: A0013213WO01 / 1123-858WO01 that do not correspond to or are not present in electrical contacts 142B of second elongated body 132B.

[0055] Second subset of header connectors 140G is configured to receive both certain electrical contacts of first elongated body 132A (e.g., less than all electrical contacts of first elongated body 132a) and of second elongated body 132B (e.g., all electrical contacts of second elongated body 132B). Thus, a total count of plurality of electrical contacts 142A (of first elongated body 132A) may be greater than a total count of second plurality of electrical contacts 142B (of second elongated body 132B), but both elongated bodies 132A and 132B may be receivable in the same elongated bore 130A. In other examples, a total count of the first plurality of electrical contacts 142A (of first elongated body 132A) is equal to the total count of second plurality of electrical contacts 142B (of second elongated body 132B).

[0056] At least one header connector of plurality of header connectors 140 may include a split connector (e.g., as described with reference to FIG.4). In some examples, third subset of header connectors 140H includes at least one split connector. For example, one, more than one, or all connectors of third subset of header connectors 140H may include split connectors. In some such examples, second subset of header connectors 140G do not include any split connectors. In other examples, one, more than one, or all header connectors of second subset of header connectors 140G include split connectors. In some examples, each header connector of the first connector pair 140A and 140B includes the split connector. In still further examples, each header connector of plurality of header connectors 140 includes a split connector. In some examples, plurality of header connectors 140 includes a total count of split connectors being twelve, and plurality of header connectors 140 is configured to connect to up to twenty four electrical contacts of elongated body 132A (or some other elongated body, e.g., having contacts complementary to plurality of header connectors 140).

[0057] Header 100 may include a proximal feature configured to stop insertion of elongated body 132A beyond a predetermined axial length of elongated body 132A within elongated bore 130A. For example, the proximal feature may include a protrusion, or a portion having a diameter greater than a diameter of elongated bore 130A. In some examples, the proximal feature is configured to provide a tactile feedback to a clinician upon insertion of a predetermined axial length of elongated body 132A within elongated bore 130A. In some examples, header 100 is configured to function even if only a subset of header connectors 140 receive or are in electrical communication with electrical contacts 142A. For example, the proximal feature may be associated with a length of elongated body 132A having a predetermined number of electrical contacts 142A, and a corresponding number of header connectors 140 (e.g., less than a totalDocket No.: A0013213WO01 / 1123-858WO01 count of header connectors 140) may electrically contact the predetermined number of electrical contacts 142A when the proximal feature engages elongated bore 130A.

[0058] In some examples, plurality of header connectors 140 comprises a proximal-most header connector 140E, and proximal-most header connector 140E is configured to detent elongated body 132A at a predetermined location along elongated body 132A to resist insertion of elongated body 132A beyond a predetermined depth into elongated bore 130A. For example, elongated body 132A may define a protrusion 144 at the predetermined location along elongated body 132A, and proximal-most header connector 140E may define a recess 146 configured to receive and hold protrusion 144 of elongated body 132A. In some examples, a proximal-most electrical contact of plurality of electrical contacts 142A is dimensioned to be received and retained in recess 146. For example, the proximal-most electrical contact may define protrusion 144, or otherwise have a diameter that is greater than respective diameters of the remaining electrical contacts of plurality of electrical contacts 142A, or greater than a diameter of elongated bore 130A, such that the proximal-most electrical contact resists further distal movement of elongated body 132A into elongated bore 130A. In some examples, instead of or in addition to protrusion 144, elongated body 132A defines a stop ridge 148. For example, stop ridge 148 may be positioned at a proximal portion of elongated body 132A, and configured to resist insertion of elongated body 132A into elongated bore 130A beyond a predetermined length. In some examples, the proximal-most electrical contact may define stop ridge 148. In some examples, stop ridge 148 may provide a tactile and / or auditory feedback to a clinician indicating proper insertion and / or alignment of elongated body 132A into elongated bore 130A. In some examples, the proximal-most electrical contact includes a set screw. In some examples, recess 146 includes a circumferential groove defined by proximal-most connector 140E.

[0059] Header 100 may include only one elongated bore, or two or more elongated bores having different configurations of header connectors 140. For example, elongated bore 130A may be a first elongated bore, and header 100 may define a second elongated bore 130B.

