Devices, systems and methods for transcutaneous delivery of neurostimulation arrays

Abstract

Embodiments of the present disclosure relate to devices, systems, and methods for percutaneous delivery of a neurostimulation array. In one embodiment, the neurostimulation lead includes a body portion configured to transition from a collapsed delivery configuration to an expanded, deployed configuration. In some aspects, the expanded, deployed configuration is wider than the collapsed delivery configuration. Additionally, in some embodiments, transitioning the neurostimulation lead from the collapsed delivery configuration to the expanded, deployed configuration includes an unfolding or unwrapping operation that is not perpendicular to a central axis of the delivery system. In certain embodiments, the neurostimulation lead includes an array of electrodes disposed on the body portion, the array of electrodes being electrically coupled to an implantable pulse generator (IPG).

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 176,690, filed April 19, 2021, which is incorporated herein by reference in its entirety for all purposes.

[0002] Field FIELD OF THE DISCLOSURE The present disclosure relates generally to devices, systems and methods for neurostimulation arrays, and more particularly to devices, systems and methods for transcutaneous delivery of neurostimulation arrays. [Background technology]

[0003] background A spinal cord stimulator is an implantable device that electrically stimulates the spinal cord to relieve pain. Spinal cord stimulation is typically used after non-surgical pain treatment options have failed to provide adequate relief. A spinal cord stimulator system has three main parts: (i) an array of electrodes placed along the spinal cord in the epidural space; (ii) an implantable pulse generator (IPG), a pacemaker-like module containing a battery and electronics that generate the necessary electrical waveform pulses; and (iii) an external controller placed outside the body. The IPG is placed under the skin, usually near the buttocks or abdomen, and wires run under the skin from the IPG to the electrode array. The controller allows patients and clinicians to turn off or adjust stimulation waveform parameters. In some instances, the controller can also wirelessly charge the battery in the implantable IPG. Summary of the Invention

[0004] Abstract The embodiments disclosed herein improve upon previous embodiments by disclosing an electrode array that can be delivered percutaneously and has a wide range of application.

[0005] According to one example ("Example 1"), a neurostimulation lead includes a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the expanded deployed configuration is wider than the collapsed delivery configuration, and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG).

[0006] According to one example ("Example 2"), in the neurostimulation lead of Example 1, the width of the body portion in the expanded, deployed configuration is configured to extend across at least a portion of the spinal cord and one or more dorsal root ganglia.

[0007] According to one example ("Example 3"), in the neurostimulation lead of any one of Examples 1-2, the width of the body portion is greater than 6 mm.

[0008] According to one example ("Example 4"), in the nerve stimulation lead of any one of Examples 1 to 3, the width of the main body portion is 6 mm to 15 mm.

[0009] According to one example ("Example 5"), in the neurostimulation lead of any one of Examples 1-4, the body portion comprises a non-zero curvature when the body portion is in the expanded, deployed configuration.

[0010] According to one example ("Example 6"), in the neurostimulation lead of any one of Examples 1 to 5, the body portion is in a coiled configuration while the body portion is in a collapsed delivery configuration, the body portion is in an uncoiled configuration while the body portion is in an expanded, deployed configuration, and the body portion is configured to uncoil in order to transition from the collapsed delivery configuration to the expanded, deployed configuration.

[0011] According to one example ("Example 7"), in the neurostimulation lead of any one of Examples 1-6, the body portion includes one or more reinforcing members extending laterally across at least a portion of the body portion.

[0012] According to one example ("Example 8"), the neurostimulation lead of any one of Examples 1 to 7 is configured to be delivered via a catheter having a side slot, and the main body portion extends through the side slot to transition from a collapsed delivery configuration to an expanded deployment configuration.

[0013] According to one example ("Example 9"), in the neurostimulation lead of any one of Examples 1 to 5 and Examples 7 to 8, the body portion is in a collapsed configuration while the body portion is in a collapsed delivery configuration, the body portion is in an unfolded configuration while the body portion is in an expanded, deployed configuration, and the body portion is configured to unfold in order to transition from the collapsed delivery configuration to the expanded, deployed configuration.

[0014] According to one example ("Example 10"), in the neurostimulation lead of any one of Examples 1-9, the body portion comprises a central spine and a plurality of side supports.

[0015] According to one example ("Example 11"), in the neurostimulation lead of any one of Examples 1 to 10, the body portion has a coil shape when the body portion is in the expanded, deployed configuration.

[0016] According to one example ("Example 12"), in the neurostimulation lead of any one of Examples 1-10, the body portion has a serpentine shape when the body portion is in the expanded, deployed configuration.

