Distal connector assembly configurations and methods for using the same

Abstract

A device according to at least one embodiment of the present disclosure includes: a proximal end; a distal end; a plurality of electrical contacts positioned between the proximal end and the distal end; and a conductor coil extending from the proximal end toward the distal end and including a plurality of conductive wires, each of which is electrically connected to a respective electrical contact of the plurality of electrical contacts, where at least some wires of the conductor coil are at least partially wrapped around a respective contact of the plurality of electrical contacts.

Description

DISTAL CONNECTOR ASSEMBLY CONFIGURATIONS AND METHODS FOR USING THE SAME

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 676,202, filed July 26, 2024, the entire content of which is incorporated herein by reference.BACKGROUND

[0002] The present disclosure is generally directed to electrical stimulation therapy, and relates more particularly to connector assemblies for use in electrical stimulation therapies.

[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, tremors, Parkinson’s disease, other movement disorders, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. A medical device delivers 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. Electrical stimulation is used in different therapeutic applications, such as Deep Brain Stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).BRIEF SUMMARY

[0004] Distal end connectors may connect implantable medical devices (IMDs) to implantable medical leads to enable stimulation signals to be passed from the HMDs to the medical leads to provide one or more stimulation therapies. Some distal end connectors implement “minicoils,” which electrically connect a main body coil connected to the IMD to electrical contacts in the distal end connectors to pass current to the medical leads. The use of such minicoils often requires crimp or weld sleeves to connect the minicoils to the main body coil, increasing manufacturing costs. According to embodiments of the present disclosure, conductive wires within the main body coil are welded to the electrical contacts in the distal end connector. The main body coil may include one or more coiltransitions, where the diameter, pitch, location, etc. of the main body coil and / or the wires therein are changed to enable the wires of the main body coil to electrically connect to the electrical contacts. Such embodiments reduce or eliminate the need for implementing separate minicoils and crimp sleeves to electrically connect the main body coil with the electrical contacts.

[0005] Example aspects of the present disclosure include:

[0006] A device according to at least one embodiment of the present disclosure comprises: a proximal end; a distal end; a plurality of electrical contacts positioned between the proximal end and the distal end; and a conductor coil extending from the proximal end toward the distal end and comprising a plurality of conductive wires, each of which is electrically connected to a respective electrical contact of the plurality of electrical contacts, wherein at least some wires of the conductor coil are at least partially wrapped around a respective contact of the plurality of electrical contacts.

[0007] Any of the aspects herein, wherein the plurality of electrical contacts comprises eight or more contacts, and wherein the conductor coil comprises eight or more wires.

[0008] Any of the aspects herein, wherein a first portion of the conductor coil is coiled in a first configuration, and wherein a second portion of the conductor coil is coiled with a second configuration different than the first configuration.

[0009] Any of the aspects herein, wherein the second portion is coiled with a smaller diameter than the first portion.

[0010] Any of the aspects herein, wherein the second portion is coiled with a larger diameter than the first portion.

[0011] Any of the aspects herein, wherein the plurality of electrical contacts comprises a first contact and a second contact, and wherein the first contact is positioned closer to the proximal end than the second contact.

[0012] Any of the aspects herein, wherein a portion of the conductor coil extends beyond the first contact toward the distal end.

[0013] A system according to at least one embodiment of the present disclosure comprises: an electrical lead; and a connector device connectable to the electrical lead, the connector device comprising: a proximal end; a distal end; a plurality of electrical contacts positioned between the proximal end and the distal end; and a conductor coil extending from the proximal end toward the distal end and comprising a plurality of conductivewires, each of which is electrically connected to a respective contact of the plurality of electrical contacts, wherein at least some wires in the conductor coil are at least partially wrapped around a respective contact of the plurality of electrical contacts.

[0014] Any of the aspects herein, wherein the plurality of electrical contacts comprises eight or more conductors, and wherein the conductor coil comprises eight or more wires.

[0015] Any of the aspects herein, wherein a first portion of the conductor coil is coiled in a first configuration, and wherein a second portion of the conductor coil is coiled with a second configuration different than the first configuration.

[0016] Any of the aspects herein, wherein the second portion is coiled with a smaller diameter than the first portion.

[0017] Any of the aspects herein, wherein the second portion is coiled with a larger diameter than the first portion.

[0018] Any of the aspects herein, wherein the plurality of electrical contacts comprises a first contact and a second contact, and wherein the first contact is positioned closer to the proximal end than the second contact.

[0019] Any of the aspects herein, wherein a portion of the conductor coil extends beyond the first contact toward the distal end.

[0020] Any of the aspects herein, further comprising: an implantable medical device connectable to the proximal end.

[0021] A device according to at least one embodiment of the present disclosure comprises: a proximal end; a distal end; a plurality of electrical contacts positioned between the proximal end and the distal end and comprising a first contact and a second contact positioned distally from the first contact; and a conductor coil extending from the proximal end toward the distal end and comprising a plurality of conductive wires, wherein a first wire of the plurality of conductive wires is electrically connected to the first contact, and at least some of the plurality of conductive wires extend past the first contact and toward the distal end.

[0022] Any of the aspects herein, wherein a first portion of the conductor coil is coiled in a first configuration, and wherein a second portion of the conductor coil is coiled with a second configuration different than the first configuration.

[0023] Any of the aspects herein, wherein the second portion is coiled with a smaller diameter than the first portion.

[0024] Any of the aspects herein, wherein the second portion is coiled with a larger diameter than the first portion.

[0025] Any of the aspects herein, wherein the first wire is at least partially wrapped around the first contact.

[0026] Any aspect in combination with any one or more other aspects.

[0027] Any one or more of the features disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein.

[0029] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0030] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0031] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0032] Fig. l is a diagram of aspects of a system according to at least one embodiment of the present disclosure;

[0033] Fig. 2A is a view of aspects of a connector assembly according to at least one embodiment of the present disclosure;

[0034] Fig. 2B is an alternative view of additional aspects of the connector assembly according to at least one embodiment of the present disclosure;

[0035] Fig. 2C is an alternative view of additional aspects of the connector assembly according to at least one embodiment of the present disclosure;

[0036] Fig. 3 A is a view of a conductor coil according to at least one embodiment of the present disclosure;

[0037] Fig. 3B is a view of aspects of the connector assembly and the conductor coil according to at least one embodiment of the present disclosure;

[0038] Fig. 3C is an alternative view of aspects of the connector assembly and the conductor coil according to at least one embodiment of the present disclosure;

[0039] Fig. 4A is a view of aspects of the connector assembly and a conductor coil according to at least one embodiment of the present disclosure;

[0040] Fig. 4B is an alternative view of the connector assembly and the conductor coil according to at least one embodiment of the present disclosure;

[0041] Fig. 5A is a view of aspects of the connector assembly and a conductor coil according to at least one embodiment of the present disclosure;

[0042] Fig. 5B is an alternative view of aspects of the connector assembly and the conductor coil according to at least one embodiment of the present disclosure;

[0043] Fig. 6A is a view of aspects of the connector assembly and a conductor coil according to at least one embodiment of the present disclosure;

[0044] Fig. 6B is an alternative view of aspects of the connector assembly and the conductor coil according to at least one embodiment of the present disclosure;

[0045] Fig. 7 is a diagram of aspects of an implantable medical device (IMD) according to at least one embodiment of the present disclosure;

[0046] Fig. 8 is a diagram of aspects of an external programmer according to at least one embodiment of the present disclosure; and

[0047] Fig. 9 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0048] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one ormore aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0049] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0050] Lead extensions used in DBS therapies may include a flexible distal connector assembly that allows the assembly to conform to patient anatomy. Some assemblies may utilize “minicoils,” small single filar coils, within the connector to help facilitate flexibility. But the use of minicoils may increase the overall cost of the assembly and may require additional mechanical joints to mate the minicoils to the main body conductor coil.

