Connector ring configurations and methods for manufacturing and using the same

Abstract

A device according to at least one embodiment of the present disclosure includes: at least one conductor wire extending along a longitudinal axis of the device from a proximal end toward a distal end; and a connector ring positioned between the proximal end and the distal end, the connector ring including: an inner diameter; an outer diameter; and a shoulder with a weld face that enables the at least one conductor wire to be welded to the connector ring, where the weld face biases a weld between the weld face and the at least one conductor wire toward the inner diameter of the connector ring.

Description

A0012052W001CONNECTOR RING CONFIGURATIONS AND METHODS FOR MANUFACTURING AND USING THE SAMECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority to U.S. Provisional ApplicationNo. 63 / 759,952 filed February 18, 2025, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The present disclosure is generally directed to electrical stimulation therapy, and relates more particularly to connector ring configurations 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] Example aspects of the present disclosure include:

[0005] A device according to at least one embodiment of the present disclosure comprises: at least one conductor wire extending along a longitudinal axis of the device from a proximal end toward a distal end; and a connector ring positioned between the proximal end and the distal end, the connector ring comprising: an inner diameter; an outer diameter; and a shoulder with a weld face that enables the at least one conductor wire to be welded to the connector ring, wherein the weld face biases a weld between the weld face and the at least one conductor wire toward the inner diameter of the connector ring.

[0006] A connector ring according to at least one embodiment of the present disclosure comprises: an outer diameter; an inner diameter; and a shoulder with a weld face that enables a conductor wire to be welded to the connector ring to electrically connect the connector ring to the conductor wire, wherein the weld face biases a weld between the conductor wire and the connector ring toward the inner diameter of the connector ring.A0012052W001

[0007] A system according to at least one embodiment of the present disclosure comprises: an electrical lead; and a connector device connected to the electrical lead, the connector device comprising: a connector ring positioned between a proximal end and a distal end of the connector device, the connector ring comprising: an outer diameter; an inner diameter; and a shoulder with a weld face that enables a conductor wire to be welded to the connector ring to electrically connect the connector ring to the conductor wire, wherein the weld face biases a weld between the weld face and the conductor wire toward the inner diameter of the connector ring.

[0008] Any aspect in combination with any one or more other aspects.

[0009] Any one or more of the features disclosed herein.

[0010] Any one or more of the features as substantially disclosed herein.

[0011] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0012] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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.

[0014] Fig. 1A is a diagram of aspects of a system according to at least one embodiment of the present disclosure;

[0015] Fig. IB is a diagram of additional aspects of the system according to at least one embodiment of the present disclosure;

[0016] Fig. 2A is a cross-section view of a portion of a connector device according to at least one embodiment of the present disclosure;

[0017] Fig. 2B is a cross-section view of a portion of the connector device after a grinding step according to at least one embodiment of the present disclosure;

[0018] Fig. 2C is a detailed cross-section view of a connector ring of the connector device according to at least one embodiment of the present disclosure;A0012052W001

[0019] Fig. 3A is a cross-section view of a first connector ring according to at least one embodiment of the present disclosure;

[0020] Fig. 3B is a cross-section view of the first connector ring after welding and overmolding according to at least one embodiment of the present disclosure;

[0021] Fig. 3C is a detailed view of a portion of the first connector ring after a grinding step according to at least one embodiment of the present disclosure;

[0022] Fig. 3D is a detailed view of a portion of the first connector ring after an alternative grinding step according to at least one embodiment of the present disclosure;

[0023] Fig. 4A is a cross-section view of a second connector ring according to at least one embodiment of the present disclosure;

[0024] Fig. 4B is a cross-section view of the second connector ring after welding and overmolding according to at least one embodiment of the present disclosure;

[0025] Fig. 4C is a detailed view of a portion of the second connector ring after a grinding step according to at least one embodiment of the present disclosure;

[0026] Fig. 4D is a detailed view of a portion of the second connector ring after an alternative grinding step according to at least one embodiment of the present disclosure;

[0027] Fig. 5A is a cross-section view of a third connector ring according to at least one embodiment of the present disclosure;

[0028] Fig. 5B is a cross-section view of the third connector ring after welding and overmolding according to at least one embodiment of the present disclosure;

[0029] Fig. 5C is a detailed view of a portion of the third connector ring after a grinding step according to at least one embodiment of the present disclosure;

[0030] Fig. 5D is a detailed view of a portion of the third connector ring after an alternative grinding step according to at least one embodiment of the present disclosure;

[0031] Fig. 6A is a cross-section view of a fourth connector ring according to at least one embodiment of the present disclosure;

[0032] Fig. 6B is a cross-section view of the fourth connector ring after welding and overmolding according to at least one embodiment of the present disclosure;

[0033] Fig. 6C is a detailed view of a portion of the fourth connector ring after a grinding step according to at least one embodiment of the present disclosure;

[0034] Fig. 6D is a detailed view of a portion of the fourth connector ring after an alternative grinding step according to at least one embodiment of the present disclosure;A0012052W001

[0035] Fig. 7A is a cross-section view of a fifth connector ring according to at least one embodiment of the present disclosure;

[0036] Fig. 7B is a cross-section view of the fifth connector ring after welding and overmolding according to at least one embodiment of the present disclosure;

[0037] Fig. 7C is a detailed view of a portion of the fifth connector ring after a grinding step according to at least one embodiment of the present disclosure;

[0038] Fig. 7D is a detailed view of a portion of the fifth connector ring after an alternative grinding step according to at least one embodiment of the present disclosure;

[0039] Fig. 8 is a diagram of aspects of an implantable medical device (IMD) according to at least one embodiment of the present disclosure;

[0040] Fig. 9 is a diagram of aspects of an external programmer according to at least one embodiment of the present disclosure; and

[0041] Fig. 10 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0042] 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 or more 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.

[0043] 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.

[0044] Lead extensions used in DBS therapies and / or pelvic nerve therapies may include connectors for electrically connecting electrical leads (such as those that stimulate and / or sense patient physiological response signals) to stimulation generators. In one example, an electrical leadA0012052W001may comprise a distal end with electrodes for delivering stimulation signals and / or sensing physiological responses and a proximal end opposite the distal end with a plurality of connector rings. The connector rings of the proximal end may be configured to interface with spring contacts in a distal connector of the lead extension to electrically connect the electrodes to the lead extension. The lead extension may also include a proximal connector with a plurality of connector rings opposite the distal connector that electrically connects the lead extension to the stimulation generators. In this way, the connector rings may facilitate electrical connection between the stimulation generator and the electrical leads.

[0045] Related art methods of manufacturing connectors include welding, injection molding, and grinding of the outer surface. The welding may use a thin weld shoulder on the connector ring for jointing the connector ring to the conductor wire. Plastic is then injection molded up to and over the end of the connector ring. The plastic and metal ring are then both ground down to create a smooth finish for electrical sealing. The weld shoulder may be positioned below the grind plane, such that once ground down, the weld shoulder is covered by plastic. However, connectors are often space limited due to the small diameter of the connectors, making it difficult to find a balance between manufacturability of the lead connector and performance.

[0046] The connector on the proximal end of the lead may require a large inner diameter to ensure internal electrical isolation between the electrodes on the distal end of the lead (e.g., to better detect stimulation signals). In order to improve the internal electrical isolation, leads may require additional diametrical space inside the lead. As a result, the weld may be shifted radially outward to accommodate this additional diametrical space such that the weld may no longer be positioned under the plastic after grinding.

[0047] According to embodiments of the present disclosure, a weld face on a connector ring is provided that biases the weld between the connector ring and the conductor wire toward an inner diameter of the connector ring. In this way, less of the weld is removed during grinding, improving conductive efficiency of the connector ring.

[0048] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) excessive insulative material being present after less-than-optimal grinding steps, (2) undesirable removal of weld material during grinding, and (3) inconsistent connector ring surface area exposure after grinding.

[0049] Turning first to Figs. 1A-1B, aspects of 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 DBSA0012052W001may 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.

[0050] 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, nonhuman 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, anxiety disorders, 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.

[0051] 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, and a lead 114B with a set of electrodes 118.

[0052] In the example shown in Fig. 1A, 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,A0012052W001ventralus 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.

[0053] 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 of the 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.

[0054] 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.

[0055] 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, electrocorticogramA0012052W001(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.

[0056] 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.

[0057] 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.

[0058] 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 onA0012052W001the 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 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.