[0017] According to one example ("Example 13"), in the neurostimulation lead of any one of Examples 1-10, the body portion has a wing-like shape when the body portion is in the expanded, deployed configuration.

[0018] According to one example ("Example 14"), in the neurostimulation lead of any one of Examples 1 to 13, the main body portion includes a frame made of a shape memory material, and the relaxed shape of the shape memory material is when the frame is in an expanded, deployed configuration.

[0019] According to one example ("Example 15"), in the neurostimulation lead of Example 14, the shape memory material is nitinol.

[0020] According to one example ("Example 16"), the neurostimulation lead of any one of Examples 1-15, wherein the body portion forms an elastomeric sleeve.

[0021] According to one example ("Example 17"), in the neurostimulation lead of any one of Examples 1 to 5, 7 to 8, and 10 to 16, the body portion is in an unexpanded configuration while the body portion is in a collapsed delivery configuration, and the body portion is in an expanded configuration while the body portion is in an expanded, deployed configuration, and the body portion is configured to be expanded to transition from the collapsed delivery configuration to the expanded, deployed configuration.

[0022] According to one example ("Example 18"), in the neurostimulation lead of Example 17, the body portion is pneumatically or hydraulically expanded.

[0023] According to one example ("Example 19"), the neurostimulation lead of any one of Examples 1 to 18 includes a sclerosing agent for securing the body portion in the expanded, deployed configuration.

[0024] According to one example ("Example 20"), in the neurostimulation lead of any one of Examples 1-19, the expanded deployment configuration is thinner than the collapsed delivery configuration.

[0025] According to one example ("Example 21"), the neurostimulation lead of any one of Examples 1 to 20 further includes an anchor for securing the body portion to a spine.

[0026] According to one example ("Example 22"), in the neurostimulation lead of Example 21, the anchor is a barb.

[0027] According to one example ("Example 23"), the neurostimulation lead of Example 21, wherein the anchor is configured to promote tissue attachment to the anchor.

[0028] According to one example ("Example 24"), the neurostimulation lead of any one of Examples 1-23, at least a portion of the neurostimulation lead includes a material that promotes tissue ingrowth.

[0029] According to one example ("Example 25"), the neurostimulation lead of any one of Examples 1 to 24 further comprises an IPG.

[0030] According to one example ("Example 26"), the neural stimulation lead of Example 25 further comprises an external controller communicatively coupled to the IPG.

[0031] According to one example ("Example 27"), the neural stimulation lead includes a plurality of first portions that are thicker than second portions of the neural stimulation lead, and the neural stimulation lead is arranged in a pattern such that the location of at least one of the plurality of first portions does not overlap another first portion of the plurality of first portions.

[0032] According to one example ("Example 28"), the plurality of first portions includes an array of electrodes.

[0033] According to one example ("Example 29"), the neurostimulation lead of any one of Examples 1-28, wherein a cross-sectional area of ​​the solid material of the neurostimulation lead is smaller in the collapsed delivery configuration than in the expanded deployed configuration.

[0034] According to one example ("Example 30"), in any one of Examples 1 to 29, the transition of the neurostimulation lead from the collapsed delivery configuration to the expanded deployed configuration includes an unfolding or unwrapping action that is not perpendicular to the central axis of the delivery system.

[0035] According to one example ("Example 31"), a method for implanting a neurostimulation lead in a subject includes percutaneously inserting a catheter into the subject, wherein a distal end of the catheter is positioned adjacent to an implantation site in the subject, the implantation site being located within the epidural space of the subject; delivering the neurostimulation lead to the implantation site through the catheter while the neurostimulation lead is in a collapsed delivery configuration, wherein the neurostimulation lead is according to one of Examples 1 to 30; and transitioning the neurostimulation lead from the collapsed delivery configuration to an expanded, deployed configuration.

[0036] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of the inventive concepts otherwise provided by this disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0037] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments and, together with the description, serve to explain the principles of the disclosure.

[0038] [Figure 1] FIG. 1 is a diagram of a neuromodulation system according to at least some embodiments of the present disclosure.

[0039] [Figure 2] FIG. 2A is a cross-sectional view of a spinal column including a neurostimulation lead implanted in the epidural space of the spinal column, according to at least some embodiments of the present disclosure, and FIG. 2B is a perspective view of the neurostimulation lead implanted in the epidural space.

[0040] [Figure 3] 3A-3M illustrate side and distal end views of an exemplary delivery device and neurostimulation lead transitioning from a collapsed delivery configuration to an expanded deployed configuration, according to at least some embodiments of the present disclosure.