[0060] FIG.2D is a conceptual diagram illustrating a partial view of header 100 of IMD 106 of FIG.1 in a third configuration 100C with first elongated body 132A received in first elongated bore 130A and second elongated body 132B received in second elongated bore 130B. In such examples, plurality of header connectors 140 may be a first plurality of header connectors, and header 100 may include a second plurality of header connectors along second elongated bore 130B. Second elongated bore 130B may be identical to first elongated bore 130A, but spaced from first elongated bore. In other examples, second elongated bore 130B may differ from first elongated bore 130A in one or more of bore length, bore diameter, bore shape, header connector size, header connector shape, header connector number, header connector spacing.Docket No.: A0013213WO01 / 1123-858WO01

[0061] While FIGS.2A to 3D show first elongated body 132A and second elongated body 132B having different lengths for illustrative purposes, both first elongated body 132A and second elongated body 132B may have the same length, and the same number of electrical contacts. Thus, the same or identical elongated bodies may be inserted in both first elongated bore 130A and in second elongated bore 130B.

[0062] Header connectors 140 may have any suitable shape or configuration. For example, an axial width of respective header connectors 140 may be the same or different along elongated bore 130A. In some examples, a distal subset of header connectors 140 has a smaller axial width than a proximal subset of header connectors 140 along first elongated bore 130A. Such a configuration may permit a same length of elongated bore 130A to operatively receive elongated bodies having different lengths, or an elongated body having lead connectors of different axial widths or spacings in distal and proximal sections of the elongated body. In some examples, respective axial widths of all header connectors 140 may be further reduced so that elongated bore 130A can operatively receive an elongated body including relatively close-packed electrical contacts.

[0063] In some examples, a distal subset of header connectors 140 has a different inner diameter than that of a proximal subset of header connectors 140. For example, the distal subset of header connectors 140 may have a smaller inner diameter than the proximal subset of header connectors. Such a configuration may permit receiving of a portion of an elongated body (e.g., first elongated body 132A) having an outer diameter that is smaller than the inner diameter of the proximal subset within contact with the proximal subset of header connectors, and resist receiving of a portion of an elongated body having a greater diameter. For example, an elongated body (or a portion thereof) having an outer diameter greater than the inner diameter of the proximal subset would be stopped in the bore. In some examples, a first elongated body may have a first subset of electrical contacts having an outer diameter that is smaller than an outer diameter of a second subset of electrical contacts of a second lead. In such examples, the first elongated body may be receivable in the elongated bore to result in electrical coupling of the first subset of electrical contacts and the distal subset of header connectors, but the second elongated body may be receivable only to a depth of the elongated bore that results in electrical coupling of the second subset of electrical contacts and the proximal subset of header connectors. In some such examples, a protrusion or detent may not be necessary to restrict movement of the second elongated body beyond a predetermined depth of elongated bore 130A, because the greater diameter of the second elongated body may resist movement of the second elongated body distally beyond the predetermined depth (e.g., beyond the proximal subset of header connectors 140).Docket No.: A0013213WO01 / 1123-858WO01

[0064] In some examples, at least one header connector of the plurality of header connectors 140 includes a ring connector. FIG.3 is a conceptual diagram illustrating a cross-sectional view of a ring connector 140 for header 100.

[0065] In other examples, at least one header connector of plurality of header connectors 140 may include electrically isolated regions, for example as described with reference to FIG.4.

[0066] FIG.4 is a conceptual diagram illustrating a cross-sectional view of a split connector 240 for a header. Split connector 240 may be similar to ring connector 140, but may include at least two electrically isolated regions 240A and 240B. Regions 240A and 240B may be configured to electrically couple to corresponding electrical regions of a split electrical contact of an elongated body, or may be configured to electrically couple to a same electrical contact (e.g., to receive or send similar or different types of signals to or from the same electrical contact). For example, regions 240A and 240B may be independently used to transmit signals to an anode or cathode for stimulation or for sensing / recording. While two regions 240A and 240B are shown in FIG.4, split connector 240 may include three, four, or more regions. Further, the regions may be geometrically symmetrically or asymmetrically disposed (e.g., circumferentially) about split connector 240. In some examples, at least one electrical contact of an elongated body may have a complementary split or geometry configured to electrically couple corresponding regions of split connector 240. Header 100 described with reference to FIG.1 may include a plurality of split connectors 240. In some examples, a first subset of plurality of header connectors 140 is positioned at a different circumferential position around elongated bore 130A than a second subset of plurality of header connectors 140. For example, the first subset of plurality of header connectors 140 may correspond to first regions 240A of respective split connectors 240, and the second subset of plurality of header connectors 140 may correspond to second regions 240B of respective split connectors 240.