[0059] 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.

[0060] Further, the example techniques discussed herein are not limited to examples where one or more of electrodes 116, 118 are circumferentially-segmented electrodes. The example 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 andA0012052W001sensing 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.

[0061] As shown in Fig. IB, the lead extension 110 includes a proximal connector 128 that 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 Figs. 1 A-1B, 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 also comprises a distal connector 124, which enables a proximal connector 132 of the lead 114A to connect to the IMD 106 (e.g., via electrical contact between a plurality of ring connectors positioned in the proximal connector 132 and a plurality of spring contacts in the distal connector 124). In some cases, a similar lead extension may be provided for the lead 114B. In other words, each of the leads 114A and 114B (collectively the “leads 114”) may comprise a separate or dedicated lead extension that respectively connects the leads 114 to the IMD 106. In one example, 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.

[0062] Although the leads 114 are shown in Figs. 1 A-1B 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 to position 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 capableA0012052W001of 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).

[0063] In the example shown in Figs. 1A-1B, 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 Figs. 1 A-1B. 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.

[0064] 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 the IMD 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.A0012052W001

[0065] 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.

[0066] 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).

[0067] 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 with which 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.A0012052W001

[0068] 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.

[0069] 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).

[0070] Turning next to Figs. 2A-2C, aspects of an example connector 224 are shown in accordance with embodiments of the present disclosure. The connector 224 may be similar to or the same as the proximal connector 132 or the proximal connector 128 in some cases. In other words, the example connector 224 may correspond to a connector positioned on a proximal end of a lead (such as the lead 114A), a connector positioned on a proximal end of a lead extension (such as the lead extension 110), or a combination thereof. In cases where the connector 224 is similar to the proximal connector 128 of the lead extension 110, the connector 224 may be connectable to the IMD 106. In cases where the connector 224 is similar to the proximal connector 132 of the lead 114A, the connector 224 may be connectable to a distal connector of the lead extension 110. The connector 224 extends along a longitudinal axis 206 from a proximal end 204 to a distal end 208. The connector 224 illustrated in Figs. 2A-2C comprises a plurality of ring connectors 212A-212H and a coil of conductor wires 216.

[0071] In some cases, reference may be made to the dimensions, angles, directions, relative positions, and / or movements associated with one or more components of the connector 224 with respect to a coordinate system 202. The coordinate system 202 as shown in the accompanying figures, includes three dimensions comprising an X-axis, a Y-axis, and a Z-axis. Additionally or alternatively, the coordinate system 202 may be used to define planes (e.g., the XY-plane, the XZ-plane, and the YZ-plane) of the connector 224 and / or components thereof. These planes may be disposed orthogonally, or at 90 degrees, to one another. While the origin of the coordinate system 202 may be placed at any point, for the purposes of description, the axes of the coordinate system 202 are disposed along the same directions from figure to figure. Additionally or alternatively, theA0012052W001directionality of the X-axis, the Y-axis, and the Z-axis may be flipped, as noted with negative directionality (e.g., the negative Z-axis direction is the opposite direction of the Z-axis direction illustrated by the direction of the associated arrow). In some cases, the coordinate system 202 may be defined based on or using cartesian coordinates, cylindrical coordinates, polar coordinates, combinations thereof, and / or the like.

[0072] The plurality of ring connectors 212A-212H comprises eight conductive rings: a first connector ring 212A, a second connector ring 212B, a third connector ring 212C, a fourth connector ring 212D, a fifth connector ring 212E (not shown), a sixth connector ring 212F (not shown), a seventh connector ring 212G (not shown), and an eighth connector ring 212H (not shown). It is to be understood that, while eight connector rings are discussed herein, the connector 224 may comprise an additional or alternative number of connector rings. In cases where the connector 224 is similar to the proximal connector 132 of the lead 114 A, each connector ring of the plurality of ring connectors 212A-212H may be electrically connectable to the electrodes 116 of the lead 114A. For example, the first connector ring 212A, the second connector ring 212B, the third connector ring 212C, and the fourth connector ring 212D, the fifth connector ring 212E, the sixth connector ring 212F, the seventh connector ring 212G, and the eighth connector ring 212H may be electrically connected to respective electrodes of the electrodes 116 of the lead 114A. The electrical connection between the plurality of ring connectors 212A-212H and the electrodes 116 may enable the connector 224 to transmit electrical signals (e.g., electrical signals for stimulating patient tissue) from the IMD 106 to the electrodes 116 and / or to provide electrical signals from the electrodes 116 (e.g., measured neurological responses such as ERNA signals) to the IMD 106. In examples where the connector 224 is similar to the proximal connector 128 of the lead extension 110, each connector ring of the plurality of connector rings 212A-212H may be electrically connectable to the IMD 106 to deliver signals from the IMD 106 to the lead connected to the lead extension.

[0073] The coil of conductor wires 216 extends from the distal end 208 of the connector 224 toward the proximal end 204 of the connector 224. In some cases, such as when the IMD 106 is inserted into a pectoral pocket of the patient 112, the connector 224 may be positioned between the lead extension 110 and the lead 114A (e.g., on a proximal end of the lead 114A to interface with a distal connector on the extension 110). In such cases, the coil of conductor wires 216 may be electrically connected to the electrodes 116 of the lead 114A and may extend through the lead 114A to the connector 224. The coil of conductor wires 216 may comprise a plurality of conductor wires 216A-216H that electrically connects the electrodes 116 of the lead 114A to the plurality of ring connectors 212A-212H. In other words, each individual wire of the plurality of conductor wiresA0012052W001216A-216H may include an end portion thereof that is electrically connected (e.g., resistance welded) to a respective location of the plurality of ring connectors 212A-212H — such as a shoulder of the ring connector — to carry stimulation signals from the electrodes 116 to the IMD 106 (and vice versa). In an alternative embodiment, the coil of conductor wires 216 may comprise a plurality of conductor wires 216A-216H that extend through the lead extension 110 to connect the distal connector of the lead extension 110 to the connector 224 to carry stimulation signals between the electrodes 116 and the IMD 106. Each wire in the coil of conductor wires 216 may be made of MP35N alloy or other known conductive material that enables electrical signals to be passed from the electrodes 116 to the IMD 106 and vice versa. One or more portions of each of the conductor wires may be at least partially encased in insulative material (e.g., to prevent electrical shorts between the wires in the coil of conductor wires 216).

[0074] In the example illustrated in Fig. 2A, the coil of conductor wires 216 is initially coiled around the longitudinal axis 206 as the coil of conductor wires 216 extends from the distal end 208 of the connector 224 toward the proximal end 204 of the connector 224. The diameter of the coil of conductor wires 216 may be chosen as appropriate. Thus, while some figures depict the coil of conductor wires 216 and / or one or more conductor wires 216A-216H abutting an inner diameter 244 of a connector ring, in other examples there is clearance between the coil and the connector ring. Such clearance may enable plastic to fill the interior of the connector ring during the overmolding process. At each connector ring of the plurality of connector rings 212A-212N, one or more wires of the coil of conductor wires 216 is unwound or otherwise separated from the coil of conductor wires 216 and electrically connected to a respective contact (e.g., via welding to a respective shoulder 228A-228D) of the plurality of connector rings 212A-212N. In an example depicted in Fig. 2A, the first conductor wire 216A is electrically connected to the first connector ring 212A via resistance welding to a first shoulder 228A, the second conductor wire 216B is electrically connected to the second connector ring 212B via resistance welding to a second shoulder 228B, the third conductor wire 216C is electrically connected to the third connector ring 212C via resistance welding to a third shoulder 228C, and the fourth conductor wire 216D is electrically connected to the fourth connector ring 212D via resistance welding to a fourth shoulder 228D.

[0075] In some cases, such as when the interior diameter of the lead extension 110 and / or the lead 114A is increased (e.g., to enable greater spacing of the electrodes 116 in a radial direction or for any other reason), the resulting inner diameter of the connector 224 may expand outward (e.g., the distance between an outer diameter 230 and the inner diameter 244 of the connector ring decreases). Such a change may result in a portion of the weld between the shoulder and the wire on theA0012052W001connector ring (e.g., the weld between the first shoulder 228A and the first conductor wire 216A on the first connector ring 212A) being exposed and removed during the manufacturing process as depicted in Fig. 2B. To address this issue, embodiments of the present disclosure provide connector rings with various shoulders that enable welding between the wire and the connector ring while mitigating the downsides of an increased inner diameter.