[0041] [Figure 4-5] 4 is a side view of an exemplary neural stimulation lead, and FIG. 5 is an opposite side view of the exemplary neural stimulation lead shown in FIG. 4, according to at least some embodiments of the present disclosure.

[0042] [Figure 6] 6A-6B are perspective views of an exemplary neural stimulation lead, according to at least some embodiments of the present disclosure.

[0043] [Figure 7] FIG. 7A is a view of the distal end of an exemplary neural stimulation lead, and FIG. 7B is a side view of an exemplary neural stimulation lead, in accordance with at least some embodiments of the present disclosure.

[0044] [Figure 8] 8A-8B are side views and FIG. 8C is a perspective view of an exemplary neural stimulation lead, according to at least some embodiments of the present disclosure.

[0045] [Figure 9] FIG. 9 is a side view of a neural stimulation lead according to at least some embodiments of the present disclosure.

[0046] [Figure 10-11] 10 is a perspective view of a frame for a neural stimulation lead according to at least some embodiments of the present disclosure, and FIG. 11 is a cross-sectional view of a portion of the neural stimulation lead shown in FIG.

[0047] [Figure 12-13]12 is a side view of a neural stimulation lead transitioning from a collapsed delivery state to an expanded deployed state, according to at least some embodiments of the present disclosure, and FIG. 13 is an enlarged view of a portion of the neural stimulation lead shown in FIG. 12.

[0048] [Figure 14] FIG. 14 is a side view of a neural stimulation lead transitioning from a collapsed delivery state to an expanded deployed state in accordance with an embodiment of the present disclosure.

[0049] [Figure 15] 15A-15H are side views of a neurostimulation lead transitioning from an expanded deployed state to a collapsed delivery state according to an embodiment of the present disclosure.

[0050] [Figure 16] 16A-16B are side views and FIG. 16C is a perspective view of an exemplary neural stimulation lead, according to at least some embodiments of the present disclosure.

[0051] [Figure 17] FIG. 17 is a perspective view of a ribbed neurostimulation lead and delivery device according to at least some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0052] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a restrictive manner, for example, the terms used in this application should be read broadly in the context of the meanings ascribed to such terms by experts in the field.

[0053] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to a stated measurement, including any measurement reasonably close to the stated measurement. A measurement reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as understood and easily ascertained by one of ordinary skill in the relevant art. Such deviations may result from measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, fine-tuning made to optimize performance and / or structural parameters given differences in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and the like. If it is determined that the value of such a reasonably small difference would not be easily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0054] Description of Various Embodiments Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0055] Most spinal cord stimulators require two procedures: device trial and implantation. During the trial period, the surgeon implants a temporary electrode array to determine how effective the treatment is for a given patient. The array can consist of two flexible tubular leads with multiple electrodes along their length. One lead is placed on the right side of the spine and the other on the left. The leads are inserted percutaneously under fluoroscopic x-ray guidance. The location of pain determines the placement of the electrodes along the spine. The trial procedure typically requires an incision in the lower back to place the electrodes. The trial implantable pulse generator (IPG) is external and typically placed on a belt worn around the waist. The trial period typically lasts 4 to 7 days, allowing the patient to evaluate how well the device relieves pain. If pain levels are reduced by 50% or more, the trial is considered successful. After the trial period, the leads are removed. If the trial is successful, surgery to permanently implant the device is scheduled.

[0056] During the permanent implant procedure, the IPG is placed under the skin in the upper buttocks / back, upper chest wall, or abdominal area, and the trial electrodes are replaced with either a set of percutaneous electrode leads similar to those used in the trial, or a surgically placed paddle electrode array. Percutaneous leads have a single row of electrodes distributed axially along the length of the active portion of the lead. Paddle electrode arrays have electrodes distributed in two dimensions. The large width and overall size of current paddle arrays means that they must be implanted in a surgical (non-minimally invasive) procedure, typically performed by laminectomy (removal of the posterior part of the vertebrae).

[0057] Compared to surgical placement of paddle electrode arrays, placement of percutaneous electrode leads is a quicker and less invasive procedure. Also, percutaneous procedures can be performed by an anesthesiologist, spine surgeon, or neurosurgeon trained in pain management, whereas paddle arrays must be implanted by a surgeon. However, compared to surgically placed paddle arrays, percutaneously placed leads have limited coverage, are more likely to migrate, and provide less focused charge injection (which can limit pain targeting accuracy and negatively impact battery life).