[0067] In some examples, at least one header connector of plurality of header connectors 140 of header 100 includes a split connector (e.g., identical to or similar to split connector 240). In some examples, each header connector of plurality of header connectors 140 includes split connector 240. While header 100 described with reference to FIG.2 may include at least one split connector 240, any suitable header may include at least one split connector. In some examples, a header including at least one split connector 240 may be similar to header 100, but may have a uniform inter-connector spacing (e.g., spacings between respective connector pairs of plurality of header connectors 140 being substantially the same in an axial direction along elongated bore 130A). In other examples, the header connectors including at least one split connector may differ in inter-connector spacing along the bore.Docket No.: A0013213WO01 / 1123-858WO01

[0068] In some examples, an elongated bore may be configured to receive an elongated body at a predetermined rotational orientation, for example, only in one relative rotational position.

[0069] FIG.5A is a conceptual diagram illustrating a cross-sectional view of an elongated bore 230 of a header 200 defining an alignment channel 235. FIG.5B is a conceptual diagram illustrating a cross-sectional view of an elongated body 232 defining an alignment boss 237 configured to be received in alignment channel 235 of the elongated bore 230 of FIG.5A. Thus, elongated bore 230 will receive elongated body 232 in a relative rotational configuration in which alignment boss 237 is receivable or slidable along alignment channel 235. Such alignment may facilitate alignment of complementary or corresponding rotational elements, for example, of header connectors of header 230 and electrical contacts of lead 232.

[0070] For example, elongated bore 230 may define alignment channel 235 extending along elongated bore 230 and configured to engage alignment boss 237 of elongated body 232 and cause elongated body 232 to be received in elongated bore 230 in a predetermined angular orientation. One or both of alignment channel 235 or alignment boss 237 may extend along any predetermined axial length in a direction along bore 230 or elongated body 232.

[0071] FIG.6 is a flowchart illustrating an example technique for detecting electrical coupling between at least one header connector of a header and at least one electrode of an elongated body. As an example, the technique of FIG.6 is described with reference to system 10 of FIG.1. However, the technique of FIG.6 may be performed using any suitable system according to the present disclosure.

[0072] In some examples, the technique of FIG.6 includes introducing elongated body 132A into bore 130A of header 100 of IMD 106 (300). The technique may further include determining, by processing circuitry (e.g., of IMD 106), an impedance of at least one header connector of plurality of header connectors 140 (302). The technique may further include repositioning elongated body 132A in bore 130A in response to determining that the impedance is greater than a predetermined threshold (304). For example, a reduction in impedance may be indicative of electrical communication between a respective header connector of plurality of header connectors 140 and an electrical contact of plurality of electrical contacts 142A. If the impedance does not reduce, or remains greater than the predetermined threshold, the header connector may not have properly electrically coupled with a corresponding electrical contact. Thus, elongated body 132A may be repositioned (e.g., by one or both of axial or rotational movement) until the impedance is reduced below the predetermined threshold. In some examples, determining the impedance 302 may include determining a plurality of impedances associated with respective header connector of plurality of header connectors 140 (for example, a subset or an entirety of header connectors 140). In some such examples, each impedance may beDocket No.: A0013213WO01 / 1123-858WO01 compared to a corresponding threshold, and elongated body 132A may be repositioned until each respective impedance is lower than the predetermined respective threshold. In addition to, or instead of, facilitating positioning or repositioning of elongated body 132A, the technique may include detecting a change in impedance to determine whether elongated body 132A has been inserted in elongated bore 130A, or whether elongated bore 130A is empty. For example, an impedance being lesser than a predetermined threshold may indicate that elongated body 132A has been received within elongated bore 130A, and the impedance being greater or equal to the predetermined threshold may indicate that elongated body 132A has not been received within elongated bore 130A.

[0073] FIG.7 is a functional block diagram illustrating components of the IMD 106 of FIG. 1, in accordance with one or more techniques of this disclosure. As seen in FIG.7, the IMD 106 includes processing circuitry 340, a memory 342, stimulation generation circuitry 344, sensing circuitry 346, telemetry circuitry 350, and a power source 352. The processing circuitry 340 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 340, may be provided by a hardware device and embodied as software, firmware, hardware, or any combination thereof.

[0074] In the example shown in FIG.7, the sensing circuitry 346 senses bioelectric brain signals of the patient 112 via select combinations of electrodes of the sets of electrodes 116, 118. The sensing circuitry 346 may include circuitry that measures the electrical activity of a particular region, e.g., an anterior nucleus, thalamus or cortex of the brain 120 via select electrodes of the sets of electrodes 116, 118. The specific location may be chosen to detect thalamic bursts for monitoring epilepsy. Leads 114A and 114B may be electrically coupled to IMD 106 via header 360 which is indicated by a dotted line. Header 360 may be similar to any headers described herein, such as header 100 of FIGS.1 and 2A. Therefore, header 360 may provide electrical connections between proximal contacts on each of leads 144 and circuitry within IMD 106, such as stimulation generation circuitry 344 and sensing circuitry 346.