[0051] In accordance with embodiments of the present disclosure, the distal connector assembly may enable a more direct connection of the main body conductor coil to the spring contacts in the assembly — which may eliminate the need for the minicoils — while maintaining the flexibility of the connector assembly. The reduced number of components and removal of the mechanical joints may also reduce cost while providing the same or increased reliability of the distal connector assembly.

[0052] In accordance with embodiments of the present disclosure, various coiling methods and systems are provided herein that maintain flexibility in the connector assembly without compromising the reliability of the solid conductors in the flexible environment. In one example, the body conductor coil may be stepped-up or “flared” where the diameter of the coil is increased and helically wound around the connector stack. Each wire of the conductor coil may then be individually joined to the spring contact. In another example, the coil may be wound with straight wires left on an end and each straight wire may be individually wrapped around the connector stack and welded to a respective spring contact. In yet another example, the coil may be stepped down where the diameter of the coil is decreased and positioned alongside the connector stack. Each wire may spatially terminate in line with a respective spring contact and welded thereto. In yet another example, the coil may be separated into individual coiled wires that extendalongside the connector and welded to a respective spring contact. In yet another example, the coil may be separated into straight wires that are positioned alongside the connector stack and that are welded to spring contacts. In this example, the wires may be positioned inside polymer tubes. The polymer tubes may enable adjustments to the length of the wires to help maintain flexibility in the connector assembly. For example, when the connector stack bends and the wires on a first side of the connector stack experience tension, the polymer tubes may enable the additional wiring to be pulled into the polymer tube to accommodate extra length needed. Conversely, when the first side of the connector stack experiences compression, the wires on the first side of the connector stack can slide to accommodate the reduced wire length needed without kinking.

[0053] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) excessive connector components, and (2) connector assemblies that are expensive to manufacture.

[0054] Turning first to Fig. 1, aspects of a conceptual diagram illustrating a system 100 are shown in accordance with embodiments of the present disclosure. The conceptual diagram depicts an implantable medical device (IMD) 106 configured to deliver a DBS therapy to a patient 112. In some examples, the DBS may be closed-loop in the sense that the IMD 106, as one example, may adjust, increase, or decrease the magnitude of one or more parameters of the DBS in response to changes in patient activity or movement, a severity of one or more symptoms of a disease of the patient, a presence of one or more side effects due to the DBS, and / or one or more sensed signals of the patient.

[0055] In one example, the system 100 comprises a bi-directional DBS system with capabilities to both deliver stimulation, sense intrinsic neuronal signals, and sense neural signals that are evoked in response to delivery of stimulation. The system 100 may be configured to treat a patient condition, such as a movement disorder (e.g., ET, Parkinson’s, etc.), neurodegenerative impairment, a mood disorder, or a seizure disorder of the patient 112. The patient 112 is ordinarily a human patient. In some cases, however, the system 100 may be applied to other mammalian or non-mammalian, non-human patients. While movement disorders and neurodegenerative impairment are primarily referred to herein, in other examples, the system 100 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxietydisorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)). At least some of these disorders may be manifested in one or more patient movement behaviors. As described herein, a movement disorder or other neurodegenerative impairment may include symptoms such as, for example, muscle control impairment, motion impairment or other movement problems, such as rigidity, spasticity, bradykinesia, rhythmic hyperkinesia, nonrhythmic hyperkinesia, and akinesia. In some cases, the movement disorder may be a symptom of Parkinson’s disease or ET. However, the movement disorder may be attributable to other conditions of the patient.

[0056] The system 100 is illustrated to comprise a programmer 104, the IMD 106, a lead extension 110, a lead 114A with a set of electrodes 116, a lead 114B with a set of electrodes 118, and a distal connector 124 (also referred to herein as a “connector assembly”) that couples the leads 114A, 114B to the lead extension 110.

[0057] In the example shown in FIG. 1, the electrodes 116, 118 of the leads 114A, 114B are positioned to deliver electrical stimulation to a tissue site within the brain 120 of the patient 112, such as a deep brain site under the dura mater of the brain 120 of the patient 112. The IMD 106 may be implanted within a subcutaneous pocket above the clavicle, or, alternatively, on or within the cranium 122 or at any other suitable site within the patient 112. Generally, the IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. The IMD 106 may comprise a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory. In some examples, delivery of stimulation to one or more regions of the brain 120, such as the subthalamic nucleus (STN), globus pallidus or thalamus, ventralus intermediate (VIM), anterior nucleus (ANT), ventral internal capsule / ventral striatum (VCVS), cortico-basal ganglia-thalamocortical circuit, or anterior insular cortex (AIC), may be an effective treatment to manage disorders, such as Parkinson’s disease.

[0058] Some or all of the electrodes 116, 118 also may be positioned to sense neurological brain signals within the brain 120 of the patient 112. In some examples, some of the electrodes 116, 118 may be configured to sense neurological brain signals and others of the electrodes 116, 118 may be configured to deliver electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118 are configured to both sense neurological brain signals and deliver electrical stimulation to the brain 120. In some examples, unipolar stimulation may be possible where one electrode is on the housing ofthe IMD 106. Although the IMD 106 is described as delivering electrical stimulation therapy to the brain 120, the IMD 106 may be configured to direct electrical stimulation to other anatomical regions of the patient 112. Further, an IMD may provide other electrical stimulation such as spinal cord stimulation to treat a movement disorder.

[0059] The IMD 106 includes a therapy module (e.g., which may include processing circuitry or other electrical circuitry configured to perform the functions attributed to the IMD 106) that includes stimulation generation circuitry configured to generate and deliver electrical stimulation therapy to the patient 112 via a subset of the electrodes 116, 118 of the leads 114A and 114B, respectively. The subset of the electrodes 116, 118 that are used to deliver electrical stimulation to the patient 112, and, in some cases, the polarity of the subset of the electrodes 116, 118, may be referred to as a stimulation electrode combination. In some examples, the stimulation electrode combination can be selected for a particular patient and target tissue site (e.g., selected based on the patient condition). The group of the electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes. In some examples, the plurality of the electrodes 116 and / or 118 may have a complex electrode geometry such that two or more electrodes are located at different positions around the perimeter of the respective lead.

[0060] In some examples, the neurological signals sensed within the brain 120 may reflect changes in electrical current produced by the sum of electrical potential differences across brain tissue. There may be various examples of neurological brain signals that the electrodes 116, 118 may be configured to sense. One example of a neurological brain signal is an Evoked Resonant Neural Activity (ERNA) signal, which may be evoked through delivery of electrical stimulation within the brain 120. The electrical stimulation delivered within brain 120 to evoke the ERNA signal need not necessarily provide therapeutic benefit, but therapeutic benefit from the electrical stimulation used to evoke the ERNA signal is possible. Electroencephalogram (EEG) signals, electrocorticogram (ECoG) signals, or local field potential (LFP) signals are also examples of neurological signals that may be sensed by the IMD 106. For example, neurons generate the neurological signals, and if measured at depth, it is LFP or ERNA (if evoked); if measured on the dura, it is ECoG; and if on scalp, it is EEG. In another example, the neurological signals may be or comprise Evoked Compound Action Potential (ECAP) signals.

[0061] In some examples, the neurological brain signals that are used to select a stimulation electrode combination may be sensed within the same region of the brain 120 as the target tissue site for the electrical stimulation. As previously indicated, the target tissue sites may include tissue sites within anatomical structures such as the thalamus, STN, or globus pallidus of the brain 120, as well as other target tissue sites. The specific target tissue sites and / or regions within the brain 120 may be selected based on the patient condition. Thus, in some examples, both a stimulation electrode combination and sense electrode combinations may be selected from the same set of the electrodes 116, 118. In other examples, the electrodes used for delivering electrical stimulation may be different than the electrodes used for sensing neurological brain signals.