[0058] Embodiments of the present disclosure provide solutions to these problems by disclosing a neural stimulation lead that can be delivered percutaneously and that can be transitioned from a collapsed delivery configuration to an expanded, deployed configuration, thereby covering a larger surface area than conventional percutaneously delivered leads, as discussed in more detail below. In certain aspects, the embodiments disclosed below that address transitioning a neural stimulation lead from a collapsed delivery configuration to an expanded, deployed configuration can be performed in reverse to transition the neural stimulation lead from the expanded, deployed configuration to the collapsed delivery configuration to withdraw the lead from a subject and / or reposition the lead during a procedure. For example, the neural stimulation lead can be placed in a delivery device before implanting the neural stimulation lead, and the neural stimulation lead can be withdrawn and / or repositioned after and / or during the implant procedure.

[0059] 1 is a diagram of a neuromodulation system 100 in accordance with at least some embodiments of the present disclosure. This diagram is merely an example, which should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0060] In the illustrated embodiment, the system 100 includes a controller 102, an implantable pulse generator (IPG) 104, and a neural stimulation lead 106 implanted within a subject 108. In certain embodiments, the neural stimulation lead 106 includes an array of electrodes implanted within the subject's epidural space 132 (shown in more detail in FIGS. 2A and 2B ). According to certain embodiments, the IPG 104 is electrically coupled to the neural stimulation lead 106 and includes one or more power sources and / or electrical components configured to generate and deliver one or more stimulating electrical waveforms to the neural stimulation lead 106, which are then transmitted to the subject's 108's nervous system to produce a therapeutic effect. In certain examples, the IPG 104 is implanted beneath the subject's 108's skin, for example, near the abdomen or buttocks of the subject 108. The IPG 104 is then electrically coupled to the neural stimulation lead 106 via one or more wires disposed beneath the subject's 108's skin.

[0061] According to certain embodiments, the controller 102 is configured to wirelessly couple to the IPG 106 and enable the subject 108 and / or clinician to communicate with the IPG 106. In certain embodiments, the controller 102 can include a programming device that enables the subject 108 and / or clinician to initialize and adjust settings on the IPG 106. For example, the controller 102 can enable the subject 108 and / or clinician to turn off and / or adjust the stimulating electrical waveforms generated by the IPG 104. In certain examples, the controller 102 is configured to wirelessly charge the IPG 104.

[0062] According to certain embodiments, the neural stimulation lead 106 may include a collapsed delivery configuration for percutaneously delivering the neural stimulation lead 106 to an implantation site via a catheter. Once the neural stimulation lead 106 is positioned at the implantation site, the neural stimulation lead 106 may be deployed to an expanded, deployed configuration. In certain embodiments, the expanded, deployed configuration may be wider than the collapsed delivery configuration. The wider, expanded, deployed configuration allows the neural stimulation lead 106 to stimulate a wider area than conventional neural stimulation leads that are implanted percutaneously. Furthermore, the neural stimulation lead 106 offers an advantage over larger neural stimulation leads that require a laminectomy because the neural stimulation lead 106 may be implanted percutaneously.

[0063] Additional details about the neural stimulation lead 106 and the collapsed delivery configuration and expanded deployed configuration of the neural stimulation lead 106 are described below. As noted above, in certain aspects, embodiments disclosed herein that support transitioning the neural stimulation lead 106 from a collapsed delivery configuration to an expanded deployed configuration can be implemented in reverse to transition the neural stimulation lead 106 from an expanded deployed configuration to a collapsed delivery configuration.

[0064] 2A is a cross-sectional view of a spinal column including a neurostimulation lead implanted in the epidural space 132 of the spine, and FIG. 2B is a perspective view of a neurostimulation lead 106 implanted in the epidural space 132. These illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art will recognize many variations, alternatives, and modifications. For example, while the neurostimulation lead 106 has a winged shape, this is only one embodiment; other examples are shown in the figures below.

[0065] In the illustrated embodiment, the neural stimulation lead 106 is in an expanded, deployed configuration. As shown, the neural stimulation lead 106 is implanted within the epidural space 132. In certain embodiments, the neural stimulation lead 106 includes a body portion 110 that is positioned near the midline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134. According to certain embodiments, the body portion 110 includes an array of electrodes 112 disposed thereon. The array of electrodes 112 can be coupled to an IPG (e.g., the IPG 104) to receive electrical waveforms from the IPG and deliver waveforms that stimulate the left and right sides of the spinal cord 133 and / or the dorsal root ganglion 134.