[0076] In some examples, the length of the first conductor wire 216A (or more generally, the wire associated with the most proximal connector ring of the plurality of ring connectors 212A-212H) may be longer than the lengths of the other individual wires in the coil of conductor wires 216, since the first connector ring 212A is the most proximal ring. In other words, the length of each individual wire in the coil of conductor wires 216 may be chosen based on the location of each contact in the plurality of ring connectors 212A-212H, with wires that are welded to more proximate contacts being longer than wires that are welded to more distal contacts. In such examples, as the coil of conductor wires 216 extends toward the proximal end 204 of the connector 224, some of the wires may extend further proximally than other wires.

[0077] After the conductor wires of the coil of conductor wires 216 have been electrically connected to the plurality of ring connectors 212A-212H, one or more components of the connector 224 may be over-molded. For example, the plurality of connector rings 212A-212N, the coil of conductor wires 216, and / or the like may be encased in insulative material 232. The insulative material 232 may be or comprise polyurethane or other similar flexible, insulative material. The overmolding of the connector 224 and / or components thereof with the insulative material 232 may electrically insulate the connector 224 and / or components thereof from surrounding patient tissue, mitigating or reducing the likelihood of patient harm (e.g., electric shock). In some cases, the polyurethane or other material may form the outer surface of the connector 224. In some cases, the insulative material 232 may also fill the interior of the connector ring(s) of the connector 224, including up to or around one or more wires of the coil of conductor wires 216. In other words, while the insulative material 232 is depicted in the figures as being limited to the exterior of the connector 224, the insulative material 232 may additionally or alternatively be dispensed in an interior of the connector 224. The overmolding process may be or comprise a polymer injection molding process or any other known process to overmold the connector 224 and / or components thereof with the polyurethane or other material. After overmolding, the outer surface of the connector 224 may be ground down to form a smooth outer surface 240. The smooth outer surface 240 may beneficially enhance electrical sealing to avoid inadvertent or accidental patient shock or harm.A0012052W001

[0078] With reference to Figs. 3A-3D, aspects of a connector ring 312 are shown in accordance with embodiments of the present disclosure. The connector ring 312 may in some cases be similar to or the same as one or more connector rings of the plurality of connector rings 212A-212N. The connector ring 312 may be positioned between the proximal end 204 and the distal end 208 of the connector 224 and aligned with the longitudinal axis 206 of the connector 224. In some cases, the connector ring 312 may be cylindrically symmetric about the longitudinal axis 206.

[0079] The connector ring 312 comprises an outer surface 340 and an inner surface 344 positioned opposite the outer surface 340, as well as a shoulder 328. In some cases, the shoulder 328 may be positioned on a distal end or edge of the connector ring 312, while in other cases the shoulder 328 may be positioned on a proximal end or edge of the connector ring 312. In still other cases, the shoulder 328 may be placed on both the proximal and distal ends or edges of the connector ring 312. In any event, the shoulder 328 may extend from the inner surface 344 toward the outer surface 340, but may end at a first surface 348 along a transverse direction (e.g., a Y-axis direction) before the outer surface 340 of the connector ring 312. In other words, the connector ring 312 may include a second surface 352 that extends from the outer surface 340 toward the inner surface 344 that interfaces with the first surface 348 at a right angle, as depicted in Fig. 3A.

[0080] The shoulder 328 may comprise a weld face 350 that enables a conductor wire such as the first conductor wire 216A to be welded to the connector ring 312. In some cases, the weld face 350 may be orthogonal to the longitudinal axis 206. In other words, the weld face 350 may extend in a direction parallel to the transverse axis (e.g., the Y-axis direction) toward the outer surface 340 and may interface with the first surface 348 at a right angle. The weld face 350 may provide a surface to enable the conductor wire to be welded (e.g., resistance welded) to the connector ring 312.

[0081] After the conductor wire has been welded to the connector ring 312 (e.g., via resistance welding the end of the first conductor wire 216A to the connector ring 312), the connector ring 312 may be overmolded with an insulative material 232. The insulative material 232 may be or comprise polyurethane or other material that is injection molded to overmold the connector ring 312 and / or other components of the connector 224, such as when the connector ring 312 is a connector ring in the connector 224. In some examples, the second surface 352 may beneficially facilitate the molding process of the connector ring 312. For example, the second surface 352 may enable the mold to position the connector ring 312 in place for the molding process.

[0082] Once overmolded, the outer surface of the connector 224 may be ground down such that the outer surface 340 of the connector ring 312, as well as any of the insulative material 232 that forms the outer surface of the connector 224, is removed from the connector 224. The grinding mayA0012052W001create a smooth outer surface of the connector 224 for electrical sealing, which in turn may beneficial help insulate the connector 224 from inadvertently shocking or otherwise harming the patient 112 when the connector 224 is implanted into the patient 112.

[0083] In some cases, the connector ring 312 may be ground down to a first grind plane 356. As depicted in Fig. 3C, grinding the exterior of the connector ring 312 down to the first grind plane 356 may result in portions of the insulative material 232 being exposed on the outer surface of the connector 224 after grinding. In other words, some portions of the insulative material 232 above the first surface 348 may remain abutting the outer surface of the connector ring 312 after the connector ring 312 is ground down to the first grind plane 356. In some cases, the presence of the insulative material 232 on the exterior surface of the connector 224 may result in an inconsistent length of the connector ring 312 after the connector ring 312 is ground down to the first grind plane 356. For example, the presence of the insulative material 232 may result in some of the connector rings of the connector 224 having different amounts of surface area exposed on the outer surface 240 of the connector 224 after grinding. Such inconsistency may alter the characteristics (e.g., amplitude) of the currents passed from the IMD 106 to the electrodes 116, 118 and vice versa. In some examples, the depth of the first grind plane 356 (e.g., how close the first grind plane 356 is to the inner surface 344 of the connector ring 312) may depend on machining tolerances of the device(s) used to grind down the outer surface 340 of the connector ring 312.

[0084] In other cases, the connector ring 312 may be ground down to a second grind plane 360. As depicted in Fig. 3D, grinding the exterior of the connector ring 312 down to the second grind plane 360 may result in the first surface 348 of the shoulder 328 being exposed to the outer surface of the connector 224 after grinding. In other words, the second grind plane 360 may be sufficiently close to the inner surface 344 of the connector ring 312 as to remove the excess insulative material 232 that occupied the space between the outer surface 340 of the connector ring 312 and the first surface 348 of the connector ring 312. In some cases, the removal of the excess insulative material 232 may result in a consistent length of the connector ring 312 after the connector ring 312 has been ground down to the second grind plane 360. Stated differently, the surface area of the connector ring 312 that is exposed in the connector 224 after the connector 224 has been ground down may be consistent with the other connector rings in the connector 224. In some examples, the depth of the second grind plane 360 (e.g., how close the second grind plane 360 is to the inner surface 344 of the connector ring 312) may depend on machining tolerances of the device(s) used to grind down the outer surface 340 of the connector ring 312.A0012052W001

[0085] With reference to Figs. 4A-4D, aspects of a connector ring 412 are shown in accordance with embodiments of the present disclosure. The connector ring 412 may in some cases be similar to or the same as one or more connector rings of the plurality of connector rings 212A-212N and / or the connector ring 312. The connector ring 412 may be positioned between the proximal end 204 and the distal end 208 of the connector 224 and aligned with the longitudinal axis 206 of the connector 224. In some cases, the connector ring 412 may be cylindrically symmetric about the longitudinal axis 206.

[0086] The connector ring 412 comprises an outer surface 440 and an inner surface 444 positioned opposite the outer surface 440, as well as a shoulder 428. In some cases, the shoulder 428 may be positioned on a distal end or edge of the connector ring 412, while in other cases the shoulder 428 may be positioned on a proximal end or edge of the connector ring 412. In other examples, the shoulder 428 may be placed on both the proximal and distal ends or edges of the connector ring 412. Either way, the shoulder 428 may comprise a chamfered surface 462 that extends along a chamfer axis 464. In some cases, the chamfered surface 462 may result in a tapered shape of the connector ring 412. The chamfered surface 462 may extend along the chamfered surface 462 at an angle relative to the transverse axis (e.g., the Y-axis direction) from, for example, a distal end of the connector ring 412 to the outer surface 440 of the connector ring 412, as illustrated in Fig. 4A.