[0062] Therapeutic electrical stimulation generated by the IMD 106 may be configured to manage a variety of disorders and conditions. In some examples, the stimulation generation circuitry of the IMD 106 is configured to generate and deliver therapeutic electrical stimulation pulses to the patient 112 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generation circuitry of the IMD 106 may be configured to generate and deliver a continuous wave signal (e.g., a sine wave or triangle wave). In either case, stimulation generation circuitry within the IMD 106 may generate the electrical stimulation therapy for DBS according to a selected therapy program. In examples in which the IMD 106 delivers therapeutic electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., parameters), such as a stimulation electrode combination for delivering stimulation to the patient 112, 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 therapeutic stimulation signals to tissue of the patient 112 and the respective polarities of the selected electrodes.

[0063] In some examples, the electrodes 116, 118 may be circumferentially-segmented DBS arrays of electrodes, and include some non-segmented electrodes as well, such as ring electrodes. Circumferentially-segmented DBS arrays refer to electrodes that are segmented circumferentially along the lead. As one example, the leads 114A and 114B may include a first set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a levelof circumferentially-segmented array of electrodes. The leads 114A and 114B may include a second set of electrodes arranged circumferentially around the leads 114A and 114B that are all at the same height level on the leads 114A and 114B. Each of the electrodes in the first set of electrodes is a separate segmented electrode and form a level of circumferentially-segmented array of electrodes. The electrodes may be beneficial by enabling directional stimulation and sensing. In some cases and as discussed in further detail below, the first and second sets of electrodes may evoke and measure ERNA signal responses from various anatomical tissues in the brain 120 of the patient 112, with such ERNA signal responses being used to plan and / or confirm the trajectory and target location of the leads 114A and 114B.

[0064] With the electrodes, the IMD 106 may be configured to perform both directional stimulation and sensing, thereby enhancing the ability to target the source of the ERNA activities (also referred to as pathological neuronal activities). For example, the IMD 106 may be configured to perform directional sensing to determine a direction and / or orientation of the ERNA source (e.g., signal source that generates the ERNA). The IMD 106 may direct the electrical stimulation toward the signal source to optimize the ERNA signal component produced by the signal source (e.g., amplitude, frequency, etc.), as one example. In another example, the IMD 106 may determine a direction and / or orientation of the ERNA source, and may use such information along with information about the current pose of the leads 114A and 114B to determine whether the leads 114A and 114B are correctly placed at a target location. For instance, the IMD 106 may receive ERNA responses from surrounding anatomical tissue and, using processing circuitry, determine a location of target nuclei that are to receive directional stimulation. The processing circuitry may further compare the location of the target nuclei to the location of the leads 114A and 114B (or the electrodes 116, 118) and, when a difference between the location of the target nuclei and the location of the leads 114A and 114B meet or exceed a threshold value, generate an alert indicating that the leads 114A and 114B have not been implanted in the correct location. Such an alert may enable a physician, the patient 112, or the like to adjust the implant location of the leads 114A and 114B, adjust which electrodes of the electrodes 116, 118 are used to perform the stimulation, combinations thereof, and / or the like.

[0065] Further, the example techniques discussed herein are not limited to examples where one or more of electrodes 116, 118 are circumferentially-segmented electrodes. Theexample of using circumferentially-segmented electrodes is described as a way of directional stimulation and sensing. However, the example techniques are also useable in examples where directional stimulation and sensing are not available or are not used. Moreover, there may be other ways of performing directional stimulation and sensing that do not require the use of circumferentially-segmented electrodes. In an example for DBS, the IMD 106 may be configured to deliver therapeutic electrical stimulation signals based on one or more parameters such as amplitude, pulse width, and frequency.

[0066] As shown in FIG. 1, the lead extension 110 is coupled to the IMD 106 via a connector 108 (also referred to as a connector block or a header of the IMD 106). In the example of FIG. 1, the lead extension 110 traverses from the implant site of the IMD 106 and along the neck of the patient 112 to the cranium 122 of the patient 112 to access the brain 120. The lead extension 110 comprises distal connector 124, which enables the leads 114A and 114B to connect to the IMD 106. In the example shown in FIG. 1, the leads 114A and 114B (collectively the “leads 114”) are implanted within the right and left hemispheres (or in just one hemisphere in some examples), respectively, of the patient 112 in order to deliver electrical stimulation to one or more regions of the brain 120, which may be selected based on the patient condition or disorder controlled by the system 100. 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 and / or other sensed patient parameters. Other implant sites of the leads 114A, 114B and the IMD 106 are contemplated. For example, the IMD 106 may be implanted on or within the cranium 122, in some examples. The leads 114A and 114B may be implanted within the same hemisphere or the IMD 106 may be coupled to a single lead implanted in a single hemisphere, in some examples. Existing lead sets include axial leads carrying ring electrodes disposed at different axial positions and so-called "paddle" leads carrying planar arrays of electrodes. In some examples, more complex lead array geometries may be used.

[0067] Although the leads 114 are shown in FIG. 1 as being coupled to a common lead extension, in other examples, the leads 114 may be coupled to the IMD 106 via separate lead extensions. The leads 114 may be positioned to deliver electrical stimulation to one or more target tissue sites within the brain 120 to manage patient symptoms associated with, for example, a movement disorder of the patient 112. The leads 114 may be implanted toposition the electrodes 116, 118 at desired locations of the brain 120 through respective holes in the cranium 122. The leads 114 may be placed at any location within the brain 120 such that the electrodes 116, 118 are capable of providing electrical stimulation to target tissue sites within the brain 120 during treatment. For example, the electrodes 116, 118 may be surgically implanted under the dura mater of the brain 120 or within the cerebral cortex of the brain 120 via a burr hole in the cranium 122 of the patient 112, and electrically coupled to the IMD 106 via one or more leads (e.g., the leads 114).

[0068] In the example shown in FIG. 1, the electrodes 116, 118 of the leads 114 are shown as ring electrodes. Ring electrodes may be used in DBS applications because ring electrodes are relatively simple to program and are capable of delivering an electrical field to any tissue adjacent to the electrodes 116, 118. In other examples, the electrodes 116, 118 may have different configurations. For example, at least some of the electrodes 116, 118 of the 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 directed in a specific direction from the leads 114 to enhance therapy efficacy and reduce possible adverse side effects from stimulating a large volume of tissue. For example, one or more electrodes 116, 118 may be circumferentially-segmented DBS arrays of electrodes, and one or more electrodes 116, 118 may be non-segmented electrodes such as ring electrodes, as described above. In some examples, electrodes 116, 118 may only be circumferentially-segmented DBS arrays of electrodes, and in some examples, electrodes 116, 118 may only be non-segmented electrodes, such as ring electrodes. In some examples, a housing of the IMD 106 may include one or more stimulation and / or sensing electrodes. In some examples, the leads 114 may have shapes other than elongated cylinders as shown in FIG. 1. For example, the 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.

[0069] The IMD 106 includes a memory to store a plurality of therapy programs that each define a set of therapy parameter values. In some examples, the IMD 106 may select a therapy program from the memory based on various parameters, such as sensed patient parameters and the identified patient behaviors. The stimulation generation circuitry of theIMD 106 may deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters. Then, the processing circuitry may determine a second set of one or more parameters for a second set of one or more therapeutic electrical stimulation signals based on, for example, one or more ERNA signals and cause the stimulation generation circuitry to deliver the second set of the one or more therapeutic electrical stimulation signals. The second set of one or more parameters may comprise changes to the first set of one or more parameters.