[0066] According to certain embodiments, the neurostimulation lead 106 has a width 107 when the neurostimulation lead 106 is in an expanded deployed configuration, which is greater than the width when the neurostimulation lead 106 is in a collapsed delivery configuration. According to certain embodiments, the width 107 of the neurostimulation lead 106 is measured in a direction perpendicular to a longitudinal axis 113 of the neurostimulation lead 106. In certain instances, when the neurostimulation lead 106 is implanted, at least a portion of the width 107 (e.g., a central portion 115) extends perpendicular to a sagittal plane 117 and parallel to a coronal plane of the person in whom the neurostimulation lead 106 is implanted.

[0067] In one embodiment, the width 107 of the neural stimulation lead 106 is greater than 6 mm. In another embodiment, the width 107 of the neural stimulation lead 106 is greater than 7 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 8 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 9 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 10 mm. In another embodiment, the width 107 of the neural stimulation lead 106 is greater than 11 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 12 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 13 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is greater than 14 mm.

[0068] According to certain embodiments, the width 107 of the neural stimulation lead 106 is between 6 mm and 15 mm. In another embodiment, the width 107 of the neural stimulation lead 106 is between 7 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 8 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 9 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 10 mm and 15 mm. In another embodiment, the width 107 of the neural stimulation lead 106 is between 11 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 12 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 13 mm and 15 mm. In yet another embodiment, the width 107 of the neural stimulation lead 106 is between 14 mm and 15 mm.

[0069] Additionally or alternatively, the neural stimulation lead 106 has a cross-sectional thickness 109 that is thinner when the neural stimulation lead 106 is in the expanded, deployed configuration (shown in FIG. 2A ) than when the neural stimulation lead 106 is in the collapsed delivery configuration (see, e.g., FIG. 3D ). According to certain embodiments, the cross-sectional thickness 109 can be measured as the height of the neural stimulation lead 106 along a line 117 that bisects the sagittal plane of the neural stimulation lead 106, where the line 117 extends parallel to the sagittal plane. Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 106 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. In at least some embodiments, the cross-sectional thickness 109 and the cross-sectional area are taken perpendicular / transverse to the longitudinal axis 113. In certain examples, the longitudinal axis 113 may be referred to, for example, as the central axis of the delivery system of the neural stimulation lead 106 and / or the neural stimulation lead 106.

[0070] According to certain embodiments, the neural stimulation lead 106 can be curved when the neural stimulation lead 106 is in the expanded, deployed configuration to conform to the anatomy of the subject 108 (e.g., the spinal cord 133), as shown in FIG. 2A . In these examples, the central portion 115 can be disposed in a posterior direction 121 relative to the end portions 123, such that the end portions 123 are disposed in an anterior direction 125 relative to the central portion 115. Additionally or alternatively, the neural stimulation lead 106 can include a non-zero curvature 127 when the neural stimulation lead 106 is in the expanded, deployed configuration, as shown in FIG. 2A . In some embodiments, the non-zero curvature can be the reciprocal of the radius of curvature. In some embodiments, the non-zero curvature 127 is configured so that the neural stimulation lead 106 conforms to the spinal cord 133. In some examples, the non-zero curvature 127 can increase as the neural stimulation lead 106 extends in a lateral direction 129 away from the central portion 115. Additionally, in some examples, the neurostimulation lead 106 can include a bend point 131 such that the neurostimulation lead 106 curves in a direction opposite to the non-zero curvature 127 as the neurostimulation lead 106 extends in a lateral direction 129 away from the bend point 131 .

[0071] According to certain embodiments, one or more electrodes of the electrode array 112 can be positioned near the perimeter 114 of the body portion 110. Additionally or alternatively, one or more electrodes of the electrode array 112 can be positioned away from the perimeter 114 of the body portion 110, for example, near the central portion 116 of the body portion 110. Additionally or alternatively, one or more electrodes of the electrode array 112 can be positioned near the distal portion 118, the proximal portion 120, the left portion 122, and / or the right portion 124 of the body portion 110. In certain embodiments, one or more electrodes of the electrode array 112 can be arranged in one or more columns, e.g., column 126. Additionally or alternatively, one or more electrodes of the electrode array 112 can be arranged in one or more rows, e.g., row 128. Each column 126 and / or row 128 can include multiple electrodes.

[0072] According to certain embodiments, the wide coverage of body portion 110 and / or electrode array 112 allows neurostimulation lead 106 to provide better and / or more precise stimulation than narrower neurostimulation leads. As described in more detail below, body portion 110 is wider when body portion 110 is in the expanded, deployed configuration (shown) than when body portion 110 is in the collapsed delivery configuration. Thus, neurostimulation lead 106 can be delivered percutaneously while neurostimulation lead 106 is in the collapsed delivery configuration, providing a less invasive implant procedure than prior embodiments.

