Lead for spinal cord stimulation system, devices, and methods

Abstract

Systems, devices, and methods allow for electrical stimulation to be applied to an epidural space of a spinal cord of a patient. A system comprises a lead head comprising a plurality of conductive electrodes. At least one conductor is constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes. A stimulation source is electrically coupled to the at least one conductor that generates the electrical stimulation signals. In some embodiments, an expansion system modifies an area of coverage of the conductive electrodes. In some embodiments, a spatial modification system modifies a spatial orientation of the lead head.

Description

[0001] PCT INTERNATIONAL PATENT APPLICATION FOR

[0002] LEAD FOR SPINAL CORD STIMULATION SYSTEM, DEVICES, AND METHODS

[0003] Inventors:

[0004] Mark Mahan, a citizen of The United States of America, residing at: 1334 E. Chandler Drive, Salt Lake City, UT 84103

[0005] Lorenzo Soletti, a citizen of The United States of America, residing at: 217 Vine Street, Pittsburgh, PA 15218

[0006] Assignee: STARK Devices PercStim, LLC

[0007] 1334 E. Chandler Drive, Salt Lake City, UT 84103

[0008] Entity: Small

[0009] LEAD FOR SPINAL CORD STIMULATION SYSTEM, DEVICES, AND METHODS

[0010] CROSS-REFERENCE TO RELATED APPLICATION

[0011]

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 704,158, filed on October 7, 2024, the content of which is incorporated by reference in its entirety.

[0012] TECHNICAL FIELD

[0013]

[0002] The present inventive concepts relate generally to systems, devices, mode of use, and methods for the delivery of electrical stimulation to the spinal cord with multiple advantages over existing solutions.

[0014] BACKGROUND

[0015]

[0003] Spinal Cord Stimulation (SCS) has maintained the same fundamental technology for the implanted elements delivering the electrical signal to the spinal cord (leads) for the past 40 years. SCS is used for chronic pain management derived from a variety of conditions such as failed back surgery syndrome, complex regional pain syndrome, neuropathic pain, non-surgical back pain, spinal cord injury, angina (rarely), and GI disorders. While there has been significant development for the electronics in the internal or external pulse generator systems (IPG or EPG, respectively) and their controlling algorithms, there has not been much development in the implantable leads since their commercial introduction in the 1980s.

[0016]

[0004] There are three main types of electrical stimulation using current waveforms with 0.5- 5.0 mA amplitude: 1) Low Frequency stimulation, which uses conventional SCS tonic electrical stimulation at 40-60Hz to create paresthesia i.e., tingling, buzzing, pin and needles, pressure sensations), which overlaps with and masks / suppresses pain with some level of success (51% success rate); 2) Mid Frequency stimulation, which uses burst of electrical pulses at 500Hz. This has shown to improve pain relief without the creation of paresthesia (60% success rate), and; 3) High Frequency stimulation, which uses electrical pulses at 1-lOkHz that have been shown to lead to a significant improvement in pain relief without paresthesia (80% success rate). The actual mechanism of action for the mid- and high-frequency approaches are not known. While these methods are more effective, the only way to assess their efficacy has been by patient reported reduction in pain after several hours of stimulation, whereas the low frequency method allows realtime objective assessment via electrophysiology monitoring, which can detect the efficacy of the induced paresthesia. The success of the IPG and stimulation waveforms, however, depends upon the leads and electrodes, including: 1) successful anatomical location of stimulating leads, in respect to the spinal level, location of the patient pain, laterality, etc , 2) availability of multiple electrodes, most commonly electrode pairs (or more for complex tripolar or other stimulation paradigms), for inducing current in the appropriate location within the spinal cord; 3) appropriate conductivity, commonly referred to as lead impedance; among a whole host of other requirements for a commercial successful product.

[0017]

[0005] Two fundamental types of SCS leads are currently manufactured: 1) percutaneous leads which have a cylindrical shape with a diameter of approximately 1 mm and can be inserted into the epidural space percutaneously using a standard epidural access needle (e.g., Tuohy, Coude', etc.y, 2) paddle leads which have wider (8-10 mm) geometric patterns of electrode contacts affording a: a) stable (not shifting with respect to each other) bi-dimensional array of electrodes; b) reduced risk of movement (with respect to the spinal cord); c) single flat surface (conduction is focused towards the spinal cord); among other benefits, but requires surgical / open epidural access (i.e., laminotomy) for insertion.

[0018]

[0006] SCS is initiated via a trial period, in which a pain physician / anesthesiologist / physiatrist inserts, under fluoroscopic guidance, most likely one of two temporary percutaneous leads. This allows the physician to define the correct electrode placement to stimulate the patient's spinal cord via connection of the leads to an EPG. This also allows to assess whether SCS is effective and well tolerated by the patient, for determination to proceed to a permanent lead and IPG implantation. The trial period usually lasts 3-10 days. If the trial period is successful (i.e., a typical requirement by insurance is the attainment of 50% or better pain relief during the trial period), a permanent implant with an IPG is likely to be performed. In this procedure, either one of two new percutaneous leads (providing 8 or 16 electrodes for midline or bilateral stimulation, respectively), or a paddle lead (16-32 electrodes) is implanted. About 67-75% of permanent leads are percutaneous leads, whereas the remaining 25-33% are paddle leads.

[0019]

[0007] While percutaneous leads do not require open epidural access and afford significant practical and financial benefits for providers, they are associated with significant drawbacks and high complication rates. In particular, they require higher power consumption; higher rates of lead migration (23% rate), which may require additional programming, revision surgeries, and patient dissatisfaction; limited programming capacity from decreased ability to correctly space electrode contacts in the epidural space. Higher power consumption occurs due to diffusive current losses from the cylindrical leads / bands covering a 360-degree area around the lead. This leads to more frequent recharging (for rechargeable IPGs) or limited battery life of non-rechargeable IPGs. Due to the requirement to space leads, there may be greater procedural time to position the lead in the correct / optimal position, as imprecisely aligned leads / bands allow limited ability to customize the stimulation patterns.

[0020]

[0008] Current paddle leads can only be implanted and positioned in the epidural dorsal space with surgical access, (i.e., opening the spinal canal by the removal or destruction of the spine structural anatomy), which is associated with greater tissue trauma, increased risk for epidural bleeding, which may cause spinal cord compression and / or injury, greater risk of epidural infection, and greater volume occupation by the paddle lead. Additionally, some patients’ anatomy precludes the use of a paddle lead due to this larger volume and consequent spinal cord compression. Furthermore, current paddle epidural leads have multiple additional limitations: 1) Require surgical expertise and experience for successful placement in the epidural space due to the inherent risk of spinal cord injury; 2) Require additional dedicated surgical equipment to access the epidural space in order to insert the paddle; 3) Do not have any system for steering the paddle in the epidural space during the paddle advancement, unlike percutaneous leads - which can be steered / guided by an internal removable curved stylet wire; 4) Do not have any system for modifying their geometry while in the epidural space, which may become necessary to advance the paddle when an anatomic restriction or other obstacle is found; 5) Despite some intrinsic material flexibility is provided by the rubber polymers employed for the paddle constructions (e.g., Polydimethylsiloxane (PDMS)-based polyurethanes, etc.), they often lack ideal static and dynamic deformability properties, which might limit their conformability to the complex 3D geometry of the epidural space and curved surface of the thecal sac. This deformability / conformability is important in multiple ways. For example, currently surgeons frequently are required to make separate laminotomies (removal of the dorsal spinal bone) in order to steer the paddle into an appropriate location or remove obstacles and restrictions. In other words, in some cases a single laminotomy is sufficient, but, because the paddle does not steer, either a surgeon has to spend more time and lead to additional risk to achieve a better position, or accept a suboptimal position of the paddle in the epidural space. Steerage of the paddle (when the active steerability features presented here are enabled) enables fine position control, reduced invasiveness, risk reduction and better placement. Optimized geometry and deformability helps to ensure optimal contact between the electrodes and the thecal sac. Despite these limitations, paddle leads have significant benefits. In particular, they benefit from flat electrodes providing current directed at the spinal cord and greater consequent stimulation and with increased IPG battery efficiency. Paddle leads have a significantly reduced risk of epidural migration due to the laterally expanded profile which remains permanently anchored in place by the remodeled tissue surrounding the paddle. Said alternatively, the paddle size and geometry helps to ensure that the position is not altered by the patient's spine movements and deformations, unlike current percutaneous leads which tend to ‘piston’ along their scar tract with fixed anchors in the fascia. The fixed geometry between electrode contacts creates better stimulation optimization including typically ensuring bilateral coverage, high directionality and improved stimulation selectivity, flexibility, and programmability.

[0021] BRIEF SUMMARY

[0022]

[0009] These tradeoffs and limitations of both SCS percutaneous and paddle leads suggest that a clinical need exists for novel SCS lead solutions embodying the advantages of each lead type and without their limitations. These solutions are described in the present inventive concepts.

[0023]

[0010] According to an aspect of the present inventive concepts, a system for delivering spinal cord stimulation with multiple benefits over existing solutions is described here. The Spinal Cord Stimulation Lead (SCSL) system here presented can comprise an Access System, an External Anchoring System, a Structural System, an Alignment System, a Geometry Modification Control System, a Steerability System, and Internal Anchoring System, an Electrical Stimulation Conduction and Isolation System, and a Feedback System.

[0024] [Oi l] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0025]

[0012] In an aspect, a system delivers electrical stimulation to an epidural space of a spinal cord of a patient. The system comprises a lead head comprising a plurality of conductive electrodes; at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; a stimulation source electrically coupled to the at least one conductor that generates the electrical stimulation signals; and an expansion system that modifies an area of coverage of the conductive electrodes.

[0026]

[0013] In some embodiments, the at least one conductor comprises a plurality of conductors constructed and arranged to deliver the electrical stimulation signals to a like plurality of the conductive electrodes.

[0027]

[0014] In some embodiments, the expansion system modifies a width of the lead head

[0028]

[0015] In some embodiments, the expansion system modifies at least a width dimension of the lead head, wherein the width dimension is related to a lateral direction spanning from a left side to a right side of the patient.

[0029]

[0016] In some embodiments, the expansion system modifies the width of the lead head so that it is increased from a first delivery width W1 to a second deployment width W2, wherein W2 > W1

[0017] In some embodiments, first and second electrodes of the conductive electrodes are spaced apart by a first distance DI when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a second distance D2 when the lead head width is the second deployment width W2, and wherein D2 > DI

[0018] In some embodiments, first and second electrodes of the conductive electrodes are spaced apart by a first longitudinal distance LD1 (along the cranial -caudal direction of the patient) when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a second longitudinal distance LD2 when the lead head width is the second deployment width W2, and wherein LD2 is not equal to LD1

[0030]

[0019] In some embodiments, the expansion system modifies the area of coverage of the conductive electrodes between a first area of coverage Al to a second area of coverage A2, wherein A2 > A1

[0031]

[0020] In some embodiments, the stimulation source comprises at least one electric signal generator coupled to the at least one conductor

[0032]

[0021] In some embodiments, the at least one electric signal generator comprises a plurality of electric signal generators; the at least one conductor comprises a plurality of conductors, each of the plurality of conductors being coupled to a corresponding one of the plurality of electric signal generators; and the plurality of conductive electrodes are each coupled to one of the plurality of conductors and the corresponding one of the electric signal generators, so that each of the plurality of electrodes receives an independent electrical stimulation signal generated by one of the plurality of electric signal generators.

[0033]

[0022] In some embodiments, the system permits access into the epidural space without a need for light-based visualization

[0034]

[0023] In some embodiments, the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm.

[0035]

[0024] In some embodiments, the at least one arm comprises a first arm and a second arm, and wherein a first conductive electrode is positioned at the first arm and a second conductive electrode is positioned at the second arm.

[0036]

[0025] In some embodiments, the lead head further comprises a bridle, and wherein the least one arm is mechanically coupled to the bridle at at least one hinge.

[0026] In some embodiments, the system further comprises: a hinge pulley at the at least one hinge; and an arm actuator engaging the at least one hinge that initiates motion of the arm about the hinge relative to the bridle.

[0037]

[0027] In some embodiments, the arm actuator comprises at least one fdament.

[0038]

[0028] In some embodiments, the at least one hinge comprises at least one corresponding hinge anchor.

[0039]

[0029] In some embodiments, the first arm comprises multiple first arms and wherein the second arm comprises multiple second arms and further comprising at least one link arm coupling neighboring ones of the multiple first arms and second arms.

[0040]

[0030] In some embodiments, the link arm causes neighboring ones of the first and second arms to move in unison when engaged.

[0041]

[0031] In some embodiments, each link arm remains parallel to a longitudinal axis of the system the lead head upon modification of the lead head width from a first delivery width W1 to a second deployment width W2, wherein W2 > W1.

[0042]

[0032] In some embodiments, the system further comprises a lead leash comprising at least one lumen, wherein the at least one conductor is positioned within the at least one lumen of the lead leash.

[0043]

[0033] In some embodiments, the lead leash comprises a leash actuator

[0044]

[0034] In some embodiments, the leash actuator provides for control over a degree of expansion of the expansion system.

[0045]

[0035] In some embodiments, the leash actuator further comprises actuation retention marks.

[0046]

[0036] In some embodiments, the actuation retention marks provide visual indicia of the relative position of the leash actuator and lead leash

[0047]

[0037] In some embodiments, the actuation retention marks provide physical indicia of the relative position of the leash actuator and lead leash

[0048]

[0038] In some embodiments, the physical indicia comprises tactile feedback

[0049]

[0039] In some embodiments, the leash actuator further comprises a biasing mechanism for fixation of the relative position of the leash actuator and lead leash

[0050]

[0040] In some embodiments, the leash actuator further comprises a ratcheting spring mechanism for fixation of the relative position of the leash actuator and lead leash

[0041] In some embodiments, the leash actuator further comprises a linear actuator for fixation of the relative positions of the leash actuator and lead leash

[0051]

[0042] In some embodiments, the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other

[0052]

[0043] In some embodiments, the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes

[0053]

[0044] In some embodiments, the leash actuator is connected to a hinge anchor concentrically positioned at a hinge axle of the arm

[0054]

[0045] In some embodiments, the lead head comprises at least one arm, the plurality of conductive electrodes are positioned at the at least one arm, and the at least one arm is outwardly biased relative to the lead head.

[0055]

[0046] In some embodiments, the system further comprises a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0056]

[0047] In some embodiments, the control of a position of the lead head retraction sheath provides for control over a degree of expansion of the expansion system.

[0057]

[0048] In some embodiments, the lead head retraction sheath comprises a deployable sheath.

[0058]

[0049] In some embodiments, the system further comprises a leash slit that enables the deployment of the lead head retraction sheath.

[0059]

[0050] In some embodiments, the leash slit enables the deployment of the deployable sheath by communicating motion from an interior of the leash to an exterior of the leash and head where the deployable sheath resides.

[0060]

[0051] In some embodiments, the system further comprises a leash actuator coupled to the lead head retraction sheath for controlling a position of the lead head retraction sheath.

[0061]

[0052] In some embodiments, the leash slit shifts the lead head retraction sheath for full removal from the lead head when deployed

[0062]

[0053] In some embodiments, the leash slit shifts the lead head retraction sheath for partial removal from the lead head when deployed.

[0063]

[0054] In some embodiments, the lead head retraction sheath further comprises at least one side opening through which the at least one arm extends when deployed.

[0055] In some embodiments, the leash slit enables to shift the deployable sheath out of its initial overlap with the lead head when deployed

[0064]

[0056] In some embodiments, the leash slit shifts the deployable sheath for partial removal from the lead head when deployed.

[0065]

[0057] In some embodiments, the deployable sheath further comprises at least one side opening through which the at least one arm extends when deployed.

[0066]

[0058] In some embodiments, a position of the at least one side opening controls an amount of extension of the at least one arm

[0067]

[0059] In some embodiments, the at least one arm is linear when fully extended.

[0068]

[0060] In some embodiments, the at least one arm comprises a curvature when fully extended.

[0069]

[0061] In some embodiments, the at least one arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0070]

[0062] In some embodiments, the plurality of conductive electrodes comprises an array of conductive electrodes.

[0071]

[0063] In some embodiments, the array of conductive electrodes extends along a longitudinal axis (z) of the system.

[0072]

[0064] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0073]

[0065] In some embodiments, the array of conductive electrodes extends along a first transverse axis (x) that is transverse the longitudinal axis (z).

[0074]

[0066] In some embodiments, the expansion system expands the area of coverage in a direction along the first transverse axis (x).

[0075]

[0067] In some embodiments, the expansion system expands the area of coverage in a direction along the first transverse axis (x) and in a direction along the longitudinal axis (z).

[0076]

[0068] In some embodiments, the array of conductive electrodes extends along a second transverse axis (y) that is orthogonal to the first transverse axis (x) and transverse the longitudinal axis (z).

[0077]

[0069] In some embodiments, the expansion system expands the area of coverage in a direction along the second transverse axis (y).

[0070] In some embodiments, the expansion system expands the area of coverage in a direction along the second transverse axis (y) and in a direction along the longitudinal axis (z).

[0078]

[0071] In some embodiments, the array of conductive electrodes extends along the longitudinal (cranial-caudal) axis (z) of the patient.

[0079]

[0072] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0080]

[0073] In some embodiments, the array of conductive electrodes extends along the dorsal- ventral axis (y) of the patient that is perpendicular to the longitudinal axis (z).

[0081]

[0074] In some embodiments, the expansion system expands the area of coverage in a direction along the axis (y).

[0082]

[0075] In some embodiments, the array of conductive electrodes extends along the transverse (from the left to the right side of the patient) axis (x) of the patient that is perpendicular to the longitudinal axis (z) and to the dorsal -ventral axis (y).

[0083]

[0076] In some embodiments, the expansion system expands the area of coverage in a direction along the transverse axis (x).

[0084]

[0077] In some embodiments, the expansion system expands the area of coverage in a direction along the transverse axis (y).

[0085]

[0078] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0086]

[0079] In some embodiments, the expansion system expands the area of coverage in a curved direction resulting from combinations of the three axes (x, y, and z) in order to position the electrodes along the curved surface of the thecal sac.

[0087]

[0080] In some embodiments, the lead head comprises at least one arm, wherein a proximal end of the at least one lead head is anchored to a portion of the lead head, the plurality of conductive electrodes are positioned at the at least one arm, and the at least one arm is outwardly biased relative to the lead head.

[0088]

[0081] In some embodiments, a lead head retraction sheath constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0089]

[0082] In some embodiments, the at least one arm has a sigmoidal shape when released at deployment.

[0083] In some embodiments, the sigmoidal arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0090]

[0084] In some embodiments, the system further comprises a deployable sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0091]

[0085] In some embodiments, the at least one arm has a sigmoidal shape when released at deployment with the parallel peripheral portions of the sigmoid parallel / aligned with the longitudinal axis (z).

[0092]

[0086] In some embodiments, the lead head comprises multiple lead arms, and further comprising: a plurality of link arms; and a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, wherein the link arms are coupled to the multiple lead arms at opposite ends of the multiple lead arms, each link arm coupled between one of the multiple lead arms and a deployable arm, so that at deployment, the distance between the multiple lead arms is decreased in a direction along a longitudinal axis of the system, and a distance between the corresponding deployable arms is increased in a direction along a transverse axis of the system

[0093]

[0087] In some embodiments, the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of shaped link arms; and a leash actuator passing through the plurality of deployable arms and the plurality of shaped link arms in serial arrangement, wherein a distal end of the leash actuator is anchored at a distal-most arm of the plurality of deployable arms and the plurality of shaped link arms, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of shaped link arms.

[0094]

[0088] In some embodiments, at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system

[0095]

[0089] In some embodiments, at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the shaped link arms is increased in a direction along a transverse axis of the system

[0096]

[0090] In some embodiments, the plurality of conductive electrodes are positioned at the shaped arms,

[0091] In some embodiments, the system further comprises a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of shaped link arms prior to deployment and releases the plurality of deployable arms and the plurality of shaped link arms at deployment.

[0097]

[0092] In some embodiments, the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of bracket arms; and a leash actuator passing through the bracket arms and pairs of the plurality of deployable arms in parallel arrangement, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of bracket arms.

[0098]

[0093] In some embodiments, at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system

[0099]

[0094] In some embodiments, at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the bracket arms is increased in a direction along a transverse axis of the system

[0100]

[0095] In some embodiments, the plurality of conductive electrodes are positioned at the bracket arms,

[0101]

[0096] In some embodiments, the system further comprises a lead head retraction or deploy able sheath that constrains the plurality of deploy able arms and the plurality of bracket arms prior to deployment and releases the plurality of deployable arms and the plurality of bracket arms at deployment.

[0102]

[0097] In some embodiments, the system further comprises a spatial modification system that modifies a spatial orientation of the lead head.

[0103]

[0098] In some embodiments, the spatial modification system rotates the lead head around the dorsal -ventral axis of the patient (yaw movement of the lead head).

[0104]

[0099] In some embodiments, the spatial modification system facilitates advancement of the lead head into the epidural space.

[0105]

[0100] In some embodiments, the spatial modification system further comprises a leash steering actuator, which operates to modify the spatial orientation of the lead head, when actuated.

[0106]

[0101] In some embodiments, the leash steering actuator provides for control over a degree of modification of the spatial orientation of the lead head

[0102] In some embodiments, a distal end of the leash steering actuator is coupled to a hinge anchor at the lead head.

[0107]

[0103] In some embodiments, the spatial modification system further comprises first and second leash steering actuators, the first leash steering actuator operating to modify the spatial orientation of the lead head in a first direction when actuated, and the second leash steering actuator operating to modify the spatial orientation of the lead head in a second direction when actuated.

[0108]

[0104] In some embodiments, the first direction corresponds to a yaw rotation around the dorsal -ventral axis in the clockwise direction, and wherein the second direction corresponds to a yaw rotation around the dorsal-ventral axis in the counterclockwise direction.

[0109]

[0105] In some embodiments, the lead head comprises first and second lead heads and wherein the first leash steering actuator is coupled to a first hinge anchor of the first lead head and wherein the second leash steering actuator is coupled to a second hinge anchor of the second lead head.

[0110]

[0106] In some embodiments, the system further comprises a hinge spring coupled between the first and second lead heads at intermediate positions thereof.

[0111]

[0107] In some embodiments, engaging the first leash steering actuator operates to retract the first lead head which steers the area of coverage of the plurality of electrodes in a first direction and wherein engaging the second leash steering actuator operates to retract the second lead head which steers the area of coverage of the plurality of electrodes in a second direction.

[0112]

[0108] In some embodiments, the lead head comprises first and second deployable arms and wherein the first leash steering actuator is coupled to a first hinge anchor of the first deployable arm and wherein the second leash steering actuator is coupled to a second hinge anchor of the second deployable arm.

[0113]

[0109] In some embodiments, the system further comprises a hinge spring coupled between the first and second deployable arm at intermediate positions thereof.

[0114]

[0110] In some embodiments, engaging the first leash steering actuator operates to retract the first deployable arm which steers the area of coverage of the plurality of electrodes in a first direction (e.g., to the left lateral side of the patient) and wherein engaging the second leash steering actuator operates to retract the second deployable arm which steers the area of coverage of the plurality of electrodes in a second direction (e.g., to the right lateral side of the patient).

[0111] In some embodiments, the leash steering actuator further comprises a lead leash and wherein an axial force applied to the lead leash operates to rotate the lead head about a longitudinal axis of the system.

[0115]

[0112] In some embodiments, the spatial modification system comprises a steering leash and further comprising a linear steering actuator for fixation of the relative position of the steering leash and lead head.

[0116]

[0113] In some embodiments, the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other.

[0117]

[0114] In some embodiments, the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes

[0118]

[0115] In some embodiments, the spatial modification system facilitates turning of the lead head from a straight configuration relative to the lead leash to a turned configuration relative to the lead leash

[0119]

[0116] In some embodiments, the spatial modification system comprises a flexible neck base that couples the lead leash and the lead head

[0120]

[0117] In some embodiments, the flexible neck base comprises a corrugated material to facilitate flexion.

[0121]

[0118] In some embodiments, the flexible neck base comprises a corrugated soft rubber tubing to facilitate flexion

[0122]

[0119] In some embodiments, the system further comprises an anchoring system that anchors the lead head in position in the epidural space.

[0123]

[0120] In some embodiments, the anchor system comprises an anchor actuator; and at least one anchor arm at the lead head and coupled to the anchor actuator, the at least one anchor arm responsive to the anchor actuator to engage the anchor arm, thereby anchoring the lead head in position.

[0124]

[0121] In some embodiments, the anchor actuator provides for control over a degree of anchoring of the lead head

[0125]

[0122] In some embodiments, the anchor actuator comprises at least one filament.

[0126]

[0123] In some embodiments, the anchor actuator comprises a gas or fluid-based actuation system.

[0124] In some embodiments, at least one anchor arm is outwardly biased relative to the lead head.

[0127]

[0125] In some embodiments, at least one anchor arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0128]

[0126] In some embodiments, the lead head further comprises a bridle, and wherein the least one anchor arm is mechanically coupled to the bridle at at least one hinge.

[0129]

[0127] In another aspect, a delivers electrical stimulation to an epidural space of a spinal cord of a patient, comprising: a lead head comprising a plurality of conductive electrodes; at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; a stimulation source electrically coupled to the at least one conductor that generates the electrical stimulation signals; and a spatial modification system that modifies a spatial orientation of the lead head.

[0130]

[0128] In some embodiments, the spatial modification system comprises a spatial orientation modification system.

[0131]

[0129] In some embodiments, the spatial modification system facilitates advancement of the lead head into the epidural space.

[0132]

[0130] In some embodiments, the spatial modification system creates steerage and facilitates the correct positioning and / or alignment of the plurality of conductive electrodes to deploy electrical stimulation signals.

[0133]

[0131] In some embodiments, the spatial modification system rotates the lead head around the dorsal -ventral axis of the patient (yaw movement of the lead head).

[0134]

[0132] In some embodiments, the spatial modification system further comprises a leash steering actuator, which operates to modify the spatial orientation of the lead head, when actuated.

[0135]

[0133] In some embodiments, the leash steering actuator provides for control over a degree of modification of the spatial orientation of the lead head

[0136]

[0134] In some embodiments, a distal end of the leash steering actuator is coupled to a hinge anchor at the lead head.

[0137]

[0135] In some embodiments, the spatial modification system further comprises first and second leash steering actuators, the first leash steering actuator operating to modify the spatial orientation of the lead head in a first direction when actuated, and the second leash steering actuator operating to modify the spatial orientation of the lead head in a second direction when actuated.

[0138]

[0136] In some embodiments, the first direction corresponds to a yaw rotation around the dorsal -ventral axis in the clockwise direction, and wherein the second direction corresponds to a yaw rotation around the dorsal -ventral axis in the counterclockwise direction.

[0139]

[0137] In some embodiments, the lead head comprises first and second lead heads and wherein the first leash steering actuator is coupled to a first hinge anchor of the first lead head and wherein the second leash steering actuator is coupled to a second hinge anchor of the second lead head.

[0140]

[0138] In some embodiments, the system further comprises a hinge spring coupled between the first and second lead heads at intermediate positions thereof.

[0141]

[0139] In some embodiments, engaging the first leash steering actuator operates to push the first lead head which steers the area of coverage of the plurality of electrodes in a first direction and wherein engaging the second leash steering actuator operates to push the second lead head which steers the area of coverage of the plurality of electrodes in a second direction.

[0142]

[0140] In some embodiments, the leash steering actuator further comprises a lead leash and wherein an axial force applied to the lead leash transmitted operates to rotate the lead head about a longitudinal axis of the system.

[0143]

[0141] In some embodiments, the lead head comprises first and second deployable arms and wherein the first leash steering actuator is coupled to a first hinge anchor of the first deployable arm and wherein the second leash steering actuator is coupled to a second hinge anchor of the second deployable arm.

[0144]

[0142] In some embodiments, the system further comprises a hinge spring coupled between the first and second deployable arm at intermediate positions thereof.

[0145]

[0143] In some embodiments, engaging the first leash steering actuator operates to retract the first deployable arm which steers the area of coverage of the plurality of electrodes in a first direction (e.g., to the left lateral side of the patient) and wherein engaging the second leash steering actuator operates to retract the second deployable arm which steers the area of coverage of the plurality of electrodes in a second direction (e.g., to the right lateral side of the patient).

[0146]

[0144] In some embodiments, the spatial modification system comprises a steering leash and further comprising a linear steering actuator for fixation of the relative position of the steering leash and lead head.

[0145] In some embodiments, the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other.

[0147]

[0146] In some embodiments, the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes

[0148]

[0147] In some embodiments, the spatial modification system facilitates turning of the lead head from a straight configuration relative to the lead leash to a turned configuration relative to the lead leash

[0149]

[0148] In some embodiments, the spatial modification system comprises a flexible neck base that couples the lead leash and the lead head

[0150]

[0149] In some embodiments, the flexible neck base comprises a corrugated material to facilitate flexion.

[0151]

[0150] In some embodiments, the flexible neck base comprises a corrugated soft rubber tubing to facilitate flexion

[0152]

[0151] In some embodiments, the lead head comprises a paddle head, and the plurality of conductive electrodes are arranged in a two-dimensional array arranged along a longitudinal axis (z) of the system and along a transverse axis (x) of the system.

[0153]

[0152] In some embodiments, the system further comprises a leash to which the paddle head is coupled.

[0154]

[0153] In some embodiments, the paddle head has a width that is greater than the width of a leash to which the paddle head is coupled.

[0155]

[0154] In some embodiments, the system further comprises a hinge coupling the paddle head to the leash, and wherein the paddle head is pivotable relative to the leash.

[0156]

[0155] In some embodiments, the system further comprises aleash steering actuator that pivots the paddle head relative to the leash in first and second directions.

[0157]

[0156] In some embodiments, the paddle head pivoting relative to the leash creates steerage and facilitates advancement of the lead head into the epidural space.

[0158]

[0157] In some embodiments, the paddle head pivoting relative to the leash creates steerage and facilitates the correct positioning and / or alignment of the array of conductive electrodes to deploy electrical stimulation signals.

[0158] In some embodiments, the leash steering actuator comprises first and second filaments coupled to the paddle head at first and second positions that are spaced apart from each other.

[0159]

[0159] In some embodiments, the paddle head comprises a material that is deformable in a direction of the transverse axis (x) of the system

[0160]

[0160] In some embodiments, the paddle head deformation in the transverse axis creates steerage and facilitates advancement of the lead head into the epidural space.

[0161]

[0161] In some embodiments, the paddle head deformation in the transverse axis facilitates the correct positioning and / or alignment of the array of conductive electrodes to deploy electrical stimulation signals.

[0162]

[0162] In some embodiments, paddle head comprises regions of reduced thickness for promoting deformability of the paddle head and its conformality to the surface upon which it is applied.

[0163]

[0163] In some embodiments, the deformability of the paddle head enables it to conforms the paddle head to the curved thecal sac surface and / or accommodates flexion of the spine

[0164]

[0164] In some embodiments, the paddle head comprises void regions for promoting deformability of the paddle head.

[0165]

[0165] In some embodiments, the deformability of the paddle head enables it to conforms the paddle head to the curved thecal sac surface and / or accommodates flexion of the spine

[0166]

[0166] In some embodiments, the system further comprises a leash steering actuator that bends the paddle head relative to the leash in first and second directions.

[0167]

[0167] In some embodiments, the leash steering actuator comprises first and second filaments coupled to the paddle head at first and second positions that are spaced apart from each other.

[0168]

[0168] In some embodiments, an expansion system modifies an area of coverage of the conductive electrodes.

[0169]

[0169] In some embodiments, the at least one conductor comprises a plurality of conductors constructed and arranged to deliver the electrical stimulation signals to a like plurality of the conductive electrodes.

[0170]

[0170] In some embodiments, the expansion system modifies a width of the lead head

[0171]

[0171] In some embodiments, the expansion system modifies the width of the lead head is increased from a first delivery width W1 to a second deployment width W2, wherein W2 > W1

[0172] In some embodiments, first and second electrodes of the conductive electrodes are spaced apart by a first distance DI when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a second distance D2 when the lead head width is the second deployment width W2, and wherein D2 > DI

[0172]

[0173] In some embodiments, the expansion system modifies the area of coverage of the conductive electrodes between a first area of coverage Al to a second area of coverage A2, wherein A2 > A1

[0173]

[0174] In some embodiments, the stimulation source comprises at least one electric signal generator coupled to the at least one conductor

[0174]

[0175] In some embodiments, the at least one electric signal generator comprises a plurality of electric signal generators; the at least one conductor comprises a plurality of conductors, each of the plurality of conductors being coupled to a corresponding one of the plurality of electric signal generators; and the plurality of conductive electrodes are each coupled to one of the plurality of conductors and the corresponding one of the electric signal generators, so that each of the plurality of electrodes receives an independent electrical stimulation signal generated by one of the plurality of electric signal generators.

[0175]

[0176] In some embodiments, the system permits access into the epidural space without a need for light-based visualization

[0176]

[0177] In some embodiments, the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm.

[0177]

[0178] In some embodiments, the at least one arm comprises a first arm and a second arm, and wherein a first conductive electrode is positioned at the first arm and a second conductive electrode is positioned at the second arm.

[0178]

[0179] In some embodiments, the lead head further comprises a bridle, and wherein the least one arm is mechanically coupled to the bridle at at least one hinge.

[0179]

[0180] In some embodiments, the system further comprises: a hinge pulley at the at least one hinge; and an arm actuator engaging the at least one hinge that initiates motion of the arm about the hinge relative to the bridle.

[0180]

[0181] In some embodiments, the arm actuator comprises at least one filament.

[0181]

[0182] In some embodiments, the at least one hinge comprises at least one corresponding hinge anchor.

[0183] In some embodiments, the first arm comprises multiple first arms and wherein the second arm comprises multiple second arms and further comprising at least one link arm coupling neighboring ones of the multiple first arms and second arms.