[0070] The programmer 104 wirelessly communicates with the IMD 106 as needed to provide or retrieve therapy information. The programmer 104 is an external computing device that the user, (e.g., a clinician and / or the patient 112), may use to communicate with the IMD 106. For example, the programmer 104 may be a clinician programmer that the clinician uses to communicate with the IMD 106 and program one or more therapy programs for the IMD 106. Alternatively, the programmer 104 may be a patient programmer that allows the patient 112 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 and sensitive tasks may be reserved for the clinician programmer to prevent an untrained patient from making undesirable changes to the IMD 106.

[0071] When the programmer 104 is configured for use by the clinician, the programmer 104 may be used to transmit initial programming information to the IMD 106. This initial information may include hardware information, such as the type of leads and the electrode arrangement, the position of the leads 114 within the brain 120, the configuration of the electrodes 116, 118, initial programs defining therapy parameter values, and any other information the clinician desires to program into the IMD 106. The programmer 104 may also be capable of completing functional tests (e.g., measuring the impedance of the electrodes 116, 118 of the leads 114).

[0072] The clinician may also store therapy programs within the IMD 106 with the aid of the programmer 104. During a programming session, the clinician may determine one or more therapy programs that may provide efficacious therapy to the 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 combinations withwhich stimulation is delivered to the brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by the patient 112 or based on one or more physiological parameters of the patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). In some examples, ERNA signals may be used to evaluate the efficacy of the specific program being evaluated (e.g., certain resonant activity in the ERNA signal may be indicative of efficacious therapy). Alternatively, identified patient behavior from video information may be used as feedback during the initial and subsequent programming sessions. The 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.

[0073] The programmer 104 may also be configured for use by the patient 112. When configured as a patient programmer, the programmer 104 may have limited functionality (compared to a clinician programmer) in order to prevent the patient 112 from altering critical functions of the IMD 106 or applications that may be detrimental to the patient 112. In this manner, the programmer 104 may only allow the patient 112 to adjust values for certain therapy parameters or set an available range of values for a particular therapy parameter.

[0074] The programmer 104 may also provide an indication to the patient 112 when therapy is being delivered, when patient input has triggered a change in therapy or when the power source within the programmer 104 or the IMD 106 needs to be replaced or recharged. For example, the programmer 104 may include an alert LED, may flash a message to the 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).

[0075] Turning next to Figs. 2A-2C, aspects of an example connector assembly 200 are shown in accordance with embodiments of the present disclosure. The connector assembly 200 may be similar to or the same as the distal connector 124 in some cases. The connector assembly 200 extends along a longitudinal axis 202 from a proximal end 204 to a distal end 208. The proximal end 204 of the connector assembly 200 may be connectable to the lead extension 110 of the IMD 106, and the distal end 208 of the connector assembly 200 may comprise an interface that enables the connector assembly 200 toconnect to the leads 114. The connector assembly 200 illustrated in Figs. 2A-2C comprises a connector stack 220 with a plurality of contacts 224A-224H (also referred to herein as spring contacts) and a conductor coil 212.

[0076] The plurality of contacts 224A-224H comprises eight conductive contacts: a first contact 224A, a second contact 224B, a third contact 224C, a fourth contact 224D, a fifth contact 224E, a sixth contact 224F, a seventh contact 224G, and an eighth contact 224H. It is to be understood that, while eight contacts are illustrated and discussed herein, the connector assembly 200 may comprise an additional or alternative number of contacts. Each contact of the plurality of contacts 224A-224H may be electrically connected to the electrodes 116, 118 of the leads 114 A, 114B. For example, the first contact 224 A, the second contact 224B, the third contact 224C, and the fourth contact 224D may be electrically connected to the electrodes 116 of the lead 114 A, and the fifth contact 224E, the sixth contact 224F, the seventh contact 224G, and the eighth contact 224H may be electrically connected to the electrodes 118 of the lead 114B. The electrical connection between the plurality of contacts 224A-224H and the electrodes 116, 118 may enable the connector assembly 200 to transmit electrical signals (e.g., electrical signals for stimulating patient tissue) from the IMD 106 to the electrodes 116, 118 and / or to provide electrical signals from the electrodes 116, 118 (e.g., measured neurological responses such as ERNA signals) to the IMD 106.

[0077] The conductor coil 212 extends from the proximal end 204 of the connector assembly 200 toward the distal end 208 of the connector assembly 200. In some cases, such as when the IMD 106 is inserted into a pectoral pocket of the patient 112, the connector assembly 200 may be positioned between the lead extension 110 and the leads 114 A, 114B. In such cases, the conductor coil 212 may be electrically connected to the IMD 106 and may extend through the lead extension 110 to the connector assembly 200. The conductor coil 212 may comprise a plurality of conductive wires 216A-216H that electrically connects stimulation generation circuitry 702 of the IMD 106 to the plurality of contacts 224A-224H. In other words, each individual wire of the conductor coil 212 may include an end portion thereof that is electrically connected (e.g., welded) to a respective contact of the plurality of contacts 224A-224H to carry stimulation signals from the IMD 106 to the electrodes 116, 118. One or more portions of each of the conductivewires may be at least partially encased in insulative material (e.g., to prevent electrical shorts between the wires in the conductor coil 212).

[0078] Each wire in the conductor coil 212 may be made of MP35N alloy or other known conductive material. In cases where there is an undesirable material combination between the material of the wire and the material of the contact, such as when the material combination prevents the wire from being directly welded to the contact, the contact may comprise a welding crimp sleeve or similar structure(s) than serve as an intermediary to electrically connect the wire and the contact. For example, a contact of the plurality of contacts 224A-224H may comprise a crimp sleeve that is weldable to the both the wire and the contact to electrically connect the two. In some cases, each contact of the plurality of contacts 224A-224H may comprise a crimp sleeve or similar structure to enable respective wires of the conductor coil 212 to be welded to the contacts.

[0079] In the example illustrated in Figs. 2A-2C, the conductor coil 212 is initially coiled around the longitudinal axis 202 as the conductor coil 212 extends from the proximal end 204 of the connector assembly 200 toward the connector stack 220. The conductor coil 212 may comprise one or more coil transitions, where the diameter, pitch, location, combinations thereof, and / or the like of the conductor coil 212 changes to enable the plurality of conductive wires in the conductor coil 212 to be terminated or unwound, separated, and / or otherwise electrically connected (e.g., via spot welding) to a respective contact of the plurality of contacts 224A-224H. In one example depicted in Fig. 2A, the conductor coil 212 comprises two coil transitions. In a first coil transition 228, both the pitch and diameter of the conductor coil 212 increase as the conductor coil 212 is helically wrapped around the longitudinal axis 202 and a portion of the connector stack 220. In a second coil transition 232, the diameter and pitch of the conductor coil 212 decreases and the conductor coil 212 is coiled such that the conductor coil 212 extends alongside the connector stack 220 (as opposed to helically wrapping around the connector stack 220) toward the distal end 208 of the connector assembly 200. In some cases, the first coil transition 228 and / or the second coil transition 232 may comprise a change in axis about which the conductor coil 212 coils. In the example shown in Fig. 2A, the conductor coil 212 may initially coil about the longitudinal axis 202 and then may coil about a secondary axis after the first coil transition 228 and / or the second coil transition 232. In other words, the conductor coil 212 may coil about different axes that are offset from one another inone or more dimensions as the conductor coil 212 extends from the proximal end 204 of the connector assembly 200 to the distal end 208 of the connector assembly 200.