[0075] The sensing circuitry 346 may sample the bioelectric brain signal substantially 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. The sensing circuitry 346 includes circuitry for determining a voltage difference between two electrodes of the sets of electrodes 116, 118, which generally indicates the electrical activity within the particular region of the brain 120. One electrode of the sets of electrodes 116, 118 may act as a reference electrode, and, if the sensing circuitry 346 is implanted within the patientDocket No.: A0013213WO01 / 1123-858WO01 112, a housing of the IMD 106 or the sensing module in examples in which the sensing circuitry 346 is separate from the IMD 106, may include one or more electrodes that may be used to sense bioelectric brain signals.

[0076] The processing circuitry 340 may receive the output of the sensing circuitry 346. In some cases, the processing circuitry 340 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. In addition, in some examples, the sensing circuitry 346 or the processing circuitry 340 may filter the signal from the selected electrodes of the sets of electrodes 116, 118 in order to remove undesirable artifacts from the signal, such as noise from cardiac signals generated within the body of the patient 112. Although the sensing circuitry 346 is incorporated into a common outer housing with the stimulation generation circuitry 344 and the processing circuitry 340 in FIG.7, in other examples, the sensing circuitry 346 is in a separate outer housing from the outer housing of the IMD 106 and communicates with the processing circuitry 340 via wired or wireless communication techniques. In other examples, a bioelectric brain signal is sensed via external electrodes (e.g., scalp electrodes).

[0077] In some examples, the sensing circuitry 346 includes circuitry to tune to and extract a power level of a particular frequency band of a sensed brain signal. Thus, the power level of a particular frequency band of a sensed brain signal may be extracted prior to digitization of the signal by the processing circuitry 340. By tuning to and extracting the power level of a particular frequency band before the signal is digitized, it may be possible to run frequency domain analysis algorithms at a relatively slower rate compared to systems that do not include a circuit to extract a power level of a particular frequency band of a sensed brain signal prior to digitization of the signal. In some examples, the sensing circuitry 346 includes more than one channel to monitor simultaneous activity in different frequency bands, i.e., to extract the power level of more than one frequency band of a sensed brain signal. These frequency bands may include an alpha frequency band (e.g., 8 Hz to 12 Hz), a beta frequency band (e.g., approximately 12 Hz to approximately 35 Hz), a gamma frequency band (e.g., between approximately 35 Hz to approximately 200 Hz), or other frequency bands. In any case, the power of the sensed signal may be measured and compared to a threshold value in order to detect thalamic bursts.

[0078] In some examples, the sensing circuitry 346 includes an architecture that merges chopper-stabilization with heterodyne signal processing to support a low-noise amplifier. In some examples, the sensing circuitry 346 includes a frequency selective signal monitor that includes a chopper-stabilized superheterodyne instrumentation amplifier and a signal analysis unit.Docket No.: A0013213WO01 / 1123-858WO01

[0079] A frequency selective signal monitor may utilize a heterodyning, chopper-stabilized amplifier architecture to convert a selected frequency band of a physiological signal to a baseband for analysis. The physiological signal may include a bioelectric brain signal, which may be analyzed in one or more selected frequency bands to detect bioelectric brain signals oscillating at a pathological frequency and, in response, deliver electrical stimulation to modulate the oscillating frequency of the bioelectric brain signals in accordance with some of the techniques described herein. The frequency selective signal monitor may provide a physiological signal monitoring device comprising a physiological sensing element that receives a physiological signal, an instrumentation amplifier comprising a modulator that modulates the signal at a first frequency, an amplifier that amplifies the modulated signal, and a demodulator that demodulates the amplified signal at a second frequency different from the first frequency. A signal analysis unit may analyze a characteristic of the signal in the selected frequency band. The second frequency may be selected such that the demodulator substantially centers a selected frequency band of the signal at a baseband.

[0080] In some examples, the sensing circuitry 346 senses brain signals substantially at the same time that the IMD 106 delivers therapy to the patient 112. In other examples, the sensing circuitry 346 senses brain signals and the IMD 106 delivers therapy at different times.