[0182]

[0184] In some embodiments, the link arm causes neighboring ones of the first and second arms to move in unison when engaged.

[0183]

[0185] In some embodiments, each link arm remains parallel to a longitudinal axis of the system the lead head upon modification of the lead head width from a first delivery width W1 to a second deployment width W2, wherein W2 > Wl.

[0184]

[0186] In some embodiments, the system further comprises a lead leash comprising at least one lumen, wherein the at least one conductor is positioned within the at least one lumen of the lead leash.

[0185]

[0187] In some embodiments, the lead leash comprises a leash actuator further comprising actuation retention marks.

[0186]

[0188] In some embodiments, the leash actuator provides for control over a degree of expansion of the expansion system.

[0187]

[0189] In some embodiments, the leash actuator further comprises actuation retention marks.

[0188]

[0190] In some embodiments, the actuation retention marks provide visual indicia of the relative position of the leash actuator and lead leash

[0189]

[0191] In some embodiments, the actuation retention marks provide physical indicia of the relative position of the leash actuator and lead leash

[0190]

[0192] In some embodiments, the physical indicia comprises tactile feedback

[0191]

[0193] In some embodiments, the leash actuator further comprises a biasing mechanism for fixation of the relative position of the leash actuator and lead leash.

[0192]

[0194] In some embodiments, the leash actuator further comprises a ratcheting spring mechanism for fixation of the relative position of the leash actuator and lead leash

[0193]

[0195] In some embodiments, the leash actuator further comprises a linear actuator for fixation of the relative positions of the leash actuator and lead leash

[0194]

[0196] In some embodiments, linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other

[0197] In some embodiments, the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes

[0195]

[0198] In some embodiments, the leash actuator is connected to a hinge anchor concentrically positioned at a hinge axle of the arm.

[0196]

[0199] In some embodiments, the lead head comprises at least one arm, the plurality of conductive electrodes are positioned at the at least one arm, and the at least one arm is outwardly biased relative to the lead head.

[0197]

[0200] In some embodiments, the system further comprises a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0198]

[0201] In some embodiments, the lead head retraction sheath comprises a deployable sheath.

[0199]

[0202] In some embodiments, the system further comprises a leash slit that deploys the lead head retraction sheath.

[0200]

[0203] In some embodiments, the system further comprises a leash actuator coupled to the lead head retraction sheath for controlling a position of the lead head retraction sheath.

[0201]

[0204] In some embodiments, the leash slit deploys the deployable sheath by communicating motion from an interior of the leash to an exterior of the leash and head where the deployable sheath resides.

[0202]

[0205] In some embodiments, the leash slit shifts the lead head retraction sheath for full removal from the lead head when deployed

[0203]

[0206] In some embodiments, the leash slit shifts the lead head retraction sheath for partial removal from the lead head when deployed.

[0204]

[0207] In some embodiments, the lead head retraction sheath further comprises at least one side opening through which the at least one arm extends when deployed.

[0205]

[0208] In some embodiments, the leash slit allows to shift the deployable sheath out of its initial overlap with the lead head when deployed

[0206]

[0209] In some embodiments, the leash slit shifts the deployable sheath for partial removal from the lead head when deployed.

[0207]

[0210] In some embodiments, the deployable sheath further comprises at least one side opening through which the at least one arm extends when deployed.

[0211] In some embodiments, a position of the at least one side opening controls an amount of extension of the at least one arm

[0208]

[0212] In some embodiments, a position of the at least one side opening controls an amount of extension of the at least one arm

[0209]

[0213] In some embodiments, the at least one arm is linear when fully extended.

[0210]

[0214] In some embodiments, the at least one arm comprises a curvature when fully extended.

[0211]

[0215] In some embodiments, the at least one arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0212]

[0216] In some embodiments, the plurality of conductive electrodes comprises an array of conductive electrodes.

[0213]

[0217] In some embodiments, the array of conductive electrodes extends along a longitudinal axis (z) of the system.

[0214]

[0218] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0215]

[0219] In some embodiments, the array of conductive electrodes extends along a first transverse axis (x) that is transverse the longitudinal axis (z).

[0216]

[0220] In some embodiments, the expansion system expands the area of coverage in a direction along the first transverse axis (x).

[0217]

[0221] In some embodiments, the expansion system expands the area of coverage in a direction along the first transverse axis (x) and in a direction along the longitudinal axis (z).

[0218]

[0222] In some embodiments, the array of conductive electrodes extends along a second transverse axis (y) that is orthogonal to the first transverse axis (x) and transverse the longitudinal axis (z).

[0219]

[0223] In some embodiments, the expansion system expands the area of coverage in a direction along the second transverse axis (y).

[0220]

[0224] In some embodiments, the expansion system expands the area of coverage in a direction along the second transverse axis (y) and in a direction along the longitudinal axis (z).

[0221]

[0225] In some embodiments, the array of conductive electrodes extends along the longitudinal (cranial-caudal) axis (z) of the patient.

[0226] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0222]

[0227] In some embodiments, the array of conductive electrodes extends along the dorsal- ventral axis (y) of the patient that is perpendicular to the longitudinal axis (z).

[0223]

[0228] In some embodiments, the expansion system expands the area of coverage in a direction along the axis (y).

[0224]

[0229] In some embodiments, the array of conductive electrodes extends along the transverse (from the left to the right side of the patient) axis (x) of the patient that is perpendicular to the longitudinal axis (z) and to the dorsal -ventral axis (y).

[0225]

[0230] In some embodiments, the expansion system expands the area of coverage in a direction along the transverse axis (x).

[0226]

[0231] In some embodiments, the expansion system expands the area of coverage in a direction along the transverse axis (y).

[0227]

[0232] In some embodiments, the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

[0228]

[0233] In some embodiments, the expansion system expands the area of coverage in a curved direction resulting from combinations of the three axes (x, y, and z) in order to position the electrodes along the curved surface of the thecal sac.

[0229]

[0234] In some embodiments, the lead head comprises at least one arm, wherein a proximal end of the at least one lead head is anchored to a portion of the lead head, the plurality of conductive electrodes are positioned at the at least one arm, and the at least one arm is outwardly biased relative to the lead head.

[0230]

[0235] In some embodiments, the system further comprises a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0231]

[0236] In some embodiments, the at least one arm has a sigmoidal shape when released at deployment.

[0232]

[0237] In some embodiments, the sigmoidal arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0233]

[0238] In some embodiments, the system further comprises a deployable sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

[0239] In some embodiments, the at least one arm has a sigmoidal shape when released at deployment with the parallel peripheral portions of the sigmoid parallel / aligned with the longitudinal axis (z).

[0234]

[0240] In some embodiments, the lead head comprises multiple lead arms, and further comprising: a plurality of link arms; and a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, wherein the link arms are coupled to the multiple lead arms at opposite ends of the multiple lead arms, each link arm coupled between one of the multiple lead arms and a deployable arm, so that at deployment, the distance between the multiple lead arms is decreased in a direction along a longitudinal axis of the system, and a distance between the corresponding deployable arms is increased in a direction along a transverse axis of the system

[0235]

[0241] In some embodiments, the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of shaped link arms; and a leash actuator passing through the plurality of deployable arms and the plurality of shaped link arms in serial arrangement, wherein a distal end of the leash actuator is anchored at a distal-most arm of the plurality of deployable arms and the plurality of shaped link arms, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of shaped link arms.

[0236]

[0242] In some embodiments, at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system

[0237]

[0243] In some embodiments, at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the shaped link arms is increased in a direction along a transverse axis of the system

[0238]

[0244] In some embodiments, the plurality of conductive electrodes are positioned at the shaped arms

[0239]

[0245] In some embodiments, the system further comprises a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of shaped link arms prior to deployment and releases the plurality of deployable arms and the plurality of shaped link arms at deployment.

[0240]

[0246] In some embodiments, the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of bracket arms; and a leash actuator passing through the bracket arms and pairs of the plurality of deployable arms in parallel arrangement, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of bracket arms.

[0241]

[0247] In some embodiments, at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system

[0242]

[0248] In some embodiments, at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the bracket arms is increased in a direction along a transverse axis of the system

[0243]

[0249] In some embodiments, the plurality of conductive electrodes are positioned at the bracket arms,

[0244]

[0250] In some embodiments, the system further comprises a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of bracket arms prior to deployment and releases the plurality of deployable arms and the plurality of bracket arms at deployment.

[0245]

[0251] In some embodiments, the system further comprises an anchoring system that anchors the lead head in position in the epidural space.

[0246]

[0252] In some embodiments, the anchor system comprises an anchor actuator; and at least one anchor arm at the lead head and coupled to the anchor actuator, the at least one anchor arm responsive to the anchor actuator to engage the anchor arm, thereby anchoring the lead head in position.

[0247]

[0253] In some embodiments, the anchor actuator provides for control over a degree of anchoring of the lead head

[0248]

[0254] In some embodiments, the anchor actuator comprises at least one filament.

[0249]

[0255] In some embodiments, the anchor actuator comprises a gas or fluid-based actuation system.

[0250]

[0256] In some embodiments, the at least one anchor arm is outwardly biased relative to the lead head.

[0251]

[0257] In some embodiments, the at least one anchor arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

[0258] In some embodiments, the lead head further comprises a bridle, and wherein the least one anchor arm is mechanically coupled to the bridle at at least one hinge.

[0252]

[0259] In another aspect, a method for delivering electrical stimulation to an epidural space of a spinal cord of a patient comprises: providing a lead head comprising a plurality of conductive electrodes; providing at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; electrically coupling a stimulation source to the at least one conductor that generates the electrical stimulation signals; and modifying an area of coverage of the conductive electrodes at an expansion system

[0253]

[0260] In another aspect, a method for delivering electrical stimulation to an epidural space of a spinal cord of a patient comprises: providing a lead head comprising a plurality of conductive electrodes; providing at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; electrically coupling a stimulation source to the at least one conductor that generates the electrical stimulation signals; and modifying a spatial orientation of the lead head at a spatial modification system.

[0254]

[0261] In another aspect, a spinal-cord stimulation alignment system comprises: a lead leash configured for advancement with an epidural canal; a lead head coupled to the lead leash; a leash aligner disposed along at least a portion of the lead leash and configured to geometrically conform the lead leash to a curvature of a thecal sac; a head aligner disposed along at least a portion of the head and configured to orient the lead head within the epidural canal and to conform the lead head longitudinally to a curved thecal surface during spinal flexion; a head coupler located in at least a portion of the lead head; and a leash coupler located in at least a portion of the lead leash.

[0255]

[0262] In some embodiments, the head coupler and leash coupler are configured to join two or more lead heads or lead leashes to form a stabilized rail structure having controlled spacing and adapted to align and maneuver with a curved surface of the thecal sac during advancement into the epidural space

[0256]

[0263] In some embodiments, at least one of the leash aligner and the head aligner defines a hydrodynamically efficient geometry selected from bullet- or spear-shaped profiles to control drag of the system within the epidural space.

[0257]

[0264] In some embodiments, the lead leash or lead head comprises a concave crescent crosssection positioned with its concavity facing the thecal sac.

[0265] In some embodiments, the lead leash or lead head comprises at least one ventral keel cross-section positioned with its concavity facing the thecal sac.

[0258]

[0266] In some embodiments, the lead leash or lead head comprises at least one flexible lateral extension arranged to contact opposing lateral walls of the epidural space and resist lateral translation of the lead.

[0259]

[0267] In some embodiments, the lead leash or lead head comprises at least one dorsally positioned keel configured to contact and align with a dorsal portion of the epidural portion of the epidural space.

[0260]

[0268] In some embodiments, the lead leash or lead head comprises an elongated dorsal spine extending along a longitudinal access to align the lead with the epidural canal.

[0261]

[0269] In some embodiments, the lead leash or lead head comprises an formed cross-section shaped to mimic an epidural transverse geometry to achieve rotational and translational stability.

[0262]

[0270] In some embodiments, the lead leash or lead head comprises a V-shaped geometry configured to achieve rotational and translational stability along a main axis of the thecal sac.

[0263]

[0271] In some embodiments, the lead leash or lead head comprises two-bodies connected by at least one flexible element configured to achieve rotational and translational stability along a main axis of the thecal sac.

[0264]

[0272] In some embodiments, the lead leash or lead head comprises at least three-bodies connected by at least two connecting elements configured to achieve rotational and translational stability along a main axis of the thecal sac.

[0265]

[0273] In some embodiments, the system further comprises: a first head-aligner enabling curvature about a cranio-caudal axis; a second head-aligner enabling curvature about a lateral or horizontal axis; a third head-aligner enabling curvature about a dorsal -ventral axis.

[0266]

[0274] In some embodiments, simultaneous rotation about the three axes yields a partially rotated ribbon geometry.

[0267]

[0275] In some embodiments, the head portion is configured to be temporarily bent or twisted to clean an anatomical obstruction and to return to its aligned geometry.

[0268]

[0276] In some embodiments, the system is configured to maintain orientation of the lead head during spinal flexion, extension, or lateral bending.

[0269]

[0277] In some embodiments, at least one head-aligner comprises a thinned section of structural material.

[0278] In some embodiments, the system further comprises a lead head comprising multiple sub-elements connected by a plurality of joints.

[0270]

[0279] In some embodiments, various combinations of rotations may be applied.

[0271]

[0280] In some embodiments, the plurality of joints are oriented along at least one of the cranio-caudal, lateral, or dorsal -ventral axes to increase the degrees of freedom of the lead head.

[0272]

[0281] In some embodiments, deformation about each axis can occur independently or concurrently to conform the lead head to the epidural canal.

[0273]

[0282] In some embodiments, deformation of the lead head maintains a predetermined electrode orientation relative to a dorsal surface of the spinal cord during spinal motion.

[0274]

[0283] In some embodiments, the lead head is biased towards its aligned configuration after deformation

[0275]

[0284] In another aspect, an actuation control system comprises: a structural base supporting internal components; an external shell enclosing the base, providing a handle and a cover; an internal actuation system generating mechanical energy; an external actuation system including a knob operatively coupled to the internal system; a leash adaptor mechanically coupled with the internal actuation system; and a leash lock configured to secure and release the connectivity port relative to the adaptor leash.

[0276]

[0285] In some embodiments, the structural system and external shell are integrated in the same component forming handle base assembled with a handle cover.

[0277]

[0286] In some embodiments, an actuation knob is mounted onto a knob shaft and allows the operator to provide various types of actuation forces or motions by rotating clockwise or counterclockwise.

[0278]

[0287] In some embodiments, an actuation knob is mounted onto a knob shaft and allows the operator to provide various types of actuation forces or motions by pulling or pushing the actuation knob.

[0279]

[0288] In some embodiments, clockwise rotation of the actuation knob actuates an expansion in geometry in a lead head and / or increases in lead or electrode spacing within the epidural space by pulling on one of two leash actuators.

[0280]

[0289] In some embodiments, counterclockwise rotation of the actuation knob actuates a contraction in geometry and / or decreases the spacing or configuration within the epidural space.

[0290] In some embodiments, an actuation knob includes an internal ratchet system configured to provide tactile feedback to the operator about the amount of movement obtained.

[0281]

[0291] In some embodiments, an actuation knob includes an internal ratchet system configured to provide unidirectional motion reversible with a button or lever.

[0282]

[0292] In some embodiments, the actuation knob further comprises a position indicator allowing the operator to establish the current level of actuation.

[0283]

[0293] In some embodiments, the system further comprises at least one leash adapter to hose two lead leashes following their entry into the system through two ports within the handle base.

[0284]

[0294] In some embodiments, the actuation knob is mounted onto a knob shaft coupled with the handle base via shaft supports that allow axial translation and rotation of the knob shaft.

[0285]

[0295] In some embodiments, the knob shaft includes an internal ratchtet to provide tactile feedback about the degree of movement and / or unidirectional motion reversible with a button or lever.

[0286]

[0296] In some embodiments, the knob shaft provides a knob position indicator allowing the operator to establish the current level of actuation.

[0287]

[0297] In some embodiments, the knob shaft is coupled with an actuation shifter such that translational motion of the knob shaft is transmitted into the same motion for the actuation shifter.

[0288]

[0298] In some embodiments, the actuation shifter mechanically engages with a leash actuator to communicate linear motion after a connectivity port system or lead leash has been inserted into the leash adaptor;

[0289]

[0299] In some embodiments, the leash lock locks the connectivity port into the leash adaptor through a spring-loaded latch engaging a catch feature of the connectivity port.

[0290]

[0300] In some embodiments, depression of the leash lock releases both the connectivity port and the leash actuator from the leash adaptor and the actuation shifter.

[0291]

[0301] In some embodiments, penetration of the connectivity port into the leash adaptor mechanically engages the leash actuator with the actuation shifter.

[0292]

[0302] In some embodiments, depression of the actuation knob extends deploy able arms of the lead head, such that progressive pushing of the actuation knob with tactile and visual feedback allows the operator to control deployment of the deployable arms to expand geometry of the lead head within the epidural space.

[0303] In another aspect, a steering control system comprises: a structural system configured to support and mechanically couple internal components of the steering control system; an external shell enclosing the structural system and defining a handheld housing; an internal steering system configured to generate motion for steering actuation of a spinal-cord-stimulation lead assembly; and an external steering system including a user-operable interface configured to control the internal steering system.

[0293]

[0304] In some embodiments, the system further comprises a leash adaptor configured to mechanically engage the internal steering system and a connectivity port or a lead leash.

[0294]

[0305] In some embodiments, the system further comprises a leash lock configured to secure and release the connectivity port or the lead leash relative to the leash adaptor.

[0295]

[0306] In some embodiments, the system further comprises a signal communication system including electrically conductive elements configured to couple a conduction and insolation system with an IPG or EPG to perform stimulation testing during positioning of a lead head.

[0296]

[0307] In some embodiments, actuation of the external steering system transmits motion through the internal steering system to the lead leash to effect steering of the lead head.

[0297]

[0308] In some embodiments, the structural system and the external shell are integrated into a handle based enclosed by a handle cover assembled by snap-fit features to form a handheld device configured for single-handed operation.

[0298]

[0309] In some embodiments, the system further comprises a steering knob mounted to a steering shaft and configured to translate rotational and / or linear input into a corresponding motion of the internal steering system.

[0299]

[0310] In some embodiments, clockwise rotation of the steering knob pulls a first leash steering actuator and simultaneously pushes a second leash steering actuator to steer the lead head in a first direction, and counter-clockwise rotation produces steering in an opposite direction.

[0300]

[0311] In some embodiments, the steering knob includes a ratchet mechanism configured to provide tactile feedback corresponding to incremental steering displacement and a position indicator configured to indicate a neutral or straight configuration of the lead head.

[0301]

[0312] In some embodiments, the handle base defines internal walls supporting a plurality of shaft supports, each incorporating a bearing to reduce rotational or translational friction of internal shafts.

[0313] In some embodiments, the system further comprises a knob shaft coupled to the steering knob and to a knob gear, the knob shaft including notches engageable by a retainer to define at least two longitudinal positions corresponding to open and closed states of the steering control system.

[0302]

[0314] In some embodiments, the knob gear meshes with a first steering gear coupled to a steering shaft, the first steering gear being meshed with a second steering gear coupled to steering worm gears that engage steering rack gears mounted to steering wagons constrained along a linear rail.

[0303]

[0315] In some embodiments, each steering wagon is mechanically coupled to a leash adaptor engaging a corresponding leash steering actuator to transmit linear steering motion.

[0304]

[0316] In some embodiments, rotation of the steering knob is transmitted through the knob gear and the steering gears to generate opposite rotational motion of the steering shafts and corresponding opposing linear translation of the steering rack gears, thereby producing differential motion of the leash steering actuators to steer the lead head.

[0305]

[0317] In some embodiments, the steering knob includes a knob position indicator providing visual feedback of steering level and direction relative to the handle base.

[0306]

[0318] In some embodiments, the handle base includes perpendicular shaft supports accommodating a knob shaft and a steering shaft, the knob shaft coupled to a knob gear in at or about a one to one ratio with a first steering gear, the steering gears meshed with opposing steering rack gears configured to move in equal and opposite linear directions along the handle base.

[0307]

[0319] In another aspect, an anchoring control system comprises: a structural system configured to support and mechanically couple internal components of the anchoring control system; an external shell enclosing the structural system and defining a handheld housing; an internal anchoring control system configured to generate mechanical motion to actuate an anchoring element of a spinal-cord-stimulation lead assembly; and an external anchoring control system including a user-operable interface coupled to the internal anchoring control system and configured to transmit operator input to selectively deploy or retract an anchoring mechanism of the lead assembly.

[0308]

[0320] In some embodiments, the external shell and the structural system are integrated into a handle base enclosed by a handle cover assembled by snap-fit features to form a handheld device suitable for single hand operation.

[0321] In some embodiments, the system further comprises a leash adaptor configured to mechanically engage a connectivity port or a lead leash to communication motion between the internal anchoring control system and the lead assembly.

[0309]

[0322] In some embodiments, the system further comprises a leash lock configured to secure or release the connectivity port or the lead leash relative to the leash adaptor.

[0310]

[0323] In some embodiments, the external anchoring control system comprises an anchoring knob mounted to a knob shaft supported within the structural system by shaft supports permitting axial translation and rotation of the knob shaft.

[0311]

[0324] In some embodiments, the support shaft includes a ratchet mechanism configured to provide tactile feedback corresponding to incremental movement of the anchoring knob.

[0312]

[0325] In some embodiments, the knob shaft includes a position indicator configured to indicate a current level of anchoring actuation.

[0313]

[0326] In some embodiments, the system further comprises an anchoring shifter mechanically coupled with the knob shaft such that translational motion of the knob shaft is transmitted to the anchoring shifter to actuate a leash anchoring actuator.

[0314]

[0327] In some embodiments, insertion of the connectivity port into the leash adaptor mechanically engages the leash anchoring actuator with the anchoring shifter and disengages an anchoring retention system, permitting relative motion of the leash anchoring actuator and the lead leash.

[0315]

[0328] In some embodiments, actuation of the leash lock releases both the connectivity port and the leash anchoring actuator from the leash adaptor and the anchoring shifter, and re-engages the anchoring retention system to restrict relative motion.

[0316]

[0329] In some embodiments, axial translation of the anchoring knob relative to the external shell progressively deploys deployable arms of a lead head to anchor the lead head within an epidural space.

[0317]

[0330] In another aspect, a spinal-cord-stimulation system comprises: a lead head defining a paddle-type body configured for deployment within an epidural canal via a laminotomy access; a plurality of head lead electrodes disposed on a ventral surface of the lead head and configured to deliver electrical stimulation to the spinal cord; a pair of leash steering actuators coupled to the lead head and configured for relative motion to deform the lead head about a transverse axis to steer the lead head within the epidural canal; and a head aligner comprising structural regions of reduced thickness or grooves configured to permit controlled curvature of the paddle to conform to the thecal sac and to accommodate spinal flexion.

[0318]

[0331] In some embodiments, lead head defines a V-shaped transverse cross-section having a thicker medial portion and thinner lateral portions configured to conform to the curvature of the epidural canal.

[0319]

[0332] In some embodiments, a ventral portion of the paddle conforms with the convex curvature of the thecal sac and a dorsal portion conforms with the concave curvature of the epidural canal.

[0320]

[0333] In some embodiments, the paddle comprises a wider base along a cranio-caudal direction and a narrower paddle head configured to enhance steerability during advancement through the epidural canal.

[0321]

[0334] In some embodiments, the wider base of the paddle includes thin lateral walls configured to contact lateral surface of the epidural canal and to flex laterally to accommodate anatomical obstacles.

[0322]

[0335] In some embodiments, the paddle comprises a cranio-caudally oriented thin region forming a head aligner and a plurality of bilateral head steering folds forming additional head aligners.

[0323]

[0336] In some embodiments, each head steering fold comprising a triangular cuts allowing the paddle to deform into an arched configuration by compression of folds on one side and expansion on an opposite side.

[0324]

[0337] In some embodiments, deformation of the paddle head about the transverse axis generates steerage to facilitate advancement and alignment of the electrodes within the epidural space.

[0325]

[0338] In some embodiments, the lead head comprises a region of reduced thickness or void regions to promote deformability and conformality to the surface of the thecal sac.

[0326]

[0339] In some embodiments, the lead head includes two banks of head lead electrodes disposed of on a slightly angled planes to maximize surface contact with the thecal sac.

[0327]

[0340] In some embodiments, each lead electrode is embedded within and exposed on the ventral surface of the lead head and connected to a lead conductive wire insulated by a lead wire insulation.

[0341] In some embodiments, the lead head conductive wires are organized into two banks converging into respective leash steering actuators through a tension-relief bundling element.

[0328]

[0342] In some embodiments, each leash steering actuator is coupled to the proximal end of the paddle lead head at a hinge anchor.

[0329]

[0343] In some embodiments, the system further comprises a deployable sheath surrounding the leash steering actuators and functioning as a lead leash to facilitate advancement of the lead head into the epidural space.

[0330]

[0344] In some embodiments, the deployable sheath includes a sheath-splitting feature extending along its length to allow removal of the sheath following placement of the lead head.

[0331]

[0345] In some embodiments, relative displacement between the two leash steering actuators deforms the paddle lead head to steer the lead head during advancement or retraction within the epidural space.

[0332]

[0346] In some embodiments, the steerable paddle lead head is configured to three- dimensionally deform about a transverse axis and a ventro-dorsal axis to navigate anatomic obstacles and conforms to the surface of the thecal sac.

[0333]

[0347] In another aspect, a method for alignment of a spinal-cord stimulation system comprises: providing a lead leash configured for advancement with an epidural canal; providing a lead head coupled to the lead leash; disposing a leash aligner along at least a portion of the lead leash and configured to geometrically conform the lead leash to a curvature of a thecal sac; disposing a head aligner along at least a portion of the head and configured to orient the lead head within the epidural canal and to conform the lead head longitudinally to a curved thecal surface during spinal flexion; positioning a head coupler at at least a portion of the lead head; and positioning a leash coupler at at least a portion of the lead leash.

[0334]

[0348] In another aspect, a method for actuation control of a system comprises: providing a structural base supporting internal components; providing an external shell enclosing the base, providing a handle and a cover; providing an internal actuation system generating mechanical energy; providing an external actuation system including a knob operatively coupled to the internal system; providing a leash adaptor mechanically coupled with the internal actuation system; and providing a leash lock configured to secure and release the connectivity port relative to the adaptor leash.

[0349] In another aspect, a method for steering control of a system comprises: providing a structural system configured to support and mechanically couple internal components of the steering control system; providing an external shell enclosing the structural system and defining a handheld housing; providing an internal steering system configured to generate motion for steering actuation of a spinal-cord-stimulation lead assembly; and providing an external steering system including a user-operable interface configured to control the internal steering system.

[0335]

[0350] In another aspect, a method for anchoring control of a system comprises: providing a structural system configured to support and mechanically couple internal components of the anchoring control system; providing an external shell enclosing the structural system and defining a handheld housing; providing an internal anchoring control system configured to generate mechanical motion to actuate an anchoring element of a spinal-cord-stimulation lead assembly; and providing an external anchoring control system including a user-operable interface coupled to the internal anchoring control system and configured to transmit operator input to selectively deploy or retract an anchoring mechanism of the lead assembly.

[0336]

[0351] In another aspect, a spinal-cord-stimulation method comprises: providing a lead head defining a paddle-type body configured for deployment within an epidural canal via a laminotomy access; providing a plurality of head lead electrodes disposed on a ventral surface of the lead head and configured to deliver electrical stimulation to the spinal cord; providing a pair of leash steering actuators coupled to the lead head and configured for relative motion to deform the lead head about a transverse axis to steer the lead head within the epidural canal; and providing a head aligner comprising structural regions of reduced thickness or grooves configured to permit controlled curvature of the paddle to conform to the thecal sac and to accommodate spinal flexion.

[0337] INCORPORATION BY REFERENCE

[0338]

[0352] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes. BRIEF DESCRIPTION OF THE DRAWINGS

[0339]

[0353] Fig. 1 illustrates a schematic view of a system comprising a SCSL System 10, consistent with the present inventive concepts.

[0340]

[0354] Fig. 2A illustrates a schematic view of an Access System 100, consistent with the present inventive concepts.

[0341]

[0355] Fig. 2B illustrates an embodiment of Access System 100, consistent with the present inventive concepts.

[0342]

[0356] Fig. 2C illustrates an embodiment of Access System 100, consistent with the present inventive concepts.

[0343]

[0357] Fig. 2D illustrates additional details of the embodiment of Access System 100 shown in Fig. 2C, consistent with the present inventive concepts.

[0344]

[0358] Fig. 2E illustrates additional details of the embodiment of Access System 100 shown in Fig. 2C, consistent with the present inventive concepts.

[0345]

[0359] Fig. 2F illustrates additional details of the embodiment of Access System 100 shown in Fig. 2C, consistent with the present inventive concepts.

[0346]

[0360] Fig. 2G illustrates an embodiment of Lead Steering Control System 113, consistent with the present inventive concepts.

[0347]

[0361] Fig. 2H illustrates an embodiment of Access System 100 comprising the embodiment of System 113 shown in Fig. 2G, consistent with the present inventive concepts.

[0348]

[0362] Fig. 21 illustrates additional details of the embodiment of Access System 100 shown in Fig. 2H, consistent with the present inventive concepts.

[0349]

[0363] Fig. 2J illustrates additional details of the embodiment of Access System 100 shown in Fig. 2H, consistent with the present inventive concepts.

[0350]

[0364] Figs. 2K, 2L, 2M, 2N, 20 illustrate an embodiment of Access System 100, consistent with the present inventive concepts.

[0351]

[0365] Fig. 2P illustrates an embodiment of Access System 100, consistent with the present inventive concepts.

[0352]

[0366] Fig. 3A illustrates a schematic view of an External Anchoring System 200, consistent with the present inventive concepts.

[0353]

[0367] Figs. 3B, 3C, and 3D illustrate an embodiment of an External Anchoring System 200, consistent with the present inventive concepts.

[0368] Fig. 3E illustrates an embodiment of an External Anchoring System 200, consistent with the present inventive concepts.

[0354]

[0369] Figs. 3F, 3G, 3H, and 31 illustrate an embodiment of an External Anchoring System 200 shown in Fig.3E in combination with the embodiment of Access System 100 shown in Fig. 2K, consistent with the present inventive concepts.

[0355]

[0370] Fig. 4 illustrates a schematic view of a Structure System 300, consistent with the present inventive concepts.

[0356]

[0371] Fig. 5A illustrates a schematic view of a Lead Alignment System 400, consistent with the present inventive concepts.

[0357]

[0372] Fig. 5B illustrates embodiments of a Lead Alignment System 400, consistent with the present inventive concepts.

[0358]

[0373] Fig. 5C illustrates embodiments of a Lead Alignment System 400, consistent with the present inventive concepts.

[0359]

[0374] Fig. 5D illustrates embodiments of a Lead Alignment System 400, consistent with the present inventive concepts.

[0360]

[0375] Fig. 5E illustrates embodiments of a Lead Alignment System 400, consistent with the present inventive concepts.

[0361]

[0376] Fig. 6A illustrates a schematic view of a Geometry Control System 500, consistent with the present inventive concepts.

[0362]

[0377] Fig. 6B illustrates an embodiment of a Geometry Control System 500, consistent with the present inventive concepts.

[0363]

[0378] Fig. 6C illustrates an embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0364]

[0379] Fig. 6D illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0365]

[0380] Fig. 6E illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0366]

[0381] Fig. 6F illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0367]

[0382] Fig. 6G illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0383] Fig. 6H illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0368]

[0384] Fig. 61 illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0369]

[0385] Fig. 6 J illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0370]

[0386] Fig. 6K illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0371]

[0387] Fig. 6L illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0372]

[0388] Fig. 6M illustrates another embodiment of a Head Actuation System 550, consistent with the present inventive concepts.

[0373]

[0389] Fig. 6N illustrates a schematic view of Actuation Control System 570, consistent with the present inventive concepts.

[0374]

[0390] Fig. 60 illustrates an embodiment of Actuation Control System 570, consistent with the present inventive concepts.

[0375]

[0391] Fig. 6P illustrates an embodiment of Actuation Control System 570, consistent with the present inventive concepts.

[0376]

[0392] Fig. 7A illustrates a schematic view of a Steerability System 600, consistent with the present inventive concepts.

[0377]

[0393] Fig. 7B illustrates an embodiment of a Steerability System 600, consistent with the present inventive concepts.

[0378]

[0394] Fig. 7C illustrates an embodiment of Head Steering System 650, consistent with the present inventive concepts.

[0379]

[0395] Fig. 7D illustrates another embodiment of Head Steering System 650, consistent with the present inventive concepts.

[0380]

[0396] Fig. 7E illustrates another embodiment of Head Steering System 650, consistent with the present inventive concepts.

[0381]

[0397] Fig. 7F illustrates another embodiment of Head Steering System 650, consistent with the present inventive concepts.

[0398] Fig. 7G illustrates a schematic view of Steering Control System 670, consistent with the present inventive concepts.

[0382]

[0399] Fig. 7H illustrates an embodiment of Steering Control System 670, consistent with the present inventive concepts.

[0383]

[0400] Fig. 71 illustrates another embodiment of Steering Control System 670, consistent with the present inventive concepts.

[0384]

[0401] Fig. 7 J illustrates another embodiment of Steering Control System 670, consistent with the present inventive concepts.

[0385]

[0402] Fig. 7K illustrates another embodiment of Steering Control System 670, consistent with the present inventive concepts.

[0386]

[0403] Fig. 8A illustrates a schematic view of Internal Anchoring System 700, consistent with the present inventive concepts.

[0387]

[0404] Fig. 8B illustrates a schematic view of Internal Anchoring System 700, consistent with the present inventive concepts.

[0388]

[0405] Fig. 8C illustrates a schematic view of Anchoring Control System 760, consistent with the present inventive concepts.