[0080] In some examples, such as those depicted in Figs. 2A and 2C, the distal end 208 of the connector assembly 200 and the connector stack 220 may be coaxial. In such examples, the conductor coil 212 may be offset from the longitudinal axis 202 of the connector assembly 200 to enable the conductor coil 212 to extend toward the distal end 208 of the connector assembly 200. In other examples, such as those depicted in Fig. 2B, the connector stack 220 may optionally not be coaxial with the distal end 208 of the connector assembly 200. In such examples, the conductor coil 212 may not be offset from the distal end 208 of the connector assembly 200. In other words, the first coil transition 228 and / or the second coil transition 232 of the conductor coil 212 may not include an offset, translation, and / or other change to the axis about which the conductor coil 212 is coiled.

[0081] In some cases and as previously discussed, the coil transition(s) may comprise a translation in the axis about which the conductor coil 212 coils relative to the longitudinal axis 202. In the example depicted in Fig. 2C, the conductor coil 212 is translated from coiling about and extending along a direction of the longitudinal axis 202 to coiling about and extending along a direction of a second axis 222 that runs parallel to the longitudinal axis 202 and alongside the connector stack 220. In this example, each wire of the conductor coil 212 may be individually separated from the conductor coil 212 to wrap at least partially around and be electrically connected to a respective contact of the plurality of contacts 224A-224H (e.g., a first wire 216A is separated from the conductor coil 212 and is spatially terminated tangent to the first contact 224A for welding, a second wire 216B is separated from the conductor coil 212 and is spatially terminated tangent to the second contact 224B for welding, etc.). In some cases, the wires may spatially terminate at respective contacts and be at least partially wrapped around the respective contact. For example, the first wire 216A may be wrapped at least partially around the circumference of the first contact 224A (e.g., 90 degrees, 120 degrees, 180 degrees, etc.) and welded thereto.

[0082] In some examples, the length of the first wire 216A (or more generally, the wire associated with the most proximal contact of the plurality of contacts 224A-224H) may be shorter than the lengths of the other individual wires in the conductor coil 212, since thefirst contact 224A is the most proximal contact. In other words, the length of each individual wire in the conductor coil 212 may be chosen based on the location of each contact in the plurality of contacts 224A-224H, with wires that are welded to more proximate contacts being shorter than wires that are welded to more distal contacts. In such examples, as the conductor coil 212 extends toward the distal end 208 of the connector assembly 200, some of the wires may extend further distally than other wires.

[0083] After the conductive wires of the conductor coil 212 have been electrically connected to the plurality of contacts 224A-224H, one or more components of the connector assembly 200 may be over-molded. For example, the conductor coil 212, the connector stack 220, and / or the like may be encased in silicone rubber or other similar flexible, insulative material. The overmolding of the connector assembly 200 and / or components thereof may electrically insulate the connector assembly 200 and / or components thereof from surrounding patient tissue, mitigating or reducing the likelihood of patient harm (e.g., electric shock). Additionally or alternatively, the overmolding may provide for a flexible connector assembly, such that the connector assembly 200 can be placed within the patient 112 to provide electrical connection between the IMD 106 and the leads 114 while minimizing patient discomfort and such that the conductive wires of the conductor coil 212 experience less fatigue when the connector assembly 200 flexes, bends, or otherwise moves. In some cases, the silicone rubber or other material may form the outer surface of the connector assembly 200. The overmolding process may be or comprise a polymer injection molding process or any other known process to overmold the connector assembly 200 and / or components thereof with the silicone rubber or other material.

[0084] With reference to Figs. 3A-3C, aspects of the connector assembly 200 with a conductor coil 302 are shown in accordance with embodiments of the present disclosure. The conductor coil 302 may in some cases be similar to or the same as the conductor coil 212. The conductor coil 302 comprises a first portion 304 and a second portion 308 that is coiled around the longitudinal axis 202 with a larger diameter than the first portion 304. Stated differently, the coil transition 306 of the conductor coil 302 may comprise an increase in the diameter at which the conductor coil 302 is coiled. Alternatively, the second portion 308 of the conductor coil 302 may be coiled with a smaller diameter than the first portion 304 of the conductor coil 302. In some cases, the second portion 308 maywrap helically around the connector stack 220 with both a different pitch and diameter than the first portion 304. Each individual wire of the conductor coil 302 may be separated and connected to a respective contact of the plurality of contacts 224A-224H. For example, the first wire 216A, the second wire 216B, the third wire 216C, the fourth wire 216D, the fifth wire 216E, the sixth wire 216F, seventh wire 216G, and the eighth wire 216H may be respectively connected to the first contact 224 A, the second contact 224B, the third contact 224C, the fourth contact 224D, the fifth contact 224E, the sixth contact 224F, the seventh contact 224G, and the eighth contact 224H. In such examples, the length of the individual wires in the conductor coil 302 may each be uniquely sized to enable the wire to extend from the IMD 106 to the spring contact in the connector stack 220. For example, the first wire 216A may be shorter in length than the eighth wire 216H when the first contact 224A is the contact positioned closest to the proximal end 204 of the connector assembly 200 than the eighth contact 224H, and the eighth wire 216H may be the longest wire that extends more distally than the first contact 224A, the second contact 224B, the third contact 224C, the fourth contact 224D, the fifth contact 224E, the sixth contact 224F, and the seventh contact 224G.

[0085] With reference to Figs. 4A-4B, aspects of the connector assembly 200 with a conductor coil 402 are shown in accordance with embodiments of the present disclosure. The conductor coil 402 may in some cases be similar to or the same as the conductor coil 212 and / or the conductor coil 302. The conductor coil 402 may comprise a first portion 404 which may be similar to the first portion 304. The conductor coil 402 may also comprise a second portion 408. In the second portion 408, the wires of the conductor coil 402 may be individually straightened or otherwise separated out and separately wrapped around the connector stack 220. In other words, the coil transition of the conductor coil 402 may comprise a change in diameter and / or pitch that is different or unique for each conductive wire in the conductor coil 402. For example, the diameter and / or pitch of the first wire 216A when helically wrapped around the connector stack 220 may be different than the diameter and / or pitch of the second wire 216B, of the third wire 216C, etc. when each is helically wrapped around the connector stack 220. This may differ from the coil transition of the conductor coil 302, where the individual wires of the conductor coil 302 shared a similar diameter and / or pitch when wrapped helically around the connector stack 220. In other examples, the wires of the conductor coil 402 may remain grouped togetherto wrap around the connector stack 220 (e.g., the wires are not separately wrapped around the connector stack 220). In such examples, the length of the wires of the conductor coil 402 may be chosen such that each wire spatially terminates at a respective contact of the plurality of contacts 224A-224H, such that the wires wrap together around the connector stack 220 when the connector stack 220 is twisted (e.g., during manufacturing). In some examples, the second portion 408 of the conductor coil 402 may comprise straight wires that have not been coiled. In other words, the coiling of the conductor coil 402 may terminate and the straight wires may extend along the connector stack 220.

[0086] With reference to Figs. 5A-5B, aspects of the connector assembly 200 with a conductor coil 502 are shown in accordance with embodiments of the present disclosure. In some examples, the conductor coil 502 may be similar to or the same as the conductor coil 212, the conductor coil 302, and / or the conductor coil 402. The conductor coil 502 may comprise a first portion 504 coiled in a first configuration and a second portion 508 that is coiled in a second configuration as the conductor coil 502 extends along the connector stack toward the distal end 208 of the connector assembly 200. The second portion 508 may comprise each individual wire of the conductor coil 502 being separated into minicoils that extend toward the distal end 208 of the connector assembly 200 and are individually welded to a respective contact of the plurality of contacts 224A-224H. In other words, the coil transition for the conductor coil 502 may comprise the individual wires of the conductor coil 502 being separated out and each being coiled about an individual axis.