[0087] The shoulder 428 may comprise a weld face 450 that enables a conductor wire (e.g., the first conductor wire 216A) to be welded to the connector ring 412. In some cases, the weld face 450 may be orthogonal to the longitudinal axis 206 or, in other words, may extend in a direction parallel to the transverse axis (e.g., the Y-axis direction) toward the outer surface 440 of the connector ring 412. The weld face 450 may in some examples extend to the chamfered surface 462.

[0088] After the conductor wire has been welded to the connector ring 412 (e.g., via resistance welding the end of the coil of conductor wires 216A to the shoulder 428 of the connector ring 412), the connector ring 412 may be overmolded with the insulative material 232 as shown in Fig. 4B. The insulative material 232 may be or comprise polyurethane or other material that is injection molded to overmold the connector ring 412 and / or other components of the connector 224, such as when the connector ring 412 is a connector ring in the connector 224. After the connector ring 412 and the connector 224 have been overmolded, the outer surface of the connector 224 may be ground down to expose a portion of the connector ring 412 on the outer surface of the connector 224.

[0089] In some cases, the connector ring 412 may be ground down to a first grind plane 456. As depicted in Fig. 4C, grinding the outer surface 440 of the connector ring 412 down to the first grind plane 456 may result in portions of the insulative material 232 being exposed on the outer surface ofA0012052W001the connector 224. Stated differently, portions of the insulative material 232 may be positioned above the chamfered surface 462 and abut the connector ring 412, such that the chamfered surface 462 is not exposed on the outer surface of the connector 224. Similar to the first grind plane 356, the presence of the insulative material 232 as a result of grinding to the first grind plane 456 may result in an inconsistent length of the connector ring 412 in the connector 224. In other words, grinding to the first grind plane 456 may result in differing amounts of surface area being exposed on the outer surface of the connector 224, which may in turn change the characteristics of currents passed from the IMD 106 to the electrodes 116, 118 and vice versa. In some examples, the depth of the first grind plane 456 (e.g., how close the first grind plane 456 is to the inner surface 444 of the connector ring 412) may depend on machining tolerances of the device(s) that are used to grind down the outer surface 440 of the connector ring 412.

[0090] In other cases, the connector ring 412 may be ground down to a second grind plane 460. As depicted in Fig. 4D, grinding the exterior of the connector ring 412 to the second grind plane 460 may result in the shoulder 428 being exposed to the outer surface of the connector 224 after grinding. In other words, the second grind plane 460 may be sufficiently close to the inner surface 444 of the connector ring 412 as to remove the excess insulative material 232 that occupied the space between the outer surface 440 of the connector ring 412 and an end of the chamfered surface 462 that abutted the weld face 450. In some cases, grinding down to the second grind plane 460 may result in a consistent length of the connector ring 412 in the connector 224. In other words, the surface area of the connector ring 412 that is exposed in the connector 224 after the connector 224 has been ground down may be consistent with the other connector rings of the connector 224. In some examples, the depth of the second grind plane 460 (e.g., how close the second grind plane 460 is to the inner surface 444 of the connector ring 412) may depend on machining tolerances of the device(s) used to grind down the outer surface 440 of the connector ring 412.

[0091] The presence of the chamfered surface 462 may beneficially enhance the amount of surface area exposed by the connector ring 412 in cases of less-than-ideal grinding. For example, the use of the chamfered surface 462 may result in less insulative material 232 being exposed on the outer surface of the connector 224 after grinding when the grind plane is between the first grind plane 456 and the second grind plane 460 along the Y-axis direction. Because of the chamfered surface 462, a greater portion of the shoulder 428 is located closer to the outer surface 440 of the connector ring 412 than, say, the shoulder 328 of the connector ring 312. As a result, when the connector ring 412 is ground to a grind plane that is between the first grind plane 456 and the second grind plane 460 along the Y-axis direction, a greater amount of the shoulder 428 is exposed. As a result, the amountA0012052W001of surface area of the connector ring 412 exposed (and used in the connector 224 for transmitting electrical signals) may be beneficially increased relative to, say, the connector ring 312 in cases of less-than-ideal grinding (e.g., grinding to grind planes that are closer to the outer surface 440 of the connector ring 412 than the second grind plane 460 along the Y-axis direction).

[0092] With reference to Figs. 5A-5D, aspects of a connector ring 512 are shown in accordance with embodiments of the present disclosure. The connector ring 512 may in some cases be similar to or the same as one or more connector rings of the plurality of connector rings 212A-212N, the connector ring 312, and / or the connector ring 412. The connector ring 512 may be positioned between the proximal end 204 and the distal end 208 of the connector 224 and aligned with the longitudinal axis 206 of the connector 224. In some cases, the connector ring 512 may be cylindrically symmetric about the longitudinal axis 206.

[0093] The connector ring 512 comprises an outer surface 540 and an inner surface 544 positioned opposite the outer surface 540, as well as a shoulder 528. In some cases, the shoulder 528 may be positioned on a distal end or edge of the connector ring 512, while in other cases the shoulder 528 may be positioned on a proximal end or edge of the connector ring 512. In still other cases, the shoulder 528 may be placed on both the proximal and distal ends or edges of the connector ring 512. In any event, the shoulder 528 may comprise a chamfered surface 562 that extends along a chamfer axis 564, and a second surface 552. In some cases, the chamfered surface 562 may result in a tapered shape of the connector ring 512. The chamfered surface 562 may extend along the chamfered surface 562 at an angle relative to the transverse axis (e.g., the Y-axis direction) from, for example, a weld face 550 of the connector ring 512 to the second surface 552. The second surface 552 may extend in a direction parallel to the Y-axis direction of a coordinate system 202 and end at the outer surface 540 of the connector ring 512, as illustrated in Fig. 5A.

[0094] The weld face 550 may enable a conductor wire such as the first conductor wire 216A to be welded (e.g., resistance welded) to the connector ring 512. In some cases, the weld face 550 may be orthogonal to the longitudinal axis 206 or, on other words, may extend in a direction parallel to the transverse axis (e.g., the Y-axis direction) from the inner surface 544 of the connector ring 512 toward the outer surface 540 up to the chamfered surface 562.

[0095] After the conductor wire has been welded to the connector ring 512 (e.g., via resistance welding the end of the coil of conductor wires 216A to the weld face 550 of the connector ring 512), the connector ring 512 may be overmolded with the insulative material 232 as shown in Fig. 5B. The insulative material 232 may be or comprise polyurethane or other material that is injection molded to overmold the connector ring 512 and / or other components of the connector 224, such as when theA0012052W001connector ring 512 is a connector ring in the connector 224. In some cases, the second surface 552 may beneficially facilitate the molding process of the connector ring 512, such as by enabling the mold to position, hold, or otherwise secure the connector ring 512 in the correct place for the molding process. After the connector ring 512 and the connector 224 have been overmolded, the outer surface of the connector 224 may be ground down to expose a portion of the connector ring 512.

[0096] In some cases, the connector ring 512 may be ground down to a first grind plane 556. As depicted in Fig. 5C, grinding the outer surface 540 of the connector ring 512 down to the first grind plane 556 may result in portions of the insulative material 232 being exposed on the outer surface of the connector 224. In other words, portions of the insulative material 232 may be positioned above the chamfered surface 562, such that the chamfered surface 562 is not exposed to the outer surface of the connector 224. Similar to the first grind plane 456, the presence of the insulative material 232 as a result of grinding to the first grind plane 556 may result in an inconsistent length of the connector ring 512 in the connector 224. Stated differently, grinding to the first grind plane 556 may result in differing amounts of surface area being exposed on the outer surface of the connector 224, which may in turn change the characteristics of currents passed from the IMD 106 to the electrodes 116, 118 and vice versa. In some examples, the depth of the first grind plane 556 (e.g., how close the first grind plane 556 is to the inner surface 544 of the connector ring 512) may depend on machining tolerances of the device(s) that grind down the outer surface 540 of the connector ring 512.