[0389]

[0406] Fig. 8D illustrates an embodiment of Anchoring Control System 760, consistent with the present inventive concepts.

[0390]

[0407] Fig. 9 illustrates a schematic view of Conduction and Isolation System 800, consistent with the present inventive concepts.

[0391]

[0408] Fig. 10 illustrates a schematic view of Feedback System 900, consistent with the present inventive concepts.

[0392]

[0409] Figs. 11A illustrates a schematic view of Assembler System 1000, consistent with the present inventive concepts.

[0393]

[0410] Fig. 11B illustrates an embodiment of System 10, consistent with the present inventive concepts.

[0394]

[0411] Figs. 12A and 12B illustrate an embodiment of System 10, consistent with the present inventive concepts.

[0395]

[0412] Figs. 13A and 13B illustrate an embodiment of System 10, consistent with the present inventive concepts.

[0413] Figs. 14A and 14B illustrate an embodiment of System 10, consistent with the present inventive concepts.

[0396]

[0414] Fig. 15 illustrates an embodiment of System 10, consistent with the present inventive concepts.

[0397]

[0415] Fig. 16A illustrates an embodiment of System 10, consistent with the present inventive concepts.

[0398]

[0416] Fig. 16B illustrates an embodiment of System 10, consistent with the present inventive concepts.

[0399]

[0417] Fig. 17 illustrates an embodiment of System 10, consistent with the present inventive concepts.

[0400] DETAILED DESCRIPTION OF THE DRAWINGS

[0401]

[0419] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0402]

[0420] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0403]

[0421] It will be further understood that, although the terms first, second, third, and so on may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0404]

[0422] It will be further understood that when an element is referred to as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," and the like).

[0405]

[0423] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g, within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0406]

[0424] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate to an anatomical site (e.g, a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0407]

[0425] As used herein, the term “proximal”, and "distal" when used to describe a location or direction of any components of the inventive matter here presented are intended from the perspective of the patient’s anatomy and within the intended modality of use for the component being described. For example, the proximal portion of any component described is the one closer to the patient’s head (z.e., cranial), while using the component as intended. Vice versa, the distal portion of the same component is the one farther from the patient’s head (i.e., caudal), while using the component as intended.

[0408]

[0426] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper" and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. , rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0409]

[0427] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0428] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example, "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0410]

[0429] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0411]

[0430] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0412]

[0431] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have

[0413] A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A,

[0414] B, and C, the feature can have only one or two of A, B, or C.

[0415]

[0432] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0416]

[0433] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0417]

[0434] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0418]

[0435] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereinabove.

[0419]

[0436] As described herein, “room temperature” shall mean temperature of the environment surrounding the systems and devices of the present inventive concepts. Higher temperature includes temperature above room temperature or simply a temperature that is greater than another temperature, such as a positive differential temperature across one or more components of a system. Lower temperature includes temperature below room temperature or a temperature that is less than another temperature, such as a negative differential temperature across one or more components of a system.

[0420]

[0437] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross- sectional area as the cross section of the component being described.

[0438] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0421]

[0439] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and / or a transducer. In some embodiments, a functional element is configured to deliver energy and / or otherwise treat tissue (e.g., a functional element configured as a treatment element). Alternatively, or additionally, a functional element (e.g., a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluidmaintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0422]

[0440] The term "actuator" where used herein is to be taken to include any component or combination of components that transfer mechanical energy from one location / position to another location / position, and / or convert other forms of energy into mechanical energy. For example, an actuator can be a rod that can transfer a force applied at one of its two ends, to the second end. An actuator can be active, such a stepper motor that converts electrical energy into mechanical rotational or translational force, or passive, such as a rod that communicates a force applied at one end to the other end of the rod, etc.

[0441] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb), sound (e.g. , a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively, or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. , a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0423]

[0442] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0424]

[0443] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0425]

[0444] As used herein, the term “electrode array” and “lead” are synonymous, as current manufacturers use these terms synonymously. The lead is the implant that remains within the patient at the end of the implant procedure, whether during a trial implant or a permanent implant.

[0426]

[0445] As used herein, “delivery” refers to generally the insertion of a lead head into the critical region, for example the epidural space. “Deployment” refers generally to the operation of expanding a width of the lead head following insertion into the epidural space.

[0427]

[0446] As used herein, “percutaneous” epidural access and “percutaneously” refers to the access into the epidural space obtained by minimally invasive approach by penetrating through the fascia, muscle, and ligamentum flavum with a small object without the need for light-based visualization, such as an open surgical approach entailing incisions into the soft tissue surrounding the spine and a laminotomy or laminectomy.

[0428]

[0447] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0429]

[0448] It is to be understood that at least some of the figures and descriptions of the inventive concepts are not in scale, and / or the relative scale among different elements within the same image are not necessarily meant to have equivalent scales, and have been simplified for formatting purposes and to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0430]

[0449] It is to be understood that at least some of the figures and description of the inventive concepts provide a two-dimensional schematic representation of the components, which in some cases might not reflect the accurate order of the components along the z-axis (perpendicular to the plane of observation), or accurate transparency shadings in order to facilitate the visibility of the components and reduce clutter in the image. However, the correct order of such elements can be clearly established by those skilled in the art based on the described function.

[0431]

[0450] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0432]

[0451] Embodiments of the systems, devices, mode of use, and methods described herein can be directed to systems, devices, mode of use, and methods to deliver temporary and / or permanent electrical stimulation to the spinal cord in the epidural space with multiple advantages over existing solutions.

[0433]

[0452] Referring now to Fig. 1. A schematic view of a SCSL System 10, comprising multiple subsystems and components and combinations thereof consistent with the present inventive concepts, as follows. One or more of the following subsystems and components can be omitted or combined in specific embodiments of SCSL System 10 herein presented. The order of presentation of the following subsystems and components is not necessarily indicative of the chronological order used in the modes of use and methods here presented, and will be specifically described in the specific embodiments of SCSL System 10 herein presented.

[0434]

[0453] Access System 100 (e.g., access needle) to enable delivery and guidance of SCSL into the epidural space from the either the skin during trial lead implantation, or subcutaneous space (following skin incision and retraction) during the permanent lead implantation, through the muscle layers and ligamentum flavum.

[0435]

[0454] External Anchoring System 200 to enable the secure, safe, and consistent temporary and / or permanent anchoring and positioning of SCSL components (e.g, Access System, Lead Leash, etc.) outside the epidural space during and / or after lead implantation. For example, a rigid / semi-rigid support structure sutured to the muscle / fascia layer for preventing motion of Lead Leash after implantation. System 200 enables to hold Access System 100 with more reliability, controllability, and stability, especially when enhanced features like those described in this application (e.g, geometry expansion, steering, anchoring, etc. , which may require more mechanical stability, are in place.

[0436]

[0455] Structure System 300 comprising one or more elements to provide the structural framework to enable sufficient static and dynamic mechanical cohesiveness for SCSL throughout its implantation and lifespan.

[0437]

[0456] Alignment System 400 to enable the internal alignment of the lead along the thecal sac during lead advancement and the efficient / effective electrode positionings.

[0457] Geometry Control System 500 to enable SCSL geometry / size / configuration expansion into the epidural space, and / or SCSL geometry / size / configuration contraction to retrieve SCSL from patient and / or reposition SCSL, and / or to achieve the correct electrode spacing (in the cranio-caudal, and / or lateral directions), and / or lateral curvature of the lead array, and / or other configuration of the lead electrodes.

[0438]

[0458] Steerability System 600 to achieve reliable and accurate SCSL positioning (along the cranio-caudal, and / or lateral, and / or dorsal-ventral directions) of any individual lead pair and / or the full lead array following epidural access and during lead insertion / advancement, and / or lead placement, and / or lead retrieval. System 600 can provide multi-axis directional control, including advancement, retraction and rotation / angulation.

[0439]

[0459] Internal Anchoring System 700 to achieve lead stability and prevent lead migration / displacement or lateral movement within the epidural space temporarily during SCSL advancement into the epidural space, and / or temporarily or permanently after correct lead placement has been achieved.

[0440]

[0460] Electrical Stimulation Conduction and Isolation System 800 to safely and efficiently communicate electrical stimulation to the spinal cord within the SCSL.

[0441]

[0461] Feedback System 900 to provide passive (e.g., radio-opaque material, marks to define penetration depths, colors to discriminate among different components, etc.) and / or active feedback about SCSL position and / or its function, about the patient, or interactions thereof.

[0442]

[0462] Assembler System 1000 to provide optional, temporary guidance, and temporary or permanent assembly and / or anchoring function to other components of System 10 (e.g., a support catheter with one or more functions such as steerability, which can be additionally inserted in the epidural space to provide control and function to other components of System 10, or to existing percutaneous leads or paddle lead, etc.).

[0443]

[0463] Referring now to Fig. 2A. A more detailed schematic view of an Access System 100 (System 100) consistent with the present inventive concepts: System 100 can comprise a separate component comprising one or more Existing Access Needle 101 (e.g., Tuohy or Coude' epidural access needles; 14G - 2.108mm OD; 1.6mm ID), and / or one or more Enhanced Access System 102 (System 102). System 102 can comprise the following features: An Internal Lumen 103 with a regular or varying circular or modified / modifiable cross-sectional area e.g., oval with round or pointed ends, elliptic, crescent, rectangular, squared, V-shaped, U-shaped; S-shaped; star-shaped, slot-shaped, other rounded geometries, and combinations); An External Cylindrical Needle 104, which can have different lengths, geometries, and curvatures and can comprise at least expandable material; An Access Hub 105 of various geometries for the handling and positioning of System 100; A Port 106 for enabling watertight / airtight pressurization of the lumen of System 100; An Orifice 107 connected to Lumen 103 and Needle 104 with equal or different cross-sectional area and shape to those of Lumen 103 (e.g., oval with round or pointed ends, elliptic, pointed oval, crescent, rectangular, squared, astroid, V-shaped, U-shaped; S-shaped; star-shaped, slot-shaped, other rounded geometries, and combinations), and a regular or varying orifice longitudinal profile (e.g., blunt regular bevel, stepped bevel, etc. , Position Identification Aids 108 to aid in the identification of the position of the access system relative to the patient and / or relative to the lead position (e.g., markings to identify the depth of the access system relative to patient's anatomy); Rotation Control Flanges 109 to enable the application of suitable torque to rotated System 100 around its main axis; A Position Control System 110 aid in the continuous or stepwise controlled longitudinal and rotational movement of System 100 by providing a tactile and acoustic feedback; A Position Lock System 111 to secure / lock and / or release / unlock the position and orientation of the Access System during and after positioning (e.g., integration with external support / anchoring system); A Lead Rotation Control System 112 to aid in the orientation (e.g., rotation around its main axis) of the SCSL; A Lead Steering Control System 113 to aid in the steering of the SCSL; A Lead Geometry Control System 114 to aid in the Geometry Control System (e.g., SCSL unfolding - upon entrance or folding - upon retrieval can occur via the interaction between the geometry of the SCSL and that of the Access System); An Access Splitting Feature 115 enabling the splitting of the access system in two halves (i.e., allowing the splitting / opening of Access Lumen 104); A Protective Feature 116 at the tip of System 100 which mechanically protects the thecal sac upon System 10 access to the epidural space, and can further aid in the dissection and / or tissue compartmentalization during System 10 access to the epidural space and can be permanent, deployable, or removable; An Access Stylet 117, a removable internal lumen component with sharp point for use during initial insertion of System 100; an Access Obturator 118, a removable internal lumen-occluding component with round and soft point to seal and protect the access system lumen when needed, a removable Dilator 119, a removable element, which expands the cross-sectional area of Needle 104 when needed, and; any combinations of these features.

[0464] Referring now to Fig. 2B. In a non-limiting embodiment consistent with the present inventive concepts, System 100 is an enhancement of a Tuohy or Coude' (shown) needle to allow the fine control of its penetration depth into the skin (when used for trial lead insertion), lumbar- dorsal fascia, back muscles, and ligamentum flavum. This embodiment is intended for the combined use of System 100 with an External Anchoring System 200. In this embodiment, Position Control System 110 and Position Lock System comprise a series of fine circumferential grooves of defined width (e.g., 0.5mm), depth (e.g., 0.3mm), and spacing (e.g., 0.5mm) regularly distributed along the length on Needle 104. Each of these grooves has a number of equally spaced pits (e.g., pit diameter 0.5mm and pit depth 0.3mm) distributed along the circumference of the groove. When slidingly inserting System 100 into the lumen of External Anchoring System 200, these grooves can allow the insertion (and removal) of System 100 in a stepwise manner with a concurrent tactile and auditory feedback provided to the operator when each subsequent groove is engaged by the dedicated feature of System 200. Furthermore, the pits allow for the stepwise rotation and tactile / auditory feedback after a number of pits is engaged by a dedicated feature in System 200. An additional feature in System 200 can lock the ability to advance / retract and / or rotate System 100 into System 200. This figure also shows representative embodiments of the System 100 components Stylet 117, Obturator 118, and Dilator 119.

[0444]

[0465] Referring now to Figs. 2C-F. In another non-limiting embodiment consistent with the present inventive concepts, System 100 is again an enhancement of a Tuohy or Coude' (shown) needle (Fig. 2C-a) to allow its penetration through the ligamentum flavum with a lower resistance than that encountered with standard circular cross-section epidural access needles (shown in Fig. 2C-b), thus reducing the risk of spinal cord injury. The ligamentum flavum, given its anisotropic and tightly compacted fibrous collagenous nature (characterized by dominant fiber orientation along the cranio-caudal direction), offers the highest resistance during the epidural access procedure, and as such, it requires the highest insertion forces. Given the high forces involved and the minimal margin of penetration depth error allowed due to the narrow space (1-2 mm) separating the ventral surface of the ligamentum flavum from the delicate thecal sac dorsal surface, the controlled penetration of System 100 through the ligamentum flavum and into the epidural space represents the highest procedural risk for spinal cord lesion during epidural access applications despite the use of standard "loss of resistance" approaches and imaging guidance (e.g., fluoroscopy). In order to mitigate this risk, at least the cross-sectional geometry of the System 100 at the level of Orifice 107 can have a non-circular geometry (e.g., pointed oval, elliptic, etc.) characterized by a longer axis and a shorter axis, as shown in examples in Fig. 2C-c / d. Aligning the longer axis of such a non-circular geometry with the dominant direction (z.e., vertical / cranio- caudal) of the collagen fibers in the ligamentum flavum facilitates the insertion of System 100 by extending the length of the vertical dissection of the amorphous membrane (interfibrous membrane) embedding the two adjacent bundles of vertically-oriented fibers at the point of needle entry, and resulting in smaller retraction angles between fibers. This approach can be used to either reduce the resistance of System 100's entry with similar cross-sectional areas (Fig. 2C-c) to that of standard circular needles (Fig. 2C-b), and / or to maintain a similar entry resistance as that of a standard circular access needle despite System 100 having larger cross-sectional areas (Fig. 2C- d). This embodiment of System 100 can further leverage Rotation Control Flanges 109 to easily overcome the torque required to rotate the needle 90° around its main axis following the insertion of the needle tip into the epidural space (Fig. 2D-g / h). Such orientation enables to further insert / advance System 100 into the epidural space with the short axis of its modified cross-section parallel to the dorsal -ventral axis. In this orientation System 100's rotation around its main axis is prevented by the geometry of the epidural space (Fig. 2D-i; cross-sectional perspective).

[0445]

[0466] Fig. 2D illustrates a qualitative comparison in vertical dissection lengths and retraction angles in the ligamentum flavum resulting from the insertion of a standard access needle (SAN; a; typical Fiber Retraction Angle 9SAN = 90°; SAN Vertical Dissection Length = 1) and one of the embodiments of System 100 (S100; b; Osioo = 38°; S100 Vertical Dissection Length = 2).

[0446]

[0467] Fig. 2E-a illustrates a model and formula used to estimate the Horizontal Tension (TfX) generated by the insertion of System 100 between two vertical fibers under Tension (T) as a Function of the Fiber Retraction Angle (0). This model suggests that the horizontal tension (and resulting frictional forces) acting on the surface of System 100 during its insertion through the ligamentum flavum greatly increases with increasing Fiber Retraction Angle. Fig. 2E-b illustrates a model and formulas to estimate the Fiber Vertical Dissection Length as a function of the retracting object diameter (OD) and the Fiber Retraction Angle (0). This model shows how increasing Fiber Vertical Dissection Lengths and decreasing retracting object diameter produce smaller Fiber Vertical Dissection Lengths.

[0447]

[0468] Fig. 2F illustrates a graph and numerical examples estimating the relationship between Fiber Retraction Angle (Horizontal Axis) and both 1) Horizontal Tension as a multiple of the Vertical Tension (Tvert) acting on the fibers of the ligamentum flavum (Left Vertical Axis), and the Vertical Dissection Length as a multiple of the outer diameter (OD) of the access needle use (Right Vertical Axis). This numerical estimation example shows that a standard access needle with outer diameter OD producing a Fiber Retraction Angle of 90° produces a baseline Horizontal Tension acting on its walls equal to the vertical force acting on the fibers of the ligamentum flavum (Tvert). In contrast, the embodiment of System 100 described in Figs. 2C-E with a cross-section smaller axis equal to OD and a larger axis length approximately double of OD, produces a significantly smaller Fiber Retraction Angle of 38° and a resulting Horizontal Tension approximately 1 / 3 than that calculated for the standard access needle. This example corroborates the advantage of System 100 described in Figs. 2C-E.

[0448]

[0469] Referring now to Figs. 2G-I. In another non-limiting embodiment of System 100 consistent with the present inventive concepts, a Lead Steering Control System 113 (System 113) is illustrated. In Fig. 2G, System 113 comprises additional elements to be used in combination with a standard or an enhanced Tuohy or Coude' needle. System 113 can comprise a Steering Control Hub 113a (a plastic hub similar to the hub ofa standard access needle allowing the operator to handle, push-pull, and rotate System 113), a Port 113b (e.g., a female quick connect medical port allowing for the connection to a syringe and for the separate insertion of a SCSL), Position Aids 113c (e.g., markings impressed on Hub 113a to allow the operator to track the rotational position of Hub 113a relative to that of Access Hub 105), a Needle 113d (e.g., an elongated plastic or metal tubing with an outer diameter similar to the inner diameter of Needle 104), a Lumen 113e with an inner diameter allowing the internal hosting and sliding of an SCSL, a Flexible Joint 113f positioned toward the proximal end of System 113, allowing the elastic bending of Needle 113d around a solid angle lower than 30° without generating any permanent deformation or kinking, an Orifice 113g at the proximal end of Needle 113d, a Flexible Protective Feature 116a (e. ., a flexible curved ramp with lateral walls facing Orifice 113 able to envelope a portion of the cylindrical walls of a SCSL and bend it to an equivalent curvature) which may be dynamically used during the advancement, deployment, and retraction of the SCSL to aid in its steering and alignment while further allowing to protect the thecal sac from mechanical injury due to its rounded back geometry and the redirection of the SCSL preventing the SCSL to impinge directly into the thecal sac, and a Spacer 113h (e.g., a C-shaped cylindrical component, which can be securely clipped on Steering Control Hub 113a to engage it in different positions within Spacer 113h. Following this engagement, Spacer 1 13h allows the relative rotation but not the translation between Spacer 113h and Hub 113a).

[0449]

[0470] Fig. 2H illustrates an embodiment of the present invention in which Access System 100 comprises a standard or an enhanced Tuohy or Coude' (shown) needle combined with the embodiment of System 113 described in Fig. 2G. In this embodiment, System 113 is coaxially and slidingly inserted into Lumen 103 of Needle 104 through Port 106, which creates a circumferential seal around Needle 113b. Needle 113d can slide in and out and rotate relative to Needle 104. The relative rotational position between these two components can be adjusted by holding Hub 105 and rotating Hub 113a in relation to Hub 105, and measured / controlled via Position Identification Aids 108 and Position Aids 113c, respectively. Spacer 113h can be clipped to engage both Hub 113a and Hub 105, prevent the relative longitudinal sliding of Needle 113d and Needle 104, and maintain a fixed distance between the proximal end of Hub 113a and the distal end of Hub 105 while allowing the relative rotation between Hub 113a / Needle 113d and Hub 105 / Needle 104. In this embodiment, two configurations can be obtained as follows: a retracted configuration shown in Fig. 2H-a and an extended configuration shown in Fig. 2H-b. In the retracted configuration, Spacer 113h holds Hub 105 and Steering Control Hub 113a at a defined distance allowing the Flexible Protective Feature 116a to be retracted within Needle 104 (i.e., not protruding externally to Orifice 107). This configuration can be used during the insertion of this embodiment of Access System 100 into the epidural space. During the insertion of Access System 200 into the skin, fascia, and muscle layer, a Stylet 117 (not shown) can be inserted into the Lumen 113e and secured through Port 113b. After encountering the high resistance of the ligamentum flavum, the operator would disconnect the hub of Stylet 117 from Port 113b and connect a standard 'loss of resistance' syringe to detect the entrance into the epidural space. Following this step, the operator would disconnect the syringe from Port 113b and switch the configuration of this embodiment of System 100 into an extended configuration by temporarily removing Spacer 113h, pressing Steering Control Hub 113a against Hub 105 to push the Flexible Protective Feature 116a outside Orifice 107, and by replacing Spacer 113h to firmly hold the system in the extended configuration. In another similar embodiment, Spacer 113h is constructed to allow stepwise changes in relative longitudinal position between Hub 113a / Needle 113d and Hub 105 / Needle 104 with a mechanism similar to that described for Position Control and Lock Systems 110 / 111 (Grooves and Pits) in Fig. 2B, while still allowing the relative rotation between these pairs of components. In this embodiment, progressively approximating Hub 113a / Needle 1 13d and Hub 105 / Needle 104 causes a progressive extension of Flexible Protective Feature 116a out of Orifice 113g into the epidural space. This progressive extension allows a progressive increase in the angle of curvature imparted by Flexible Protective Feature 116a to Lead Head 350. In some embodiments, the relative angle of curvature of Flexible Protective Feature 116a can be comprised between 0° and 90°. Flexible Protective Feature 116a can prevent Orifice 107 to inadvertently injure the thecal sac. In an alternative embodiment, multiple extended configurations can be obtained by enabling Spacer 113h to hold Hub 105 and Steering Control Hub 113a at a discrete number of progressively smaller distances. In this alternative embodiment, the level of release of Flexible Protective Feature 116a can be modulated to obtain different levels of curvatures of the ramp. Once the Flexible Protective Feature 116a has been extended to the desired level, a SCSL (figure shows a standard percutaneous lead) can be routed into this embodiment of Access System 100 through Port 113b by pushing Lead Leash 330 while holding Steering Control Hub 113a. As Lead Head 350 passes Orifices 113g and 107 and engages with the ramp of Flexible Protective Feature 116a, an additional curvature is given to Lead Leash 330. By changing the relative rotation of Hub 105 to patient and the relative rotation of Steering Control Hub 113a and Hub 105, the operator can effectively adjust the position of Lead Leash at the point of epidural access to correct the solid angle required for epidural access and obtain full alignment of the SCSL Lead Leash 330 with the main axis (cranial-caudal) of the epidural space at the level of the epidural access. This is because needles are necessarily placed at an angle to the cranial-caudal midline axis due to the presence of the spinous processes, the correction of the initial angle to this axis obtained by Flexible Protective Feature 116a as described above adds degrees of freedom to steerage and guidance enhancing accuracy and speed of lead placement. This system can be further used in combination with standard methods for steering a percutaneous lead to enhance the steering and positional control capabilities of existing systems.

[0471] Fig. 21 illustrates the use of the embodiment of Access System 100 described in Fig. 2H following its access into the epidural space through the ligamentum flavum. Fig. 2I-a shows a coronal view (dorsal perspective) of a portion of the lumbar spine in which a simplified representation of Access System 100 is shown (ligamentum flavum at the point of access is hidden). Following the extension (partial or complete) of Flexible Protective Feature 116a and the deployment of Lead Head 350, as described in Fig. 2H-b, it is possible to change the alignment / orientation ( / .e., steer) of Lead Head 350 (initially) and Lead Leash 330 (subsequently) during the lead advancement into the epidural space by rotating Steering Control Hub 113a relatively to Hub 105. For example, a counterclockwise rotation of Steering Control Hub 113a while holding Hub 105 steady, will cause the Flexible Protective Feature 116a (which has a curved ramp channeling the lead) to turn the lead (head / leash) to the left into the epidural space, as vice versa. This new degree of freedom allowing the independent articulation / rotation of the lead at the point of epidural access can allow to better control the 3D alignment of the SCSL within the epidural space during its insertion / advancement and its final positioning. Fig. 2I-b shows a sagittal view (left perspective) showing the epidural space in a portion of the lumbar spine in which Access System 100 is shown. Following the extension (partial or complete) of Flexible Protective Feature 116a, the thecal sac is protected from the potential injury caused by the inadvertent over-insertion of Needle 104 into the epidural space. Flexible Protective Feature 116a further prevents potential perforation injuries caused by the inadvertent impingement of the SCSL on the thecal sac.

[0450]

[0472] Fig. 2 J further illustrates the use of the embodiment of Access System 100 described in Fig. 2H following its access into the epidural space through the ligamentum flavum. Again, a coronal view (dorsal perspective) of a portion of the lumbar spine in which a simplified representation of Access System 100 is shown (ligamentum flavum at the point of access is hidden). Following the extension (partial or complete) of Flexible Protective Feature 116a and the deployment of Lead Head 350, as described in Fig. 2H-b, it is possible to create a more complex articulation than that allowed with a standard Coude' access needle, whose curved tip enables a limited degree of steerage by rotating Hub 105 relative to the patient. In particular, with the addition of Lead Steering Control System 113 as described in Figs. 2G and 2H, the independent rotation of Steering Control Hub 113a can allow an additional degree of freedom to obtain alignment / orientation (z.e., steer) of Lead Head 350 (initially) and Lead Leash 330 (subsequently) during the lead advancement into the epidural space by rotating Steering Control Hub 113a relatively to Hub 105 after Hub 105 has been rotated relatively to the patient. For example, assuming the epidural access has been achieved from the left side of the spinous process (as shown), a clockwise rotation of Hub 105 will allow the Coude' curved tip to impart a right-hand rotation of the lead toward the mid axis of the spine. From this position, a counterclockwise rotation of Steering Control Hub 113a while holding Hub 105 steady, will impart a secondary lefthand rotation allowing the cranial -caudal alignment of Lead Head 350 / Lead Leah 330 along the mid axis of the spine.

[0473] Fig. 2K illustrates an embodiment of the present invention in which Access System 100 comprises an enhanced Tuohy (shown in Fig. 2K-a) or Coude' needle in which additional features enable to increase the cross-sectional area of Needle 104, Lumen 103, and Orifice 107 following its access through the ligamentum flavum and into the epidural space using standard methods. The increase in cross-sectional area of access into the epidural space can enable functionalities and features in SCSL System 10 consistently with the present invention. One of the features providing enhanced function to a standard access needle in this embodiment, is an embodiment of Position Control and Lock Systems 110 / 111 previously described. In this embodiment, Systems 110 / 111 consists of multiple features, including two adjacent circumferentially-oriented grooves carved into the cylindrical surface of Needle 104 (as shown in Fig. 2K-a-l), and shade / color modifications of standard Position (Depth) Identification Aids 108 to inform the operator of the progressive attainment of a longitudinal positioning. The most distal of the two grooves has a vertical wall distally and a ramp-shaped wall with increasing diameters from the distal toward the proximal direction of Needle 104. The more proximal groove has a vertical wall at both ends. The circumferential surface of the proximal groove has two round pits positioned at the opposite ends of the circumference. The location of these grooves on Needle 104, the orientation of the pits into the proximal groove, and the shading rationale for Aids 108 will be explained later in this section. This embodiment of Access System 100 further includes a Dilator 119 component / system (shown in Figs. 2K-b / c), which consists of a C-shaped Hub 119a, circumferentially open via a Dilator Hub Channel 119b with a width closely similar to the diameter of Needle 104, and provided with a distal Dilator Port 119c of internal diameter larger than the diameter of Needle 104. Within Hub 119a (as shown in Section 2K-c), internal hollow compartments host a Lock Release Button 119e emerging from the external circumferential surface of Hub 119 which can slide in a channel whose main axis is oriented perpendicularly to the external circumferential surface of Hub 119a. Button 119e is internally mechanically coupled with a V-shaped Lock Release Spring 119f Each of the two opposite arms of Spring 119f is further mechanically coupled with a Locking Pin 119g. Each of the two Pin 119g can slide within a channel whose main axis is oriented perpendicularly to both the external circumferential surface of Hub 119a and the previously described channel for Button 119e. The assembly of Button 119e, Spring 119f, and the two Pin 119g within the internal hollow compartments of Hub 119a are arranged in a manner that, at rest, the two Pin 119g tips are coaxial and at a mutual distance smaller than the outer diameter of Needle 104. This assembly is also arranged in such a manner that, when depressing Button 119e, the structure of Spring 119f causes a progressive increase in mutual distance between the two tips of Pin 119g, and when releasing Button 119e, the distance between the two tips of Pin 119g returns to the original resting position. The same assembly enables an opposing force (proportional to the elastic modulus of Spring 119f and to the distance between the two Pin 119g tips) when the distance between the two Pin 119g tips is increased. Dilator 119 is further provided with a cylindrical Sheath 119h which stems from Hub 119a and extends for a length shorter than the length of Needle 104, but with an external diameter larger than the diameter of it and tapering at its proximal tip into the same outer diameter of Needle 104 with a beveled Dilator Orifice 119j. Sheath 119h is provided with a Dilator Lumen 119k following the same cylindrical and tapered tip geometry of that of Sheath 119h with an internal diameter also larger than that of Needle 104. Sheath 119h is further provided with a longitudinally-oriented Sheath Slit 119i of width smaller than the outer diameter of Needle 104 and extending between Hub 119a and Orifice 119j aligned with the midlines of Dilator Hub Channel 119b and the beveled geometry of Orifice 119j . Dilator 119 is further provided with a tubular tapered Sleeve 119m, which internally lines Sheath 119h with an outer diameter closely following the inner diameter of Sheath 119h and with inner diameter closely following the outer diameter of Needle 104. Sleeve 119m further provides additional structural stability to Dilator 119, especially during its insertion into the epidural space. Sleeve 119m is also provided with a longitudinally oriented slit aligned with Sheath Slit 119i. The wall of Sleeve 119m is also provided with two distal small openings oriented 180° from each other around the circumferential surface of Sleeve 119m (not shown). These openings are further oriented in such a way that the axis connecting the centroids of the two openings is perpendicular to the circumferential location of the slit on Sleeve 119m. These two openings allow the two Locking Pin 119g to pass the thickness of Sleeve 119m (mechanically coupling and aligning Sleeve 119m within Dilator 119) and engage with the underlying Position Control and Lock Systems 110 / 111 (Grooves and Pits) on Needle 104. Sleeve 119m is further provided with a Sleeve Hub 1191 that enables the operator to control the longitudinal position of Sleeve 119m and its removal from Sheath 119h. Optionally, an additional feature (besides the two aforementioned openings) can be added to Sleeve Hub 1191 and Dilator Hub 119a to ensure that the slit of Sleeve 119m is rotationally aligned with Sheath Slit 119i.

[0474] Referring now to Fig. 2L. An assembly view of the embodiment of Access 100 described in Fig. 2K is shown. In this assembly, Dilator 119 (shown rotated axially 90° counterclockwise and with a sectional view of Sheath 119h and Sleeve 119m) is fully coupled with Needle 104. In this assembly view it is possible to appreciate how the openings of Orifice 107 and Sheath Orifice 119j are coincident and how the tapered geometry of Sheath 119h is progressively expanding the diameter of Needle 104 into that of the body of Sheath 119h. This view also allows one to appreciate how the flexible / elastic nature of Sheath 119h allows it to follow the tip curvature of a Tuohy (shown) or Coude' needle. The assembly further shows how Sleeve 119m fills the internal space between Needle 104 and Dilator Lumen 119k. The operator can control and align the relative rotational alignment of Dilator Hub 119a over Hub 105 (in order to achieve the aforementioned coincidence between the orifices of the Needle 104 and Sheath Orifice 119j) using the Sheath Orientation Aid 119d (on Dilator Hub 119a) in reference to the Position (Rotation) Identification Aids 108 (on Hub 105).

[0451]

[0475] Referring now to Figs. 2M, 2N, and 20. These figures show a possible sequence of operation for the embodiment of Access 100 described in Figs. 2K-L to achieve an epidural access of a larger cross-sectional area than that achieved with a standard access system. Fig. 2M-a shows the achievement of an epidural access with the enhanced Tuohy needle described in Figs. 2K-L via standard techniques. Following the correct positioning of Needle 104 (Fig. 2M-a), the operator can approach the exposed portion of Needle 104 with Dilator 119 at an angle with Sheath Slit 119i facing Needle 104, engage Dilator Orifice 119j with Needle 104 (Fig. 2M-b). The operator can then progressively merge the axes of Dilator 119 and Needle 104 shrouding Needle 104 with Dilator 119 via the deformation and opening of Sheath Slit 119i while pushing Dilator 119 toward the proximal portion of Needle 104 and reducing the initial angle between Dilator 119 and Needle 104 (not shown). While this merging of axes occurs, Dilator 119 progressively follows Needle 104 into the fascia / muscle (or skin and fascia / muscle) tissue until the axes are fully coincident and Dilator Hub 119a has received Needle 104 through Dilator Hub Channel 119b (Fig. 2N-a). In this configuration, the operator can then progressively push Dilator 119 on Needle 104 while controlling their relative position using Position Control and Lock Systems 110 / 111 (Grooves and Pits) to anticipate the achievement of the correct longitudinal alignment of Dilator 119 on Needle 104 via: 1) the visual shading on the marks impressed on Needle 104; 2) the tactile achievement of the first groove on Needle 104 engaged by the two Locking Pin 119g, and; 3) the achievement of the final (correct) longitudinal and rotational position by the tactile and fail safe achievement of the second groove and the engagement of the two pits by the two Locking Pin 119g (Fig. 2N-b). The operator can then firmly hold Dilator Hub 119a and depress Lock Release Button 119e with one hand, while carefully removing both Sleeve 119m and Needle 104 by holding Sleeve Hub 1191 and Needle 104 with the other hand (Fig. 2O-a), until leaving in place only Dilator 119 correctly positioned into the epidural space (Fig. 2O-b), which can now be accessed through Dilator Port 119c with a significantly larger cross-sectional area lead than that afforded with any standard access needle.