[0087] With reference to Figs. 6A-6B, aspects of the connector assembly 200 with a conductor coil 602 are shown in accordance with embodiments of the present disclosure. In some examples, the conductor coil 602 may be similar to the conductor coil 212, the conductor coil 302, the conductor coil 402, and / or the conductor coil 502. The conductor coil 602 may pass through a sleeve 604 that separates each wire in the conductor coil 602. After passing through the sleeve 604, each wire of the conductor coil 602 may extend individually and linearly alongside the connector stack 220 and be respectively connected to a contact of the plurality of contacts 224A-224H. In some cases, the wiring of the conductor coil 602 may comprise straight wires that have not been coiled. In other words, the coiling of the conductor coil 602 may terminate at the sleeve 604 and the straight wires may extend along the connector stack 220.

[0088] In some cases, each wire may be positioned inside polymer slip tubes. The polymer slip tubes may be or comprise a single lumen tube that is closely fitted to the wire and that provides a layer between the wire and the silicone rubber when the connector assembly 200 is overmolded. The wiring may be capable of rotating and / or translating within the slip tube such that, after overmolding, each wire can move when the connector assembly 200 bends. The enabled movement of the wire may reduce the strain on the wires. The reduced strain may reduce the risk of wire kinking or tension breaks when the wire is respectively positioned on a compressive or tensile side when the connector assembly 200 is bent. In some examples and as previously discussed, the length of each wire of the conductor coil 602 may be different and depend on the position of the contact to which the wire is connected. For instance, the second wire 216B may be shorter than the seventh wire 216G when the second contact 224B is positioned closer to the proximal end 204 of the connector assembly 200 than the seventh contact 224G. In this example, the seventh wire 216G may extend past the second wire 216B and the second contact 224B toward the distal end 208 to connect to the seventh contact 224G.

[0089] Fig. 7 is a block diagram of an example IMD 706 for delivering DBS therapy. In some cases, the IMD 706 may be similar to or the same as the IMD 106. In the example shown in Fig. 7, the IMD 706 includes processing circuitry 710, a memory 712, the stimulation generation circuitry 702, sensing circuitry 704, telemetry circuitry 708, and a power source 722. Each of these circuits may be or include electrical circuitry configured to perform the functions attributed to each respective circuit. The memory 712 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, any memory discussed herein, and / or the like. The memory 712 may store computer-readable instructions that, when executed by the processing circuitry 710, cause the IMD 706 to perform various functions. The memory 712 may be a storage device or other non-transitory medium. In some examples, the IMD 706 may include or may be referred to as a signal generator.

[0090] The stimulation generation circuitry 702, under the control of the processing circuitry 710, generates stimulation signals (e.g., electrical stimulation signals for evoking ERNA signals and / or therapeutic electrical stimulation signals for delivering therapy) for delivery to the patient 112 via electrodes 716, 718 (which may be similar to or the same asthe electrodes 116, 118, respectively). An example range of electrical parameters believed to be effective in DBS to manage a movement disorder of patient include: a pulse rate (or frequency) between approximately 5 Hertz (Hz) and approximately 500Hz, such as between approximately 5 to 220Hz or such as approximately 130Hz; in examples with a voltage controlled system, a voltage amplitude between approximately 0.1 volts (V) and approximately 50V, such as between approximately 2V and approximately 3 V; in examples with a current controlled system, a current amplitude between approximately 0.1 milliamps (mA) and approximately 3.5mA, such as between approximately 1.0mA and approximately 1.75mA; and / or a pulse width between approximately 20 microseconds (ps) and approximately 500ps, such as between approximately 50ps and approximately 200ps. Other ranges of therapy parameter values may also be useful, and may depend on the target stimulation site within patient 112. While stimulation pulses are described, stimulation signals may be of any form, such as continuous-time signals (e.g., sine waves) or the like. In addition to delivering therapeutic electrical stimulation signals, stimulation generation circuitry 702 may be configured to deliver electrical stimulation signals for evoking ERNA signals (e.g., where information indicative of the ERNA signals are stored). Example parameters of the electrical stimulation signals for evoking ERNA signals include amplitude within range of 0 to 7.5mA, such as 0 to 5mA, frequency within range of 5 to 250Hz, such as 80 to 220Hz, and pulse width in range of 20 to 450ps, such as 60 to 120ps.

[0091] The processing circuitry 710 may include fixed function processing circuitry and / or programmable processing circuitry, and may comprise, for example, any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to the processing circuitry 710 herein may be embodied as firmware, hardware, software or any combination thereof. The processing circuitry 710 may control the stimulation generation circuitry 702 according to therapy programs stored in the memory 712 to apply particular parameter values specified by one or more of programs, such as voltage amplitude or current amplitude, pulse width, and / or pulse rate.

[0092] The sensing circuitry 704 is configured to monitor signals from any combination of the electrodes 716, 718. Although the sensing circuitry 704 is incorporated into acommon housing with the stimulation generation circuitry 702 and the processing circuitry 710 in Fig. 7, in other examples, the sensing circuitry 704 may be in a separate housing from the IMD 706 and may communicate with the processing circuitry 710 via wired or wireless communication techniques.

[0093] In some examples, the sensing circuitry 704 includes one or more amplifiers, filters, and analog-to-digital converters. The sensing circuitry 704 may be used to sense physiological signals, such as ERNA signals. In some examples, sensing circuitry 704 measures ERNA signals from a particular combination of the electrodes 716, 718. In some cases, the particular combination of electrodes for sensing includes different electrodes than a set of electrodes 716, 718 used to deliver electrical stimulation signals (e.g., therapeutic electrical stimulation signals or electrical stimulation signals for evoking ERNA signals). Alternatively, in other cases, the particular combination of electrodes used for sensing includes at least one of the same electrodes as a set of electrodes used to deliver stimulation signals to the patient 112. The sensing circuitry 704 may provide signals to an analog-to-digital converter, for conversion into a digital signal for processing, analysis, storage, or output by the processing circuitry 710.

[0094] The electrodes 716, 718 on the respective leads 714A, 714B (which may be similar to or the same as the leads 114 A, 114B, respectively) may be constructed of a variety of different designs. For example, one or both of the leads 714 may include two or more electrodes at each longitudinal location along the length of the lead, such as multiple electrodes, e.g., arranged as segments, at different perimeter locations around the perimeter of the lead at each of the locations.

[0095] As an example, one or both of the leads 714 may include circumferentially- segmented DBS arrays of electrodes and non-segmented electrodes (e.g., ring electrodes). As one example, there may be a first ring electrode of the electrodes 716 around the perimeter of the lead 714A at a first longitudinal location on the lead 714A (e.g., location A). Below the first ring electrode, there may be three segmented electrodes of the electrodes 716 around the perimeter of lead 714A at a second longitudinal location on the lead 714A (e.g., location B). Below the three segmented electrodes, there may be another set of three segmented electrodes of the electrodes 716 around the perimeter of the lead 714A at a third longitudinal location of the lead 714A (e.g., location C). Below the three segmented electrodes, there may be a second ring electrode of the electrodes 716 aroundthe perimeter of the lead 714A (e.g., location D). The electrodes 718 may be similarly positioned along the lead 714B.

[0096] The above is one example of the array of electrodes, and the example techniques should not be considered limited to such an example. There may be other configurations of electrodes for DBS. Moreover, the example techniques are not limited to DBS, and other electrode configurations are possible.

[0097] In one example, the electrodes 716, 718 may be electrically coupled to stimulation the stimulation generation circuitry 702 and the sensing circuitry 704 via respective wires that are straight or coiled within the housing of the lead and run to connectors 724, 728 (each of which may be similar to or the same as the distal connector 124 and / or the connector assembly 200) at the proximal end of the lead.