[0097] In other cases, the connector ring 512 may be ground down to a second grind plane 560. As depicted in Fig. 5D, grinding the exterior of the connector ring 512 to the second grind plane 560 may result in the shoulder 528 being exposed to the outer surface of the connector 224 after grinding. In other words, the second grind plane 560 may be sufficiently close to the inner surface 544 of the connector ring 512 as to remove the excess insulative material 232 that occupied the space between the outer surface 540 of the connector ring 512 and an end of the chamfered surface 562 that abutted the weld face 550, and / or insulative material that abutted the second surface 552. In some cases, grinding down to the second grind plane 560 may result in a consistent length of the connector ring 512 in the connector 224. In other words, the surface area of the connector ring 512 that is exposed in the connector 224 after the connector 224 has been ground down may be consistent with the other connector rings of the connector 224. In some examples, the depth of the second grind plane 560 (e.g., how close the second grind plane 560 is to the inner surface 544 of the connector ring 512) may depend on machining tolerances of the device(s) used to grind down the outer surface 540 of the connector ring 512.A0012052W001

[0098] The presence of the chamfered surface 562 and the second surface 552 may beneficially enhance the amount of surface area exposed by the connector ring 512 in cases of less-than-ideal grinding. For example, the use of the chamfered surface 562 and the second surface 552 may result in less insulative material 232 being exposed on the outer surface of the connector 224 after grinding when the grind plane is between the first grind plane 456 and the second grind plane 460 along the Y-axis direction. Because of the chamfered surface 562 and the second surface 552, a greater portion of the shoulder 528 is located closer to the outer surface 540 of the connector ring 512 than, say, the shoulder 328 of the connector ring 312. As a result, when the connector ring 512 is ground to a grind plane that is between the first grind plane 556 and the second grind plane 560 along the Y-axis direction, a greater amount of the shoulder 528 is exposed. As a result, the amount of surface area of the connector ring 512 exposed (and used in the connector 224 for transmitting electrical signals) may be beneficially increased relative to, say, the connector ring 312.

[0099] With reference to Figs. 6A-6D, aspects of a connector ring 612 are shown in accordance with embodiments of the present disclosure. The connector ring 612 may in some cases be similar to or the same as one or more connector rings of the plurality of connector rings 212A-212N, the connector ring 312, the connector ring 412, and / or the connector ring 512. The connector ring 612 may be positioned between the proximal end 204 and the distal end 208 of the connector 224 and aligned with the longitudinal axis 206 of the connector 224. In some cases, the connector ring 612 may be cylindrically symmetric about the longitudinal axis 206.

[0100] The connector ring 612 comprises an outer surface 640 and an inner surface 644 positioned opposite the outer surface 640, as well as a shoulder 628. In some cases, the shoulder 628 may be positioned on a distal end or edge of the connector ring 612, while in other cases the shoulder 628 may be positioned on a proximal end or edge of the connector ring 612. In some examples, both the proximal end / edge and the distal end / edge of the connector ring 612 may comprise the shoulder 628. In any event, the shoulder 628 may extend from the inner surface 644 toward the outer surface 640, but may end at a first surface 648 along a transverse direction (e.g., a Y-axis direction) before the outer surface 640 of the connector ring 612. In other words, the shoulder 628 may include a second surface 652 that extends from the outer surface 640 toward the inner surface 644 that interfaces with the first surface 648 at a right angle. In some examples, the second surface 652 may help facilitate the molding process of the connector ring 612, such as by providing a surface onto which the mold can connect to secure the connector ring 612 in place for molding.

[0101] The shoulder 628 may comprise an angled weld face 668 that enables a conductor wire such as the first conductor wire 216A to be welded to the connector ring 612. In some cases, theA0012052W001angled weld face 668 may extend along a weld face axis 670 that is angled relative to the transverse axis (e.g., the Y-axis of the coordinate system 202) of the connector 224. In other words, the angled weld face 668 may not be parallel to the end of the first conductor wire 216A. The angled weld face 668 may extend from the inner surface 644 along the weld face axis 670 up to the first surface 648, as depicted in Fig. 6A. The angle of the weld face axis 670 relative to the transverse axis is not limited, and in one example the weld face axis 670 is between about 1 degree and about 15 degrees. In other words, the angled weld face 668 may extend at an angle between about 1 degree and about 15 degrees toward the first surface 648.

[0102] The angle of the angled weld face 668 relative to the transverse axis of the connector 224 may beneficially enhance the resistance weld between the first conductor wire 216A and the connector ring 612. Given the angling of the angled weld face 668 along the weld face axis 670, the weld between the connector ring 612 and the first conductor wire 216A may be biased toward the inner surface 644 of the connector ring 612. In other words, a greater amount of material constituting the weld between the first conductor wire 216A and the connector ring 612 may be positioned closer to the inner surface 644 than to the outer surface 640 of the connector ring 612. As a result, less weld material is removed during the grinding of the connector ring 612.

[0103] In some cases, the connector ring 612 may be ground down to a first grind plane 656. As depicted in Fig. 6C, the presence of the angled weld face 668 may result in the shoulder 628 being exposed on the outer surface of the connector 224 after grinding. In other words, the first grind plane 656 may be sufficiently close to the inner surface 644 of the connector ring 612 as to remove the excess insulative material 232 that occupied the space between the outer surface 640 of the connector ring 612 and the first surface 648 of the connector ring 612. In some cases, the removal of the insulative material 232 on the exterior surface of the connector 224 may result in a consistent length of the connector ring 612 after the connector ring 612 is ground down to the first grind plane 656. In some examples, the depth of the first grind plane 656 (e.g., how close the first grind plane 656 is to the inner surface 644 of the connector ring 612) may depend on machining tolerances of the device(s) that grind down the outer surface 640 of the connector ring 612.

[0104] In other cases, the connector ring 612 may be ground down to a second grind plane 660. As depicted in Fig. 6D, grinding the exterior of the connector ring 612 down to the second grind plane 660 may result in the shoulder 628 being exposed to the outer surface of the connector 224 after grinding. In other words, the second grind plane 660 may be sufficiently close to the inner surface 644 of the connector ring 612 as to remove the excess insulative material 232 that occupied the space between the outer surface 640 of the connector ring 612 and the first surface 648 of theA0012052W001connector ring 612. In some cases, the removal of the excess insulative material 232 may result in a consistent length of the connector ring 612 after the connector ring 612 has been ground down to the second grind plane 660. Stated differently, the surface area of the connector ring 612 that is exposed in the connector 224 after the connector 224 has been ground down may be consistent with the other connector rings in the connector 224. In some examples, the depth of the second grind plane 660 (e.g., how close the second grind plane 660 is to the inner surface 644 of the connector ring 612) may depend on machining tolerances of the device(s) used to grind down the outer surface 640 of the connector ring 612. Additionally and as previously mentioned, the weld between the shoulder 628 and the connector ring 612 is biased toward the inner surface 644 of the connector ring 612, such that a greater portion of the weld remains even after the connector ring 612 is ground down to the second grind plane 660. This may beneficially enhance the use of the connector ring 612, since a greater amount of insulative material can be removed without jeopardizing the weld between the first conductor wire 216A and the connector ring 612. Additionally or alternatively, the biasing of the weld toward the inner surface 644 of the connector ring 612 may enable the thickness (e.g., the distance between the inner surface 644 and the first surface 648) of the angled weld face 668 to be increased, which in turn may enable the weld material to be conserved after grinding to either of the first grind plane 656 or the second grind plane 660. In other words, the angled weld face 668 may be thick enough that grinding tolerances (demonstrated with the first grind plane 656 and the second grind plane 660) have lesser or no impact on the ring length variation.

[0105] With reference to Figs. 7A-7D, aspects of a connector ring 712 are shown in accordance with embodiments of the present disclosure. The connector ring 712 may in some cases be similar to or the same as one or more connector rings of the plurality of connector rings 212A-212N, the connector ring 312, the connector ring 412, the connector ring 512, and / or the connector ring 612. The connector ring 712 may be positioned between the proximal end 204 and the distal end 208 of the connector 224 and aligned with the longitudinal axis 206 of the connector 224. In some cases, the connector ring 712 may be cylindrically symmetric about the longitudinal axis 206.

[0106] The connector ring 712 comprises an outer surface 740 and an inner surface 744 positioned opposite the outer surface 740, as well as a shoulder 728. In some cases, the shoulder 728 may be positioned on a distal end or edge of the connector ring 712, while in other cases the shoulder 728 may be positioned on a proximal end or edge of the connector ring 712. In some cases, the shoulder 728 may be located on both the distal end / edge and the proximal end / edge of the connector ring 712. The shoulder 728 may extend from the inner surface 744 toward the outer surface 740, but may end at a first surface 748 along a transverse direction (e.g., a Y-axis direction) before the outer surfaceA0012052W001740 of the connector ring 712. In other words, the connector ring 712 may include a second surface 752 that extends from the outer surface 740 toward the inner surface 744 that interfaces with the first surface 748 at a right angle, as illustrated in Fig. 7A. The shoulder 728 may also comprise a stepped weld face 774 that includes a third surface 778 that connects the stepped weld face 774 to the first surface 748, as depicted in Fig. 7A.