[0452]

[0476] Fig. 2P illustrates an embodiment of the present invention in which Access System 100 comprises an enhanced Tuohy (shown in Fig. 2P-a) or Coude' needle in which additional features include a Hub 105 with a Port 106 with internal diameter larger than the internal diameter of Needle 104. Hub 105 is further provided with a Position (Rotation) Identification Aids 108 which allows the operator to track the position of the proximal Orifice 107, and a Splitting Feature 115 consisting of a thinning and / or weakening and / or embrittling treatment made along a straight line covering the full length of the upper side (side facing the orifice) of Needle 104. This treatment is also made along the full length of the curved proximal tip of Needle 104 at the lower side of the needle. This feature enables to increase the cross-sectional area of Needle 104, Lumen 103, and Orifice 107 following Needle 104 access through the ligamentum flavum and into the epidural space using standard methods. In another embodiment (not shown), Needle 104 can be made of a polymeric material that can be deformed via elastic, plastic, viscoelastic, or combination thereof modalities. The expansion of Needle 104 is achieved by mechanically breaching Splitting Feature 115 (or by deforming Needle 104) via the insertion of a larger caliber Dilator 119 (whose embodiment is described below) throughout the full length of Lumen 103. The increase in cross- sectional area of access into the epidural space can enable functionalities and features in SCSL System 10 consistently with the present invention. In this embodiment, Dilator 119 (shown in Figs. 2P-b / c), consists of a Hub 119a provided with a distal Dilator Port 119c of diameter larger than the inner diameter of Needle 104 (Lumen 103), and a Sheath Orientation Aid 119d, which assist in maintaining the rotational orientation of Dilator 119 relative to that of Needle 104 under control. Dilator 119 is further provided with a cylindrical Sheath 119h which stems from Hub 119a and extends for a length sufficient to fully penetrate into Needle 104 after passing through Hub 105 / Port 106, but with an external diameter larger than both the inner (Lumen 103) and outer diameter of Needle 104 and tapering at its proximal tip with a beveled Dilator Orifice 119j . Sheath 119h is provided with a Dilator Lumen 119k with diameter larger than that of Needle 104. As shown in Fig. 2P-c, once Dilator is fully inserted into Port 106, the proximal surface of Hub 119a contacts the distal surface of Hub 105 and can no longer be moved forward (proximally) relative to Needle 104. As Dilator 119 is pushed past the length of Port 106 ensuring that Sheath Orientation Aid 119d is aligned with Position (Rotation) Identification Aids 108, a breach is created into the upper Splitting Feature 115, the breach opens cylindrical wall of Needle 104, which creates an open, U-Shaped guide / rail for Dilator 119h. As Dilator 119h is further pushed into Port 106, the upper breach propagates proximally until the full length of the upper Splitting Feature 115 is breached and Dilator 119h further breaches the shorter bottom Splitting Feature 115. In this configuration, Dilator Orifice 119j is now positioned into the epidural space and Dilator Port 119c can be used for the insertion of a larger caliber SCSL.

[0453]

[0477] Referring now to Fig. 3A. A more detailed schematic view of an External Anchoring System 200 (System 200) consistent with the present inventive concepts is shown: System 200 can comprise one or more separate (or detachable) subsystems and / or one or more features, components, or subsystems tethered to the SCSL. System 200 allows the temporary secure insertion, anchoring, and positioning / repositioning of Access System 100 (during the lead insertion and placement) and the temporary and permanent anchoring of the SCSL leash (during the lead insertion and placement and throughout the SCSL lifespan after the implant procedure is complete). The External Anchoring System can be mechanically anchored temporarily to the skin or to an external structure, and / or temporarily or permanently anchored to the fascia layers or muscle overlying the spine, and / or to one or more vertebral bodies (e.g., spinous process, lamina, etc. ) of the spine. This attachment can be achieved via an adhesive, glue, suture, metal staples, or mechanisms incorporated into System 200. System 200 can comprise one or more Base Plates 201, one or more Surface Textures 202, one or more Anchoring Features 203, one or more Hub Bases 204, one or more Hubs 205, one or more Hub Channel 206, one or more Hub Brakes 207, and one or more Depth Control Mechanism 208. System 200 can further include a Plate Splitting Feature 209 and a Hub Splitting Feature 210.

[0454]

[0478] Referring now to Figs. 3B, 3C, and 3D. In a non-limiting embodiment shown in Fig. 3B and consistent with the present inventive concepts, System 200 allows the firm holding of System 100 and the fine control of its penetration depth and independent 3D rotation / orientation around the 3 axes (pitch, yawn, and roll) to adjust and maintain its (System 100) desired orientation / position relative to the patient. System 200 can comprise a Base Plate 201 with one or more through Passage 201a to allow the passage of System 100 through Base Place 201. Base Plate's 201's side facing the spine comprises a Plate Texture 202 to maximize the grip on the underlying tissue (e.g., rigid spikes to penetrate the tissue, concentric circular ridges, engraved patterns, etc.). Base Plate 201 also comprises multiple mechanical Anchoring Features 203 distributed around the perimeter of the plate (e.g., small bores for suture anchoring to underlying tissue). Base Plate 201 comprises a Hub Base 204, which can include at one end a hollow space including a spherical surface acting as the female / socket of a spherical hinge with or without surface treatment to increase friction when a mating male / plug surface is pressed against the female surface, and at the other end, a tubular structure characterized by a smooth cylindrical luminal wall contiguous with the spherical hollow surface and a threaded abluminal wall. Hub 205 also comprises an internal Hub Channel 206 covering the full length of Hub 205 and allowing the insertion / passage and holding of Access System 100. System 200 also comprises a Hub Brake 207, which can be engaged and disengaged to lock and unlock the position of Hub 205 relative to Base Plate 201 (e.g., a thumb nut whose tightening can create sufficient friction between Hub 205 and Hub Base 204 resulting in the locking in place of Hub 205 relative to Hub Base 204 / Plate Base 201). Hub 205 can further comprise a Depth Control Mechanism 208 embodied in one or more ratchet pawls with hemi-circumferential profile located within Hub 205 to finely adjust and limit the penetration of System 100 into Hub Channel 206. Ratchet 208 can be engaged, disengaged, and locked. When engaged, Ratchet 208 allows the unidirectional, stepwise penetration of System 200 into Hub 205 at determined intervals e.g., 0.5 mm per step, etc.). When disengaged, System 200 can freely slide in both directions into Hub 205. When locked, System 200 is firmly locked relative to Hub 205 and cannot be slid in either direction. Each component of System 200 can be constructed of an implantable plastic (e.g., polyethylene, Nylon, Silicone, silicone-based polyurethanes, PEEK, PTFE, etc.), metal (e.g., titanium alloy, cobalt / chrome alloys, magnesium alloys, tantalus, etc.), ceramic (e.g., zirconium, etc.), or composite / combination thereof. Fig. 3C shows the embodiment of System 200 here described in combination with System 100 and in relation to an epidural access use case for temporary lead implantation in which System 100 is inserted directly through the skin and System 200 would be anchored to the skin. Fig. 3D shows the embodiment of System 200 here described in combination with System 100 and in relation to an epidural access use case for permanent lead implantation in which an incision is made to the skin to access the underlying lumbo-Dorsal fascia. In this use case System 100 is inserted in the lumbo-dorsal fascia on which System 200 would be anchored.

[0455]

[0479] Referring now to Figs. 3E, 3F, 3G, 3H, and Fig. 31. In a non-limiting embodiment shown in Fig. 3E and consistent with the present inventive concepts, System 200 allows the firm holding of the embodiment of System 100 described in Fig. 2K in which a larger caliber Dilator 119 can be applied on a smaller caliber standard access system to increase the diameter of the epidural access after an access with a smaller diameter has been achieved. This embodiment of System 200 also enables the reliable and coaxial engagement and coupling of Dilator 119 with System 100. This embodiment of System 200 resembles that shown in Fig. 3B and similarly enables the independent 3D rotation / orientation around the 3 axes (pitch, yawn, and roll) to adjust and maintain System 100's desired orientation / position relative to the patient. Also in this embodiment, System 200 can comprise a Base Plate 201 with one or more through Passage 201a to allow the passage of System 100 through Base Place 201. Base Plate's 201's side facing the spine comprises a Plate Texture 202 to maximize the grip on the underlying tissue (e.g., rigid spikes to penetrate the tissue, concentric circular ridges, engraved patterns, etc.). Base Plate 201 also comprises multiple mechanical Anchoring Features 203 distributed around the perimeter of the plate (e.g., small bores for suture anchoring to underlying tissue). Base Plate 201 comprises a Hub Base 204, which can include at one end a hollow space including a spherical surface acting as the female / socket of a spherical hinge with or without a surface treatment to increase friction when a mating male / plug surface is pressed against the female surface, and at the other end a tubular structure characterized by a smooth cylindrical luminal wall contiguous with the spherical hollow surface and a threaded abluminal wall. System 200 also comprises a Hub 205, which comprises externally at one end the male portion of the spherical hinge (with or without a surface treatment to increase friction when pressed against the female surface) coupling with the female socket of Hub Base 204. At the other end, Hub 205 comprises the outer wall of a tubular surface which flares into a y-shape obtained by merging a second tubular body at an acute angle with the main tubular body of Hub 205 and by removing the inner walls between the two merging tubular bodies. Hub 205 has a through internal Hub Channel 206 allowing the insertion / passage and holding of Access System 100 and a Hub Side Channel 206a enabling the slidingly side insertion / merging of Dilator 119 with a planar alignment of the main axes of Hub Channel 206 / System 100 and Hub Side Channel 206a / Dilator 119. System 200 also comprises a Hub Brake 207 (e.g., a threaded thumb nut) and a Brake Internal Feature 207a (e.g., a washer with a tapered geometry similar to that of a compression fitting washer). These features can be engaged to lock the position of Hub 205 relative to Base Plate 201 in the desired 3D orientation by tightening Hub Brake 207 on the threaded male portion of Hub Base 204, which compresses Feature 207a against the male spherical surface of Hub 205 and resulting in the compression of the same male spherical surface against the female spherical surface of Hub Base 204. This compression can create sufficient friction between the male spherical surface of Hub 205 and the female spherical socket of Hub Base 204 to result in the locking in place of Hub 205 relative to Hub Base 204 / Plate Base 201). Conversely, by untightening Hub Brake 207, it is possible to resume the relative motion of the Hub 205 and Hub Base 204 / Plate 201.

[0456]

[0480] Figs. 3F-3I show a possible sequence of operation for the embodiment of Access 100 described in Figs. 3E to achieve an epidural access of a larger cross-sectional area than that achieved with a standard access system. Fig. 3F-a shows the placement (without anchoring) of System 200 on the Lumbo-Dorsal Fascia (shown) or the back skin (not shown) at the desired spinal level. The Brake Internal Feature 207a is disengaged at this stage. Fig. 3F-b shows the achievement of an epidural access through Hub Channel 206 with the enhanced Tuohy needle described in Figs. 2K-L via standard techniques. Following the correct positioning of Needle 104, the operator can align and anchor System 200 through Anchoring Feature 203, and lock Hub 205 in the desired orientation through Hub Brake 207. Fig. 3G-a shows how the operator can then approximate Dilator 119 to the exposed portion of Needle 104 and insert Dilator 119 into Hub Side Channel 206a following the predefined angle of approach built into Hub 205. With the correct rotational orientation of Dilator 119, the pushing of Dilator 119 into Hub Side Channel 206a causes the overlap and dilation of Dilator 119's Sheath Slit 119i to host the outer diameter of System 100 and progressively apply Sheath 119h on Needle 104. During this process, Sheath 119h curves to merge into Hub Channel 106 coaxially with Needle 104 (Fig. 3G-b). The operator can then progressively shroud Needle 104 with Dilator 119 while pushing Dilator 119 toward the proximal portion of Needle 104 into the fascia / muscle (or skin, fascia / muscle) tissue while controlling their relative position using Position Control 110 to anticipate the achievement of the correct longitudinal alignment of Dilator 119 on Needle 104 (Fig. 3H-a). The operator can then firmly hold Dilator Hub 119a with one hand, while carefully removing both Sleeve 119m and Needle 104 by holding Sleeve Hub 1 191 and Needle 104 with the other hand (Fig. 3H-b), until leaving in place only Dilator 119 correctly positioned into the epidural space (Fig. 31), which can now be accessed through Dilator Port 119c with a significantly larger cross-sectional area lead than that afforded with any standard access needle.

[0457]

[0481] Referring now to Fig. 4. A more detailed schematic view of a Lead Structure System 300 (System 300) consistent with the present inventive concepts is shown. System 300 can comprise multiple subsystems and components and combinations thereof described starting from its distal location toward its proximal location as follows: one or more Lead Connectivity Port 310 (i.e., portion of lead body functionally connecting to an IPG / controller and other external systems); one or more Internal Channel 320 running through the full length of the SCSL; one or more Lead Leash 330 (i.e., elongated portion extending between the Lead Connectivity Port 310 at one end and the Lead Head 350 at the opposite end); one or more Leash-Head Joint 340 (i.e., a transition component between the Lead Leash 330 and Lead Head 350); one or more Lead Head 350 (z.e., portion of SCSL comprising the exposed spine-stimulating electrodes and other systems); one or more lead stylet comprising a Lead Stylet Leash 360, a Lead Stylet Head 370, and a Lead Stylet Hub, which can be inserted into Internal Channel 320 to increase the rigidity of Lead Leash 330 and add a curvature between Lead Leash 330 and Lead Head 350 through Leash-Head 340.

[0458]

[0482] Referring now to Fig. 5A. A more detailed schematic view of an Alignment System 400 (System 400) consistent with the present inventive concepts is shown. System 400 can comprise a Leash Aligner 410 located in at least a portion of Lead Leash 330, and / or a Head Aligner 420 located in at least a portion of Lead Head 350. These systems enable the alignment and / or geometric circumferential conformity of the Lead Leash 330 and / or Lead Head 350 into the epidural canal and around the thecal sac during the advancement of the lead and / or during / after the correct lead position has been achieved. Head Aligner 420 can further include features to facilitate the longitudinal conformity of Lead Head 350 along a curved thecal sac during spinal flexion. Leash Aligner 410 and Head Aligner 420 can further comprise hydrodynamically efficient geometries (e.g., bullet, spear, etc.) to reduce or increase the drag of System 10 within the epidural space during and after placement. System 400 can further comprise a Head Coupler 430 located in at least a portion of Lead Head 350 and Leash Coupler 440 located in at least portion of Lead Leash 330. These systems (430 and 440) allow to join two or more Lead Head 350 and / or Lead Leash 330 creating a more stable 'rail' structure with controlled spacing intrinsically able to align and maneuver with the curved surface of the thecal sac while advancing into the epidural space.

[0459]

[0483] Referring now to Fig. 5B. In non-limiting embodiments consistent with the present inventive concepts, Lead Alignment System 400 can comprise a crescent-shaped cross-section (Fig. 5B-a), or one or more ventrally positioned keels (Fig. 5B-b), or one or more flexible lateral extension (Fig.5B-c) for Lead Leash 330 and / or Lead Head 350 which, when inserted in the epidural space with the concave crescent or keeled portion in contact with the curved thecal sac surface, or when the flexible lateral arms are in contact with the lateral walls of the epidural space, prevents the lead from rotating around its main axis, and / or translating laterally, and / or along the dorsal -ventral direction allowing to maintain the alignment of the lead along the main axis of the thecal sac.

[0460]

[0484] Referring now to Fig. 5C. In other non-limiting embodiments consistent with the present inventive concepts, Lead Alignment System 400 can comprise one or more dorsally positioned keels (Fig. 5C-a), an elongated dorsally positioned spine intended to contact and align with the dorsal portion of the epidural space (Fig. 5C-b), or a formed cross-section intended to mimic the epidural transversal geometry to achieve alignment (Fig.5C-c) for Lead Head 350 which, when inserted in the epidural space, prevent the lead from rotating around its main axis, and / or translating laterally, and / or along the dorsal-ventral direction allowing to maintain the alignment of the lead along the main axis of the thecal sac.

[0461]

[0485] Referring now to Fig. 5D. In other non-limiting embodiments consistent with the present inventive concepts, Lead Alignment System 400 can comprise a V-shaped cross-section (Fig. 5D-a), or multiple bodies connected by one or more flexible elements (2 -bodies with one central element are shown) (Fig. 5D-b), or again multiple bodies connected by one or more flexible elements (3-bodies with two connecting elements are shown) (Fig.5D-c) for Lead Head 350 which, when inserted in the epidural space, prevent the lead from rotating around its main axis, and / or translating laterally, and / or along the dorsal -ventral direction allowing to maintain the alignment of the lead along the main axis of the thecal sac.

[0462]

[0486] Referring now to Fig. 5E. In another non-limiting embodiment consistent with the present inventive concepts, Lead Alignment System 400 can comprise the presence of one or more elements that facilitate the deformation / curvature or change in configuration of Lead Head 350 to increase its conformality with the complex curved geometry / surfaces of the epidural space and thecal sac during and after Lead Head 350 placement / advancement into the epidural space. The same elements can ensure that Lead Head 350 can be transiently deformed to clear potential anatomic restrictions encountered during its placement / advancement into the epidural space. The same elements can ensure that Lead Head 350 position is not altered by the patient’s spine movements and deformations. One or more of these elements, Head Aligner 420a, allow the deformation / curvature or change in configuration of Lead Head 350 around a Cranio-Caudal axis (Fig.5E-a / c). For example, these elements can facilitate the conformality of Lead Head 350 to the transversal curvature of the thecal sac. One or more of these elements, Head Aligner 420b, allow the deformation / curvature or change in configuration of Lead Head 350 around a horizontal lateral axis (Fig.5E-b). For example, these elements can facilitate the conformality of Lead Head 350 to the sagittal curvature of the spine, including that generated during spine flexion. One or more of these elements, Head Aligner 420c, allow the deformation / curvature or change in configuration of Lead Head 350 around a dorsal-ventral axis (Fig.5E-a). For example, these elements can facilitate the conformality of Lead Head 350 during spine lateral flexion. The combined effect of Head Aligner 420a, 420b, and 420c can result in complex 3D deformations / changes in geometry for Lead Head 350 due to various combinations of rotations round the three axes (e.g., Lead Head 350 can assume a partially rotated ribbon geometry as that occurring when a flat paddle configuration partially deforms simultaneously around the ventro-dorsal, cranio-caudal, and lateral horizontal axes, as shown in Fig.5E-d). In non-limiting embodiments, Head Aligner 420a, 420b, and 420c can comprise thinning of the structural material used to construct Lead Head 350 to increase its deformability. In other non-limiting embodiments, Lead Head 350 is composed of multiple subelements connected by joints (e.g., hinge, etc.). In these embodiments they can further comprise one or more joints to allow to increase the number of degrees of freedom for the sub-elements of Lead Head 350 and its overall deformability.

[0463]

[0487] Referring now to Fig. 6A. A more detailed schematic view of a Geometry Control System 500 (System 500) consistent with the present inventive concepts is shown. System 500 can comprise an Actuation Port 510 used as connectivity point for controlling the actuation of System 500 (e.g., a port to infuse under pressure a gas or fluid, a port to access or connect to an actuator element, etc. ,- One or more Actuation Channel 520 used to allow the transfer of the actuation energy necessary to actuate System 500 (e.g., channel to enable the airtight / watertight flow of a gas or fluid throughout the SCSL; channel to allow the sliding or rotation within of one or more actuation elements, etc.),- one or more Leash Actuator 530, and element to transfer and / or generate and / or convert mechanical energy throughout the Lead Leash 330 (e.g., gas or fluid column; wire enabling tensile, and / or compressive, and / or torsional forces along its axis, etc. , An Actuation Retention System 540 (System 540) used to maintain the desired level of actuation of System 500 (e.g., a valve to control the level of fdling and pressurization of Actuation Channel 520; a mechanical brake, lock, or ratchet to maintain the position of an actuation element, etc.); A Head Actuator System 550 (System 550) to transfer and / or generate and / or convert the actuation energy to and within the Lead Head 350 to actuate geometrical modifications in lead / electrodes configuration in the epidural space; An Actuation Deactivation System 560 (System 560), which allows the disconnection of actuator elements from the Head Actuator System 550 (e.g., by electrical detachment using a small electrical current similar to Guglielmi coil detachment with 2- 4 volts and 1 milliamp, mechanical separation using torque fracture, or disengagement by rotation like a screw into thread, etc. , and; An Actuation Control System 570, which can be temporarily engaged with SCSL to allow the operator to control the geometry of the SCSL.

[0464]

[0488] Referring now to Fig. 6B. In a non-limiting embodiment consistent with the present inventive concepts, Geometry Control System 500 comprises a Leash Actuator 530 comprising a high strength filament (e.g., titanium, titanium alloy, aramid, Polybenzoxazole, carbon fiber, Basalt Fiber and S-Glass Fiber, etc.) running into an Actuation Channel 520 hosted within Lead Leash 330. Leash Actuator 530 has suitable length allowing it to be pushed forward and / or pulled backward relatively to Lead Leash 330. The relative axial motion between Leash Actuator 530 and Lead Leash 330 is transferred to System 550, which is embedded into the Lead Head 350. System 550 consists of a Bridle 551 of multiple high strength filaments (as described for Leash Actuator 530) mechanically coupled at their proximal ends to Leash Actuator 530. The distal end of each filament within Bridle 551 is mechanically coupled to a separate Deployable Arm 552 and the underlying Lead Head 350 through a Hinge Pulley 553 and a Hinge Anchor 554, which also couples the same Deployable Arm 552 to Lead Head 350. This coupling allows to convert the axial pulling force transmitted by Leash Actuator 530 into a momentum causing the controlled outward / lateral rotation (and extension) of each Deployable Arm 552 into an 'Open Lead Configuration', as shown in Fig. 6B-b. Conversely, the flexural rigidity of Leash Actuator further allows to retract each Deployable Arm 552 into a 'Closed Lead Configuration' (shown in Fig. 6B- a) by pushing the Leash Actuator 530 into the Lead Leash 330. Alternately, a torsional spring (not shown) built into Hinge Pulley 553 or an elastic component (not shown) within Deployable Arm, ensures that Deployable Arm 552 is in a Closed Lead Configuration when either the torsional spring of elastic component is unloaded. When a tension is applied to Leash Actuator 530, it causes the extension of Deployable Arm 552 and the torsional loading of the torsional spring and the flexural loading of the elastic component. The degree of outward / lateral rotation (and extension) of all Deployable Arm 552 (from fully open to fully closed) can be finely controlled by the extent of relative motion between Leash Actuator 530 and Lead Leash 330. Lead Head 350 can comprise 4 - 16 Deployable Arm 552 split into two opposing banks of Deployable Arm 552. System 540 can comprise a Rubber Orifice 541 (e.g., a rubber membrane with a bore; an O-Ring; a rubber gasket, etc.) through which Leash Actuator 530 is threaded. The area of the Rubber Orifice 541 is smaller than that of the Leash Actuator and, as a result, it provides sufficient friction / resistance with the surface of Leash Actuator 530 to prevent the relative motion between Leash Actuator 530 and Lead Leash 330 unless active force is applied to overcome friction and cause relative axial motion. The operator can monitor the relative position between Leash Actuator 530 and Lead Leash 330 (and hence the degree of all Deployable Arm 552 deployment) through Actuation Marks 542 impressed on Leash Actuator 530. In another embodiment, Actuation Marks 542 can provide stepwise tactile / acoustic feedback to the operator to inform the relative motion and the respective degree of rotation / extension of the Deployable Arm 552. In another embodiment, the actuation marks can comprise visual indicia of the position of the deployable arm. In another embodiment, System 540 can comprise a biasing mechanism, such as a spring mechanism (with or without a ratchet system) that locks the relative position between Leash Actuator 530 and Lead Leash 330 unless a button is depressed to release the spring mechanism and allow the relative motion until the button is released.

[0465]

[0489] Referring now to Fig. 6C. In another embodiment consistent with the present inventive concepts, System 550 still comprises two banks of Deployable Arm 552, but is depicted for simplicity with a reduced number of Deployable Arm 552, whose number can be still comprised between 4 and 16. Each Deployable Arm 552 is mechanically coupled with Lead Head 350 with a Hinge 556. In this embodiment, each of the two banks of Deployable Arm 552 is coupled with a Link Arm 555 connected to each Deployable Arm 552 in that bank via a Hinge 556. This configuration allows the rotation (and lateral extension) of all Deployable Arm 552 in each bank by rotating (and extending) even a single Deployable Arm 552 in that bank. In this embodiment, Leash Actuator 530 is connected to Bridle 551, which consists of two fdaments each connected to a Hinge Anchor 554 positioned concentrically with one of the Hinge 556 for each bank of Deployable Arm 552. The two filaments of Bridle 551 converge into a single point coupled with Leash Actuator 530. In this embodiment, System 550 can be shifted from a 'Closed Lead Configuration' shown in Fig. 6C-a into an 'Open Lead Configuration' (shown in Fig. 6C-b) by pushing the Leash Actuator 530 into the Lead Leash 330, and vice versa. The degree of outward rotation (and lateral extension) of Deployable Arm 552 (from fully open to fully closed) can be also finely controlled by the extent of relative motion between Leash Actuator 530 and Lead Leash 330.

[0466]

[0490] Referring now to Fig. 6D. In another embodiment consistent with the present inventive concepts, System 550 still comprises two banks of Deployable Arm 552, but is depicted again for simplicity with a reduced number of Deployable Arm 552, whose number can be still comprised between 4 and 16. Each Deployable Arm 552 is mechanically coupled with Lead Head System 350 with a Hinge 556 (for each deployable arm). In this embodiment, each of the two banks of Deployable Arm 552 is again coupled with a Link Arm 555 connected to each Deployable Arm 552 in that bank via a Hinge 556. This configuration also allows the rotation (and lateral extension) of all Deployable Arm 552 in each bank by rotating a single Deployable Arm 552 in that bank. In this embodiment, the Leash Actuator 530 acts as a torque bar, and is engaged by rotation (rather than translation / sliding, as previously described). The distal end of Leash Actuator 530 is solidly coupled with Linear Actuator Female 557, which can comprise a cylindrical body with a threaded coaxial bore; as such, it rotates together with Leash Actuator 530. Linear Actuator Female 557 hosts a Linear Actuator Male 558, which can comprise a threaded screw, whose rotational motion around its main axis is prevented by its mechanical coupling with Bridle 551. In this embodiment, a rotation of Linear Actuator Female 557 (from a rotation of Leash Actuator 530) causes a translation of Linear Actuator Male 558, and thus a translation of Bridle 551. In this embodiment, Bridle 551 consists of two high strength filaments, as previously described, converging into a single point. Each end of Bridle 551 is coupled via a Hinge Anchor 554 positioned concentrically with one of the Hinge 556 for each bank of Deployable Arm 552. In this embodiment, System 550 can be shifted from a 'Closed Lead Configuration' shown in Fig. 6D-a into an 'Open Lead Configuration' (shown in Fig. 6D-b) by rotating Leash Actuator 530 into Lead Leash 330. The degree of outward swinging of Deployable Arm 552 (from fully open to fully closed) can be also finely controlled by the extent of rotation of Leash Actuator 530 within Lead Leash 330.

[0467]

[0491] Referring now to Fig. 6E. In another embodiment consistent with the present inventive concepts, System 550 (again depicted for simplicity with a reduced number of Deploy able Arm 552) comprises a single bank of Deploy able Arm 552, whose number can be still comprised between 4 and 16. In this embodiment, each Deployable Arm 552 is individually mechanically coupled with Lead Head 350 with a Hinge 556, and with all the other Deployable Arm 552 through a Link Arm 555 and an additional Hinge 556 for each Deployable Arm 552. This configuration also allows the rotation (and lateral extension) of all Deployable Arm 552 by rotating / ext ending a single Deployable Arm 552. In this embodiment, Leash Actuator 530 can be directly connected through a Hinge Anchor 554 positioned concentrically with one of the Hinge 556 connected to Link Arm 555. Also in this embodiment, System 550 can be shifted from a 'Closed Lead Configuration' shown in Fig. 6E-a into an 'Open Lead Configuration' (shown in Fig. 6E-b) by pushing the Leash Actuator 530 into the Lead Leash 330. The degree of outward swinging of Deployable Arm 552 (from fully open to fully closed) can be also finely controlled by the extent of relative motion between Leash Actuator 530 and Lead Leash 330.

[0468]

[0492] Referring now to Fig. 6F. In another embodiment consistent with the present inventive concepts, System 550 comprises two banks of Deployable Arm 552, whose number can be comprised between 8 (as shown) and 32. In this embodiment, each Deployable Arm 552 is made of a flexible elastic material whose base is structurally anchored to Lead Head 350. In one embodiment, each Deployable Arm 552 is a partial cutout of Lead Head 350. Each of these flexible Deployable Arm 552 has a permanent curved shape, which, when compressed against the body of Lead Head 350 by a cylindrical Deployable Sheath 558, able to slide on both Lead Head 350 and Lead Leash 330, forces the flexible Deploy able Arm 552 to straighten and coalesce into the silhouette of Lead Head 350. The geometry and flexural elastic modulus of Deployable Arm 552 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Deployable Arm 552 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, over-compress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend in the space available. In this embodiment Deployable Sheath 558 can be slid in a forward (proximal) position ('Closed Lead Configuration1) to coalesce all Deployable Arm 552 as shown in Fig. 6F-a by pushing Leash Actuator 530 into the Lead Leash 330 / Actuation Channel 520 via a Deployable Sheath Tab 559 (mechanically coupled to the Proximal end of Leash Actuator 530 and to Deployable Sheath 558), which can slide into Leash Slit 559b. Still in this embodiment, Deployable Sheath 558 can be slid in a backward (distal) position ('Open Lead Configuration') to extend all Deployable Arm 552 as shown in Fig. 6F-b by pulling Leash Actuator 530 from the Lead Leash 330 / Actuation Channel 520 via a Deployable Sheath Tab 559 (mechanically coupled to the Proximal end of Leash Actuator 530 and to Deployable Sheath 558) which can slide into Leash Slit 559b.

[0469]

[0493] Referring now to Fig. 6G. In another similar embodiment to that presented in Fig. 6F consistent with the present inventive concepts, System 550 comprises the same elements and properties described for the embodiment in Fig. 6F, except for cylindrical Deployable Sheath 558 has a Sheath Side Opening 558a for each of the flexible Deployable Arm 552. This feature allows to control the degree of outward swinging of Deployable Arm 552 (from fully open, as in Fig. 6G- a, to fully closed, as in Fig. 6G-b) by controlling the extent of relative motion between Leash Actuator 530 and Lead Leash 330. The geometry and flexural elastic modulus of Deployable Arm 552 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Deployable Arm 552 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, over-compress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend within the space available.

[0470]

[0494] Referring now to Fig. 6H. In another similar embodiment to that presented in Figs. 6F-G consistent with the present inventive concepts, System 550 comprises the same elements and properties described for the embodiments in Fig. 6F-G, except for cylindrical Deployable Sheath 558 is now extended to cover the majority of the length of Lead Head 350 and Lead Leash 330. In this configuration, it is possible to control the relative movement / sliding of Deployable Sheath 558 over Lead Head 350 and Lead Leash 330 at the proximal portion of the SCSL by directly sliding Deployable Sheath 558 over Lead Leash 330 outside of the epidural space. This embodiment also allows to control the degree of outward swinging of Deployable Arm 552 (from fully open, as in Fig. 6H-a, to fully closed, as in Fig. 6H-b) by controlling the extent of relative motion between Deployable Sheath 558 and Lead Leash 330.

[0471]

[0495] Referring now to Fig. 61. In another similar embodiment to that presented in Fig. 6H consistent with the present inventive concepts, System 550 comprises two flexible elastic Deployable Arm 552 whose bases are structurally anchored to Lead Head 350. Each of the two Deployable Arm 552 has a baseline outwardly curved (e.g., sigmoidal, etc.) shape when unstressed / uncompressed. A cylindrical Deployable Sheath 558 extended to cover the majority of the length of Lead Head 350 and Lead Leash 330 keeps the two Deployable Arm 552 under lateral compression, which causes them to assume a straighten linear shape and fit within the lumen of Deployable Sheath 558. The geometry and flexural elastic modulus of Deployable Arm 552 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Deployable Arm 552 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, over-compress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend within the space available. In this embodiment Deployable Sheath 558 can be slid in a forward (proximal) position ('Closed Lead Configuration') to coalesce both Deployable Arm 552 as shown in Fig. 61- a by pushing Deployable Sheath 558 over Lead Leash 330. Deployable Sheath 558 can be slid in a backward (distal) position ('Open Lead Configuration') to extend / deploy laterally both Deployable Arm 552 as shown in Fig. 6I-b by pulling Deployable Sheath 558 over Lead Leash 330.