[0081] In some examples, the sensing circuitry 346 monitors one or more physiological parameters of a patient other than that of bioelectric brain signals, which are indicative of a patient disorder, e.g., in combination with the monitored bioelectrical brains signals of the patients. Suitable patient physiological parameters may include, but are not limited to, muscle tone (e.g., as sensed via electromyography (EMG)), eye movement (e.g., as sensed via electroculography (EOG) or EEG), and body temperature. In some examples, patient movement may be monitored via actigraphy. In one example, the processing circuitry 340 may monitor an EMG signal reflective of the muscle tone of the patient 112 to identify physical movement of the patient. Alternatively, or additionally, the processing circuitry 340 may monitor the physical movement of a patient via one or more motion sensors, such as, e.g., one or more single or multi- axis accelerometer devices.

[0082] In some examples, the sensing circuitry 346 monitors one or more physiological parameters of a patient other than that of bioelectric brain signals, which are indicative of symptoms of a seizure or likely seizure. For examples, the sensing circuitry 346 may monitor one or more parameters indicative of movement of a particular body portion and / or stiffness of a body region. In some examples, the system detects movement via EMG signals, actigraphy, accelerometers signals, and / or other suitable signal. In some examples, in response to the detection of one or more symptoms of seizure based on the monitoring of such parameter(s), theDocket No.: A0013213WO01 / 1123-858WO01 IMD 106 may deliver electrical stimulation selected to suppress brain signals oscillating at a frequency associated with the detected symptoms.

[0083] The memory 342 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. The memory 342 may store computer-readable instructions that, when executed by the processing circuitry 340, cause the IMD 106 to perform various functions described herein. The memory 342 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., the processing circuitry 340, 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 the memory 342 is non-movable. As one example, the memory 42 may be removed from the IMD 106, 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). In some examples, memory 342 stores instructions on how to process sensed signals, determine aggregate powers of a signal, determine a threshold power, detect the presence of a thalamic burst, or perform any other function.

[0084] The stimulation generation circuitry 344 may represent a single channel or multi- channel stimulation generator. For example, the stimulation generation circuitry 344 may be capable of delivering, a single stimulation pulse, multiple stimulation pulses or a continuous signal at a given time via a single electrode combination or multiple stimulation pulses at a given time via multiple electrode combinations. The stimulation generation circuitry 344 may include independent controllable sources and sinks for each electrode. A switch or other circuitry may be configured to connect and disconnect the sensing circuitry 346 from the stimulation generation circuitry as needed to, for example, prevent delivered stimulation from damaging the sensing circuitry 346. In some examples, however, the stimulation generation circuitry 344 may be configured to deliver multiple channels on a time-interleaved basis. For example, processing circuitry 340 time divide the output of the stimulation generation circuitry 344 across different electrode combinations at different times to deliver multiple programs or channels of stimulation energy to the patient 112.

[0085] In accordance with one or more examples of the disclosure, the processing circuitry 340 and / or a processing circuitry of another device (e.g., processing circuitry of the programmer 104) may control the stimulation generation circuitry 344 to generate and deliver electrical stimulation to one or more regions of the brain 120 to modulate the oscillation frequency of bioelectric brain signals in one or more regions of the brain 120. For example, when bioelectricDocket No.: A0013213WO01 / 1123-858WO01 brain signals are oscillating at a pathological frequency within a region of the brain 120, the processing circuitry 340 may control the stimulation generation circuitry 344 to generate and deliver a sequence of pulse bursts to the region of the brain 120 at a pulse burst frequency. In some examples, the pulse burst frequency is similar to or equal to the pathological frequency at which the pathological brain signals are oscillating, but this is not required. In some examples, each pulse burst of the sequence of pulse bursts is associated with a respective intra-burst pulse frequency. Pairs of adjacent pulse bursts in the sequence of pulse bursts may have different intra-burst pulse frequencies. Pairs of adjacent pulse bursts in the sequence of pulse bursts may have intra-burst pulse frequencies that are not factors of one another.

[0086] The telemetry circuitry 350 may support wireless communication between the IMD 106 and the programmer 104 or another computing device under the control of the processing circuitry 340. The processing circuitry 340 of the IMD 106 may, for example, transmit bioelectric brain signals, thalamic burst detection, seizure probability metrics for particular sleep stages, a seizure probability profile for the patient 112, and the like via the telemetry circuitry 350 to a telemetry module within the programmer 104 or another external device. The telemetry circuitry 350 in the IMD 106, as well as telemetry modules in other devices and systems described herein, such as the programmer 104, may accomplish communication by radiofrequency (RF) communication techniques. In addition, the telemetry circuitry 350 may communicate with the programmer 104 via proximal inductive interaction of the IMD 106 with the programmer 104. Accordingly, the telemetry circuitry 350 may send information to the programmer 104 on a continuous basis, at periodic intervals, or upon request from the IMD 106 or the programmer 104.