[0107] Similar to the angled weld face 668, the stepped weld face 774 may bias the weld between the first conductor wire 216A and the connector ring 712 toward the inner surface 744 of the connector ring 712. In some cases, the first conductor wire 216A may extend further than the stepped weld face 774 toward the outer surface 740, such that once the first conductor wire 216A is resistance welded to the connector ring 712, material from the first conductor wire 216A contacts both the stepped weld face 774 and the third surface 778 of the connector ring 712, as shown in Fig.7C. The greater amount of material constituting the weld between the first conductor wire 216A and the connector ring 712 being positioned closer to the inner surface 744 than to the outer surface 740 of the connector ring 712 may beneficially result in less weld material being removed during grinding even in instances where the grinding removes portions of the shoulder 728.

[0108] In some cases, the connector ring 712 may be ground down to a first grind plane 756 as depicted in Fig. 7C or to a second grind plane 760 as depicted in Fig. 7D. The grinding of the exterior of the connector ring 712 down to the first grind plane 756 or the second grind plane 760 may result in portions of the insulative material 232 being exposed on the outer surface of the connector 224 after grinding. However, given the biasing of weld material toward the inner surface 744 of the connector ring 712, the thickness of the shoulder 728 (e.g., the distance between the first surface 748 and the third surface 778 in the Y-axis direction) may be chosen such that the machining tolerances (represented by the first grind plane 756 and the second grind plane 760) fall between the first surface 748 and the third surface 778. In this way, a consistent length of the connector ring 712 after the connector ring 712 has been ground down to the first grind plane 756 or the second grind plane 760 can be achieved. Stated differently, the surface area of the connector ring 712 that is exposed in the connector 224 after the connector 224 has been ground down may be consistent with the other connector rings in the connector 224 regardless of the machining tolerance.

[0109] The above discussion of connector rings (e.g., the connector ring 312, the connector ring 412, the connector ring 512, the connector ring 612, and the connector ring 712) was directed to connector rings positioned within the connector 224, which may be similar to or the same as the proximal connector 128 of the lead extension 110 and / or the proximal connector 132 of the lead 114A. As such, it is to be understood that the proximal connector 128 of the lead extension 110A0012052W001and / or the proximal connector 132 of the lead 114A may comprise connector rings that are similar to or the same as the connector ring 312, the connector ring 412, the connector ring 512, the connector ring 612, and / or the connector ring 712.

[0110] It is to be understood that, while the discussion of the surfaces of the connector ring 312, the connector ring 412, the connector ring 512, the connector ring 612, and the connector ring 712 makes reference to “sharp” corners (e.g., surfaces meeting one another at right angles), in other examples the corners at which surfaces meet may be radiused as appropriate.

[0111] As used herein, the terms, degrees, and angles of surfaces and / or axes relative to other surfaces and / or axes may include or otherwise account for machine tolerances. For example, a plane of the weld face 350 (or any similar weld face) of the connector ring 312 may be considered “perpendicular to” the longitudinal axis 206 when the weld face 350 extends along an axis that is between 88 and 92 (e.g., a tolerance of 2 degrees in either direction) degrees relative to the longitudinal axis 206. As another example, the weld face axis 670 being angled “about 5 degrees” from the transverse axis when the weld face axis 670 is angled at 5 degrees plus or minus machine tolerance (e.g., 0.1 degrees, 0.2 degrees, 0.5 degrees, 1 degrees, 1.5 degrees, 2 degrees, etc.). In other words, “about 5 degrees” in this example may occur when the weld face axis 670 is angled at 3 degrees, 3.5 degrees, 4 degrees, 4.5 degrees, 4.8 degrees, 4.9 degrees, 5 degrees, 5.1 degrees, 5.2 degrees, 5.5 degrees, 6 degrees, 6.5 degrees, 7 degrees, etc. from the transverse axis.

[0112] Fig. 8 is a block diagram of an example IMD 806 for delivering DBS therapy. In some cases, the IMD 806 may be similar to or the same as the IMD 106. In the example shown in Fig. 8, the IMD 806 includes processing circuitry 810, a memory 812, the stimulation generation circuitry 802, sensing circuitry 804, telemetry circuitry 808, and a power source 822. Each of these circuits may be or include electrical circuitry configured to perform the functions attributed to each respective circuit. The memory 812 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 812 may store computer-readable instructions that, when executed by the processing circuitry 810, cause the IMD 806 to perform various functions. The memory 812 may be a storage device or other non-transitory medium. In some examples, the IMD 806 may include or may be referred to as a signal generator.

[0113] The stimulation generation circuitry 802, under the control of the processing circuitry 810, 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 viaA0012052W001electrodes 816, 818 (which may be similar to or the same as the 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 802 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.

[0114] The processing circuitry 810 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 810 herein may be embodied as firmware, hardware, software or any combination thereof. The processing circuitry 810 may control the stimulation generation circuitry 802 according to therapy programs stored in the memory 812 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.

[0115] The sensing circuitry 804 is configured to monitor signals from any combination of the electrodes 816, 818. Although the sensing circuitry 804 is incorporated into a common housing with the stimulation generation circuitry 802 and the processing circuitry 810 in Fig. 8, in other examples, the sensing circuitry 804 may be in a separate housing from the IMD 806 and may communicate with the processing circuitry 810 via wired or wireless communication techniques.A0012052W001

[0116] In some examples, the sensing circuitry 804 includes one or more amplifiers, filters, and analog-to-digital converters. The sensing circuitry 804 may be used to sense physiological signals, such as ERNA signals. In some examples, sensing circuitry 804 measures ERNA signals from a particular combination of the electrodes 816, 818. In some cases, the particular combination of electrodes for sensing includes different electrodes than a set of electrodes 816, 818 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 804 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 810.

[0117] The electrodes 816, 818 on the respective leads 814A, 814B (which may be similar to or the same as the leads 114A, 114B, respectively) may be constructed of a variety of different designs. For example, one or both of the leads 814 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.

[0118] As an example, one or both of the leads 814 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 816 around the perimeter of the lead 814A at a first longitudinal location on the lead 814A (e.g., location A). Below the first ring electrode, there may be three segmented electrodes of the electrodes 816 around the perimeter of lead 814A at a second longitudinal location on the lead 814A (e.g., location B). Below the three segmented electrodes, there may be another set of three segmented electrodes of the electrodes 816 around the perimeter of the lead 814A at a third longitudinal location of the lead 814A (e.g., location C). Below the three segmented electrodes, there may be a second ring electrode of the electrodes 816 around the perimeter of the lead 814A (e.g., location D). The electrodes 818 may be similarly positioned along the lead 814B.

[0119] 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.

[0120] In one example, the electrodes 816, 818 may be electrically coupled to stimulation the stimulation generation circuitry 802 and the sensing circuitry 804 via respective wires that areA0012052W001straight or coiled within the housing of the lead and run to lead extensions 824, 828 (each of which may be similar to or the same as the lead extension 110) at the proximal end of the lead.

[0121] The telemetry circuitry 808 supports wireless communication between the IMD 806 and the programmer 104 or another computing device under the control of the processing circuitry 810. The processing circuitry 810 of the IMD 806 may receive, as updates to programs, values for various parameters such as magnitude and electrode combination, from the programmer 104 via the telemetry circuitry 808. The telemetry circuitry 808 in the IMD 806, 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 808 may communicate with an external medical device programmer via proximal inductive interaction of the IMD 806 with the programmer 104. Accordingly, the telemetry circuitry 808 may send information to the programmer 104 on a continuous basis, at periodic intervals, or upon request from the IMD 806 or the programmer 104.

[0122] The power source 822 delivers operating power to various components of the IMD 806. The power source 822 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 806. In some examples, power requirements may be small enough to allow IMD 806 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.

[0123] The DBS therapy is defined by one or more therapy programs having one or more parameters stored within the memory 812. 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 810, via the electrodes 816, 818, delivers DBS to the patient 112 and may adjust one or more parameters defining the electrical stimulation.