[0472]

[0496] Referring now to Fig. 6J. In another embodiment, System 550 consists of an accordion structure which comprises two banks of Deployable Arm 552, whose number can be comprised between 8 (as shown) and 32. In this embodiment, each Deployable Arm 552 is mechanically coupled with two Link Arm 555 (one at their proximal end and one at their distal end), which can be made of a flexible elastic material. Each Link Arm 555 is mechanically coupled at one end with a Deployable Arm 552, and at the opposite end with Lead Head 350, which comprises multiple segments aligned along the same longitudinal axis. The most proximal segment of Lead Head 350 is coupled with Leash Actuator 350, which can slide within Actuation Channel 520 and can slide within each segment of Lead Head 350. This configuration allows the length contraction of Lead Head 350 / Head Actuator System 550 and the lateral extension of all Deployable Arm 552 in each bank by pulling Leash Actuator 530. In this embodiment, System 550 can be shifted from a 'Closed Lead Configuration1shown in Fig. 6J-a into an 'Open Lead Configuration' (shown in Fig. 6J-b) by pulling the Leash Actuator 530 into the Lead Leash 330, and vice versa. The degree of outward rotation (and lateral extension) of Deployable Arm 552 (from fully open to fully closed) can be also finely controlled by the extent of relative motion between Leash Actuator 530 and Lead Leash 330 (as shown in Fig. 6J-b, which both show a partial - Left and complete - Right Leash Head 350 length contraction and extension of all Deployable Arm 552).

[0473]

[0497] Referring now to Fig. 6K. In another embodiment, System 550 consists of an assemblable / disassemblable structure which comprises multiple Deployable Arm 552, whose number can be comprised between 4 (as shown) and 16. In this embodiment, each Deployable Arm 552 is mechanically coupled with one or two Shaped Link Arm 555a (e.g., a permanently deformed structure with an internal channel) through the passage of an internal flexible Leash Actuator 530 to form a contiguous structure similar to a strand of beads. This succession of multiple Deployable Arm 552 alternating with Shaped Link Arm 555a held by Leash Actuator 530 can include an Anchor 554a to tether Leash Actuator to the Proximal end of the structure and a differently shaped Shaped Link Arm 555a at its distal end to align the assembled structure coaxially with Lead Leash 330. This multi-component structure within Leash Head 350 can be hosted into the lumen of a Deployable Sheath 558. Leash Actuator 350 can slide within Actuation Channel 520 and within each element of the multi-component structure described. This configuration allows to assemble Lead Head 350 / Head Actuator System 550 and leads to the deployment of a larger pre-formed structure including all Deployable Arm 552 and Shaped Link Arm 555. This assembly can be obtained by first pulling Deployable Sheath 558 to release the components of the multi-component structure, and second, by pulling Leash Actuator 530 until the multi-component structure is self-assembled and rigid into a larger and predefined structure. Also in this embodiment, System 550 can be shifted from a 'Closed Lead Configuration' shown in Fig. 6K-a into an 'Open Lead Configuration' (shown in Fig. 6K-b) and vice versa.

[0474]

[0498] Referring now to Fig. 6L. In another embodiment, System 550 consists of an assemblable / disassemblable structure which again comprises multiple Deployable Arm 552, whose number can be comprised between 8 (as shown) and 32. In this embodiment, each Deployable Arm 552 is mechanically coupled with two Bracket Arm 555b (e.g., a linear structure with multiple side ports with an internal channel passing throughout the structure) through the passage of an internal Bridle 551 to form a closed contiguous structure. At the distal portion of Lead Head 350, this structure also includes two Shaped Link Arm 555a into which internal lumen Bridle 551 is also threaded. This multi-component structure within Leash Head 350 can be hosted into the lumen of aDeployable Sheath 558. Leash Actuator 350 can slide within Actuation Channel 520 and can be tethered to Bridle 551 via Anchor 554a. This configuration allows to assemble Lead Head 350 / Head Actuator System 550 and leads to the deployment of a larger pre-formed structure including all Deployable Arm 552, Bracket Arm 555b, and two Shaped Link Arm 555. This assembly can be obtained by first pulling Deployable Sheath 558 to release the components of the multi-component structure, and second, by pulling Leash Actuator 530 until the multicomponent structure is self-assembled and rigid into a larger and predefined structure. Also in this embodiment, System 550 can be shifted from a 'Closed Lead Configuration1shown in Fig. 6L-a into an 'Open Lead Configuration' (shown in Fig. 6L-b / c) and vice versa.

[0475]

[0499] Referring now to Fig. 6M. In another embodiment, System 550 consists of an assemblable / disassemblable structure which again comprises multiple Deployable Arm 552, whose number can be comprised between 8 (as shown) and 32. In this embodiment, each Deployable Arm 552 is mechanically coupled with two Bracket Arm 555b (e.g., a linear structure with multiple side ports with an internal channel passing throughout the structure) through the passage of an internal Bridle 551 to form a closed contiguous structure. At the distal portion of Lead Head 350, this structure also includes two Shaped Link Arm 555a into which internal lumen Bridle 551 is also threaded. This multi-component structure within Leash Head 350 can be hosted into the lumen of a Deployable Sheath 558. Deployable Sheath 558 is optionally provided with a Sheath Splitting Feature 558b, which run along the full length of Deployable Sheath 558 and enable the splitting of the closed circumference of Deployable Sheath 558 (e.g., this feature can consist of a tearable thinning of the structure / material of Deployable Sheath 558). Leash Actuator 350 can slide within Actuation Channel 520 and can be tethered to Bridle 551 via Anchor 554a. This configuration allows to assemble Lead Head 350 / Head Actuator System 550 and leads to the deployment of a larger pre-formed structure including all Deploy able Arm 552, Bracket Arm 555b, and two Shaped Link Arm 555. This expanded assembly can be obtained by first pulling Deployable Sheath 558 to release the components of the multi-component structure, second, by pulling Leash Actuator 530 relatively to Actuation Channel 520 until the multi-component structure is self-assembled and rigid into a larger and predefined structure, and third, optionally by progressively tearing Sheath Splitting Feature 558b and pulling Deployable Sheath 558 until fully removed from the epidural space. As described, also in this embodiment, System 550 can be shifted from a 'Closed Lead Configuration1shown in Fig. 6M-a into an 'Open Lead Configuration' (shown in Fig. 6M-b / c). Should the optional Sheath Splitting Feature 558b be used to fully remove Deployable Sheath 558, the Open Lead Configuration shown in Fig. 6M-c is no longer reversible, unless a new Deployable Sheath 558 is used and the system is carefully reloaded into it.

[0476]

[0500] Referring now to Fig. 6N. A more detailed schematic view of an Actuation Control System 570 (System 570) consistent with the present inventive concepts is shown. System 570 is intended to be operated by the surgeon implanting the SCSL System 10 into the patient (e.g., a neurosurgeon, etc.) during the insertion, advancement, and positioning of Lead Head 350. System 570 can comprise one or more Structural System 571 used as a mechanical base for the coupling of all the other internal elements of System 570 e.g., a chassis made of polymeric structural material like ABS, and the like, etc.); one or more External Shell 572 used to cover Structural System 571 (e.g., an enclosure with one of more ports, removable access panels, a handle grip for the operator, etc.), one or more Internal Actuation System 573 used to generate the energy needed to actuate System 500 (e.g., an internal mechanism that controls the motion of Leash Actuator 530; a servo motor including controller and battery pack delivering mechanical energy; etc.)-, one of more External Actuation System 574, which engage with the surgeon fingers to control the actuation of System 10 (e.g,. a knob controlling the rotation of a shaft mechanically coupled with System 573; a knob controlling the rotation of a shaft mechanically coupled with a potentiometer controlling the electrical current flowing into System 573; a trigger or button controlling the linear motion of System 573, a trigger controlling an electrical switch, etc.),- one or more Leash Adaptor 575, which mechanically engages with Internal Actuation System 574 and Connectivity Port 310 or more generally with Lead Leash 330 while the surgeon is implanting System 10 into the patient and subsequently disengages with the portion of System 10 that remains implanted into the patient (e.g., a cylindrical receptable with an internal axially-oriented spring hosting and mechanically engaging Connectivity Port 310 of Lead Leash 330 and driving these components in a linear or rotational motion being driven by Internal Actuation System 574). Adaptor 575 can include electrical and pressure holding connections, and can further and independently engage with Leash Actuator 530 and with Actuation Deactivation System 560. Adaptor 575 can further include and mechanically interact with elements of Leash Lock 576, a system to lock and unlock / release the connection between Adaptor 575 and Connectivity Port 310, or more generally with Lead Leash 330. Leash Lock 576 can include a controlling element present outside System 570 (e.g., a spring- loaded button or lever, etc.) connected with elements inside the system mechanically coupled with Adaptor 575 to lock and release Connectivity Port 310 or more generally Lead Leash 330 (e.g., a small latch mechanism engaging with a dedicated catch surface present on the Connectivity Port 310 or more generally Lead Leash 330). Adaptor 575 can further include Signal Communication System 577 consisting of electrically conductive elements to transiently couple elements of Conduction and Isolation System 800 with either an IPG or EPG to perform SCS testing to optimize the positioning of the paddle. In a non-limiting embodiment, System 577 can comprise a cylindrically arranged array of electrical conductors placed within Adaptor 575 to align and map with the corresponding electrodes located in Connectivity Port 310 (and ultimately with all Head Lead Electrode 870 positioned on the Lead Head 350) when Adaptor 575 is engaged with the Lead Leash 330. This cylindrically arranged array of electrical conductors is also electrically connected to a port located on the External Shell 572 where an IPG or EPG can be connected to through a cable to provide electrical stimulation to the patient through System 570. In this embodiment, the IPG / EPG provides testing stimulation through system 570 while the while the physician is optimizing the position of the Lead Head 350 within the epidural space. In this embodiment, System 570 can be disconnected from IPG / EPG and from Connectivity Port 310 or more generally with Lead Leash 330 prior to direct connection of these components to the IPG and patient closure.

[0501] Referring now to Fig. 60. In a non-limiting embodiment consistent with the present inventive concepts, Actuation Control System 570, comprises a handheld device suitable for single hand operations and shown from different projections in Figs. 6O-a / d. In this embodiment Structural System 571 and External Shell 572 are integrated in the same component, which can be assembled as multiple subcomponents via snap fit features / elements. In particular, the device external enclosure and its internal chassis can be constructed as a single component Handle Base 571a. This components has internal structures allowing the mounting of multiple internal components, consistently with what described Fig. 6N. Handle Base 571a can be snap fit with Handle Cover 572a, an additional component which allows to close the external structure of System 570 and separate the internal components from the external environment. At the top portion of System 570, Actuation Knob 574a, mounted onto an Knob Shaft 573a (not shown) allows the operator to provide various types of actuation forces / motions by either rotating clockwise and / or counterclockwise, and / or by pulling or pushing Actuation Knob 574a. For example, the clockwise rotation of the Actuation Knob 574a can actuate an expansion in geometry in Lead Head 350 and / or increase in lead / electrodes spacing / configuration within the epidural space by pulling on one of two Leash Actuator 530 (not shown) and concurrently releasing / pushing on the second Leash Actuator 530 (not shown). Conversely, a counterclockwise rotation of Actuation Knob 574a can actuate a contraction in geometry in Lead Head 350 and / or decrease in lead / electrodes spacing / configuration within the epidural space by inverting the relative translational motion of the two Leash Actuator 530 (not shown). These forces / motions applied to Actuation Knob 574a can also be used to actuate Actuation Deactivation System 560 (not shown), allowing the optional disconnection of actuator elements from the Head Actuator System 550. Actuation Knob 574a can include an internal ratchet system or similar mechanism (not shown) to provide tactile feedback to the operator about the amount of movement obtained (e.g., a click for every degree of rotation, etc.) and / or provide unidirectional motion to Actuation Knob 574a, which can be reversed with a button or lever (not shown). Actuation Knob 574a can further comprise a position indicator (not shown), which allows the operator to establish the current level of actuation. System 570 further comprises two Leash Adaptor 575 (not shown) to host two Lead Leash 330 following their entry into System 570 through two ports within Handle Base 571a. System 570 further comprises Internal Actuation System 574 (not shown), a Leash Lock 576 to engage and disengage the Lead Leash 330 from Leash Adaptor 575 and a Signal Communication System 577 to connect to an EPG / IPG and transport the electrical signals generated by EPG / IPG to Lead Head 350 through System 570 during placement. Both Leash Lock 576 and Signal Communication System 577 can be placed on Handle Base 571a. The components of this device can be made of various plastics and metals including from Butadiene Styrene (ABS), Polycarbonate (PC) / ABS blend, Polypropylene (PP), Polyethylene (PE), Polyvinyl Chloride (PVC), Polystyrene (PS), Polyetheretherketone (PEEK), 304 and 316L Stainless Steel. These polymeric components can be obtained via injection molding or other manufacturing methods. This embodiment of System 570 can comprise external dimensions suitable for being held in one hand (e.g., external dimensions 110 x 40 x 20 mm, etc.). A modality of possible use for this embodiment of System 570 is shown in Fig. 6O-e. In this mode of use, Actuation Knob 574a positioned in the radial portion of the physician’s hand (right hand shown) while Handle Base 571a is gripped within the palm and the thumb and index fingers are operating Actuation Knob 574a (both rotation and linear translation of the knob can be used to change the geometry of Lead Head 350 within the epidural space). The surgeon holding this embodiment of System 570 (with Actuation Knob 574a oriented toward the patients and the point of entry of Lead Leash 330 into the epidural space) can advance (retract) Lead Leash 330 and Lead Head 350 into the patient by pushing (pulling) System 570 toward (away from) the patient with the hand holding System 570 (farther from the patient), while the other hand (more proximate to the patient point of epidural entrance; left hand shown) is used to further guide Lead Leash 330. Still in this embodiment, Signal Communication System 577 (e.g., one or two 4- 16 pole electric adaptor) would be oriented toward the ulnar portion of the hand and one of two connecting cable would be connected between the EPG / IPG and the System 577.

[0477]

[0502] Referring now to Fig. 6P. In a non-limiting embodiment consistent with the present inventive concepts, a similar Actuation Control System 570 as that presented in Fig. 60 is coupled with the embodiment of Geometry Control System 500 described in Fig. 6B. Actuation Knob 574a is mounted onto a Knob Shaft 573a, which is coupled with Handle Base 571a via two Shaft Supports 571b, which allow the axial translation (and rotation to operate additional functions not described in this embodiment) of Knob Shaft 573a. Shaft Supports 571b can include an internal ratchet or similar system (not shown) to provide tactile feedback to the operator about the degree of movement obtained (e.g., a click for every 0.5 mm of motion, etc.) and / or provide unidirectional motion to Knob Shaft 573a, which can be reversed with a button or lever (not shown). Knob Shaft 573a can further provide a Knob Position Indicator 574b, which allows the operator to establish the current level of actuation. Knob Shaft 573a is coupled with Actuation Shifter 573b in a manner that the translational motion of Knob Shaft 573a is transmitted into the same motion for Actuation Shifter 573b (if shaft rotation is enacted, Knob Shaft 573a allows the relative rotation without affecting the linear position of Actuation Shifter 573b). Actuation Shifter 573b can mechanically engage with Leash Actuator 530 to communicate its linear motion to it after Connectivity Port System 310 / Lead Leash 330 has been inserted into Leash Adaptor 575. Leash Lock 576 allows to lock and release Connectivity Port 310 into Leash Adaptor 575. The same component allows to secure the mechanical engagement of Actuation Shifter 573b and Leash Actuator 530. For example, a spring-loaded latch engages with a catch feature (not shown) built into Connectivity Port System 310 and locks it after sufficient penetration of Connectivity Port 310 into Leash Adaptor 575 has been achieved. When the latch locks into the catch feature of Connectivity Port System 310, an additional mechanism (not shown) coupled with the latch and with Actuation Shifter 573b allows the mechanical engagement of Leash Actuator 530 and Actuation Shifter 573b. An additional mechanism (not shown) coupled with the latch allows the disengagement of Actuation Retention System 540. In this embodiment, once Connectivity Port System 310 is fully engaged into Leash Adaptor 575, Leash Actuator 530 is also mechanically engaged with Actuation Shifter 573b and Actuation Retention System 540 (not shown) is disengaged allowing the relative motion of Leash Actuator 730 and Lead Leash 330. When Leash Lock 576 is depressed, both Connectivity Post System 310 and Leash Actuator 530 are released from Leash Adaptor 575 and Actuation Shifter 573b, respectively, and Actuation Retention System 540 is reengaged to prevent the relative motion between Leash Actuator 530 and Lead Leash 330. In this embodiment, the operator can actuate and control the level of deployment of Deployable Arm 552 by controlling the level of penetration of Actuation Knob 574a into Handle Base 571a. When Actuation Knob 574a is depressed (as shown), Deployable Arm 552 are extended out of the body of Lead Head 350. Progressively pushing of Actuation Knob 574a with tactile and visual feedback, allows the operator to finely and reliably control the progressive deployment of Deployable Arm 552 to expand the geometry of Lead Head 350 into the desired level in the epidural space.

[0478]

[0503] Referring now to Fig. 7A. A more detailed schematic view of a Steerability System 600 (System 600) consistent with the present inventive concepts is shown. System 600 can comprise a Steering Actuation Port 610 used as connectivity point for controlling the Steering of System 600 (e.g, a port to infuse under pressure a gas or fluid, a port to access or connect to an actuator element, etc.); One or more Steering Actuation Channel 620 used to allow the transfer of the steering actuation energy necessary to steer System 600 (e.g, channel to enable the airtight / watertight flow of a gas or fluid throughout the SCSL; channel to allow the sliding or rotation within of one or more actuation elements, etc.); one or more Leash Steering Actuator 630, an element to transfer and / or generate and / or convert mechanical energy throughout the Lead Leash 330 (c.g., gas or fluid column; wire enabling tensile, and / or compressive, and / or torsional forces along its axis, etc.); A Steering Retention System 640 (System 640) used to maintain the desired level of steering actuation of System 600 (e.g, a valve to control the level of filling and pressurization of Steering Actuation Channel 620; a mechanical brake to maintain the position of a steering actuation element, etc.); A Head Steering System 650 (System 650) to transfer and / or generate and / or convert the steering actuation energy to and within the Lead Head 350 to actuate steering modifications in lead / electrodes configuration in the epidural space, and; A Steering Deactivation System 670 (System 670), which allows the disconnection of actuator elements from the Head Steering System 650 (e.g., by electrical detachment using a small electrical current similar to Gugliemi coil detachment with 2-4 volts and 1 milliamp, mechanical separation using torque fracture, etc.), and; An External Steering Control System 670, which can be temporarily engaged with SCSL to allow the operator to control the steering during and / or after advancement of the SCSL in the epidural space and trigger System 660;

[0479]

[0504] Referring now to Fig. 7B. In a non-limiting embodiment consistent with the present inventive concepts, Steerability System 600 comprises a Leash Steering Actuator 630 comprising a high strength filament (e.g., titanium, titanium alloy, aramid, Polybenzoxazole, carbon fiber, Basalt Fiber and S-Glass Fiber, etc. ) running into a Steering Actuation Channel 620 hosted within Lead Leash 330. Leash Steering Actuator 630 has suitable length allowing it to be pushed forward and / or pulled backward relatively to Lead Leash 330. The relative axial motion between Leash Steering Actuator 630 and Lead Leash 330 is transferred to System 650, which is embedded into the Lead Head 350 and comprise the mechanical coupling of the distal end of Leash Steering Actuator 630 to a Hinge Anchor 554 coupled with Lead Head 350. System 650 further includes a Flexible Neck 651 element (e.g., a short segment of corrugated soft rubber tubing, etc.) connecting Lead Leash 330 to Lead Head 350 and allowing a single-axis (or multi-axis) relative rotation between Lead Leash 330 and Lead Head 350. This configuration allows to convert the axial pulling / pushing force transmitted by Leash Actuator 530 into a momentum causing the controlled rotation of Lead Head 350 from a 'Straight Configuration', as shown in Fig.7B-a, into a 'Turned Configuration', as shown in Fig. 7B-b, which can be turned to the right and to the left, by the pushing or pulling motion of Leash Steering Actuator 630 and based on the mounting position of Hinge Anchor 554. The turning of Lead Head 350 allows it to steer the SCSL during its cranial advancement (or caudal retraction) of the SCSL into the epidural space. The steering function also allows to rotate / angulate the head to optimize electrode placements. The degree of steering of Lead Head 350 (from fully to the left to fully to the right) can be finely controlled by the extent of relative motion between Leash Actuator 530 and Lead Leash 330. System 640 can comprise a Rubber Orifice 541 (e.g., a rubber membrane with a bore; an O-Ring; a rubber gasket, etc.) through which Leash Steering Actuator 630 is threaded. The area of the Rubber Orifice 541 is smaller than that of the Leash Steering Actuator and, as a result, it provides sufficient friction / resistance with the surface of Leash Steering Actuator 630 to prevent the relative motion between Leash Steering Actuator 630 and Lead Leash 330 unless active force is applied to overcome friction and cause relative axial motion. The operator can monitor the relative position between Leash Steering Actuator 530 and Lead Leash 330 and hence the central position and direction and degree of rotation of Lead Head 350) through Actuation Marks 542 impressed on Leash Steering Actuator 630. In another embodiment, Actuation Marks 542 can provide stepwise tactile / acoustic feedback to the operator to inform the relative motion and the respective degree to rotation / extension of the Deployable Arm 552. In another embodiment, System 640 can comprise a spring mechanism (with or without a ratchet system) that locks the relative position between Leash Steering Actuator 630 and Lead Leash 330 unless a button is depressed to release the spring mechanism and allow the relative motion until the button is released.

[0480]

[0505] Referring now to Fig. 7C. In a non-limiting embodiment consistent with the present inventive concepts, Head Steering System 650 comprises a Lead Head 350 coupled to a Lead Leash 330 via a Flexible Neck 651 element, which allows a single-axis (or multi-axis) relative rotation between Lead Leash 330 and Lead Head 350. It further comprises a Linear Actuator Male 558, whose rotation around its main axis is prevented by its connection to Lead Head 330 though a Hinge Anchor 554. Linear Actuator Female 557, which can comprise a cylindrical body with a threaded coaxial bore is rotationally coupled with Linear Actuator Male 558 at one end, at the other end it is solidly coupled with Leash Steering Actuator 630. In this embodiment, Leash Steering Actuator 630 acts as a torque bar, and is engaged by rotation. In this embodiment, the rotation in one direction of Leash Steering Actuator 630 causes the translation of Linear Actuator Male 558, which causes the rotation of Lead Head 350 in one direction; whereas, the rotation of Leash Steering Actuator 630 in the opposite direction causes the rotation of Lead Head 350 in opposite direction. In this configuration Lead Head 350 can be in a 'Straight Configuration', as shown in Fig.7C-a, into a 'Turned Configuration', as shown in Fig. 7C-b, which can be turned to the right and to the left, by the rotation of Leash Steering Actuator 630 in one direction and the opposite, respectively.

[0481]

[0506] Referring now to Fig. 7D. In another non-limiting embodiment consistent with the present inventive concepts, Head Steering System 650 comprises a Lead Head 350 coupled to a Lead Leash 330 via a Flexible Neck 651 element, which allows a single-axis (or multi-axis) relative rotation between Lead Leash 330 and Lead Head 350. It further comprises two Hinge Anchor 554 each coupled with the distal end of one of the two Leash Steering Actuator 630. In this embodiment, the pushing (or pulling) of one of the two Leash Steering Actuator 630 relative to Lead Leash 330 and / or the pulling (or pushing) of the other Leash Steering Actuators 630 relative to Lead Leash 330 causes the rotation of Lead Head 350 in one direction (or the other). In this configuration Lead Head 350 can be in a 'Straight Configuration1, as shown in Fig.7D-a, into a 'Turned Configuration', as shown in Fig. 7D-b, which can be turned to the right and to the left, by pushing (or pulling) of one of the two Leash Steering Actuator 630 and / or the pulling (or pushing) of the other Leash Steering Actuators 630 relative to Lead Leash 330.

[0482]

[0507] Referring now to Figs. 7E-F. In another non-limiting embodiment consistent with the present inventive concepts, Head Steering System 650 comprises a Lead Head 350 solidly coupled to a Lead Leash 330. Each of two Deployable Arm 552 is connected to Lead Head 350 through two Link Arm 555 (a proximal and a distal Link Arm 555; of equal or different lengths). Each Link Arm 555 is coupled with Hinge 556 at one end with Lead Head 350 and at the other end with Deployable Arm 552. Each Deployable Arm 552 is coupled with one of two Leash Steering Actuator 630 by a Hinge Anchor 554 connected to Hinge 556 coupling the proximal Link Arm

[0483] 555 to its Deployable Arm 552. In this configuration, each Deployable Arm 556, its two Link Arm 555, and Lead Head 350 constitute a four-bar linkage mechanism, which causes Deployable Arm

[0484] 556 to follow a well-defined path specifically designed using standard engineering methods. In this embodiment, each Deployable Arm 556 is first translated outward / away from its initial SCSL axial position, is then moved forward while its distal end is progressively returning toward its original SCSL axial position while its proximal end is further moved outward. At the end of its travel, each Deployable Arm 556 acquires an oblique angle (non parallel to SCSL axis). In this embodiment, the pushing forward of one of the two Leash Steering Actuator 630 relative to Lead Leash 330 causes the outward translation and then forward roto-translation of one of the two Deployable Arm 556, which assumes a determined angle. In this embodiment Lead Head 350 can be advanced straight in the epidural space by pulling both Leash Steering Actuator 630 relatively to Lead Leash 330, as shown in Fig.7E-a. Alternatively, by pushing one Leash Steering Actuator relatively to Lead Leash 330, it is possible to move the Deployable Arm 556 connected to the Leash Steering Actuator 630 being pushed until it assumes an angle, which creates differential directional friction while advancing the SCSL lead into the epidural, and causing a rotation of the SCSL in the opposite direction of to the Deployment Arm 556 being actuated, as shown in Fig. 7E-b. This embodiment also allows the concurrent deployment of each of the two Deployment Arm 556 by partially pushing both Leash Steering Actuator 630 relatively to Lead Leash 330 and allowing the two Deployable Arm 556 to assume a forward converging position (i.e., the distal ends of the two Deployable Arm 556 are closer to the axial position of the SCSL), as shown in Fig. 7F-a. When the two Deployable Arm 556 are held in a symmetric configuration (as shown in Fig. 7F-a), the advancement of the SCSL in the epidural space will be in a straight direction. When from this position one Leash Steering Actuator is pushed and the other is pulled, similarly to the mechanism of 'snowplow turn' in skiing, the SCSL advancement will be associated with steering, as shown in Fig. 7F-b.

[0485]

[0508] Referring now to Fig. 7G. A more detailed schematic view of a Steering Control System 670 (System 670) consistent with the present inventive concepts is shown. System 670 is intended to be operated by the surgeon implanting the SCSL System 10 into the patient (e.g., a neurosurgeon, etc.) during the insertion, advancement, and positioning of Lead Head 350. System 670 can comprise one or more Structural System 6 1 used as a mechanical base for the coupling of all the other internal elements of System 670 e.g., a chassis made of polymeric structural material like ABS, and the like, efc.); one or more External Shell 672 used to cover Structural System 671 (e.g., an enclosure with one of more ports, removable access panels, a handle grip for the operator, etc.),- one or more Internal Steering System 673 used to generate the energy needed to actuate System 600 (e.g., an internal mechanism that controls the motion of Leash Steering Actuator 630; a servo motor including controller and battery pack delivering mechanical energy; etc.) one of more External Steering System 674, which engage with the surgeon fingers to control the Steering of System 10 (e.g,. a knob controlling the rotation of a shaft mechanically coupled with System 673; a knob controlling the rotation of a shaft mechanically coupled with a potentiometer controlling the electrical current flowing into System 673; a trigger or button controlling the linear motion of System 673, a trigger controlling an electrical switch, etc.); one or more Leash Adaptor 675, which mechanically engages with Internal Steering System 674 and Connectivity Port 310 or more generally with Lead Leash 330 while the surgeon is implanting System 10 into the patient and subsequently disengages with the portion of System 10 that remains implanted into the patient (e.g., a cylindrical receptable with an internal axially-oriented spring hosting and mechanically engaging Connectivity Port 310 of Lead Leash 330 and driving these components in a linear or rotational motion being driven by Internal Steering System 674). Adaptor 675 can include electrical and pressure holding connections, and can further and independently engage with Leash Steering Actuator 630 and with Steering Deactivation System 660. Adaptor 675 can further include and mechanically interact with elements of Leash Lock 676, a system to lock and uni ock / rel ease the connection between Adaptor 675 and Connectivity Port 310, or more generally with Lead Leash 330. Leash Lock 676 can include a controlling element present outside System 670 (e.g., a spring-loaded button or lever, etc.) connected with elements inside the system mechanically coupled with Adaptor 675 to lock and release Connectivity Port 310 or more generally Lead Leash 330 (e.g., a small latch mechanism engaging with a dedicated catch surface present on the Connectivity Port 310 or more generally Lead Leash 330). Adaptor 675 can further include Signal Communication System 677 consisting of electrically conductive elements to transiently couple elements of Conduction and Isolation System 800 with either an IPG or EPG to perform SCS testing to optimize the positioning of Lead Head 350. In a non-limiting embodiment, System 677 can comprise a cylindrically arranged array of electrical conductors placed within Adaptor 675 to align and map with the corresponding electrodes located in Connectivity Port 310 (and ultimately with all Head Lead Electrode 870 positioned on the Lead Head 350) when Adaptor 675 is engaged with the Lead Leash 330. This cylindrically arranged array of electrical conductors is also electrically connected to a port located on the External Shell 672 where an IPG or EPG can be connected to through a cable to provide electrical stimulation to the patient through System 670. In this embodiment, the IPG / EPG provides testing stimulation through system 670 while the while the physician is optimizing the position of the Lead Head 650 within the epidural space. In this embodiment, System 670 can be disconnected from IPG / EPG and from Connectivity Port 310 or more generally with Lead Leash 330 prior to direct connection of these components to the IPG and patient closure.

[0486]

[0509] Referring now to Fig. 7H. In a non-limiting embodiment consistent with the present inventive concepts, Steering Control System 670, comprises a handheld device suitable for single hand operations and shown from different projections in Figs. 7H-a / d. In this embodiment Structural System 671 and External Shell 672 are integrated in the same component, which can be assembled as multiple subcomponents via snap fit features / elements. In particular, the device external enclosure and its internal chassis can be constructed as a single component Handle Base 671a. This component has internal structures allowing the mounting of multiple internal components, consistently with what described for Fig. 7G. Handle Base 671a can be snap fit with Handle Cover 672a, an additional component which allows to close the external structure of System 670 and separate / protect the internal components from the external environment and vice versa. At the top portion of System 670, Steering Knob 674a, mounted onto a Steering Shaft 674b (not shown) allows the operator to provide various types of actuation forces / motions by either rotating clockwise and / or counterclockwise, and / or by pulling or pushing Steering Knob 674a. For example, the clockwise rotation of the Steering Knob 674a can actuate a left steering motion / deformation in Lead Head 350 within the epidural space by pulling one of two Leash Steering Actuator 630 and the concurrent and reciprocating pushing of the second Leash Steering Actuator 630. Conversely, a counterclockwise rotation of Steering Knob 674a can actuate a right steering motion / deformation in Lead Head 350 within the epidural space. Steering Knob 674a can include an internal ratchet system or similar mechanism (not shown) to provide tactile feedback to the operator about the amount of movement obtained (e.g., a click for every degree of rotation, etc.). Steering Knob 674a can further comprise a position indicator (not shown), which allows the operator to establish the current level of steering (e.g., a simple example is a notch engraved onto Steering Knob 674a and a corresponding notch engraved onto Handle Base 671a to indicate, when the two notches are aligned, that Lead Head 350 is in a straight configuration, etc.). These forces / motions applied to Steering Knob 674a can also be used to actuate Steering Deactivation System 660 (not shown), allowing the optional disconnection of steering elements from the Head Steering System 650. System 670 further comprises two Leash Adaptor 675 (not shown) to host two Lead Leash 330 following their entry into System 670 through two ports within Handle Base 671a. System 670 further comprises Internal Steering System 673 (not shown), a Leash Lock 676 to engage and disengage the Lead Leash 330 from Leash Adaptor 675 and a Signal Communication System 677 to connect to an EPG / IPG and transport the electrical signals generated by EPG / IPG to Lead Head 350 through System 670 during placement. Both Leash Lock 676 and Signal Communication System 677 can be placed on Handle Base 671a. A modality of possible use for this embodiment of System 670 is shown in Fig. 7H-e. In this mode of use, Steering Knob 674a positioned in the radial portion of the physician’s hand (right hand shown) while Handle Base 671a is gripped within the palm and the thumb and index fingers are operating Steering Knob 674a (both rotation and linear translation of the knob can be used to steer Lead Head 350 within the epidural space). The surgeon holding this embodiment of System 670 (with Steering Knob 674a oriented toward the patients and the point of entry of Lead Leash 330 into the epidural space) can advance (retract) Lead Leash 330 and Lead Head 350 into the patient by pushing (pulling) System 670 toward (away from) the patient with the hand holding System 670 (farther from the patient), while the other hand (more proximate to the patient point of epidural entrance; left hand shown) is used to further guide (and support the advancement and retraction of) Lead Leash 330. Still in this embodiment, Signal Communication System 677 (e.g., one or two 4-16 pole electric adaptor) would be oriented toward the ulnar portion of the hand and one of two connecting cable would be connected between the EPG / IPG and the System 677.