[0087] The power source 352 delivers operating power to various components of the IMD 106. The power source 352 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 the IMD 106. In some examples, power requirements may be small enough to allow the 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.

[0088] The processing circuitry 340 may control the stimulation generation circuitry 344 to deliver the sequence of pulse bursts including pulse bursts of varying frequencies. That is, the processing circuitry 340 may control the stimulation generation circuitry 344 to deliver the sequence of pulse bursts at a pulse burst frequency, wherein each pulse burst of the sequence of pulse bursts is delivered at an intra-burst pulse frequency that is not necessarily the same as intra-Docket No.: A0013213WO01 / 1123-858WO01 burst pulse frequencies of one or more other pulse bursts. For example, a first pulse burst may include a first intra-burst pulse frequency and a second pulse burst may include a second intra- burst pulse frequency that is different than the first intra-burst pulse frequency. In some examples, it may be beneficial for the intra-burst pulse frequency of a pulse burst to be different than the intra-burst pulse frequencies of adjacent pulse bursts in the sequence of pulse bursts. That is, when the sequence of pulse bursts includes a first pulse burst at a first intra-burst pulse frequency, a second pulse burst at a second intra-burst pulse frequency following the first pulse burst, and a third pulse burst at a third intra-burst pulse frequency following the second pulse burst, it may be beneficial for the processing circuitry 340 to control the stimulation generation circuitry 344 to deliver the sequence of pulse bursts so that the first frequency is different than the second frequency and the third frequency is different than the second frequency. Varying the intra-burst pulse frequencies of pulse bursts within the sequence of pulse bursts may prevent the sequence of pulse bursts from entraining the pathological brain signal while still suppressing the pathological brain signal.

[0089] Moreover, it may be beneficial for the processing circuitry 340 to control the stimulation generation circuitry 344 to deliver the sequence of pulse bursts so that adjacent pulse bursts are nonharmonic in frequency in order to prevent the sequence of pulse bursts from entraining the bioelectric brain signals. That is, a factor of the intra-burst pulse frequency of one pulse burst may be different than the factors of the intra-burst pulse frequencies of adjacent pulse bursts of the sequence of pulse bursts. For example, when the sequence of pulse bursts includes a first pulse burst at a first intra-burst pulse frequency, a second pulse burst at a second intra- burst pulse frequency following the first pulse burst, and a third pulse burst at a third intra-burst pulse frequency following the second pulse burst, it may be beneficial for the processing circuitry 340 to control the stimulation generation circuitry 344 to deliver the sequence of pulse bursts so that a factor of the first frequency is different than a factor of the second frequency and a factor of the third frequency is different than the factor of the second frequency. When the IMD 106 delivers a sequence of pulse bursts where adjacent pulse bursts have nonharmonic frequencies, the IMD 106 may suppress pathological brain signals. However, the IMD 106 may avoid entraining the pathological brain signals and thus avoid affecting bioelectric brain signals across the brain 120.

[0090] In some examples, the IMD 106 delivers electrical stimulation therapy to the brain 120 of the patient 112 upon detecting the bioelectric brain signal oscillations at a pathological frequency and / or detecting manifestations of one or more symptoms associated with the pathological brain signal. Additionally, or alternatively, the IMD 106 may deliver electrical stimulation therapy periodically to the brain 120 and not in response detecting pathological brainDocket No.: A0013213WO01 / 1123-858WO01 signals and / or detecting manifestations of one or more symptoms associated with the pathological brain signal. In some examples, the IMD 106 delivers the electrical stimulation therapy based on patient input. In some examples, the IMD 106 continuously delivers the electrical stimulation to the brain 120 of the patient 112.

[0091] The following enumerated clauses set forth examples according to the present disclosure.

[0092] Clause 1: A header for an implantable medical device, the header including: a header body defining an elongated bore that is configured to receive an elongated body, the elongated body including a plurality of electrical contacts, the elongated bore extending between a proximal bore opening and a distal bore end; and a plurality of header connectors positioned along the elongated bore, at least one header connector of the plurality of header connectors being configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body, where the plurality of header connectors includes a first connector pair defining a first inter-connector spacing, and where the plurality of header connectors includes a second connector pair defining a second inter-connector spacing greater than the first inter-connector spacing.