[0073] In certain embodiments, the neural stimulation lead 106 may be formed from and / or coated with a biocompatible material. In certain examples, the neural stimulation lead 106 may include polyethylene (PE), expanded PE (ePE), and / or a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer or an expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the neural stimulation lead 106 may be formed at least in part from polyester, silicone, urethane, polyethylene terephthalate, or another biocompatible polymer, or a combination thereof. In some examples, a bioresorbable or bioabsorbable material, such as a bioresorbable or bioabsorbable polymer, may be used. In some examples, the neural stimulation lead 106 may be formed at least in part from Dacron, polyethylene (PE), expanded PE (ePE), polyolefin, carboxymethyl cellulose fabric, polyurethane, or other woven, nonwoven, or film elastomer.

[0074] According to certain embodiments, the neurostimulation lead 106 includes a frame constructed from a shape-memory material. In some instances, the frame is in a relaxed shape when the neurostimulation lead 106 is in an expanded, deployed configuration. For example, nitinol (NiTi) may be used as the frame material of the neurostimulation lead 106 (and any of the frames discussed herein), although other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof, may be used as the frame material. The superelastic properties and flexibility of NiTi can improve the conformability of the frame. Furthermore, NiTi can be shape-set to a desired shape. That is, NiTi can be shape-set so that the frame tends to self-expand into a desired shape when unconstrained, such as when the frame is deployed from a delivery system. In other words, the neurostimulation lead 106 can be collapsed as it is delivered through the catheter, and once the neurostimulation lead 106 is positioned at the implant treatment site (e.g., within the epidural space 132), the catheter can be withdrawn and the neurostimulation lead 106 will expand to its deployed position due to the initial shape of the NiTi frame.

[0075] According to certain embodiments, the neural stimulation lead 106 can be expandable. Expanding the neural stimulation lead 106 can transition the neural stimulation lead 106 from a collapsed delivery configuration to an expanded, deployed configuration. In certain aspects, the neural stimulation lead 106 can be expanded pneumatically and / or hydraulically, for example, using a hydrogel. In certain embodiments, de-expanding the neural stimulation lead 106 can transition the neural stimulation lead 106 from the expanded, deployed configuration to the collapsed delivery configuration.

[0076] According to certain embodiments, the neural stimulation lead 106 may include a sclerosing agent such that when the neural stimulation lead 106 is in the expanded, deployed configuration, the sclerosing agent secures the neural stimulation lead 106 in the expanded, deployed configuration and reduces the tendency of the neural stimulation lead 106 to compress and / or expand and / or migrate when the subject 108 moves, bends, twists, etc. In certain embodiments, the sclerosing agent may be injected into the neural stimulation lead 106.

[0077] According to certain embodiments, the neurostimulation lead 106 includes one or more anchors 130. In certain instances, the one or more anchors 130 are configured to secure the neurostimulation lead 106 to a portion of the spinal column, including a vertebra and / or another structure of the spinal column and / or soft tissue structure (see, e.g., FIG. 2A , which illustrates a cross section of a spinal column), to prevent migration and / or movement of the neurostimulation lead 106. For example, the one or more anchors 130 are configured to secure the neurostimulation lead 106 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 106. In some aspects, the one or more anchors 130 are formed in the shape of barbs for coupling to a vertebra and / or another solid structure of the spinal column. In certain embodiments, the one or more anchors 130 are formed from a shape-memory material, such as NiTi. In some instances, the one or more anchors 130 protrude from an upper portion of the neurostimulation lead 106. Additionally or alternatively, one or more anchors 130 protrude from another portion of the neurostimulation lead 106, such as the sides and / or bottom. In certain embodiments, one or more anchors 130 can be formed of a material that promotes tissue ingrowth into the one or more anchors 130. In addition to or instead of one or more anchors 130, the neurostimulation lead 106 can include different materials, some or all of which can promote tissue ingrowth / attachment to a portion of the spinal column and some of which can inhibit tissue ingrowth / attachment. For example, a material that can promote tissue ingrowth / attachment can be a material with an open, high-porosity microstructure, and a material that inhibits tissue ingrowth / attachment can be a material with a closed, low-porosity microstructure. Further details describing such materials can be found in U.S. patent application Ser. No. 7,736,576, entitled "Surface-Modified Expanded Polytetrafluoroethylene Device and Method for Manufacturing Same," and U.S. patent application Ser. No. 15 / 183,897, entitled "Asymmetric Polytetrafluoroethylene Composite Having Macrotextured Surface and Method for Manufacturing Same," the entire disclosures of which are incorporated herein by reference in their entireties for all purposes.