[0098] The telemetry circuitry 708 supports wireless communication between the IMD 706 and the programmer 104 or another computing device under the control of the processing circuitry 710. The processing circuitry 710 of the IMD 706 may receive, as updates to programs, values for various parameters such as magnitude and electrode combination, from the programmer 804 via the telemetry circuitry 708. The telemetry circuitry 708 in the IMD 706, 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 708 may communicate with an external medical device programmer via proximal inductive interaction of the IMD 706 with the programmer 104. Accordingly, the telemetry circuitry 708 may send information to the programmer 104 on a continuous basis, at periodic intervals, or upon request from the IMD 706 or the programmer 104.

[0099] The power source 722 delivers operating power to various components of the IMD 706. The power source 722 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 706. In some examples, power requirements may be small enough to allow IMD 706 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.

[0100] The DBS therapy is defined by one or more therapy programs having one or more parameters stored within the memory 712. For example, the one or more parameters include a current amplitude (for a current-controlled system) or a voltage amplitude (for a voltage-controlled system), a pulse rate or frequency, and a pulse width, or a number of pulses per cycle. In examples where the electrical stimulation is delivered according to a “burst” of pulses, or a series of electrical pulses defined by an “on-time” and an “off- time,” the one or more parameters may further define one or more of a number of pulses per burst, an on-time, and an off-time. The processing circuitry 710, via the electrodes 716, 718, delivers DBS to the patient 112 and may adjust one or more parameters defining the electrical stimulation.

[0101] Fig. 8 is a block diagram of an example programmer 804. In some cases, the programmer 804 may be similar to or the same as the programmer 104. Although the programmer 804 may generally be described as a hand-held device, the programmer 804 may be a larger portable device or a more stationary device. In addition, in other examples, the programmer 804 may be included as part of an external charging device or include the functionality of an external charging device. As illustrated in Fig. 8, the programmer 804 may include processing circuitry 810, a memory 812, a user interface 802, telemetry circuitry 808, and a power source 822.

[0102] The memory 812 may store instructions that, when executed by the processing circuitry 810, cause or enable the processing circuitry 810 and the programmer 804 to provide the functionality ascribed to the programmer 804 throughout this disclosure. Each of these components, or modules, may include electrical circuitry that is configured to perform some or all of the functionality described herein. For example, the processing circuitry 810 may include processing circuitry configured to perform the processes discussed with respect to the processing circuitry 710 of the IMD 706 as described with reference to Fig. 7. In some examples, the programmer 804 may include or may be referred to as a signal generator (e.g., in combination with or separate from the IMD 706).

[0103] In general, the programmer 804 comprises any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to the programmer 804, and the processing circuitry 810, the user interface 802, and the telemetry circuitry 808 of the programmer 804. In various examples, the programmer 804 may include one or more processors, which may include fixed functionprocessing circuitry and / or programmable processing circuitry, as formed by, for example, one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The programmer 804 also, in various examples, may include the memory 812, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, a hard disk, a CD-ROM, comprising executable instructions for causing the one or more processors to perform the actions attributed to them. Moreover, although the processing circuitry 810 and the telemetry circuitry 808 are described as separate modules, in some examples, the processing circuitry 810 and the telemetry circuitry 808 may be functionally integrated with one another. In some examples, the processing circuitry 810 and the telemetry circuitry 808 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units. The memory 812 (e.g., a storage device) may store instructions or data that, when executed by the processing circuitry 810, cause or enable the processing circuitry 810 and the programmer 804 to provide the functionality ascribed to the programmer 804 throughout this disclosure. For example, the memory 812 may include instructions that cause the processing circuitry 810 to obtain a parameter set from memory or receive a user input and send a corresponding command to the HMD 706, or instructions for any other functionality.

[0104] The user interface 802 may be or comprise a keyboard, button, keypad, mouse, trackball, monitor, television, screen, touchscreen, lights, speaker for voice commands, display (e.g., a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED)) and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 802 may be configured to display any information related to the delivery of stimulation therapy, identified patient behaviors, sensed patient parameter values, patient behavior criteria, or any other such information. The user interface 802 may also receive user input via the user interface 802. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.

[0105] In some cases, the user interface 802 may be useful to allow a physician, patient, or other user to modify instructions to be executed by the processing circuitry 810 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 802 or corresponding thereto. Although the user interface 802 is shown as part of the programmer 804, in someexamples, the user interface 802 may be housed separately from one or more remaining components of the programmer 804.

[0106] The telemetry circuitry 808 may support wireless communication between the IMD 706 and the programmer 804 under the control of the processing circuitry 810. The telemetry circuitry 808 may also be configured to communicate with another computing device via wireless communication techniques, or direct communication through a wired connection. In some examples, the telemetry circuitry 808 provides wireless communication via an RF or proximal inductive medium. In some examples, the telemetry circuitry 808 includes an antenna, which may take on a variety of forms, such as an internal or external antenna. Examples of local wireless communication techniques that may be employed to facilitate communication between the programmer 804 and the IMD 706 include RF communication according to the 802.11 or Bluetooth specification sets or other standard or proprietary telemetry protocols. In this manner, other external devices may be capable of communicating with the programmer 804 without needing to establish a secure wireless connection.

[0107] In some examples, processing circuitry 810 of the programmer 804 defines the parameters of electrical stimulation therapy, stored in the memory 812, for delivering DBS to the patient 112. In one example, the processing circuitry 810 of the programmer 804, via the telemetry circuitry 808, issues commands to the IMD 706 causing the IMD 706 to deliver electrical stimulation therapy via the electrodes 716, 718 via the leads 714. In one or more examples, the programmer 804 may be configured to perform one or more of the example techniques described in this disclosure. For instance, the processing circuitry 810 may be configured to perform one or more of the example operations described above with respect to the processing circuitry 710. For example, the processing circuitry 810 may be configured to cause the stimulation generation circuitry 702 to deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters.

[0108] Fig. 9 depicts a method 900 that may be used, for example, to connect a connector device to an implantable medical device and to an implantable medical lead for providing a stimulation therapy to a patient. It is to be understood that, while the method 900 below specifies three different steps, embodiments of the method 900 may comprisemore or fewer steps than those described below, and / or one or more steps that are different than the steps described below.

[0109] One or more steps of the method 900 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) of any system or device described herein. The at least one processor may be part of the programmer 104 and / or the IMD 106 as described with reference to Figs. 1, 7, and 8 (e.g., processing circuitry 710, processing circuitry 810, etc.) and / or may be part of a control unit (e.g., a computing device) in communication with the programmer 104 and / or the IMD 106. A processor other than the processor described herein may also be used to execute one or more steps of the method 900. The at least one processor may perform one or more steps of the method 900 by executing elements stored in a memory (such as a memory in the programmer 104 and / or the IMD 106 as described herein or a control unit, computing device, etc.). The elements stored in the memory and executed by the processor may cause or enable the processor to execute one or more steps of a function as shown in the method 900. One or more portions of the method 900 may be performed by the processor executing any of the contents of memory.

[0110] The method 900 comprises connecting an implantable medical device (IMD) to a proximal end of a connector device (step 904). The IMD may be similar to or the same as the IMD 106 and the connector device may be similar to or the same as the connector assembly 200. The IMD may be connected to the connector device via a lead extension (e.g., lead extension 110).[oni] The method 900 also comprises connecting a distal end of a connector device to an implantable medical lead (step 908). The implantable medical lead may be similar to or the same as the leads 114A, 114B. The implantable medical lead may be connected to the connector device to electrically connect the IMD to the implantable medical lead. In some cases, the IMD may be configured to be implanted into a patient (e.g., patient 112) and the implantable medical lead may be configured to be implanted into a brain of the patient to provide one or more stimulation therapies.