[0124] Fig. 9 is a block diagram of an example programmer 904. In some cases, the programmer 904 may be similar to or the same as the programmer 104. Although the programmer 904 may generally be described as a hand-held device, the programmer 904 may be a larger portable device or a more stationary device. In addition, in other examples, the programmer 904 may be included asA0012052W001part of an external charging device or include the functionality of an external charging device. As illustrated in Fig. 9, the programmer 904 may include processing circuitry 910, a memory 912, a user interface 902, telemetry circuitry 908, and a power source 922.

[0125] The memory 912 may store instructions that, when executed by the processing circuitry 910, cause or enable the processing circuitry 910 and the programmer 904 to provide the functionality ascribed to the programmer 904 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 910 may include processing circuitry configured to perform the processes discussed with respect to the processing circuitry 810 of the IMD 806 as described with reference to Fig. 8. In some examples, the programmer 904 may include or may be referred to as a signal generator (e.g., in combination with or separate from the IMD 806).

[0126] In general, the programmer 904 comprises any suitable arrangement of hardware, alone or in combination with software and / or firmware, to perform the techniques attributed to the programmer 904, and the processing circuitry 910, the user interface 902, and the telemetry circuitry 908 of the programmer 904. In various examples, the programmer 904 may include one or more processors, which may include fixed function processing 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 904 also, in various examples, may include the memory 912, 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 910 and the telemetry circuitry 908 are described as separate modules, in some examples, the processing circuitry 910 and the telemetry circuitry 908 may be functionally integrated with one another. In some examples, the processing circuitry 910 and the telemetry circuitry 908 correspond to individual hardware units, such as ASICs, DSPs, FPGAs, or other hardware units. The memory 912 (e.g., a storage device) may store instructions or data that, when executed by the processing circuitry 910, cause or enable the processing circuitry 910 and the programmer 904 to provide the functionality ascribed to the programmer 904 throughout this disclosure. For example, the memory 912 may include instructions that cause the processing circuitry 910 to obtain a parameter set from memory or receive a user input and send a corresponding command to the IMD 806, or instructions for any other functionality.A0012052W001

[0127] The user interface 902 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 902 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 902 may also receive user input via the user interface 902. The input may be, for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.

[0128] In some cases, the user interface 902 may be useful to allow a physician, patient, or other user to modify instructions to be executed by the processing circuitry 910 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 902 or corresponding thereto. Although the user interface 902 is shown as part of the programmer 904, in some examples, the user interface 902 may be housed separately from one or more remaining components of the programmer 904.

[0129] The telemetry circuitry 908 may support wireless communication between the IMD 806 and the programmer 904 under the control of the processing circuitry 910. The telemetry circuitry 908 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 908 provides wireless communication via an RF or proximal inductive medium. In some examples, the telemetry circuitry 908 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 904 and the IMD 806 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 904 without needing to establish a secure wireless connection.

[0130] In some examples, processing circuitry 910 of the programmer 904 defines the parameters of electrical stimulation therapy, stored in the memory 912, for delivering DBS to the patient 112. In one example, the processing circuitry 910 of the programmer 904, via the telemetry circuitry 908, issues commands to the IMD 806 causing the IMD 806 to deliver electrical stimulation therapy via the electrodes 816, 818 via the leads 814. In one or more examples, the programmer 904 may be configured to perform one or more of the example techniques described in this disclosure. For instance, the processing circuitry 910 may be configured to perform one or more of the exampleA0012052W001operations described above with respect to the processing circuitry 810. For example, the processing circuitry 910 may be configured to cause the stimulation generation circuitry 802 to deliver a first set of one or more therapeutic electrical stimulation signals according to a first set of one or more parameters.

[0131] Fig. 10 depicts a method 1000 that may be used, for example, to manufacture a connector device. It is to be understood that, while the method 1000 below specifies three different steps, embodiments of the method 1000 may comprise more or fewer steps than those described below, and / or one or more steps that are different than the steps described below.

[0132] The method 1000 comprises welding a conductor wire to a connector ring of a connector device (step 1004). The conductor wire (e.g., a conductor wire of the coil of conductor wires 216 such as the first conductor wire 216A) may be resistance welded to the connector ring such as the connector ring 312, the connector ring 412, the connector ring 512, the connector ring 612, or the connector ring 712 of the connector device (e.g., the connector 224). In some cases, the connector ring may comprise a weld face that biases the weld between the connector ring and the connector device toward an inner diameter of the connector ring. For example, the connector ring may comprise the angled weld face 668 that biases the weld between the conductor wire and the connector ring 612 toward the inner surface 644 of the connector ring 612. In another example, the connector ring may comprise a stepped weld face 774 that biases the weld between the conductor wire and the connector ring 712 toward the inner surface 744 of the connector ring 712.

[0133] The method 1000 also comprises dispensing a polymer into one or more portions of the connector device to overmold the connector device (step 1008). After welding, a polymer (e.g., insulative material 232) may be dispensed into one or more portions of the connector device using, for example, injection molding.

[0134] The method 1000 also comprises grinding down an outer diameter of the connector device (step 1012). After the connector device has been overmolded, an exterior surface of the connector device may be ground to create a smooth outer surface of the connector device.

[0135] In some cases, the method 1000 may continue, and the manufactured connector device may be implanted into the patient 112 along with the electrodes 116, 118 to provide, for example, DBS therapies.

[0136] The present disclosure encompasses embodiments of the method 1000 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.A0012052W001

[0137] 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 he 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.

[0138] 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.

[0139] A set of example statements is provided below:

[0140] Statement 1: A device (224), comprising: at least one conductor wire (216A) extending along a longitudinal axis (206) of the device (224) from a proximal end (204) toward a distal end (208); and a connector ring (212A, 312, 412, 512, 612, 712) positioned between the proximal end (204) and the distal end (208), the connector ring (212A, 312, 412, 512, 612, 712) comprising: an inner diameter (244); an outer diameter (230); and a shoulder (228A, 328, 428, 528, 628, 728) with a weld face (350, 450, 550, 668, 774) that enables the at least one conductor wire (216A) to be welded to the connector ring (212A, 312, 412, 512, 612, 712), wherein the weld face (350, 450, 550, 668, 774) biases a weld between the weld face (350, 450, 550, 668, 774) and the at least one conductor wire (216A) toward the inner diameter (244) of the connector ring (212A, 312, 412, 512, 612, 712).

[0141] Statement 2: The device of Statement 1, wherein the weld face (350, 450, 550, 668, 774) extends along a weld face axis (464, 564, 670) that is angled relative to a transverse axis of theA0012052W001device (224), and wherein the transverse axis of the device is orthogonal to the longitudinal axis (206) of the device (224).

[0142] Statement 3: The device of Statement 2, wherein the weld face axis (464, 564, 670) is angled relative to the transverse axis by between about 1 degree and about 15 degrees.

[0143] Statement 4: The device of Statement 1, wherein the weld face (350, 450, 550, 668, 774) comprises a stepped weld face (774).

[0144] Statement 5: The device of Statement 4, wherein the stepped weld face (774) comprises a first surface and a second surface substantially orthogonal to the first surface, and wherein the at least one conductor wire (216A) interfaces with both the first surface and the second surface of the stepped weld face (774) after welding.

[0145] Statement 6: The device of any of Statements 1-5, wherein the weld face (350, 450, 550, 668, 774) is positioned on an edge of the connector ring (212A, 312, 412, 512, 612, 712).

[0146] Statement 7: The device of any of Statements 1-6, wherein the at least one conductor wire (216A) is resistance welded to the weld face (350, 450, 550, 668, 774) to electrically connect the connector ring (212A, 312, 412, 512, 612, 712) to the at least one conductor wire (216A).

[0147] Statement 8: The device of any of Statements 1-7, wherein the outer diameter (230) of the connector ring (212 A, 312, 412, 512, 612, 712) is at least partially ground down after the at least one conductor wire (216A) is welded to the weld face (350, 450, 550, 668, 774).

[0148] Statement 9: A connector ring (212A, 312, 412, 512, 612, 712), comprising: an outer diameter (230); an inner diameter (244); and a shoulder (228A, 328, 428, 528, 628, 728) with a weld face (350, 450, 550, 668, 774) that enables a conductor wire (216A) to be welded to the connector ring (212A, 312, 412, 512, 612, 712) to electrically connect the connector ring (212A, 312, 412, 512, 612, 712) to the conductor wire (216A), wherein the weld face (350, 450, 550, 668, 774) biases a weld between the conductor wire (216A) and the connector ring (212 A, 312, 412, 512, 612, 712) toward the inner diameter (244) of the connector ring (212 A, 312, 412, 512, 612, 712).