[0078] 3A-3M are side and distal end views of an exemplary delivery device according to at least some embodiments of the present disclosure, in which a neurostimulation lead 208 is positioned within the delivery device (FIGS. 3A-3G) and then transitioned from a collapsed delivery configuration to an expanded, deployed configuration (FIGS. 3H-3M). In certain aspects, the embodiments disclosed in FIGS. 3H-3M can be executed in reverse from 3M to 3H to transition the neurostimulation lead 208 from the expanded, deployed configuration to the collapsed delivery configuration. These illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art will recognize many variations, alternatives, and modifications.

[0079] 3A shows an exemplary neural stimulation lead 208 that may be positioned within the delivery device shown in FIG. 3B. In the illustrated embodiment, the neural stimulation lead 208 includes a paddle portion 208A connected to a lead wire 208B. In some embodiments, the neural stimulation lead 208 can have the same or similar characteristics as the neural stimulation lead 106 shown in FIGS. 1-2B.

[0080] According to certain embodiments, the body portion 214 of the neural stimulation lead 208 has a width 209 that is greater when the neural stimulation lead 208 is in the expanded, deployed configuration than when the neural stimulation lead 208 is in the collapsed delivery configuration. Additionally or alternatively, the body portion 214 of the neural stimulation lead 208 has a cross-sectional thickness 211 that is smaller when the neural stimulation lead 208 is in the expanded, deployed configuration than when the neural stimulation lead 208 is in the collapsed delivery configuration, as shown by comparing FIGS. 3A and 3D . According to certain embodiments, the width 209 and the cross-sectional thickness 211 can be defined similarly to the width 107 and the cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 208 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the body portion 214 of the neural stimulation lead 208 can bend when the neural stimulation lead 208 is expanded and deployed in the same or similar manner as the neural stimulation lead 106 bends.

[0081] In certain embodiments, the delivery device includes a rod 202 with a slot 204 extending from the end of the rod 202 down the rod 202, as shown in FIG. 3B. In some embodiments, the slot 204 extends down approximately the middle of the rod 202. In certain examples, the slot 204 extends down approximately the middle of the rod 202 a distance equal to or greater than the length 213 of the paddle portion 208A of the neural stimulation lead 208. In some embodiments, the length 213 of the paddle portion 208A of the neural stimulation lead 208 can be the distance extending along the longitudinal axis 215 of the neural stimulation lead 208 from the distal end 215 of the paddle portion 208A to the proximal end 217 of the paddle portion 208A. The neural stimulation lead 208 can then be placed into the slot 204, as shown in FIG. 3C. The rod 202 can then be twisted clockwise or counterclockwise so that the neurostimulation lead 208 wraps around the rod 202, as shown in FIG. 3D.

[0082] In certain aspects, the delivery device includes a delivery sheath 206, as shown in FIG. 3E. The delivery sheath 206 can be positioned over the neurostimulation lead 208 and the rod 202 such that the delivery sheath 206 surrounds the neurostimulation lead 208 and the rod 202 to prevent the neurostimulation lead 208 from unintentionally uncoiling, for example, during an implantation procedure of the neurostimulation lead 208. According to certain embodiments, the sheath 206 includes one or more slots 210 extending from an end of the sheath 206 toward one or more sides of the sheath 206. In some embodiments, the neurostimulation lead 208 includes an edge 212 that extends into the slot 210 of the delivery sheath 206, as shown in FIG. 3F. In some examples, the delivery device can include an outer delivery sheath 213 that surrounds the delivery sheath 206 and the neurostimulation lead 208, as shown in FIG. 3G. In some examples, the outer delivery sheath 213 can surround the edge 212 of the neurostimulation lead 208 during implantation of the neurostimulation lead 208 to prevent the edge 212 from protruding during implantation of the neurostimulation lead 208. The rod 202, delivery sheath 206, and outer delivery sheath 213 can be referred to herein as a delivery device.

[0083] According to certain embodiments, the neurostimulation lead 208 and delivery devices 202, 206, 213 can be percutaneously positioned within the subject 108. Once the neurostimulation lead 208 and delivery devices 202, 206, 213 are positioned at an implant procedure site, for example, within the epidural space 132 of the subject 108, the neurostimulation lead 208 can be deployed as shown in FIGS.