[0093] Clause 2: The header of clause 1, where the elongated body is a first elongated body defining a first connection length, and where the elongated bore is dimensioned to receive a first connection length of the first elongated body or a second connection length defined by a second elongated body, the second connection length being different from the first connection length.

[0094] Clause 3: The header of clause 2, where the plurality of header connectors includes a first subset of header connectors configured to electrically couple a first plurality of electrical contacts along the first connection length of the first elongated body, and where the plurality of header connectors includes a second subset of header connectors configured to electrically couple a second plurality of electrical contacts along the second connection length of the second elongated body.

[0095] Clause 4: The header of clause 3, where a total count of the first plurality of electrical contacts is greater than a total count of the second plurality of electrical contacts.

[0096] Clause 5: The header of clause 4, where the header includes a proximal feature configured to stop insertion of the elongated body beyond a predetermined axial length of the elongated body.

[0097] Clause 6: The header of any of clauses 4 or 5, where the total count of the first plurality of electrical contacts is twelve, and where the total count of the second plurality of electrical contacts is eight.Docket No.: A0013213WO01 / 1123-858WO01

[0098] Clause 7: The header of any of clauses 1 to 6, where the plurality of header connectors includes a proximal-most connector, and where the proximal-most connector is configured to detent the elongated body at a predetermined location along the elongated body to resist insertion of the elongated body beyond a predetermined depth into the elongated bore.

[0099] Clause 8: The header of clause 7, where the elongated body defines a protrusion at the predetermined location along the elongated body, and where the proximal-most connector defines a recess configured to receive and hold the protrusion of the elongated body.

[0100] Clause 9: The header of clause 8, where the recess includes a circumferential groove defined by the proximal-most connector.

[0101] Clause 10: The header of any of clauses 1 to 9, where the elongated bore is a first elongated bore, where the plurality of header connectors is a first plurality of header connectors, where the header body defines a second elongated bore, and where the header further includes a second plurality of header connectors positioned along the second elongated bore.

[0102] Clause 11: The header of any of clauses 1 to 10, where the second inter-connector spacing is 0.110 inches (2.794 mm), and where the first inter-connector spacing is 0.085 inches (2.159 mm).

[0103] Clause 12: The header of any of clauses 1 to 11, where at least one header connector of the plurality of header connectors includes a ring connector.

[0104] Clause 13: The header of any of clauses 1 to 12, where a first subset of the plurality of header connectors is positioned at a different circumferential position around the elongated bore than a second subset of the plurality of header connectors.

[0105] Clause 14: The header of clause 13, where the elongated bore defines an alignment channel extending along the elongated bore and configured to engage an alignment boss of the elongated body and cause the elongated body to be received in the elongated bore in a predetermined angular orientation.

[0106] Clause 15: The header of any of clauses 1 to 14, where a distal subset of the plurality of header connectors has a smaller axial width than a proximal subset of the plurality of header connectors along the elongated bore.

[0107] Clause 16: The header of any of clauses 1 to 15, where at least one header connector of the plurality of header connectors includes a split connector.

[0108] Clause 17: The header of clause 16, where each header connector of the first connector pair includes the split connector.

[0109] Clause 18: The header of any of clauses 16 or 17, wherein each header connector of the plurality of header connectors includes the split connector.Docket No.: A0013213WO01 / 1123-858WO01

[0110] Clause 19: The header of clause 18, wherein a total count of split connectors is twelve, and wherein the plurality of header connectors is configured to connect to up to twenty four electrical contacts of the elongated body.

[0111] Clause 20: A header for an implantable medical device, the header including: a header body defining an elongated bore that is configured to receive an elongated body, the elongated body including a plurality of electrical contacts, the elongated bore extending between a proximal bore opening and a distal bore end; and a plurality of header connectors positioned along the elongated bore, at least one header connector of the plurality of header connectors being configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body, where the at least one header connector includes a split connector.

[0112] Clause 21: the header of clause 20, where a first subset of the plurality of header connectors is positioned at a different circumferential position around the elongated bore than a second subset of the plurality of header connectors.

[0113] Clause 22: the header of any of clauses 20 or 21, where the elongated bore defines an alignment channel extending along the elongated bore and configured to engage an alignment boss of the elongated body and cause the elongated body to be received in the elongated bore in a predetermined angular orientation.

[0114] Clause 23: A system including: the header of any of clauses 1 to 22; and at least one elongated body including a plurality of electrical contacts electrically coupled to a plurality of electrodes, where the at least one elongated body is receivable in the elongated bore of the header to electrically couple the plurality of electrodes of the at least one elongated body to the plurality of header connectors of the header by conductive contact between the plurality of header connectors of the header and the electrical contacts of the at least one elongated body.