[0487]

[0510] Referring now to Fig. 71. In a similar non-limiting embodiment of a handheld device as that described in Fig. 7H, Steering Control System 670 is shown from three projections. Figs. 7I-a / b show this embodiment of System 670 without Handle Cover 672a (not shown) to expose the internal components. Handle Base 671a comprises a single structural body with the general form of an open parallelepipedal container with one of the six faces missing (Handle Cover 672a not shown). Handle Base 671a has at least an external opening for the passage of Knob Shaft 673a, and one for the passage of Lead Leash 330 (Leash Bore 671c). Handle Base 671a further comprises an internal structure consisting of three parallel walls containing pairs of Shaft Support 671b (e.g., bores allowing the passage of a shaft) and creating three aligned axes. Each of these Shaft Support 671b can incorporate different types of Shaft Bearing 673c (not shown) to reduce rotational and / or translational friction of each shaft within the bores (e.g., sleeves, ball bearings, linear rotary bearing, etc.). A first shaft, Knob Shaft 673a is inserted between two aligned Shaft Support 671b. Knob Shaft 673a is mechanically coupled e.g., via a set screw, key, etc.) to Steering Knob 674a, Knob Gear 673d (e.g., a spur gear, etc.), and Knob Shifter 673b (e.g., only partially shown; an arm communicating the translational motion of Knob Shaft 673a to another internal location to actuate a function (not shown), but allowing the rotation of Knob Shaft 673a within Knob Shifter 673b. Knob Shaft 673a has two circumferential Knob Shaft Notch 673 e that allow to engage the shaft with a Shaft Retainer 673f (e.g., a spring-loaded mechanism like a pogo pin, etc.,- not shown) to stop Knob Shaft 673a at two pre-defined longitudinal positions (e.g., fully open and fully close, etc.) by translating Steering Knob 674a along the main axis of its shaft. A second Steering Shaft 673g is inserted through the second / central line of three aligned Shaft Support 671b. Both Steering Shaft 673g are mechanically coupled (e.g., via a set screw, key, etc.) to a Steering Gear 673h. Knob Gear 673d is mechanically coupled and meshed with the first Steering Gear 673h (e.g., a spur gear with the same pitch, pressure angle, and center distance module as Knob Gear 673d, etc.). If Knob Gear 673d has also same number of teeth as Steering Gear 673h, a 1 :1 gear ratio is obtained. To obtain finer motion control, it is possible to use a gear ratio >1 (gear reduction), and vice versa. The first Steering Gear 673h is mechanically coupled and meshed with an identical second Steering Gear 673h. Both Steering Shaft 673g are also mechanically coupled (e.g., via a set screw, key, etc.) to a Steering Worm Gear 673i. Fig. 7I-c shows the side view of this embodiment of System 670 with the additional removal of Handle Base 671a (not shown). Each Steering Worm Gear 673i is further mechanically coupled with Steering Rack Gear 673j (of tooth geometry consistent with that of Steering Worm Gear 67311), creating a high-ratio rotation to linear speed reduction for Steering Rack Gear 673j, which is nested into and mechanically coupled with Steering Wagon 673k, which is bound by a Linear Rail 671d (not shown) build into the internal bottom face of Handle Base 671a (not shown). Each Steering Wagon 673k is reversibly mechanically coupled with a Leash Actuator Adaptor 675a (e.g., a component meant to mechanically engage with Leash Steering Actuator 630).

[0488]

[0511] Referring now to Fig. 7 J. The same general embodiment of Steering Control System 670 described in Fig. 71 is here presented in simplified form and in combination with a generalized embodiment of Head Steering System 650 presented in Fig. 7D, which uses two Leash Steering Actuator 630 linearly moving in opposite directions to actuate steering function for Lead Head 350. This embodiment describes the principles of operation to obtain steering control of Lead Head 350 via the combined use of Steering Control System 670 and Head Steering System 650. After Connectivity Port System 310 / Lead Leash 330 has been inserted into Leash Adaptor 675. Leash Lock 676 allows to lock and release Connectivity Port 310 into Leash Adaptor. The same component allows to secure the mechanical engagement of each of the two Steering Wagon 673k with its respective Leash Steering Actuator 630. For example, a spring-loaded latch engages with a catch feature (not shown) built into Connectivity Port System 310 and locks it after sufficient penetration of Connectivity Port 310 into Leash Adaptor 675 has been achieved. When the latch locks into the catch feature of Connectivity Port System 310, an additional mechanism (not shown) coupled with the latch and with Steering Wagon 673k allows the mechanical engagement of Leash Steering Actuator 630 and Steering Wagon 673k. An additional mechanism (not shown) coupled with the latch allows the disengagement of Anchoring Retention System 640. In this embodiment, once Connectivity Port System 310 is fully engaged into Leash Adaptor 675, each Leash Steering Actuator 630 is also mechanically engaged with its respective Steering Wagon 673k and Steering Retention System 640 (not shown) is disengaged allowing the relative motion of Leash Steering Actuator 630 and Lead Leash 330. When Leash Lock 676 is depressed, both Connectivity Post System 310 and both Leash Steering Actuator 630 are released from Leash Adaptor 675 and both Steering Wagon 673, respectively and Steering Retention System 640 is reengaged to prevent the relative motion of either Leash Steering Actuator 630 and Lead Leash 330. A rotation of Steering Knob 674a (a clockwise rotation is shown) can be finely controlled with a Knob Position Indicator 674b, which allows the operator to establish and monitor the current level of steering. Such rotation of Steering Knob 674a is transmitted to Knob Gear 673d through Knob Shaft 673e. Knob Gear 673d transmits the rotation to Steering Gear 673h and its coupled Steering Shaft 673g, which rotate in the opposite direction of Knob Gear 673 d and its coupled Knob Shaft 673 e. If a gear ratio of 1 is used between Knob Gear 673d and Steering Gear 673h, the first Steering Gear 673h and its coupled Steering Shaft 673g perform a rotation identical and of opposite direction to that imposed on Steering Knob 674a. Still in this case, the second Steering Gear 673h and coupled Steering Shaft 673g perform a rotation identical to that imposed on Steering Knob 674a. The opposite and equal rotational motion of two Steering Shaft 673g is transmitted to the same opposite rotational motion for the two Steering Worm Gear 673i. This motion is translated into an opposite and significantly reduced linear motion for Steering Rack Gear 673j. This opposite and equal reduced / finely controlled linear motion of Steering Rack Gear 673j is transmitted through the two Steering Wagon 673k to the two Leash Steering Actuator 630. In this embodiment, the operator can actuate and control the steering of Head Steering System 650 / Lead Head 350 by controlling the rotation of Steering Knob 674a relatively to Handle Base 671a. Rotating Steering Knob 674a with the visual feedback of Knob Position Indicator 674b, the optional tactile feedback provided by a ratchet system, and the support of the standard medical imaging allow the surgeon to steer and navigate Lead Head 350 during its advancement into the epidural space.

[0489]

[0512] Referring now to Fig. 7K. In a similar non-limiting embodiment of a handheld device as that described in Fig. 7H, Steering Control System 670 is shown from three projections. Figs. 7I-a / b show this embodiment of System 670 without Handle Cover 672a (not shown) to expose the internal components. Handle Base 671a comprises a single internal structural frame part of the bottom face of an open parallelepipedal container with all wall faces not shown. Handle Base 671a comprises two perpendicular Shaft Support 671b (e.g., bores allowing the passage of a shaft). Each of these Shaft Support 671b can incorporate different types of Shaft Bearing 673c (not shown) to reduce rotational and / or translational friction of each shaft within the bores (e.g., sleeves, ball bearings, linear rotary bearing, etc.). A first shaft, Knob Shaft 673a is inserted within one Shaft Support 671b. Knob Shaft 673a is mechanically coupled (e.g., via a set screw, key, etc.) to Steering Knob 674a, Knob Gear 673d e.g., a miter gear, etc.). A second Steering Shaft 673g is inserted through a pair of Shaft Support 671b, perpendicular to that through which Knob Shaft 673a is inserted. Steering Shaft 673g is mechanically coupled (e.g., via a set screw, key, etc.) to two Steering Gear 673h (e.g., a miter gear and a spur gear, etc . Knob Gear 673d is mechanically coupled and meshed with the first Steering Gear 673h (e.g. , a miter gear with the same Shaft Angle, Pitch Cone Angle, Number of Teeth, and Apex Alignment as those of Knob Gear 673d, etc.) in a 1 : 1 gear ratio. This mechanical configuration allows for a more coarse but rapid control of the actuation motion than other configurations presented in which a high gear ratio can be obtained between Knob Gear 673d and Steering Gear 673h, and such possible high gear ratio is further compounded by that between Steering Worm Gear 673i and Steering Rack Gear 673j. The two Steering Gear 673h are mechanically coupled by their connection to Steering Shaft 673g. The second Steering Gear 673h is mechanically coupled and meshed with two mirroring Steering Rack Gear 673j, which move in equal and opposed linear motions in a direction parallel to the axis of Knob Shaft 673a. Each Steering Rack Gear 673j (of tooth geometry consistent with that of the second Steering Gear 673h is nested into and mechanically coupled with Steering Wagon 673k, which is bound by a Linear Rail 67 Id (not shown) build into Handle Base 671a (not shown). Each Steering Wagon 673k is reversibly mechanically coupled with a Leash Adaptor 675 (e.g., a component meant to mechanically engage with Lead Leash 330.

[0490]

[0513] Referring now to Fig. 8A. A more detailed schematic view of an Internal Anchoring System 700 (System 700) consistent with the present inventive concepts is shown. System 700 can comprise an Anchoring Actuation Port 710 used as connectivity point for controlling the actuation of System 700 (e.g., a port to infuse under pressure a gas or fluid, a port to access or connect to an actuator element, etc.),- One or more Anchoring Actuation Channel 720 used to allow the transfer of the actuation energy necessary to actuate System 700 (e.g., channel to enable the airtight / watertight flow of a gas or fluid throughout the SCSL; channel to allow the sliding or rotation within of one or more actuation elements, etc.), - one or more Leash Anchoring Actuator 730, and element to transfer and / or generate and / or convert mechanical energy throughout the Lead Leash 330 (e.g., gas or fluid column; wire enabling pull and / or push axis force, etc.),- An Anchoring Retention System 740 (System 740) used to maintain the desired level of actuation of System 700 (e.g., a valve to control the level of fdling and pressurization of Actuation Channel 520; a mechanical brake to maintain the position of an actuation element, c / c.); A Head Anchoring System 750 (System 750) to transfer and / or generate and / or convert the actuation energy to and within the Lead Head 350 to actuate anchoring of the Lead Head into the epidural space, and; An Anchoring Control System 760, which can be temporarily engaged with SCSL to allow the operator to control the anchoring of the SCSL.

[0491]

[0514] Referring now to Fig. 8B. In a non-limiting embodiment consistent with the present inventive concepts, Anchoring System 700 comprises a Leash Anchoring Actuator 730 comprising a high strength filament (e.g., titanium, titanium alloy, aramid, Polybenzoxazole, carbon fiber, Basalt Fiber and S-Glass Fiber, etc.) running into an Anchoring Actuation Channel 720 hosted within Lead Leash 330. Leash Anchoring Actuator 730 has suitable length allowing it to be pulled backward relatively to Lead Leash 330 (or pushed forward). The relative axial motion between Leash Anchoring Actuator 730 and Lead Leash 330 is transferred to Head Anchoring System 750, which is embedded into the Lead Head 350. In the embodiment shown, Leash Anchoring Actuator 730 is mechanically coupled to a Bridle 754, which splits the actuation control to two elastic Deployable Arm 751 (e.g., two arms made of flexible material with at least a portion of each arm's surface possessing suitable frictional properties to hold on the later portions of the epidural space tissue without causing trauma, such as surface texture, etc.). The horizontal deflection of the two ends of Bridle 754 is obtained via two Pulley 753 (e.g., a point of forced curvature for Bridle 754 allowing the sliding of the curved element of Bridle 754 without excessive friction or wear damage to the material) placed within Lead Head 350. Each Deployable Arm 751 is solidly coupled at its distal end to the distal portion of Lead Head 350 and is tethered to one end of Bridle 754 through a Hinge Anchor 752. When sufficient tension is applied and held to each Deployable Arm 751 through Leash Anchoring Actuator 730 and Anchoring Retention System 740, each Deployable Arm 751 is kept approximated within the body of Lead Head 350 in a closed configuration, as shown in Fig.8-a. Conversely, by releasing tension (or pushing) Leash Anchoring Actuator 730, the residual elastic stress stored within each Deployable Arm 751 leads to their outward bending until the lateral walls of the epidural canal are contacted / engaged leading to the anchoring of Lead Head 350, as shown in Fig.8-b. A fail-safe mechanism can be built in the mechanical properties of Deployable Arm 751 in order to generate sufficient to anchor Lead Head 350 in place, but insufficient to cause trauma to the epidural space wall (z.e., should excessive forced be generated by incorrect placing / operation or anatomic hindrance, the same forces would cause the retraction of Deployable Arm 751 rather that injury to the tissue).

[0492]

[0515] Referring now to Fig. 8C. A more detailed schematic view of an Anchoring Control System 760 (System 760) consistent with the present inventive concepts is shown. System 760 is intended to be operated by the surgeon implanting the SCSL System 10 into the patient (e.g., a neurosurgeon, etc.) after the positioning of Lead Head 350 has been achieved. System 760 can comprise one or more Structural System 761 used as a mechanical base for the coupling of all the other internal elements of System 760 (e.g., a chassis made of polymeric structural material like ABS, and the like, etc. one or more External Shell 762 used to cover Structural System 761 (e.g., an enclosure with one of more ports, removable access panels, a handle grip for the operator, etc.); one or more Internal Anchoring Control System 763 used to generate the mechanical energy needed to actuate Anchor System 700 (e.g., an internal mechanism that controls the motion of Leash Anchoring Actuator 730; a servo motor including controller and battery pack delivering mechanical energy; etc.); one of more External Anchoring Control System 764, which engage with the surgeon fingers to control the Steering of System 10 (e.g,. a knob controlling the rotation of a shaft mechanically coupled with System 763; a knob controlling the rotation of a shaft mechanically coupled with a potentiometer controlling the electrical current flowing into System 763; a trigger or button controlling the linear motion of System 763, a trigger controlling an electrical switch, etc.); one or more Leash Adaptor 765, which mechanically engages with Internal Anchoring Control System 763 and Connectivity Port 310 or more generally with Lead Leash 330 while the surgeon is implanting System 10 into the patient and subsequently disengages with the portion of System 10 that remains implanted into the patient (e.g., a cylindrical receptable with an internal axially-oriented spring hosting and mechanically engaging Connectivity Port 310 of Lead Leash 330 and driving these components in a linear or rotational motion being driven by Internal Anchoring Control System 763). Adaptor 765 can include electrical and pressure holding connections, and can further and independently engage with Leash Anchoring Actuator 730. Adaptor 765 can further include and mechanically interact with elements of Leash Lock 766, a system to lock and unlock / release the connection between Adaptor 765 and Connectivity Port 310, or more generally with Lead Leash 330. Leash Lock 766 can include a controlling element present outside System 760 (e.g., a spring-loaded button or lever, etc.) connected with elements inside the system mechanically coupled with Adaptor 765 to lock and release Connectivity Port 310 or more generally Lead Leash 330 (e. ., a small latch mechanism engaging with a dedicated catch surface present on the Connectivity Port 310 or more generally Lead Leash 330).

[0493]

[0516] Referring now to Fig. 8D. In a non-limiting embodiment consistent with the present inventive concepts, Anchoring Control System 760, comprises a handheld device suitable for single hand operations (as shown coupled with the embodiment of System 700 described in Fig. 8B). In this embodiment Structural System 761 and External Shell 762 are integrated in the same component, which can be assembled as multiple subcomponents via snap fit features / elements. In particular, the device external enclosure and its internal chassis can be constructed as a single component Handle Base 761a. This component has internal structures allowing the mounting of multiple internal components, consistently with what described for Fig. 8C. Handle Base 761a can be snap fit with Handle Cover 762a, an additional component which allows to close the external structure of System 760 and separate / protect the internal components from the external environment and vice versa. At the top portion of System 760, Anchoring Knob 764a is mounted onto a Knob Shaft 763a, which is coupled with Handle Base 761a via two Shaft Supports 761b, which allow the axial translation (and rotation to operate additional functions not described in this embodiment) of Knob Shaft 763a. Shaft Supports 761b can include an internal ratchet or similar system (not shown) to provide tactile feedback to the operator about the amount of movement obtained (e.g., a click for every 0.5 mm of motion, etc.) and / or provide unidirectional motion to Knob Shaft 763a, which can be reversed with a button or lever (not shown). Knob Shaft 763a can further provide a Knob Position Indicator 764b, which allows the operator to establish the current level of actuation. Knob Shaft 763a is coupled with Anchoring Shifter 763b in a manner that the translational motion of Knob Shaft 763a is transmitted into the same motion for Anchoring Shifter 763b (if shaft rotation is enacted, Knob Shaft 763a allows the relative rotation without affecting its position). Anchoring Shifter 763b can mechanically engage with Leash Anchoring Actuator 730 to communicate its linear motion to it after Connectivity Port System 310 / Lead Leash 330 has been inserted into Leash Adaptor 765. Leash Lock 676 allows to lock and release Connectivity Port 310 into Leash Adaptor. The same component allows to secure the mechanical engagement of Anchoring Shifter 763b and Leash Anchoring Actuator 730. For example, a spring-loaded latch engages with a catch feature (not shown) built into Connectivity Port System 310 and locks it after sufficient penetration of Connectivity Port 310 into Leash Adaptor 765 has been achieved. When the latch locks into the catch feature of Connectivity Port System 310, an additional mechanism (not shown) coupled with the latch and with Anchoring Shifter 763b allows the mechanical engagement of Leash Anchoring Actuator 730 and Anchoring Shifter 763b. An additional mechanism (not shown) coupled with the latch allows the disengagement of Anchoring Retention System 740. In this embodiment, once Connectivity Port System 310 is fully engaged into Leash Adaptor 765, Leash Anchoring Actuator 730 is also mechanically engaged with Anchoring Shifter 763b and Anchoring Retention System 740 (not shown) is disengaged allowing the relative motion of Leash Anchoring Actuator 730 and Lead Leash 330. When Leash Lock 676 is depressed, both Connectivity Post System 310 and Leash Anchoring Actuator 730 are released from Leash Adaptor 765 and Anchoring Shifter 763b, respectively and Anchoring Retention System 740 is reengaged to prevent the relative motion of Leash Anchoring Actuator 730 and Lead Leash 330. In this embodiment, the operator can actuate and control the level of deployment of Deployable Arm 751 by controlling the level of penetration of Anchoring Knob 764a into Handle Base 761a. When Anchoring Knob 764a is fully depressed (starting position), Deployable Arm 751 are fully retracted into the body of Lead Head 350. Progressively pulling of Anchoring Knob 764a with tactile and visual feedback, allows the operator to finely and reliably control the progressive deployment of Deployable Arm 751 to anchor Lead Head 350 into the desired position in the epidural space.

[0494]

[0517] Referring now to Fig. 9. A more detailed schematic view of an Electrical Conduction and Isolation System 800 (System 800) consistent with the present inventive concepts is shown. System 800 can comprise multiple Connectivity Port Lead 810 used as a multi-channel electrical interface between an EPG / IPG and / or other systems transporting electrical signals to and from the SCSL (e.g., one-dimensional or multi-dimensional array of electrodes made of a metal alloy such as platinum / iridium alloy, arranged into an organized configuration within Connectivity Port 310); One or more Connectivity Port Insulation 820 to provide electrical insulation around each Connectivity Port Lead 810 (e.g., an overmolded polyurethane (PU) rubber or silicone-based PU rubber); multiple Lead Conductive Wires 830 to transport electrical signals through Lead Leash 330 to and from Lead Head 350 (e.g., monofilaments or braided wires made of MP35N-DFT-28% Ag or similar alloys); multiple Lead Wire Insulation 840 to provide electrical insulation around each Lead Conductive Wire 830 (e.g., overmolded polyurethane (PU) rubber or silicone-based PU rubber); one or more Lead Wire Bundling Element 850 to bundle together multiple Lead Conductive Wire 830 (e.g., an overmolded polyurethane (PU) rubber or silicone-based PU rubber bundling the multiple Lead Conductive Wire 830 into one or more clusters of Lead Conductive Wire 830); A Leash-Head Lead Connector 860 to transport electrical signals within Leash-Head Joint 340 between Lead Leash 330 and Lead Head 350; Multiple Head Lead Electrode 870 to deliver spinal cord stimulation in contact with the thecal sac (e.g., one-dimensional or multidimensional array of electrodes made of a metal alloy such as platinum / iridium alloy, arranged into an organized configuration within Lead Head 350); Multiple Head Lead Insulation 880 to insulate a portion of each Head Lead Electrode 870 not intended to communicate electrical signals with the thecal sac, and; One or more Auxiliary Conductivity System to transport electrical signals to and from the SCSL to serve secondary functions than delivering electrical stimulations to the spinal cord (e. ., a system to deliver auxiliary current meant to disengage elements of the SCSL following the satisfactory placement of Lead Head 350; a system including a coil to transport auxiliary currents meant to enable steering of SCSL, etc.).

[0495]

[0518] Referring now to Fig. 10. A more detailed schematic view of a Feedback System 900 (System 900) consistent with the present inventive concepts is shown. System 900 can comprise one or more Passive Feedback System 910 providing feedback to the operator / s without requiring any additional form of energy (e.g., depth and / or rotation marks visible on Lead Leash 330 to assess the penetration depth and rotation status of the SCSL from outside the patients; radioopaque materials embedded within Lead Leash 330 and / or Lead Head 350 forming landmarks to provide information to the operator / s to assess the penetration depth, rotation, level of engagement among different components of the SCSL, level of deployment and configuration of different components of the SCLS, or other statuses of the SCSL under fluoroscopy imaging; color coding to discriminate among different components of the SCSL, etc.),' One or more Active Feedback System 920 providing feedback to the operator / s (e.g., level of engagement among different components of the SCSL, level of deployment and configuration of different components of the SCLS, or other statuses of the SCSL) leveraging one or more forms of external energy (e.g., electricity, light, mechano-transduction, sensors, etc.).

[0496]

[0519] Referring now to Fig. 11A. A more detailed schematic view of Assembler System 1000 (System 1000) consistent with the present inventive concepts is shown. System 1000 comprises dedicated components to mechanically engage, and assemble separate components of System 10 within the epidural space. System 1000 can comprise an Assembly Actuation Port 1010 used as connectivity point for controlling System 1000 (e.g., a port to infuse under pressure a gas or fluid, a port to access or connect to an actuator element, etc.); One or more Assembly Actuation Channel 1020 used to allow the transfer of the actuation energy necessary to actuate System 1000 (e.g., channel to enable the airtight / watertight flow of a gas or fluid throughout the SCSL; channel to allow the sliding or rotation within of one or more actuation elements, etc.); one or more Leash Assembly Actuator 1030, and element to transfer and / or generate and / or convert mechanical energy throughout the Lead Leash 330 (e.g., gas or fluid column; wire enabling pull and / or push axis force, etc.); An Assembly Retention System 1040 (System 1040) used to maintain the desired level of actuation of System 1000 (e.g., a valve to control the level of filling and pressurization of Assembly Actuation Channel 1020; a mechanical brake to maintain the position of an actuation element, etc.); A Head Assembly System 1050 (System 1050) to transfer and / or generate and / or convert the assembly actuation energy to and within the Lead Head 350, and; an Assembly Control System 1060, which can be temporarily engaged with SCSL to allow the operator to control the assembly of the SCSL, and; an Assembly Release System 1070, which can be used to disengage Assembly System 1000 from the intended components within the epidural space after their assembly, possibly leaving System 1050 in place and possibly removing System 1000 from the epidural space. System 1000 can leverage other components previously described for System 10 to support its function. For example, System 1000 can leverage Feedback System 900 to inform the operator of the position and status of System 1000.

[0497]

[0520] Referring now to Fig. 11B. A non-limiting embodiment of System 1000 consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. Lead Head 350 incorporates two side extendable Head Assembly Cuff 1051, a triangular shape pocket (in a simpler configuration this feature can be a snare), which can independently rotate around Hinge 556 and be hosted into the silhouette of Lead Head by applying tension on two Leash Assembly Actuator 1030, which are within two Assembly Actuation Channel 1020 hosted within Lead Leash 330. An outward elastic force applied by a Head Assembly Spring 1052 allows each Head Assembly Cuff 1051 to be outwardly extended when tension is released on the respective Leash Assembly Actuator 1030. The geometry and flexural elastic modulus of Head Assembly Spring 1052 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Head Assembly Cuff 1051 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, over-compress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend in the space available. In this extended position, a Distal Cuff Opening 1053a becomes available to access the hollow space within Cuff 1051 (the hollow chamber within Cuff 1051 can have an additional Proximal Cuff Opening 1053b - not shown). This system can be used to engage and retain another component within (and through when the additional Proximal Cuff Opening 1053b is present) the hollow chamber of each Head Assembly Cuff 1051. The retention of such a system can be obtained by applying tension to the respective Leash Assembly Actuator 1030 once the component has entered the hollow chamber. An Active Positional Feedback System 920 consisting of two pairs of fiber optic (i.e., a Fiber Optic Input Line 921a and a Fiber Optic Output Line 921b) can be incorporated into this embodiment of System 10 to inform the operator of whether each of the two Head Assembly Cuff 1051 has successfully engaged the intended component within Head Assembly Cuff 1051. Each Fiber Optic Input Line 921a is connected to a light source at the Connectivity Port System 310 in the distal end of System 10. The light source can travel within each Fiber Optic Input Line 921a and be presented at the proximal end of line 921a within the internal chamber of the respective Head Assembly Cuff 1051 creating a diffractive scatter of such light within the hollow chamber of each Head Assembly Cuff 1051. The scattered light can be detected by the Fiber Optic Output Line 921b, whose proximal end is directly facing the proximal end of Fiber Optic input Line 921a at the opposite end of Distal Cuff Opening 1053a. This system can be used to allow the operator to detect whether the component which is intended to be engaged and retained by Assembler System 1000 is indeed correctly positioned within the respective Head Assembly Cuff 1051. Such detection is based on predefined output light feature visible at the distal end of Fiber Optic Output Line 921b. An optional Deployable Sheath 558 serves as Lead Leash 330 and is optionally provided with a Sheath Splitting Feature 558b. This feature runs along the full length of Deployable Sheath 558, and enable the splitting of the closed circumference of Deployable Sheath 558 (e.g., this feature can consist of a tearable thinning of the structure / material of Deployable Sheath 558). After the correct engagement of the component intended to be engaged by each Head Assembly Cuff 1051, a Fuse Release System 1071 consisting in an electrically conductive wire running through Lead Leash 330 and connected to a resistor positioned within Lead Head 350 in contact with all components tethering Lead Leash 330 to Lead Head 350. The transient passage of a predetermined current within Fuse Release System 1071 allows to sublimate and sever all aforementioned tethers while leaving the severed ends of both Leash Assembly Actuator 1030 fused to the resistor (preventing the release of both Cuff 1051). Deployable Sheath 558 (with or without tearing Sheath Splitting Feature 558b) can be removed leaving in place solely Lead Head 350 / System 1000.

[0498]

[0521] Referring now to Figs. 12A and 12B. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. In this embodiment, Lead Head 350 has a small initial cross-sectional area enabling percutaneous epidural access through an Access System 100. Lead Head 350 can subsequently modify (expand) its geometry once in the epidural space, as well as steer and advance within the epidural space to attain the ideal position / positioning. Lead Head 350 can then deliver electrical stimulation to the spinal cord with a paddle lead configuration. In this embodiment, Lead Head 350 comprises two Deployable Arm 552 hosted within a Deployable Sheath 558. Each deployable arm is made of a plastic material and has a thin profile with a geometry resembling a round bracket with its length significantly longer than its width. Each Deployable Arm 552 has its long axis parallel to the main axis of Lead Head 350. The two Deployable Arm 552 are mutually mechanically coupled with a spring of general pointed oval shape covering both the role of a Head Expansion Spring 559c and Head Steering Element 652. Spring 559c / 652 is oriented with its long axis parallel to the long axis of each Deployable Arm 552. Spring 559c / 652 is coupled to each Deployable Arm 552 via a Hinge 556 positioned at the two poles of its short axis. Each Hinge 556 allows the relative rotation between elements 552 and 559c / 652 without allowing the separation of the two components. Each Deployable Arm 552 has embedded 4-8 Head Lead Electrode 870 placed in a linear array configuration (figure shows an 8-electrode configuration). Each of these conductive electrodes is flat, embedded within and only exposed on one face of Deployable Arm 552 (the one meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 run internally to each Deployable Arm 552 and are bundled into a Leash Steering Actuator 630 (hence incorporating components 830, 840, and Lead Wire Bundling Element 850). In this embodiment, Deployable Sheath 558 serves as Lead Leash 330 and is optionally provided with a Sheath Splitting Feature 558b. This feature runs along the full length of Deployable Sheath 558, and enable the splitting of the closed circumference of Deployable Sheath 558 (e.g., this feature can consist of a tearable thinning of the structure / material of Deployable Sheath 558). Each of the two Leash Steering Actuator 630 can slide relative to each other within Deployable Sheath 558. The relative sliding motion between the two Leash Steering Actuator 630 is limited by the geometry of element 559c / 652, which along with the two Deployable Arm 552 form a 3-bar linkage system. In this embodiment the two Deployable Arm 552 can be deployed from Lead Head 350 by pulling Deployable Sheath 558 relatively to the two Leash Steering Actuator 630 until the full length of Deployable Arm 552 is exposed. During this relative motion, the elastic energy stored within the Head Expansion Spring 559c / 652 causes the separation / expansion of the two Deployable Arm 552. As described, System 10 can be shifted from a 'Closed Lead Configuration' shown in Fig. 12A-a into an 'Open Lead Configuration' (shown in Fig. 12A-b), and vice versa. Should the optional Sheath Splitting Feature 558b be used to fully remove Deployable Sheath 558, the Open Lead Configuration shown in Fig. 12A-b is no longer reversible, unless a new Deployable Sheath 558 is used and the system is carefully reloaded into it. In this embodiment, the pushing (or pulling) of the two Leash Steering Actuator 630 relative to each other allows the steering of Lead Head 350 in one direction (left, as shown in Fig. 12B-a, or right, as shown in Fig. 12B-b) during the advancement / retraction of the lead in the epidural space. The steering is due to the rotation of element 559c / 652, which serves as a steering 'ski' while sliding on the surface of the thecal sac. This embodiment also allows the 'sliding marching' of the lead by alternating pulling and pushing motions between the two Leash Steering Actuator 630 while pushing them both forward into the epidural space. This 'sliding marching', might allow to facilitate the advancement of the lead into the epidural space. After correct placement of the Head Lead Electrode 870 array has been achieved, Sheath Splitting Feature 558b can be used to fully remove Deploy able Sheath 558 and leave in the place solely Lead Head 350 and the two Leash Steering Actuator 630.

[0499]

[0522] Referring now to Figs. 13A and 13B. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. In a similar embodiment to that presented in Fig. 6J consistent with the present inventive concepts, System 10 comprises two flexible elastic Deployable Arm 552 whose bases are structurally anchored to Lead Head 350. Each Deployable Arm 552 has embedded 4-8 Head Lead Electrode 870 placed in a linear array configuration (figure shows an 8-electrode configuration). Each of these conductive electrodes is flat, embedded within and only exposed on one face of Deployable Arm 552 (the one meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 from each electrode 870 run internally to each Deployable Arm 552, are bundled within each Deployable Arm 552, then bundled into a single Lead Conductive Wire and Insulation 830 / 840, and tunneled into Lead Leash 330. Each of the two Deployable Arm 552 has a baseline outwardly curved (e.g., sigmoidal, etc.) shape when unstressed / uncompressed. Each Deployable Arm 552 further has an internal Head Actuation Channel 520a which is a continuation of a Leash Actuation Channel 520. Two Leash Actuator 530 consisting each of a cylindrical wire with sufficient flexural rigidity to cause each deployable Arm 552 to remain in a straight linear configuration when Leash Actuator 530 occupies the Head Actuation Channel 520a. The geometry and flexural elastic modulus of each Deployable Arm 552 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Deployable Arm 552 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, overcompress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend within the space available. In this embodiment each Leash Actuator 530 can be slid in a forward (proximal) position ('Closed Lead Configuration') to coalesce both Deployable Arm 552 as shown in Fig. 13A-a. Both Leash Actuator 530 can be slid in a backward (distal) position ('Open Lead Configuration1) to extend / deploy laterally both Deployable Arm 552 as shown in Fig. 13A-b. Fig. 13B shows how this embodiment also allows the steering of Lead Head 350 by only actuating one of two Leash Actuator 530 (or by partially actuating each of them). In particular, by pulling the left Leash Actuator 530 and pushing the right Leash Actuator 530 relative to Lead Leash 330, it is possible to steer Lead Head 350 to the left while advancing Lead Leash into the epidural space (Fig. 13B-a) and vice versa (Fig. 13B-b).