[0149] Statement 10: The connector ring of Statement 9, wherein the weld face (350, 450, 550, 668, 774) is angled relative to a transverse axis of the connector ring (212A, 312, 412, 512, 612, 712).

[0150] Statement 11 : The connector ring of Statement 10, wherein the weld face (350, 450, 550, 668, 774) is angled by between about 1 degree and about 15 degrees.

[0151] Statement 12: The connector ring of Statement 9, wherein the weld face (350, 450, 550, 668, 774) comprises a stepped weld face (774).A0012052W001

[0152] Statement 13: The connector ring of Statement 12, wherein the stepped weld face (774) comprises a first surface and a second surface substantially orthogonal to the first surface, and wherein both the first surface and the second surface interface with the conductor wire (216A) after the conductor wire (216A) is welded to the connector ring (212A, 312, 412, 512, 612, 712).

[0153] Statement 14: The connector ring of any of Statements 9-13, wherein the shoulder (228A, 328, 428, 528, 628, 728) is positioned on a distal end of the connector ring (212A, 312, 412, 512, 612, 712).

[0154] Statement 15: The connector ring of any of Statements 9-14, wherein the connector ring (212A, 312, 412, 512, 612, 712) is positioned within a connector device (224).

[0155] Statement 16: A system, comprising: an electrical lead (114A); and a connector device (224) connected to the electrical lead (114 A), the connector device (224) comprising: a connector ring (212A, 312, 412, 512, 612, 712) positioned between a proximal end (204) and a distal end (208) of the connector device (224), the connector ring (212A, 312, 412, 512, 612, 712) comprising: an outer diameter (230); an inner diameter (244); and a shoulder (228A, 328, 428, 528, 628, 728) with a weld face (350, 450, 550, 668, 774) that enables a conductor wire (216A) to be welded to the connector ring (212 A, 312, 412, 512, 612, 712) to electrically connect the connector ring (212 A, 312, 412, 512, 612, 712) to the conductor wire (216A), wherein the weld face (350, 450, 550, 668, 774) biases a weld between the weld face (350, 450, 550, 668, 774) and the conductor wire (216A) toward the inner diameter (244) of the connector ring (212A, 312, 412, 512, 612, 712).

[0156] Statement 17: The system of Statement 16, wherein the connector device further comprises: a second connector ring (212B, 312, 412, 512, 612, 712) positioned between the proximal end (204) and the distal end (208) of the connector device (224), the second connector ring (212B, 312, 412, 512, 612, 712) comprising: a second outer diameter (230); a second inner diameter (244); and a second shoulder (228B, 328, 428, 528, 628, 728) with a second weld face (350, 450, 550, 668, 774) that enables a second conductor wire (216B) to be welded to the second connector ring (212B, 312, 412, 512, 612, 712) to electrically connect the second connector ring (212B, 312, 412, 512, 612, 712) to the second conductor wire (216B), wherein the second weld face (350, 450, 550, 668, 774) biases a second weld between the second weld face (350, 450, 550, 668, 774) and the second conductor wire (216B) toward the second inner diameter (244) of the second connector ring (212B, 312, 412, 512, 612, 712).

[0157] Statement 18: The system of Statement 17, wherein at least one of the weld face (350, 450, 550, 668, 774) and the second weld face (350, 450, 550, 668, 774) is angled relative to a transverse axis of the connector ring (212A, 312, 412, 512, 612, 712).A0012052W001

[0158] Statement 19: The system of Statement 17, wherein at least one of the weld face (350, 450, 550, 668, 774) and the second weld face (350, 450, 550, 668, 774) comprises a stepped weld face (774).

[0159] Statement 20: The system of Statement 19, wherein the shoulder (228A, 328, 428, 528, 628, 728) is positioned on a distal end of the connector ring (212A, 312, 412, 512, 612, 712), and wherein the second shoulder (228A, 328, 428, 528, 628, 728) is positioned on a distal end of the second connector ring (212B, 312, 412, 512, 612, 712).

Claims

A0012052W001CLAIMSWhat is claimed is:

1. A device (224), comprising:at least one conductor wire (216A) extending along a longitudinal axis (206) of the device (224) from a proximal end (204) toward a distal end (208); anda connector ring (212A, 312, 412, 512, 612, 712) positioned between the proximal end (204) and the distal end (208), the connector ring (212A, 312, 412, 512, 612, 712) comprising:an inner diameter (244);an outer diameter (230); anda shoulder (228A, 328, 428, 528, 628, 728) with a weld face (350, 450, 550, 668, 774) that enables the at least one conductor wire (216A) to be welded to the connector ring (212 A, 312, 412, 512, 612, 712), wherein the weld face (350, 450, 550, 668, 774) biases a weld between the weld face (350, 450, 550, 668, 774) and the at least one conductor wire (216A) toward the inner diameter (244) of the connector ring (212A, 312, 412, 512, 612, 712).

2. The device of claim 1, wherein the weld face (350, 450, 550, 668, 774) extends along a weld face axis (464, 564, 670) that is angled relative to a transverse axis of the device (224), and wherein the transverse axis of the device is orthogonal to the longitudinal axis (206) of the device (224).

3. The device of claim 2, wherein the weld face axis (464, 564, 670) is angled relative to the transverse axis by between about 1 degree and about 15 degrees.

4. The device of claim 1, wherein the weld face (350, 450, 550, 668, 774) comprises a stepped weld face (774).

5. The device of claim 4, wherein the stepped weld face (774) comprises a first surface and a second surface substantially orthogonal to the first surface, and wherein the at least one conductor wire (216A) interfaces with both the first surface and the second surface of the stepped weld face (774) after welding.A0012052W0016. The device of any of claims 1-5, wherein the weld face (350, 450, 550, 668, 774) is positioned on an edge of the connector ring (212A, 312, 412, 512, 612, 712).

7. The device of any of claims 1-6, wherein the at least one conductor wire (216A) is resistance welded to the weld face (350, 450, 550, 668, 774) to electrically connect the connector ring (212A, 312, 412, 512, 612, 712) to the at least one conductor wire (216A).

8. The device of any of claims 1-7, wherein the outer diameter (230) of the connector ring (212A, 312, 412, 512, 612, 712) is at least partially ground down after the at least one conductor wire (216A) is welded to the weld face (350, 450, 550, 668, 774).

9. A connector ring (212 A, 312, 412, 512, 612, 712), comprising:an outer diameter (230);an inner diameter (244); anda shoulder (228A, 328, 428, 528, 628, 728) with a weld face (350, 450, 550, 668, 774) that enables a conductor wire (216A) to be welded to the connector ring (212 A, 312, 412, 512, 612, 712) to electrically connect the connector ring (212 A, 312, 412, 512, 612, 712) to the conductor wire (216A), wherein the weld face (350, 450, 550, 668, 774) biases a weld between the conductor wire (216 A) and the connector ring (212 A, 312, 412, 512, 612, 712) toward the inner diameter (244) of the connector ring (212A, 312, 412, 512, 612, 712).

10. The connector ring of claim 9, wherein the weld face (350, 450, 550, 668, 774) is angled relative to a transverse axis of the connector ring (212A, 312, 412, 512, 612, 712).

11. The connector ring of claim 10, wherein the weld face (350, 450, 550, 668, 774) is angled by between about 1 degree and about 15 degrees.

12. The connector ring of claim 9, wherein the weld face (350, 450, 550, 668, 774) comprises a stepped weld face (774).

13. The connector ring of claim 12, wherein the stepped weld face (774) comprises a first surface and a second surface substantially orthogonal to the first surface, and wherein both the firstA0012052W001surface and the second surface interface with the conductor wire (216 A) after the conductor wire (216A) is welded to the connector ring (212A, 312, 412, 512, 612, 712).

14. The connector ring of any of claims 9-13, wherein the shoulder (228A, 328, 428, 528, 628, 728) is positioned on a distal end of the connector ring (212A, 312, 412, 512, 612, 712).

15. The connector ring of any of claims 9-14, wherein the connector ring (212A, 312, 412, 512, 612, 712) is positioned within a connector device (224).

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