[0115] Clause 24: The system of clause 23, further including processing circuitry configured to: generate at least one signal configured to be transmitted to the plurality of electrodes of the at least one elongated body via the plurality of header connectors of the header; or receive at least one signal transmitted from the plurality of electrodes of the at least one elongated body via the plurality of header connectors of the header.

[0116] The techniques described in the present disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the described techniques may be implemented within one or more processors, such as fixed function processing circuitry and / or programmable processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discreteDocket No.: A0013213WO01 / 1123-858WO01 logic circuitry, as well as any combinations of such components. The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit including hardware may also perform one or more of the techniques of the present disclosure.

[0117] Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. 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.

[0118] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a DVD, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.

[0119] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Docket No.: A0013213WO01 / 1123-858WO01 WHAT IS CLAIMED IS:

1. A header for an implantable medical device, the header comprising: a header body defining an elongated bore that is configured to receive an elongated body, the elongated body comprising a plurality of electrical contacts, the elongated bore extending between a proximal bore opening and a distal bore end; and a plurality of header connectors positioned along the elongated bore, at least one header connector of the plurality of header connectors being configured to electrically couple at least one electrical contact of the plurality of electrical contacts of the elongated body, wherein the plurality of header connectors comprises a first connector pair defining a first inter-connector spacing, and wherein the plurality of header connectors comprises a second connector pair defining a second inter-connector spacing greater than the first inter-connector spacing.

2. The header of claim 1, wherein the elongated body is a first elongated body defining a first connection length, and wherein the elongated bore is dimensioned to receive a first connection length of the first elongated body or a second connection length defined by a second elongated body, the second connection length being different from the first connection length.

3. The header of claim 2, wherein the plurality of header connectors comprises a first subset of header connectors configured to electrically couple a first plurality of electrical contacts along the first connection length of the first elongated body, and wherein the plurality of header connectors comprises a second subset of header connectors configured to electrically couple a second plurality of electrical contacts along the second connection length of the second elongated body.

4. The header of claim 3, wherein a total count of the first plurality of electrical contacts is greater than a total count of the second plurality of electrical contacts.

5. The header of claim 4, wherein the header comprises a proximal feature configured to stop insertion of the elongated body beyond a predetermined axial length of the elongated body.

6. The header of any of claims 4 or 5, wherein the total count of the first plurality of electrical contacts is twelve, and wherein the total count of the second plurality of electrical contacts is eight.Docket No.: A0013213WO01 / 1123-858WO01 7. The header of any of claims 1 to 6, wherein the plurality of header connectors comprises a proximal-most connector, and wherein the proximal-most connector is configured to detent the elongated body at a predetermined location along the elongated body to resist insertion of the elongated body beyond a predetermined depth into the elongated bore.

8. The header of claim 7, wherein the elongated body defines a protrusion at the predetermined location along the elongated body, and wherein the proximal-most connector defines a recess configured to receive and hold the protrusion of the elongated body.

9. The header of claim 8, wherein the recess comprises a circumferential groove defined by the proximal-most connector.

10. The header of any of claims 1 to 9, wherein the elongated bore is a first elongated bore, wherein the plurality of header connectors is a first plurality of header connectors, wherein the header body defines a second elongated bore, and wherein the header further comprises a second plurality of header connectors positioned along the second elongated bore.

11. The header of any of claims 1 to 10, wherein the second inter-connector spacing is 0.110 inches (2.794 mm), and wherein the first inter-connector spacing is 0.085 inches (2.159 mm).

12. The header of any of claims 1 to 11, wherein at least one header connector of the plurality of header connectors comprises a ring connector.

13. The header of any of claims 1 to 12, wherein at least one header connector of the plurality of header connectors comprises a split connector.

14. A system comprising: the header of any of claims 1 to 13; stimulation generation circuitry; processing circuitry; and a housing configured to enclose at least the stimulation generation circuitry and the processing circuitry; wherein the processing circuitry is configured to control the stimulation generation circuitry to generate at least one signal configured to be transmitted to the plurality of electrodes of the at least one elongated body via the plurality of header connectors of the header.Docket No.: A0013213WO01 / 1123-858WO01 15. The system of claim 14, further comprising at least one elongated body comprising a plurality of electrical contacts electrically coupled to a plurality of electrodes, wherein the at least one elongated body is receivable in the elongated bore of the header to electrically couple the plurality of electrodes of the at least one elongated body to the plurality of header connectors of the header by conductive contact between the plurality of header connectors of the header and the electrical contacts of the at least one elongated body.

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