[0500]

[0523] Referring now to Figs. 14A and 14B. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. In a similar embodiment to that presented in Figs. 7E and 7F consistent with the present inventive concepts, System 10 comprises two Deployable Arm 552, which have embedded 4-8 Head Lead Electrode 870 placed in a linear array configuration (figure shows an 8-electrode configuration). Each of these conductive electrodes is flat, embedded within and only exposed on one face of Deployable Arm 552 (the one meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 run internally to each Deployable Arm 552 and are bundled into a Tension Relief Lead Wire Bundling Element 850a, which allows the bridging of System 800 from Lead Head 350 to each of the two Deployable Arm 552 and then each of the two bundles of System 800 is tunneled into Lead Leash 330. Each Deployable Arm 552 is coupled to the proximal ends of two Link Arm 555 (a proximal and a distal Link Arm 555) via a Hinge 556. Each Link Arm 555 is made of a flexible elastic material whose (distal) base is structurally anchored to Lead Head 350. Each of these flexible Link Arm 555 has a permanent curved shape, which can be straightened in a linear configuration against the body of Lead Head 350. The geometry and flexural elastic modulus of Link Arm 555 can be designed with a failsafe approach to be atraumatic to the epidural space. In particular, the outward lateral extension of each Link Arm 555 can be designed to create a sufficient force to extend into the epidural space when unhampered by anatomic features, but with an insufficient strength to over-stretch, over-compress, or otherwise tear / injure the thecal sac or other delicate tissue within the epidural space when excessive forces would be required to extend in the space available. Each distal Link Arm 555 has its Hinge 556 which is allowed to slide along a partial portion of the length of Deployable Arm 552 within a Slot 559d cut into each Deployable Arm 552, which acts as a rail. Each distal Link Arm 555 is also connected to a Leash Steering Actuator 630 through a Hinge Anchor 556 positioned in an intermediate point along the length of Link Arm 555. Each Leash Steering Actuator 630 is deflected from a perpendicular (outward) position relative to the main axis of Lead Head 350 to a parallel position to the main axis of Lead Head 350 via a Pulley 753, which allows the tunneling of each Leash Steering Actuator 630 into a Steering Actuator Channel 620 hosted with Lead Leash 330. Each proximal Link Arm 555 is connected to one of the two proximal ends of Bridle 551 via a Hinge Anchor 556 positioned in an intermediate point along the length of Link Arm 555. Each proximal end Bridle 551 is deflected from a perpendicular (outward) position relative to the main axis of Lead Head 350 to a parallel position to the main axis of Lead Head 350 via a Pulley 753. The common distal end of Bridle 551 is connected to a Leash Actuator 630, which runs into Actuation Channel 520 within Lead Leash 330. This configuration can allow to incorporate the multiple functions previously described including lead head expandability, steerage, and anchoring. In particular, Fig. 14A-a shows a compacted configuration of System 10, which is obtained by pulling (or maintaining tension) for both Leash Steering Actuator 630 and Leash Actuator 530 allowing both Deployable Arm 552 to be maintained parallel to and within the area of Lead Head 350. In this configuration, an advancement into the epidural space causes a straight motion of Lead Head 350. By partially or fully releasing the tension one of the two Leash Steering Actuator 630 (the right is shown) while maintaining tension in the other Leash Steering Actuator 630 and Leash Actuator 530, the respective distal Link Arm 555 is partially or fully released outward by the elastic expansion of the distal Link Arm 555 causing the outward rotation and deployment of the distal portion of the respective Deployable Arm 552, as shown in Fig. 14A- b. In the shown configuration, the advancement of Lead Head 350 into the epidural space causes the steering of Lead Head to the left due to the asymmetric drag created by the outward swiping of the distal portion of the right distal Deployable Arm 552 (similarly to the mechanism of 'snowplow turn' in skiing). A steering in the opposite direction is obtainable by applying tension into the right Leash Steering Actuator 630 and by releasing the left one. Both Deployable Arm 552 can be then fully (or partially) extended outward to create a paddle configuration for Lead Head 350. This is obtained by fully (or partially) releasing both pairs of Leash Steering Actuator 630 and Leash Actuator 530, as shown in Fig. 14B In this configuration, the expanded Deployable Arm 552 can also serve as Head Anchoring System 750 described in Fib. 8B. Following the achievement of the correct location adjacent to Lead Head 350 the straight advancement of Lead Head 350 into the epidural space.

[0501]

[0524] Referring now to Fig. 15. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. In this embodiment, Lead Head 350 is a modification of a standard paddle lead intended to be deployed via a standard laminotomy access. The modification enables to steer the Lead Head 350 during lead advancement into the epidural space in order to attain accurate and simple paddle positioning. The modification shown in this embodiment can further include a Head Aligner 420 consisting of one or more vertical (a single vertical midline feature is shown) and horizontal (three horizontal features are shown) hinge / s obtained by thinning the structure (not shown) of Lead Head along the vertical and horizontal direction of the paddle, or by creating one or more series of grooves (shown) in the paddle head leaving a discrete number of hinge structural connections able to support the curvature of the paddle along one or more vertical and horizontal axes. These Head Aligner 420 features allow to improve the conformality of the paddle around the curved thecal sac surface (shown in Fig. 15c) and to support the flexion of the spine, respectively. Such a conformality is intended to maximize electrode surface contact with the thecal sac and minimize localized pressure on the thecal sac along the ventral -dorsal direction due to the rigidity of the paddle during spine flexion. Tn this embodiment, Lead Head 350 can deliver electrical stimulation to the spinal cord with a paddle lead configuration. As such, Lead Head 350 can comprise 16-32 Head Lead Electrode 870 (16 are shown) organized into 2-4 linear arrays (2 banks of electrodes are shown) configuration. Each of these conductive electrodes is flat, embedded within and only exposed on one face of Lead Head 350 (the one meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 run internally to Lead Head 350 and are bundled into two banks, each of which converge into a Leash Steering Actuator 630 (hence incorporating components 830, 840, and Lead Wire Bundling Element 850). Prior to its insertion into each of the two Leash Steering Actuator 630, a Tension Relief Lead Wire Bundling Element 850a is added for each bank of Electrode 870 / Insulated wires 830 / 840. Element 850a consists of a curved section of insulated bundled wires free to move relatively to Lead Head 850, which allows a limited extension and contraction of the distance between the beginning of the bundle (in proximity to the distal-most electrode) and the bundle point of entry into Leash Steering Actuator 630. This feature allows Lead Head 850 to rotate up to 30° in each direction around a ventral-dorsal axis. This rotation is enabled by the two Leash Steering Actuator 630, which are each connected at the proximal end to a Hinge Anchor 554 placed in the distal portion of Lead Head 350 enabling the relative rotation of each Leash Steering Actuator 630 and Lead Head 350. In this embodiment an optional Deploy able Sheath 558 (not structurally coupled to Lead Head 350) hosts both Leash Steering Actuator 630 and serves as Lead Leash 330 to facilitate the pushing / pulling of Lead Head 350 into the epidural space. In this embodiment, Deployable Sheath 558 is optionally provided with a Sheath Splitting Feature 558b. This feature runs along the full length of Deployable Sheath 558, and enable the splitting of the closed circumference of Deployable Sheath 558 (e.g., this feature can consist of a tearable thinning of the structure / material of Deployable Sheath 558). Each of the two Leash Steering Actuator 630 can slide relative to each other within Deployable Sheath 558. The relative sliding motion between the two Leash Steering Actuator 630 is limited by the geometry of Lead head 350. In this embodiment, the pushing (or pulling) of the two Leash Steering Actuator 630 relative to each other allows the steering of Lead Head 350 during the advancement / retraction of the lead in the epidural space (Fig. 15-a shows a straight configuration, while Fig. 15-b shows a rotation of Lead Head 350 to the right). The steering is due to the rotation of Lead Head 350, which serves as a steering 'ski' while sliding on the surface of the thecal sac. After correct placement of the Head Lead Electrode 870 array has been achieved, Sheath Splitting Feature 558b can be used to fully remove Deployable Sheath 558 and leave in the place solely Lead Head 350 and the two Leash Steering Actuator 630.

[0502]

[0525] Referring now to Fig. 16A. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. Also in this embodiment, similarly to what described in Figure 15, Lead Head 350 is a modification of a standard paddle lead intended to be deployed via a standard laminotomy access. The modification enables to steer the Lead Head 350 during lead advancement into the epidural space in order to attain accurate and simple paddle positioning. The modification shown in this embodiment can further include a Head Aligner 420 consisting of one or more vertical (a single vertical midline feature is shown) and horizontal (three horizontal features are shown) hinge / s obtained by thinning the structure (not shown) of Lead Head along the vertical and horizontal direction of the paddle, or by creating one or more series of grooves (shown) in the paddle head leaving a discrete number of hinge structural connections able to support the curvature of the paddle along one or more vertical and horizontal axes. These Head Aligner 420 features allow to improve the conformality of the paddle around the curved thecal sac surface and to support the flexion of the spine, respectively. Such a conformality is intended to maximize electrode surface contact with the thecal sac and minimize localized pressure on the thecal sac along the ventral- dorsal direction due to the rigidity of the paddle during spine flexion. Also in this embodiment, Lead Head 350 can deliver electrical stimulation to the spinal cord with a paddle lead configuration. As such, Lead Head 350 can comprise 16-32 Head Lead Electrode 870 (16 are shown) organized into 2-4 linear arrays (2 banks of electrodes are shown) configuration. Each of these conductive electrodes is flat, embedded within and only exposed on one face of Lead Head 350 (the one meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 run internally to Lead Head 350 and are bundled into two banks, each of which converge into a Leash Steering Actuator 630 (hence incorporating components 830, 840, and Lead Wire Bundling Element 850). Prior to its insertion into each of the two Leash Steering Actuator 630, a Tension Relief Lead Wire Bundling Element 850a is added for each bank of Electrode 870 / Insulated wires 830 / 840. Element 850a consists of a curved section of insulated bundled wires free to move relatively to Lead Head 850, which allows a limited extension and contraction of the distance between the beginning of the bundle (in proximity to the distal-most electrode) and the bundle point of entry into Leash Steering Actuator 630. Lead Head 350 is further provided with two banks of lateral Head Steering Fold 651, which can be triangular cuts made on each side wall of the paddle that allow the paddle to deform creating an arch shape by compressing one bank of Head Steering Fold 651 leading to a reduction of the angle in the triangular cut of each Head Steering Fold 651, and an expansion of the angle in the opposite bank. This deformation of the paddle can be obtained by the two Leash Steering Actuator 630, which are each connected at the proximal end of paddle Lead Head 350 to a Hinge Anchor 554. In this embodiment an optional Deployable Sheath 558 (not structurally coupled to Lead Head 350) hosts both Leash Steering Actuator 630 and serves as Lead Leash 330 to facilitate the pushing / pulling of Lead Head 350 into the epidural space. In this embodiment, Deployable Sheath 558 is optionally provided with a Sheath Splitting Feature 558b. This feature runs along the full length of Deployable Sheath 558, and enable the splitting of the closed circumference of Deployable Sheath 558 (e.g., this feature can consist of a tearable thinning of the structure / material of Deployable Sheath 558). Each of the two Leash Steering Actuator 630 can slide relative to each other within Deployable Sheath 558. The relative sliding motion between the two Leash Steering Actuator 630 is limited by the geometry of Lead head 350. In this embodiment, the pushing (or pulling) of the two Leash Steering Actuator 630 relative to each other allows the steering of Lead Head 350 during the advancement / retraction of the lead in the epidural space (Fig. 16A-a shows a straight configuration, while Fig. 16A-b shows a deformation of Lead Head 350 to the right). The steering is due to the deformation of Lead Head 350, which serves as a steering 'ski' while sliding on the surface of the thecal sac. After correct placement of the Head Lead Electrode 870 array has been achieved, Sheath Splitting Feature 558b can be used to fully remove Deployable Sheath 558 and leave in the place solely Lead Head 350 and the two Leash Steering Actuator 630.

[0503]

[0526] Referring now to Fig. 16B. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. Similarly to what described in Figure 16A, also for this embodiment Lead Head 350 is a steerable paddle lead intended to be deployed via a standard laminotomy access and able to deliver electrical stimulation to the spinal cord with a paddle lead configuration. The steering feature allows Lead Head 350 to actively navigate during lead advancement into the epidural space in order to attain accurate and effective paddle positioning through potential anatomic obstacles and restrictions. A V-Shape paddle cross section with thicker medial portion and thinner lateral portions is used as Head Aligner 420a to conform to the similarly shaped transversal cross-section of the epidural canal. In particular, the ventral portion of the paddle conforms with the convex curvature of the Thecal sac, while the dorsal portion of the paddle conforms with the concave curvature of the epidural canal. The paddle has a wider base along the cranio-caudal direction acting as an additional Head Aligner 420, and a narrower paddle head to allow steerage. The wider paddle base with thinner walls allows to contact / align with the lateral portions of the epidural canal. The thin flexible lateral walls of the paddle allow for a delicate contact with the lateral walls and the ability to passively curl to 1. avoid trauma; 2. allow oblique positioning of the paddle around the ventrodorsal axis during paddle steerage and navigation, and; 3. Allow for passive deformations in response to anatomic obstacles, which might otherwise prevent the paddle to clear such obstacles. This embodiment includes Head Aligner 420b consisting in a central cranio-caudally-oriented thin structure created by the removal of paddle material to create multiple bilateral Head Steering Fold 651, which also act as Head Aligner 420c. The conformality afforded by the different types of Head Aligner 420 present in the paddle is intended to maximize electrode surface contact with the thecal sac and minimize localized pressure on the thecal sac. Such conformality if further compounded by a slightly acutely angled planes between the two banks of Head Lead Electrode 870 present in the paddle here presented. Lead Head 350 can comprise 16-32 Head Lead Electrode 870 (16 electrodes are shown) organized into 2-4 linear arrays (2 banks of 8 electrodes are shown) configuration. Each of these conductive electrodes is flat, slightly rounded, or angled, embedded within and only exposed on one face of Lead Head 350 (the ventral side meant to be in contact with the thecal sac). Each Head Lead Electrode 870 is connected to a Lead Conductive Wire 830 insulated with a Lead Wire Insulation 840. Insulated wires 830 / 840 run internally to Lead Head 350 and are bundled into two banks, each of which converge into a Leash Steering Actuator 630 (hence incorporating components 830, 840, and Lead Wire Bundling Element 850). Element 850a consists of a curved section of insulated bundled wires free to move relatively to Lead Head 850, which allows a limited extension and contraction of the distance between the beginning of the bundle (in proximity to the distal-most electrode) and the bundle point of entry into Leash Steering Actuator 630. Lead Head 350 is further provided with two banks of lateral Head Steering Fold 651, which can be triangular cuts made on each side wall of the paddle that allow the paddle to deform creating an arch shape by compressing one bank of Head Steering Fold 651 leading to a reduction of the angle in the triangular cut of each Head Steering Fold 651, and an expansion of the angle in the opposite bank. This deformation of the paddle can be obtained by the two Leash Steering Actuator 630, which are each connected at the proximal end of paddle Lead Head 350 to a Hinge Anchor 554. In this embodiment an optional Deployable Sheath 558 (not structurally coupled to Lead Head 350) hosts both Leash Steering Actuator 630 and serves as Lead Leash 330 to facilitate the pushing / pulling of Lead Head 350 into the epidural space. Each of the two Leash Steering Actuator 630 can slide relative to each other within Lead Leash 630. The relative sliding motion between the two Leash Steering Actuator 630 is limited by the geometry of Lead head 350. In this embodiment, the pushing (or pulling) of the two Leash Steering Actuator 630 relative to each other allows the steering of Lead Head 350 during the advancement / retraction of the lead in the epidural space (Fig. 16A-a shows a straight configuration, while Fig. 16A-b shows a deformation of Lead Head 350 to the right). The steering is due to the deformation of Lead Head 350, which serves as a steering 'ski' while sliding and three-dimensionally deforming around the surface of the thecal sac.

[0504]

[0527] Referring now to Fig. 17. In another non-limiting embodiment consistent with the present inventive concepts, System 10 incorporates multiple subsystems previously described. In this embodiment, a pair of standard percutaneous leads are inserted bilaterally into the epidural space using standard methods (Fig. 17a). In this embodiment, System 10 is used in combination with such standard percutaneous leads and incorporates both System 600 steering features (e.g., as described in Fig. 7B - not shown) and System 1000 assembling features (e.g., as described in Fig. 11B). In this embodiment System 10 allows the engagement, steerage, and assembly (within the epidural space) of the two standard percutaneous leads into a configuration similar to a paddle lead and with some of the advanced features described for System 10. System 10 can be inserted into the epidural space prior to or following the insertion of the two percutaneous leads with access at the same level, more proximal, or more distal than the location of access for the two percutaneous leads. Following epidural access, steering function can be used in combination with fluoroscopic imaging to advance System 10 to a more proximal level than those of the proximal tips of the two percutaneous leads. Each Head Assembly Cuff 1051 can be then extended outwardly by releasing tension in each Leash Assembly Actuator 1030. In this extended configuration, the two Head Assembly Cuff 1051 can contact the lateral walls of the epidural space effectively creating two funneling channels within the epidural space for the two percutaneous leads to easily enter each

Claims

Head Assembly Cuff 1051 . The correct engagement of each percutaneous lead can be verified by the Active Positional Feedback System 920 described in Fig. 11B and / or fluoroscopic imaging. Each percutaneous lead can be then secured to System 10 by applying tension to the respective Leash Assembly Actuator 1030 (adjustments in relative position between each percutaneous lead and System 10 are easily obtainable by transiently releasing tension in the respective Leash Assembly Actuator 1030). Following the engagement of the percutaneous leads step, System 10 can be used to advance and steer the leads as needed until satisfactory lead placement is obtained (Fig. 17b). The optional Fuse Release System 1071 described in Fig. 1 IB (not shown) can be used to separate Lead Head 350 from Lead Leash 330 and Deployable Sheath 558 - not shown (with or without tearing Sheath Splitting Feature 558b - not shown) can be removed leaving in place solely Lead Head 350 / System 10 and the two percutaneous leads assembled into a paddle lead-like configuration (Fig. 17c).[528] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which is defined in the accompanying claims.WHAT IS CLAIMED IS:

1. A system that delivers electrical stimulation to an epidural space of a spinal cord of a patient, comprising: a lead head comprising a plurality of conductive electrodes; at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; a stimulation source electrically coupled to the at least one conductor that generates the electrical stimulation signals; and an expansion system that modifies an area of coverage of the conductive electrodes.

2. The system according to claim 1, wherein the at least one conductor comprises a plurality of conductors constructed and arranged to deliver the electrical stimulation signals to a like plurality of the conductive electrodes.

3. The system according to any one of the claims herein, wherein the expansion system modifies a width of the lead head4. The system according to any one of the claims herein, wherein the expansion system modifies at least a width dimension of the lead head, wherein the width dimension is related to a lateral direction spanning from a left side to a right side of the patient.

5. The system according to any one of the claims herein, wherein the expansion system modifies the width of the lead head so that it is increased from a first delivery width W1 to a second deployment width W2, wherein W2 > W16. The system according to any one of the claims herein, wherein first and second electrodes of the conductive electrodes are spaced apart by a first distance DI when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a seconddistance D2 when the lead head width is the second deployment width W2, and wherein D2 > DI7. The system according to any one of the claims herein, wherein first and second electrodes of the conductive electrodes are spaced apart by a first longitudinal distance LD1 (along the cranial-caudal direction of the patient) when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a second longitudinal distance LD2 when the lead head width is the second deployment width W2, and wherein LD2 * LD18. The system according to any one of the claims herein, wherein the expansion system modifies the area of coverage of the conductive electrodes between a first area of coverage Al to a second area of coverage A2, wherein A2 > Al9. The system according to any one of the claims herein, wherein the stimulation source comprises at least one electric signal generator coupled to the at least one conductor10. The system according to any one of the claims herein, wherein the at least one electric signal generator comprises a plurality of electric signal generators; wherein the at least one conductor comprises a plurality of conductors, each of the plurality of conductors being coupled to a corresponding one of the plurality of electric signal generators; and wherein the plurality of conductive electrodes are each coupled to one of the plurality of conductors and the corresponding one of the electric signal generators, so that each of the plurality of electrodes receives an independent electrical stimulation signal generated by one of the plurality of electric signal generators.

11. The system according to any one of the claims herein, wherein the system permits access into the epidural space without a need for light-based visualization12. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm.

13. The system according to any one of the claims herein, wherein the at least one arm comprises a first arm and a second arm, and wherein a first conductive electrode is positioned at the first arm and a second conductive electrode is positioned at the second arm.

14. The system according to any one of the claims herein, wherein the lead head further comprises a bridle, and wherein the least one arm is mechanically coupled to the bridle at at least one hinge.

15. The system according to any one of the claims herein, further comprising: a hinge pulley at the at least one hinge; and an arm actuator engaging the at least one hinge that initiates motion of the arm about the hinge relative to the bridle.

16. The system according to any one of the claims herein, wherein the arm actuator comprises at least one filament.

17. The system according to any one of the claims herein, wherein the at least one hinge comprises at least one corresponding hinge anchor.

18. The system according to any one of the claims herein, wherein the first arm comprises multiple first arms and wherein the second arm comprises multiple second arms and further comprising at least one link arm coupling neighboring ones of the multiple first arms and second arms.

19. The system according to any one of the claims herein, wherein the link arm causes neighboring ones of the first and second arms to move in unison when engaged.

20. The system according to any one of the claims herein, wherein each link arm remains parallel to a longitudinal axis of the system the lead head uponmodification of the lead head width from a first delivery width W1 to a second deployment width W2, wherein W2 > Wl.

21. The system according to any one of the claims herein, further comprising a lead leash comprising at least one lumen, wherein the at least one conductor is positioned within the at least one lumen of the lead leash.

22. The system according to any one of the claims herein, wherein the lead leash comprises a leash actuator23. The system according to any one of the claims herein, wherein the leash actuator provides for control over a degree of expansion of the expansion system.

24. The system according to any one of the claims herein, wherein the leash actuator further comprises actuation retention marks.

25. The system according to any one of the claims herein, wherein the actuation retention marks provide visual indicia of the relative position of the leash actuator and lead leash26. The system according to any one of the claims herein, wherein the actuation retention marks provide physical indicia of the relative position of the leash actuator and lead leash27. The system according to any one of the claims herein, wherein the physical indicia comprise tactile feedback28. The system according to any one of the claims herein, wherein the leash actuator further comprises a biasing mechanism for fixation of the relative position of the leash actuator and lead leash29. The system according to any one of the claims herein, wherein the leash actuator further comprises a ratcheting spring mechanism for fixation of the relative position of the leash actuator and lead leash30. The system according to any one of the claims herein, wherein the leash actuator further comprises a linear actuator for fixation of the relative positions of the leash actuator and lead leash31. The system according to any one of the claims herein, wherein the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other32. The system according to any one of the claims herein, wherein the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes33. The system according to any one of the claims herein, wherein the leash actuator is connected to a hinge anchor concentrically positioned at a hinge axle of the arm34. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm, and wherein the at least one arm is outwardly biased relative to the lead head.

35. The system according to any one of the claims herein, further comprising a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

36. The system according to any one of the claims herein, wherein control of a position of the lead head retraction sheath provides for control over a degree of expansion of the expansion system.

37. The system according to any one of the claims herein, wherein the lead head retraction sheath comprises a deployable sheath.

38. The system according to any one of the claims herein, further comprising a leash slit that enables the deployment of the lead head retraction sheath.

39. The system according to any one of the claims herein, wherein the leash slit enables the deployment of the deployable sheath by communicating motion from an interior of the leash to an exterior of the leash and head where the deployable sheath resides.

40. The system according to any one of the claims herein, further comprising a leash actuator coupled to the lead head retraction sheath for controlling a position of the lead head retraction sheath.

41. The system according to any one of the claims herein, wherein the leash slit shifts the lead head retraction sheath for full removal from the lead head when deployed42. The system according to any one of the claims herein, wherein the leash slit shifts the lead head retraction sheath for partial removal from the lead head when deployed.

43. The system according to any one of the claims herein, wherein the lead head retraction sheath further comprises at least one side opening through which the at least one arm extends when deployed.

44. The system according to any one of the claims herein, wherein the leash slit enables to shift the deployable sheath out of its initial overlap with the lead head when deployed45. The system according to any one of the claims herein, wherein the leash slit shifts the deployable sheath for partial removal from the lead head when deployed.

46. The system according to any one of the claims herein, wherein the deployable sheath further comprises at least one side opening through which the at least one arm extends when deployed.

47. The system according to any one of the claims herein, wherein a position of the at least one side opening controls an amount of extension of the at least one arm48. The system according to any one of the claims herein, wherein the at least one arm is linear when fully extended.

49. The system according to any one of the claims herein, wherein the at least one arm comprises a curvature when fully extended.

50. The system according to any one of the claims herein, wherein the at least one arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

51. The system according to any one of the claims herein, wherein the plurality of conductive electrodes comprises an array of conductive electrodes.

52. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a longitudinal axis (z) of the system.

53. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

54. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a first transverse axis (x) that is transverse the longitudinal axis (z).

55. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the first transverse axis (x).

56. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the first transverse axis (x) and in a direction along the longitudinal axis (z).

57. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a second transverse axis (y) that isorthogonal to the first transverse axis (x) and transverse the longitudinal axis (z)-58. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the second transverse axis (y).

59. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the second transverse axis (y) and in a direction along the longitudinal axis (z).

60. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the longitudinal (cranial-caudal) axis (z) of the patient.

61. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

62. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the dorsal-ventral axis (y) of the patient that is perpendicular to the longitudinal axis (z).

63. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the axis (y).

64. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the transverse (from the left to the right side of the patient) axis (x) of the patient that is perpendicular to the longitudinal axis (z) and to the dorsal -ventral axis (y).

65. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the transverse axis (x).

66. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the transverse axis (y).

67. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z)-68. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a curved direction resulting from combinations of the three axes (x, y, and z) in order to position the electrodes along the curved surface of the thecal sac.

69. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein a proximal end of the at least one lead head is anchored to a portion of the lead head. wherein the plurality of conductive electrodes are positioned at the at least one arm, and wherein the at least one arm is outwardly biased relative to the lead head.

70. The system according to any one of the claims herein, further comprising a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

71. The system according to any one of the claims herein, wherein the at least one arm has a sigmoidal shape when released at deployment.

72. The system according to any one of the claims herein, wherein the sigmoidal arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

73. The system according to any one of the claims herein, further comprising a deployable sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

74. The system according to any one of the claims herein, wherein the at least one arm has a sigmoidal shape when released at deployment with the parallel peripheral portions of the sigmoid parallel / aligned with the longitudinal axis (z).

75. The system according to any one of the claims herein, wherein the lead head comprises multiple lead arms, and further comprising: a plurality of link arms; and a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, wherein the link arms are coupled to the multiple lead arms at opposite ends of the multiple lead arms, each link arm coupled between one of the multiple lead arms and a deployable arm, so that at deployment, the distance between the multiple lead arms is decreased in a direction along a longitudinal axis of the system, and a distance between the corresponding deployable arms is increased in a direction along a transverse axis of the system76. The system according to any one of the claims herein, and wherein the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of shaped link arms; and a leash actuator passing through the plurality of deployable arms and the plurality of shaped link arms in serial arrangement, wherein a distal end of the leash actuator is anchored at a distal- most arm of the plurality of deploy able arms and the plurality of shaped link arms, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of shaped link arms.

77. The system according to any one of the claims herein, wherein at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system78. The system according to any one of the claims herein, wherein at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the shaped link arms is increased in a direction along a transverse axis of the system79. The system according to any one of the claims herein, wherein the plurality of conductive electrodes are positioned at the shaped arms,80. The system according to any one of the claims herein, further comprising a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of shaped link arms prior to deployment and releases the plurality of deploy able arms and the plurality of shaped link arms at deployment.

81. The system according to any one of the claims herein, and wherein the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of bracket arms; and a leash actuator passing through the bracket arms and pairs of the plurality of deployable arms in parallel arrangement, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deploy able arms and the plurality of bracket arms.

82. The system according to any one of the claims herein, wherein at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system83. The system according to any one of the claims herein, wherein at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the bracket arms is increased in a direction along a transverse axis of the system84. The system according to any one of the claims herein, wherein the plurality of conductive electrodes are positioned at the bracket arms,85. The system according to any one of the claims herein, further comprising a lead head retraction or deployable sheath that constrains the plurality of deployable arms and the plurality of bracket arms prior to deployment and releases the plurality of deployable arms and the plurality of bracket arms at deployment.

86. The system according to any one of the claims herein, further comprising a spatial modification system that modifies a spatial orientation of the lead head.

87. The system according to any one of the claims herein, wherein the spatial modification system rotates the lead head around the dorsal-ventral axis of the patient (yaw movement of the lead head).

88. The system according to any one of the claims herein, wherein the spatial modification system facilitates advancement of the lead head into the epidural space.

89. The system according to any one of the claims herein, wherein the spatial modification system further comprises a leash steering actuator, which operates to modify the spatial orientation of the lead head, when actuated.

90. The system according to any one of the claims herein, wherein the leash steering actuator provides for control over a degree of modification of the spatial orientation of the lead head91. The system according to any one of the claims herein, wherein a distal end of the leash steering actuator is coupled to a hinge anchor at the lead head.

92. The system according to any one of the claims herein, wherein the spatial modification system further comprises first and second leash steering actuators,the first leash steering actuator operating to modify the spatial orientation of the lead head in a first direction when actuated, and the second leash steering actuator operating to modify the spatial orientation of the lead head in a second direction when actuated.

93. The system according to any one of the claims herein, wherein the first direction corresponds to a yaw rotation around the dorsal -ventral axis in the clockwise direction, and wherein the second direction corresponds to a yaw rotation around the dorsal-ventral axis in the counterclockwise direction.

94. The system according to any one of the claims herein, wherein the lead head comprises first and second lead heads and wherein the first leash steering actuator is coupled to a first hinge anchor of the first lead head and wherein the second leash steering actuator is coupled to a second hinge anchor of the second lead head.

95. The system of according to any one of the claims herein, further comprising a hinge spring coupled between the first and second lead heads at intermediate positions thereof.

96. The system of according to any one of the claims herein, wherein engaging the first leash steering actuator operates to retract the first lead head which steers the area of coverage of the plurality of electrodes in a first direction and wherein engaging the second leash steering actuator operates to retract the second lead head which steers the area of coverage of the plurality of electrodes in a second direction.

97. The system according to any one of the claims herein, wherein the lead head comprises first and second deployable arms and wherein the first leash steering actuator is coupled to a first hinge anchor of the first deployable arm and wherein the second leash steering actuator is coupled to a second hinge anchor of the second deployable arm.

98. The system of according to any one of the claims herein, further comprising a hinge spring coupled between the first and second deployable arm at intermediate positions thereof.

99. The system of according to any one of the claims herein, wherein engaging the first leash steering actuator operates to retract the first deployable arm which steers the area of coverage of the plurality of electrodes in a first direction (e.g., to the left lateral side of the patient) and wherein engaging the second leash steering actuator operates to retract the second deployable arm which steers the area of coverage of the plurality of electrodes in a second direction (e.g., to the right lateral side of the patient).

100. The system of according to any one of the claims herein, wherein the leash steering actuator further comprises a lead leash and wherein an axial force applied to the lead leash operates to rotate the lead head about a longitudinal axis of the system.

101. The system according to any one of the claims herein, wherein the spatial modification system comprises a steering leash and further comprising a linear steering actuator for fixation of the relative position of the steering leash and lead head.

102. The system according to any one of the claims herein, wherein the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other.

103. The system according to any one of the claims herein, wherein the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes104. The system according to any one of the claims herein, wherein the spatial modification system facilitates turning of the lead head from a straightconfiguration relative to the lead leash to a turned configuration relative to the lead leash105. The system according to any one of the claims herein, wherein the spatial modification system comprises a flexible neck base that couples the lead leash and the lead head106. The system according to any one of the claims herein, wherein the flexible neck base comprises a corrugated material to facilitate flexion.

107. The system according to any one of the claims herein, wherein the flexible neck base comprises a corrugated soft rubber tubing to facilitate flexion108. The system according to any one of the claims herein, further comprising an anchoring system that anchors the lead head in position in the epidural space.

109. The system according to any one of the claims herein wherein the anchor system comprises an an anchor actuator; and at least one anchor arm at the lead head and coupled to the anchor actuator, the at least one anchor arm responsive to the anchor actuator to engage the anchor arm, thereby anchoring the lead head in position.

110. The system according to any one of the claims herein, wherein the anchor actuator provides for control over a degree of anchoring of the lead head111. The system according to any one of the claims herein wherein the anchor actuator comprises at least one filament.

112. The system according to any one of the claims herein wherein the anchor actuator comprises a gas or fluid-based actuation system.

113. The system according to any one of the claims herein wherein the at least one anchor arm is outwardly biased relative to the lead head.

114. The system according to any one of the claims herein, wherein the at least one anchor arm comprises a safe flexural modulus that prevents the creation ofsufficient forces to damage the epidural space and spinal cord tissue upon deployment.

115. The system according to any one of the claims herein, wherein the lead head further comprises a bridle, and wherein the least one anchor arm is mechanically coupled to the bridle at at least one hinge.

116. A system that delivers electrical stimulation to an epidural space of a spinal cord of a patient, comprising: a lead head comprising a plurality of conductive electrodes; at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; a stimulation source electrically coupled to the at least one conductor that generates the electrical stimulation signals; and a spatial modification system that modifies a spatial orientation of the lead head.

117. The system according to any one of the claims herein, wherein the spatial modification system comprises a spatial orientation modification system.

118. The system according to any one of the claims herein, wherein the spatial modification system facilitates advancement of the lead head into the epidural space.

119. The system according to any one of the claims herein, wherein the spatial modification system creates steerage and facilitates the correct positioning and / or alignment of the plurality of conductive electrodes to deploy electrical stimulation signals.

120. The system according to any one of the claims herein, wherein the spatial modification system rotates the lead head around the dorsal-ventral axis of the patient (yaw movement of the lead head).

121. The system according to any one of the claims herein, wherein the spatial modification system further comprises a leash steering actuator, which operates to modify the spatial orientation of the lead head, when actuated.

122. The system according to any one of the claims herein, wherein the leash steering actuator provides for control over a degree of modification of the spatial orientation of the lead head123. The system according to any one of the claims herein, wherein a distal end of the leash steering actuator is coupled to a hinge anchor at the lead head.

124. The system according to any one of the claims herein, wherein the spatial modification system further comprises first and second leash steering actuators, the first leash steering actuator operating to modify the spatial orientation of the lead head in a first direction when actuated, and the second leash steering actuator operating to modify the spatial orientation of the lead head in a second direction when actuated.

125. The system according to any one of the claims herein, wherein the first direction corresponds to a yaw rotation around the dorsal -ventral axis in the clockwise direction, and wherein the second direction corresponds to a yaw rotation around the dorsal-ventral axis in the counterclockwise direction.

126. The system according to any one of the claims herein, wherein the lead head comprises first and second lead heads and wherein the first leash steering actuator is coupled to a first hinge anchor of the first lead head and wherein the second leash steering actuator is coupled to a second hinge anchor of the second lead head.

127. The system of according to any one of the claims herein, further comprising a hinge spring coupled between the first and second lead heads at intermediate positions thereof.

128. The system of according to any one of the claims herein, wherein engaging the first leash steering actuator operates to push the first lead head which steers thearea of coverage of the plurality of electrodes in a first direction and wherein engaging the second leash steering actuator operates to push the second lead head which steers the area of coverage of the plurality of electrodes in a second direction.