[0112] The method 900 also comprises generating, using the IMD, a current that passes through the connector device to the implantable medical lead (step 912). The IMD, in conjunction with a programmer (e.g., programmer 104), may be used to provide current(e.g., stimulation signals) to the medical lead for stimulating patient tissue and delivering one or more therapies as described herein.

[0113] The present disclosure encompasses embodiments of the method 900 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0114] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0115] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0116] A set of example statements is provided below:

[0117] Statement 1 : A device, comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208); and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A-216H), each of which is electrically connected to a respective electricalcontact of the plurality of electrical contacts (224A-224H), wherein at least some wires of the conductor coil (212, 302, 402, 502, 602) are at least partially wrapped around a respective contact of the plurality of electrical contacts (224A-224H).

[0118] Statement 2: The device of Statement 1, wherein the plurality of electrical contacts (224A-224H) comprises eight or more contacts, and wherein the conductor coil (212, 302, 402, 502, 602) comprises eight or more wires.

[0119] Statement 3: The device of any of Statements 1-2, wherein a first portion of the conductor coil (212, 302, 402, 502, 602) is coiled in a first configuration, and wherein a second portion of the conductor coil (212, 302, 402, 502, 602) is coiled with a second configuration different than the first configuration.

[0120] Statement 4: The device of Statement 3, wherein the second portion is coiled with a smaller diameter than the first portion.

[0121] Statement 5: The device of Statement 3, wherein the second portion is coiled with a larger diameter than the first portion.

[0122] Statement 6: The device of any of Statements 1-5, wherein the plurality of electrical contacts (224A-224H) comprises a first contact and a second contact, and wherein the first contact is positioned closer to the proximal end (204) than the second contact.

[0123] Statement 7: The device of Statement 6, wherein a portion of the conductor coil (212, 302, 402, 502, 602) extends beyond the first contact toward the distal end (208).

[0124] Statement 8: A system, comprising: an electrical lead (114, 714); and a connector device (124, 200, 724, 728) connectable to the electrical lead, the connector device (124, 200, 724, 728) comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208); and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A- 216H), each of which is electrically connected to a respective contact of the plurality of electrical contacts (224A-224H), wherein at least some wires in the conductor coil (212, 302, 402, 502, 602) are at least partially wrapped around a respective contact of the plurality of electrical contacts.

[0125] Statement 9: The system of Statement 8, wherein the plurality of electrical contacts (224A-224H) comprises eight or more conductors, and wherein the conductor coil (212, 302, 402, 502, 602) comprises eight or more wires.

[0126] Statement 10: The system of any of Statements 8-9, wherein a first portion of the conductor coil (212, 302, 402, 502, 602) is coiled in a first configuration, and wherein a second portion of the conductor coil (212, 302, 402, 502, 602) is coiled with a second configuration different than the first configuration.

[0127] Statement 11 : The system of Statement 10, wherein the second portion is coiled with a smaller diameter than the first portion.

[0128] Statement 12: The system of Statement 10, wherein the second portion is coiled with a larger diameter than the first portion.

[0129] Statement 13: The system of any of Statements 8-12, wherein the plurality of electrical contacts (224A-224H) comprises a first contact and a second contact, and wherein the first contact is positioned closer to the proximal end (204) than the second contact.

[0130] Statement 14: The system of Statement 13, wherein a portion of the conductor coil (212, 302, 402, 502, 602) extends beyond the first contact toward the distal end (208).

[0131] Statement 15: The system of any of Statements 8-14, further comprising: an implantable medical device (106) connectable to the proximal end (204).

[0132] Statement 16: A device, comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208) and comprising a first contact and a second contact positioned distally from the first contact; and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A-216H), wherein a first wire of the plurality of conductive wires (216A-216H) is electrically connected to the first contact, and at least some of the plurality of conductive wires (216A-216H) extend past the first contact and toward the distal end (208).

[0133] Statement 17: The device of Statement 16, wherein a first portion of the conductor coil (212, 302, 402, 502, 602) is coiled in a first configuration, and wherein a second portion of the conductor coil (212, 302, 402, 502, 602) is coiled with a second configuration different than the first configuration.

[0134] Statement 18: The device of Statement 17, wherein the second portion is coiled with a smaller diameter than the first portion.

[0135] Statement 19: The device of Statement 17, wherein the second portion is coiled with a larger diameter than the first portion.

[0136] Statement 20: The device of any of Statements 16-19, wherein the first wire is at least partially wrapped around the first contact.

Claims

CLAIMSWhat is claimed is:

1. A device, comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208); and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A-216H), each of which is electrically connected to a respective electrical contact of the plurality of electrical contacts (224A-224H), wherein at least some wires of the conductor coil (212, 302, 402, 502, 602) are at least partially wrapped around a respective contact of the plurality of electrical contacts (224A-224H).

2. The device of claim 1, wherein the plurality of electrical contacts (224A- 224H) comprises eight or more contacts, and wherein the conductor coil (212, 302, 402, 502, 602) comprises eight or more wires.

3. The device of any of claims 1-2, wherein a first portion of the conductor coil (212, 302, 402, 502, 602) is coiled in a first configuration, and wherein a second portion of the conductor coil (212, 302, 402, 502, 602) is coiled with a second configuration different than the first configuration.

4. The device of claim 3, wherein the second portion is coiled with a smaller diameter than the first portion.

5. The device of claim 3, wherein the second portion is coiled with a larger diameter than the first portion.

6. The device of any of claims 1-5, wherein the plurality of electrical contacts (224A-224H) comprises a first contact and a second contact, and wherein the first contact is positioned closer to the proximal end (204) than the second contact.

7. The device of claim 6, wherein a portion of the conductor coil (212, 302, 402, 502, 602) extends beyond the first contact toward the distal end (208).

8. A system, comprising: an electrical lead (114, 714); and a connector device (124, 200, 724, 728) connectable to the electrical lead, the connector device (124, 200, 724, 728) comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208); and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A- 216H), each of which is electrically connected to a respective contact of the plurality of electrical contacts (224A-224H), wherein at least some wires in the conductor coil (212, 302, 402, 502, 602) are at least partially wrapped around a respective contact of the plurality of electrical contacts.

9. The system of claim 8, wherein the plurality of electrical contacts (224A- 224H) comprises eight or more conductors, and wherein the conductor coil (212, 302, 402, 502, 602) comprises eight or more wires.

10. The system of any of claims 8-9, wherein a first portion of the conductor coil (212, 302, 402, 502, 602) is coiled in a first configuration, and wherein a second portion of the conductor coil (212, 302, 402, 502, 602) is coiled with a second configuration different than the first configuration.

11. The system of claim 10, wherein the second portion is coiled with a smaller diameter than the first portion.

12. The system of claim 10, wherein the second portion is coiled with a larger diameter than the first portion.

13. The system of any of claims 8-12, wherein the plurality of electrical contacts (224A-224H) comprises a first contact and a second contact, wherein the first contact is positioned closer to the proximal end (204) than the second contact, and wherein a portion of the conductor coil (212, 302, 402, 502, 602) extends beyond the first contact toward the distal end (208).

14. A device, comprising: a proximal end (204); a distal end (208); a plurality of electrical contacts (224A-224H) positioned between the proximal end (204) and the distal end (208) and comprising a first contact and a second contact positioned distally from the first contact; and a conductor coil (212, 302, 402, 502, 602) extending from the proximal end (204) toward the distal end (208) and comprising a plurality of conductive wires (216A-216H), wherein a first wire of the plurality of conductive wires (216A-216H) is electrically connected to the first contact, and at least some of the plurality of conductive wires (216A- 216H) extend past the first contact and toward the distal end (208).

15. The device of claim 14, wherein the first wire is at least partially wrapped around the first contact.

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