129. The system of according to any one of the claims herein, wherein the leash steering actuator further comprises a lead leash and wherein an axial force applied to the lead leash transmitted operates to rotate the lead head about a longitudinal axis of the system.

130. The system according to any one of the claims herein, wherein the lead head comprises first and second deployable arms and wherein the first leash steering actuator is coupled to a first hinge anchor of the first deployable arm and wherein the second leash steering actuator is coupled to a second hinge anchor of the second deployable arm.

131. The system of according to any one of the claims herein, further comprising a hinge spring coupled between the first and second deployable arm at intermediate positions thereof.

132. The system of according to any one of the claims herein, wherein engaging the first leash steering actuator operates to retract the first deployable arm which steers the area of coverage of the plurality of electrodes in a first direction (e. ., to the left lateral side of the patient) and wherein engaging the second leash steering actuator operates to retract the second deployable arm which steers the area of coverage of the plurality of electrodes in a second direction (e.g., to the right lateral side of the patient).

133. The system according to any one of the claims herein, wherein the spatial modification system comprises a steering leash and further comprising a linear steering actuator for fixation of the relative position of the steering leash and lead head.

134. The system according to any one of the claims herein, wherein the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other.

135. The system according to any one of the claims herein, wherein the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes136. The system according to any one of the claims herein, wherein the spatial modification system facilitates turning of the lead head from a straight configuration relative to the lead leash to a turned configuration relative to the lead leash137. The system according to any one of the claims herein, wherein the spatial modification system comprises a flexible neck base that couples the lead leash and the lead head138. The system according to any one of the claims herein, wherein the flexible neck base comprises a corrugated material to facilitate flexion.

139. The system according to any one of the claims herein, wherein the flexible neck base comprises a corrugated soft rubber tubing to facilitate flexion140. The system according to any one of the claims herein, wherein the lead head comprises a paddle head, and wherein the plurality of conductive electrodes are arranged in a two- dimensional array arranged along a longitudinal axis (z) of the system and along a transverse axis (x) of the system.

141. The system according to any one of the claims herein, further comprising a leash to which the paddle head is coupled.

142. The system according to any one of the claims herein, wherein the paddle head has a width that is greater than the width of a leash to which the paddle head is coupled.

143. The system according to any one of the claims herein, further comprising a hinge coupling the paddle head to the leash, and wherein the paddle head is pivotable relative to the leash.

144. The system according to any one of the claims herein, further comprising a leash steering actuator that pivots the paddle head relative to the leash in first and second directions.

145. The system according to any one of the claims herein, wherein the paddle head pivoting relative to the leash creates steerage and facilitates advancement of the lead head into the epidural space.

146. The system according to any one of the claims herein, wherein the paddle head pivoting relative to the leash creates steerage and facilitates the correct positioning and / or alignment of the array of conductive electrodes to deploy electrical stimulation signals.

147. The system according to any one of the claims herein, wherein the leash steering actuator comprises first and second filaments coupled to the paddle head at first and second positions that are spaced apart from each other.

148. The system according to any one of the claims herein, wherein the paddle head comprises a material that is deformable in a direction of the transverse axis (x) of the system149. The system according to any one of the claims herein, wherein the paddle head deformation in the transverse axis creates steerage and facilitates advancement of the lead head into the epidural space.

150. The system according to any one of the claims herein, wherein the paddle head deformation in the transverse axis facilitates the correct positioning and / or alignment of the array of conductive electrodes to deploy electrical stimulation signals.

151. The system according to any one of the claims herein, wherein the paddle head comprises regions of reduced thickness for promoting deformability of the paddle head and its conformality to the surface upon which it is applied.

152. The system according to any one of the claims herein, wherein the deformability of the paddle head enables it to conforms the paddle head to the curved thecal sac surface and / or accommodates flexion of the spine153. The system according to any one of the claims herein, wherein the paddle head comprises void regions for promoting deformability of the paddle head.

154. The system according to any one of the claims herein, wherein the deformability of the paddle head enables it to conforms the paddle head to the curved thecal sac surface and / or accommodates flexion of the spine155. The system according to any one of the claims herein, further comprising a leash steering actuator that bends the paddle head relative to the leash in first and second directions.

156. The system according to any one of the claims herein, wherein the leash steering actuator comprises first and second filaments coupled to the paddle head at first and second positions that are spaced apart from each other.

157. The system according to any one of the claims herein, an expansion system that modifies an area of coverage of the conductive electrodes.

158. The system according to claim 1, wherein the at least one conductor comprises a plurality of conductors constructed and arranged to deliver the electrical stimulation signals to a like plurality of the conductive electrodes.

159. The system according to any one of the claims herein, wherein the expansion system modifies a width of the lead head160. The system according to any one of the claims herein, wherein the expansion system modifies the width of the lead head is increased from a first delivery width W1 to a second deployment width W2, wherein W2 > W1161. The system according to any one of the claims herein, wherein first and second electrodes of the conductive electrodes are spaced apart by a first distance DI when the lead head width is at the first delivery width Wl, wherein the first and second electrodes of the conductive electrodes are spaced apart by a second distance D2 when the lead head width is the second deployment width W2, and wherein D2 > D 1162. The system according to any one of the claims herein, wherein the expansion system modifies the area of coverage of the conductive electrodes between a first area of coverage Al to a second area of coverage A2, wherein A2 > Al163. The system according to any one of the claims herein, wherein the stimulation source comprises at least one electric signal generator coupled to the at least one conductor164. The system according to any one of the claims herein, wherein the at least one electric signal generator comprises a plurality of electric signal generators; wherein the at least one conductor comprises a plurality of conductors, each of the plurality of conductors being coupled to a corresponding one of the plurality of electric signal generators; and wherein the plurality of conductive electrodes are each coupled to one of the plurality of conductors and the corresponding one of the electric signal generators, so that each of the plurality of electrodes receives an independent electrical stimulation signal generated by one of the plurality of electric signal generators.

165. The system according to any one of the claims herein, wherein the system permits access into the epidural space without a need for light-based visualization166. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm.

167. The system according to any one of the claims herein, wherein the at least one arm comprises a first arm and a second arm, and wherein a first conductive electrode is positioned at the first arm and a second conductive electrode is positioned at the second arm.

168. The system according to any one of the claims herein, wherein the lead head further comprises a bridle, and wherein the least one arm is mechanically coupled to the bridle at at least one hinge.

169. The system according to any one of the claims herein, further comprising: a hinge pulley at the at least one hinge; and an arm actuator engaging the at least one hinge that initiates motion of the arm about the hinge relative to the bridle.

170. The system according to any one of the claims herein, wherein the arm actuator comprises at least one filament.

171. The system according to any one of the claims herein, wherein the at least one hinge comprises at least one corresponding hinge anchor.

172. The system according to any one of the claims herein, wherein the first arm comprises multiple first arms and wherein the second arm comprises multiple second arms and further comprising at least one link arm coupling neighboring ones of the multiple first arms and second arms.

173. The system according to any one of the claims herein, wherein the link arm causes neighboring ones of the first and second arms to move in unison when engaged.

174. The system according to any one of the claims herein, wherein each link arm remains parallel to a longitudinal axis of the system the lead head upon modification of the lead head width from a first delivery width W 1 to a second deployment width W2, wherein W2 > W1 .

175. The system according to any one of the claims herein, further comprising a lead leash comprising at least one lumen, wherein the at least one conductor is positioned within the at least one lumen of the lead leash.

176. The system according to any one of the claims herein, wherein the lead leash comprises a leash actuator further comprising actuation retention marks.

177. The system according to any one of the claims herein, wherein the leash actuator provides for control over a degree of expansion of the expansion system.

178. The system according to any one of the claims herein, wherein the leash actuator further comprises actuation retention marks.

179. The system according to any one of the claims herein, wherein the actuation retention marks provide visual indicia of the relative position of the leash actuator and lead leash180. The system according to any one of the claims herein, wherein the actuation retention marks provide physical indicia of the relative position of the leash actuator and lead leash181. The system according to any one of the claims herein, wherein the physical indicia comprises tactile feedback182. The system according to any one of the claims herein, wherein the leash actuator further comprises a biasing mechanism for fixation of the relative position of the leash actuator and lead leash183. The system according to any one of the claims herein, wherein the leash actuator further comprises a ratcheting spring mechanism for fixation of the relative position of the leash actuator and lead leash184. The system according to any one of the claims herein, wherein the leash actuator further comprises a linear actuator for fixation of the relative positions of the leash actuator and lead leash185. The system according to any one of the claims herein, wherein the linear actuator comprises a female linear actuator and male linear actuator that are threaded relative to each other186. The system according to any one of the claims herein, wherein the rotation of one of the female linear actuator and male linear actuator causes a translation of the other of the male linear actuator female linear actuator and male linear actuator and a degree of expansion of the corresponding conductive electrodes187. The system according to any one of the claims herein, wherein the leash actuator is connected to a hinge anchor concentrically positioned at a hinge axle of the arm188. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein the plurality of conductive electrodes are positioned at the at least one arm, and wherein the at least one arm is outwardly biased relative to the lead head.

189. The system according to any one of the claims herein, further comprising a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

190. The system according to any one of the claims herein, wherein the lead head retraction sheath comprises a deployable sheath.

191. The system according to any one of the claims herein, further comprising a leash slit that deploys the lead head retraction sheath.

192. The system according to any one of the claims herein, further comprising a leash actuator coupled to the lead head retraction sheath for controlling a position of the lead head retraction sheath.

193. The system according to any one of the claims herein, wherein the leash slit deploys the deployable sheath by communicating motion from an interior of the leash to an exterior of the leash and head where the deployable sheath resides.

194. The system according to any one of the claims herein, wherein the leash slit shifts the lead head retraction sheath for full removal from the lead head when deployed195. The system according to any one of the claims herein, wherein the leash slit shifts the lead head retraction sheath for partial removal from the lead head when deployed.

196. The system according to any one of the claims herein, wherein the lead head retraction sheath further comprises at least one side opening through which the at least one arm extends when deployed.

197. The system according to any one of the claims herein, wherein the leash slit allows to shift the deployable sheath out of its initial overlap with the lead head when deployed198. The system according to any one of the claims herein, wherein the leash slit shifts the deployable sheath for partial removal from the lead head when deployed.

199. The system according to any one of the claims herein, wherein the deployable sheath further comprises at least one side opening through which the at least one arm extends when deployed.

200. The system according to any one of the claims herein, wherein a position of the at least one side opening controls an amount of extension of the at least one arm201. The system according to any one of the claims herein, wherein a position of the at least one side opening controls an amount of extension of the at least one arm202. The system according to any one of the claims herein, wherein the at least one arm is linear when fully extended.

203. The system according to any one of the claims herein, wherein the at least one arm comprises a curvature when fully extended.

204. The system according to any one of the claims herein, wherein the at least one arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

205. The system according to any one of the claims herein, wherein the plurality of conductive electrodes comprises an array of conductive electrodes.

206. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a longitudinal axis (z) of the system.

207. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

208. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a first transverse axis (x) that is transverse the longitudinal axis (z).

209. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the first transverse axis (x).

210. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the first transverse axis (x) and in a direction along the longitudinal axis (z).

211. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along a second transverse axis (y) that is orthogonal to the first transverse axis (x) and transverse the longitudinal axis (z).

212. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the second transverse axis (y).

213. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the second transverse axis (y) and in a direction along the longitudinal axis (z).

214. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the longitudinal (cranial-caudal) axis (z) of the patient.

215. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

216. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the dorsal-ventral axis (y) of the patient that is perpendicular to the longitudinal axis (z).

217. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the axis (y).

218. The system according to any one of the claims herein, wherein the array of conductive electrodes extends along the transverse (from the left to the right side of the patient) axis (x) of the patient that is perpendicular to the longitudinal axis (z) and to the dorsal -ventral axis (y).

219. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the transverse axis (x).

220. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the transverse axis (y).

221. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a direction along the longitudinal axis (z).

222. The system according to any one of the claims herein, wherein the expansion system expands the area of coverage in a curved direction resulting from combinations of the three axes (x, y, and z) in order to position the electrodes along the curved surface of the thecal sac.

223. The system according to any one of the claims herein, wherein the lead head comprises at least one arm, wherein a proximal end of the at least one lead head is anchored to a portion of the lead head, wherein the plurality of conductive electrodes are positioned at the at least one arm, and wherein the at least one arm is outwardly biased relative to the lead head.

224. The system according to any one of the claims herein, further comprising a lead head retraction sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

225. The system according to any one of the claims herein, wherein the at least one arm has a sigmoidal shape when released at deployment.

226. The system according to any one of the claims herein, wherein the sigmoidal arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

227. The system according to any one of the claims herein, further comprising a deployable sheath that constrains the at least one arm at delivery and releases the at least one arm at deployment.

228. The system according to any one of the claims herein, wherein the at least one arm has a sigmoidal shape when released at deployment with the parallel peripheral portions of the sigmoid parallel / aligned with the longitudinal axis (z).

229. The system according to any one of the claims herein, wherein the lead head comprises multiple lead arms, and further comprising: a plurality of link arms; and a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, wherein the link arms are coupled to the multiple lead arms at opposite ends of the multiple lead arms, each link arm coupled between one of the multiple lead arms and a deployable arm, so that at deployment, the distance between the multiple lead arms is decreased in a direction along a longitudinal axis of the system, and a distance between the corresponding deployable arms is increased in a direction along a transverse axis of the system230. The system according to any one of the claims herein,and wherein the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of shaped link arms; and a leash actuator passing through the plurality of deployable arms and the plurality of shaped link arms in serial arrangement, wherein a distal end of the leash actuator is anchored at a distal-most arm of the plurality of deployable arms and the plurality of shaped link arms, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deploy able arms and the plurality of shaped link arms.

231. The system according to any one of the claims herein, wherein at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system232. The system according to any one of the claims herein, wherein at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the shaped link arms is increased in a direction along a transverse axis of the system233. The system according to any one of the claims herein, wherein the plurality of conductive electrodes are positioned at the shaped arms,234. The system according to any one of the claims herein, further comprising a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of shaped link arms prior to deployment and releases the plurality of deploy able arms and the plurality of shaped link arms at deployment.

235. The system according to any one of the claims herein, and wherein the lead head further comprises: a plurality of deployable arms, wherein the plurality of conductive electrodes are positioned at the deployable arms, a plurality of bracket arms; anda leash actuator passing through the bracket arms and pairs of the plurality of deployable arms in parallel arrangement, so that, at deployment, the leash actuator is tensioned to modify a position of the plurality of deployable arms and the plurality of bracket arms.

236. The system according to any one of the claims herein, wherein at deployment a distance between the plurality of deployable arms is reduced in a direction along a longitudinal axis of the system237. The system according to any one of the claims herein, wherein at deployment a width of an arrangement of the plurality of deployable arms and a plurality of the bracket arms is increased in a direction along a transverse axis of the system238. The system according to any one of the claims herein, wherein the plurality of conductive electrodes are positioned at the bracket arms,239. The system according to any one of the claims herein, further comprising a lead head retraction sheath or deployable sheath that constrains the plurality of deployable arms and the plurality of bracket arms prior to deployment and releases the plurality of deployable arms and the plurality of bracket arms at deployment.

240. The system according to any one of the claims herein, further comprising an anchoring system that anchors the lead head in position in the epidural space.

241. The system according to any one of the claims herein wherein the anchor system comprises an an anchor actuator; and at least one anchor arm at the lead head and coupled to the anchor actuator, the at least one anchor arm responsive to the anchor actuator to engage the anchor arm, thereby anchoring the lead head in position.

242. The system according to any one of the claims herein, wherein the anchor actuator provides for control over a degree of anchoring of the lead head243. The system according to any one of the claims herein wherein the anchor actuator comprises at least one filament.

244. The system according to any one of the claims herein wherein the anchor actuator comprises a gas or fluid-based actuation system.

245. The system according to any one of the claims herein wherein the at least one anchor arm is outwardly biased relative to the lead head.

246. The system according to any one of the claims herein, wherein the at least one anchor arm comprises a safe flexural modulus that prevents the creation of sufficient forces to damage the epidural space and spinal cord tissue upon deployment.

247. The system according to any one of the claims herein, wherein the lead head further comprises a bridle, and wherein the least one anchor arm is mechanically coupled to the bridle at at least one hinge.

248. A method for delivering electrical stimulation to an epidural space of a spinal cord of a patient, comprising: providing a lead head comprising a plurality of conductive electrodes; providing at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes; electrically coupling a stimulation source to the at least one conductor that generates the electrical stimulation signals; and modifying an area of coverage of the conductive electrodes at an expansion system249. A method for delivering electrical stimulation to an epidural space of a spinal cord of a patient, comprising: providing a lead head comprising a plurality of conductive electrodes; providing at least one conductor constructed and arranged to deliver electrical stimulation signals to the plurality of conductive electrodes;electrically coupling a stimulation source to the at least one conductor that generates the electrical stimulation signals; and modifying a spatial orientation of the lead head at a spatial modification system.

250. A spinal-cord stimulation alignment system comprising: a lead leash configured for advancement with an epidural canal; a lead head coupled to the lead leash a leash aligner disposed along at least a portion of the lead leash and configured to geometrically conform the lead leash to a curvature of a thecal sac; a head aligner disposed along at least a portion of the head and configured to orient the lead head within the epidural canal and to conform the lead head longitudinally to a curved thecal surface during spinal flexion; a head coupler located in at least a portion of the lead head; and a leash coupler located in at least a portion of the lead leash.

251. The system of claim 250, wherein the head coupler and leash coupler are configured to join two or more lead heads or lead leashes to form a stabilized rail structure having controlled spacing and adapted to align and maneuver with a curved surface of the thecal sac during advancement into the epidural space252. The system of any of claims 250-251, wherein at least one of the leash aligner and the head aligner defines a hydrodynamically efficient geometry selected from bullet- or spear-shaped profiles to control drag of the system within the epidural space.

253. The system of any of claims 250-252, wherein the lead leash or lead head comprises a concave crescent cross-section positioned with its concavity facing the thecal sac.

254. The system of any of claims 250-253, wherein the lead leash or lead head comprises at least one ventral keel cross-section positioned with its concavity facing the thecal sac.

255. The system of any of claims 250-254, wherein the lead leash or lead head comprises at least one flexible lateral extension arranged to contact opposing lateral walls of the epidural space and resist lateral translation of the lead.

256. The system of any of claims 250-255, wherein the lead leash or lead head comprises at least one dorsally positioned keel configured to contact and align with a dorsal portion of the epidural portion of the epidural space.

257. The system of any of claims 250-256, wherein the lead leash or lead head comprises an elongated dorsal spine extending along a longitudinal access to align the lead with the epidural canal.

258. The system of any of claims 250-257, wherein the lead leash or lead head comprises an formed cross-section shaped to mimic an epidural transverse geometry to achieve rotational and translational stability.

259. The system of any of claims 250-258, wherein the lead leash or lead head comprises a V-shaped geometry configured to achieve rotational and translational stability along a main axis of the thecal sac.

260. The system of any of claims 250-259, wherein the lead leash or lead head comprises two-bodies connected by at least one flexible element configured to achieve rotational and translational stability along a main axis of the thecal sac.

261. The system of any of claims 250-260, wherein the lead leash or lead head comprises at least three-bodies connected by at least two connecting elements configured to achieve rotational and translational stability along a main axis of the thecal sac.

262. The system of any of claims 250-261, further comprising: a first head-aligner enabling curvature about a cranio-caudal axis; a second head-aligner enabling curvature about a lateral or horizontal axis;a third head-aligner enabling curvature about a dorsal-ventral axis.

263. The system of any of claims 250-262, wherein simultaneous rotation about the three axes yields a partially rotated ribbon geometry.

264. The system of any of claims 250-263, wherein the head portion is configured to be temporarily bent or twisted to clean an anatomical obstruction and to return to its aligned geometry.

265. The system of any of claims 250-264, wherein the system is configured to maintain orientation of the lead head during spinal flexion, extension, or lateral bending.

266. The system of any of claims 250-265, wherein at least one head-aligner comprises a thinned section of structural material.

267. The system of any of claims 250-266, further comprises a lead head comprising multiple sub-elements connected by a plurality of joints.

268. The system of any of claims 250-267, wherein various combinations of rotations may be applied.

269. The system of any of claims 250-268, wherein the plurality of joints are oriented along at least one of the cranio-caudal, lateral, or dorsal-ventral axes to increase the degrees of freedom of the lead head.

270. The system of any of claims 250-269, wherein deformation about each axis can occur independently or concurrently to conform the lead head to the epidural canal.

271. The system of any of claims 250-270, wherein deformation of the lead head maintains a predetermined electrode orientation relative to a dorsal surface of the spinal cord during spinal motion.

272. The system of any of claims 250-271, wherein the lead head is biased towards its aligned configuration after deformation273. An actuation control system comprising:a structural base supporting internal components; an external shell enclosing the base, providing a handle and a cover; an internal actuation system generating mechanical energy; an external actuation system including a knob operatively coupled to the internal actuation system; a leash adaptor mechanically coupled with the internal actuation system; and a leash lock configured to secure and release the connectivity port relative to the adaptor leash.

274. The system of claim 273, wherein the structural system and external shell are integrated in the same component forming handle base assembled with a handle cover.

275. The system of any of claims 273-274, wherein an actuation knob is mounted onto a knob shaft and allows the operator to provide various types of actuation forces or motions by rotating clockwise or counterclockwise.

276. The system of any of claims 273-275, wherein an actuation knob is mounted onto a knob shaft and allows the operator to provide various types of actuation forces or motions by pulling or pushing the actuation knob.

277. The system of any of claims 273-276, wherein clockwise rotation of the actuation knob actuates an expansion in geometry in a lead head and / or increases in lead or electrode spacing within the epidural space by pulling on one of two leash actuators.

278. The system of any of claims 273-277, wherein counterclockwise rotation of the actuation knob actuates a contraction in geometry and / or decreases the spacing or configuration within the epidural space.

279. The system of any of claims 273-278, wherein an actuation knob includes an internal ratchet system configured to provide tactile feedback to the operator about the amount of movement obtained.

280. The system of any of claims 273-279, wherein an actuation knob includes an internal ratchet system configured to provide unidirectional motion reversible with a button or lever.

281. The system of any of claims 273-280, wherein the actuation knob further comprises a position indicator allowing the operator to establish the current level of actuation.

282. The system of any of claims 273-281, wherein the system further comprises at least one leash adapter to house two lead leashes following their entry into the system through two ports within the handle base.

283. The system of any of claims 273-282, wherein the actuation knob is mounted onto a knob shaft coupled with the handle base via shaft supports that allow axial translation and rotation of the knob shaft.

284. The system of any of claims 273-283, wherein the knob shaft includes an internal ratchet to provide tactile feedback about the degree of movement and / or unidirectional motion reversible with a button or lever.

285. The system of any of claims 273-284, wherein the knob shaft provides a knob position indicator allowing the operator to establish the current level of actuation.

286. The system of any of claims 273-285, wherein the knob shaft is coupled with an actuation shifter such that translational motion of the knob shaft is transmitted into the same motion for the actuation shifter.

287. The system of any of claims 273-286, wherein the actuation shifter mechanically engages with a leash actuator to communicate linear motion after a connectivity port system or lead leash has been inserted into the leash adaptor;288. The system of any of claims 273-287, wherein the leash lock locks the connectivity port into the leash adaptor through a spring-loaded latch engaging a catch feature of the connectivity port.

289. The system of any of claims 273-288, wherein depression of the leash lock releases both the connectivity port and the leash actuator from the leash adaptor and the actuation shifter.

290. The system of any of claims 273-289, wherein penetration of the connectivity port into the leash adaptor mechanically engages the leash actuator with the actuation shifter.

291. The system of any of claims 273-290, wherein depression of the actuation knob extends deployable arms of the lead head, such that progressive pushing of the actuation knob with tactile and visual feedback allows the operator to control deployment of the deployable arms to expand geometry of the lead head within the epidural space.

292. A steering control system comprising: a structural system configured to support and mechanically couple internal components of the steering control system; an external shell enclosing the structural system and defining a handheld housing; an internal steering system configured to generate motion for steering actuation of a spinal-cord-stimulation lead assembly; and an external steering system including a user-operable interface configured to control the internal steering system.

293. The system of claim 292, further comprising a leash adaptor configured to mechanically engage the internal steering system and a connectivity port or a lead leash.

294. The system of any of claims 292-293, further comprising a leash lock configured to secure and release the connectivity port or the lead leash relative to the leash adaptor.

295. The system of any of claims 292-294, further comprising a signal communication system including electrically conductive elements configured to couple aconduction and insolation system with an IPG or EPG to perform stimulation testing during positioning of a lead head.

296. The system of any of claims 292-295, wherein actuation of the external steering system transmits motion through the internal steering system to the lead leash to effect steering of the lead head.

297. The system of any of claims 292-296, wherein the structural system and the external shell are integrated into a handle based enclosed by a handle cover assembled by snap-fit features to form a handheld device configured for single- handed operation.

298. The system of any of claims 292-297, further comprising a steering knob mounted to a steering shaft and configured to translate rotational and / or linear input into a corresponding motion of the internal steering system.

299. The system of any of claims 292-298, wherein clockwise rotation of the steering knob pulls a first leash steering actuator and simultaneously pushes a second leash steering actuator to steer the lead head in a first direction, and counter-clockwise rotation produces steering in an opposite direction.

300. The system of any of claims 292-299, wherein the steering knob includes a ratchet mechanism configured to provide tactile feedback corresponding to incremental steering displacement and a position indicator configured to indicate a neutral or straight configuration of the lead head.301 The system of any of claims 292-300, wherein the handle base defines internal walls supporting a plurality of shaft supports, each incorporating a bearing to reduce rotational or translational friction of internal shafts.

302. The system of any of claims 292-301, further comprising a knob shaft coupled to the steering knob and to a knob gear, the knob shaft including notches engageable by a retainer to define at least two longitudinal positions corresponding to open and closed states of the steering control system.

303. The system of any of claims 292-302, wherein the knob gear meshes with a first steering gear coupled to a steering shaft, the first steering gear being meshed with a second steering gear coupled to steering worm gears that engage steering rack gears mounted to steering wagons constrained along a linear rail.

304. The system of any of claims 292-303, wherein each steering wagon is mechanically coupled to a leash adaptor engaging a corresponding leash steering actuator to transmit linear steering motion.

305. The system of any of claims 292-304, wherein rotation of the steering knob is transmitted through the knob gear and the steering gears to generate opposite rotational motion of the steering shafts and corresponding opposing linear translation of the steering rack gears, thereby producing differential motion of the leash steering actuators to steer the lead head.

306. The system of any of claims 292-305, wherein the steering knob includes a knob position indicator providing visual feedback of steering level and direction relative to the handle base.

307. The system of any of claims 292-306, wherein the handle base includes perpendicular shaft supports accommodating a knob shaft and a steering shaft, the knob shaft coupled to a knob gear in at or about a one to one ratio with a first steering gear, the steering gears meshed with opposing steering rack gears configured to move in equal and opposite linear directions along the handle base.

308. An anchoring control system comprising: a structural system configured to support and mechanically couple internal components of the anchoring control system; an external shell enclosing the structural system and defining a handheld housing; an internal anchoring control system configured to generate mechanical motion to actuate an anchoring element of a spinal-cord-stimulation lead assembly; andan external anchoring control system including a user-operable interface coupled to the internal anchoring control system and configured to transmit operator input to selectively deploy or retract an anchoring mechanism of the lead assembly.

309. The system of claim 308, wherein the external shell and the structural system are integrated into a handle base enclosed by a handle cover assembled by snap-fit features to form a handheld device suitable for single hand operation.

310. The system of any of claims 308-309, further comprising a leash adaptor configured to mechanically engage a connectivity port or a lead leash to communication motion between the internal anchoring control system and the lead assembly.

311. The system of any of claims 308-310, further comprising a leash lock configured to secure or release the connectivity port or the lead leash relative to the leash adaptor.

312. The system of any of claims 308-311, wherein the external anchoring control system comprises an anchoring knob mounted to a knob shaft supported within the structural system by shaft supports permitting axial translation and rotation of the knob shaft.

313. The system of any of claims 308-312, wherein the support shaft includes a ratchet mechanism configured to provide tactile feedback corresponding to incremental movement of the anchoring knob.

314. The system of any of claims 308-313, wherein the knob shaft includes a position indicator configured to indicate a current level of anchoring actuation.

315. The system of any of claims 308-314, further comprising an anchoring shifter mechanically coupled with the knob shaft such that translational motion of the knob shaft is transmitted to the anchoring shifter to actuate a leash anchoring actuator.

316. The system of any of claims 308-315, wherein insertion of the connectivity port into the leash adaptor mechanically engages the leash anchoring actuator with the anchoring shifter and disengages an anchoring retention system, permitting relative motion of the leash anchoring actuator and the lead leash.

317. The system of any of claims 308-316, wherein the actuation of the leash lock releases both the connectivity port and the leash anchoring actuator from the leash adaptor and the anchoring shifter, and re-engages the anchoring retention system to restrict relative motion.

318. The system of any of claims 308-317, wherein axial translation of the anchoring knob relative to the external shell progressively deploys deployable arms of a lead head to anchor the lead head within an epidural space.

319. A spinal-cord-stimulation system comprising: a lead head defining a paddle-type body configured for deployment within an epidural canal via a laminotomy access; a plurality of head lead electrodes disposed on a ventral surface of the lead head and configured to deliver electrical stimulation to the spinal cord; a pair of leash steering actuators coupled to the lead head and configured for relative motion to deform the lead head about a transverse axis to steer the lead head within the epidural canal; and a head aligner comprising structural regions of reduced thickness or grooves configured to permit controlled curvature of the paddle to conform to the thecal sac and to accommodate spinal flexion.

320. The system of claim 319, wherein the lead head defines a V-shaped transverse cross-section having a thicker medial portion and thinner lateral portions configured to conform to the curvature of the epidural canal.

321. The system of any of claims 319-320, wherein a ventral portion of the paddle conforms with the convex curvature of the thecal sac and a dorsal portion conforms with the concave curvature of the epidural canal.

322. The system of any of claims 319-321, wherein the paddle comprises a wider base along a cranio-caudal direction and a narrower paddle head configured to enhance steerability during advancement through the epidural canal.

323. The system of any of claims 319-322, wherein the wider base of the paddle includes thin lateral walls configured to contact lateral surface of the epidural canal and to flex laterally to accommodate anatomical obstacles.

324. The system of any of claims 319-323, wherein the paddle comprises a cranio- caudally oriented thin region forming a head aligner and a plurality of bilateral head steering folds forming additional head aligners.

325. The system of any of claims 319-324, wherein each head steering fold comprising a triangular cuts allowing the paddle to deform into an arched configuration by compression of folds on one side and expansion on an opposite side.

326. The system of any of claims 319-325, wherein deformation of the paddle head about the transverse axis generates steerage to facilitate advancement and alignment of the electrodes within the epidural space.

327. The system of any of claims 319-326, wherein the lead head comprises a region of reduced thickness or void regions to promote deformability and conformality to the surface of the thecal sac.

328. The system of any of claims 319-327, wherein the lead head includes two banks of head lead electrodes disposed of on a slightly angled planes to maximize surface contact with the thecal sac.

329. The system of any of claims 319-328, wherein each lead electrode is embedded within and exposed on the ventral surface of the lead head and connected to a lead conductive wire insulated by a lead wire insulation.

330. The system of any of claims 319-329, wherein the lead head conductive wires are organized into two banks converging into respective leash steering actuators through a tension-relief bundling element.

331. The system of any of claims 319-330, wherein each leash steering actuator is coupled to the proximal end of the paddle lead head at a hinge anchor.

332. The system of any of claims 319-331, further comprising a deployable sheath surrounding the leash steering actuators and functioning as a lead leash to facilitate advancement of the lead head into the epidural space.

333. The system of any of claims 319-332, wherein the deployable sheath includes a sheath-splitting feature extending along its length to allow removal of the sheath following placement of the lead head.

334. The system of any of claims 319-333, wherein relative displacement between the two leash steering actuators deforms the paddle lead head to steer the lead head during advancement or retraction within the epidural space.

335. The system of any of claims 319-334, wherein the steerable paddle lead head is configured to three-dimensionally deform about a transverse axis and a ventrodorsal axis to navigate anatomic obstacles and conforms to the surface of the thecal sac.

336. A method for alignment of a spinal-cord stimulation system comprising: providing a lead leash configured for advancement with an epidural canal; providing a lead head coupled to the lead leash disposing a leash aligner along at least a portion of the lead leash and configured to geometrically conform the lead leash to a curvature of a thecal sac; disposing a head aligner along at least a portion of the head and configured to orient the lead head within the epidural canal and to conform the lead head longitudinally to a curved thecal surface during spinal flexion; positioning a head coupler at at least a portion of the lead head; and positioning a leash coupler at at least a portion of the lead leash.

337. A method for actuation control of a system comprising:providing a structural base supporting internal components; providing an external shell enclosing the base, providing a handle and a cover; providing an internal actuation system generating mechanical energy; providing an external actuation system including a knob operatively coupled to the internal system; providing a leash adaptor mechanically coupled with the internal actuation system; and providing a leash lock configured to secure and release the connectivity port relative to the adaptor leash.

338. A method for steering control of a system comprising: providing a structural system configured to support and mechanically couple internal components of the steering control system; providing an external shell enclosing the structural system and defining a handheld housing; providing an internal steering system configured to generate motion for steering actuation of a spinal-cord-stimulation lead assembly; and providing an external steering system including a user-operable interface configured to control the internal steering system.

339. A method for anchoring control of a system comprising: providing a structural system configured to support and mechanically couple internal components of the anchoring control system; providing an external shell enclosing the structural system and defining a handheld housing; providing an internal anchoring control system configured to generate mechanical motion to actuate an anchoring element of a spinal-cord- stimulation lead assembly; and

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