[0084] To transition the neural stimulation lead 208 from the collapsed delivery configuration shown in FIG. 3H to the expanded, deployed configuration shown in FIG. 3M, the outer delivery sheath 213 can be retracted, as shown by the transitions in FIGS. 3H-3I. Thereafter, to deploy the neural stimulation lead 208, the slot 210 in the delivery sheath 206 can first be aligned to lie in a coronal anatomical plane. Next, the neural stimulation lead 208 and rod 202 can be twisted in a direction opposite to the direction in which the neural stimulation lead 208 was twisted to wrap the neural stimulation lead 208 around the rod 202. For example, if the neural stimulation lead 208 is twisted in a clockwise direction to wrap the neural stimulation lead 208 around the rod 202, the neural stimulation lead 208 can be twisted in a counterclockwise direction to begin deployment of the neural stimulation lead 208. Conversely, if the neural stimulation lead 208 is twisted counterclockwise to wrap the neural stimulation lead 208 around the rod 202, the rod 202 can be twisted clockwise to initiate deployment of the neural stimulation lead 208. As shown in FIG. 3J , when the neural stimulation lead 208 and rod 202 are rotated to initiate deployment of the neural stimulation lead 208, the edge 212 of the neural stimulation lead 208 protrudes from the slot 204 of the rod 202 until the neural stimulation lead 208 is fully expanded, as shown in FIG. 3K . In some embodiments, once the neural stimulation lead 208 is fully expanded, the delivery sheath 206 can be retracted, as shown in FIG. 3L . In some examples, once the neural stimulation lead 208 is expanded and the neural stimulation lead 208 is implanted in the epidural space 132 of the subject 108, the rod 202 can be retracted, as shown in FIG. 3M . The neural stimulation lead can include an element made of a shape memory material to assist in the deployment process. All components of the delivery device may be manufactured in a manner that makes them mechanically flexible to facilitate navigation of the delivery device to the deployment site.

[0085] 4 and 5 respectively show a side view of the neurostimulation lead 208 and an opposite side view of the neurostimulation lead 208. These illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0086] According to certain embodiments, the neurostimulation lead includes a body portion 214. The body portion 214 can have a generally rectangular shape, as shown. Furthermore, the body portion 214 can be positioned near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134.

[0087] According to certain embodiments, the body portion 214 includes an array of electrodes 216 disposed on the body portion 214. The array of electrodes 216 can be coupled to an IPG (e.g., the IPG 104) to receive electrical waveforms from the IPG and deliver the waveforms to stimulate locations on the spinal cord 133 and / or dorsal root ganglion 134.

[0088] According to certain embodiments, one or more electrodes of the electrode array 216 may be positioned near the perimeter 218 of the body portion 214. Additionally or alternatively, one or more electrodes of the electrode array 216 may be positioned away from the perimeter 218 of the body portion 214, for example, near the central portion 220 of the body portion 214. Additionally or alternatively, one or more electrodes of the electrode array 216 may be positioned near the distal portion 222, the proximal portion 224, the left portion 226, and / or the right portion 228 of the body portion 214. In certain embodiments, one or more electrodes of the electrode array 216 may be arranged in one or more columns, e.g., column 230. Additionally or alternatively, one or more electrodes of the electrode array 216 may be arranged in one or more rows, e.g., row 232. As shown, each column 230 and / or row 232 may include multiple electrodes.

[0089] According to certain embodiments, the neural stimulation lead 208 may provide better and / or more precise stimulation than narrower neural stimulation leads due to the wide coverage of the body portion 214 and / or electrode array 216. Furthermore, the neural stimulation lead 208 may be implanted percutaneously due to the smaller profile of the neural stimulation lead 208 while the neural stimulation lead 208 is in the collapsed delivery configuration.

[0090] In certain embodiments, the neurostimulation lead 208 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE.

[0091] According to certain embodiments, the neurostimulation lead 208 includes a frame extending around the periphery 218 that is constructed of a shape memory material. In some instances, the frame is in a relaxed shape when the neurostimulation lead 208 is in an expanded, deployed configuration. For example, NiTi can be used as the material for the frame of the neurostimulation lead 208 (and any of the frames described herein), although other materials can be used as the frame material, including, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, Pyhnox, Elgiloy, or any other suitable biocompatible material and combinations thereof.

[0092] Additionally or alternatively, the neural stimulation lead 208 may include one or more reinforcement bands 234. In certain examples, the one or more reinforcement bands 234 may be formed from a shape memory material, such as NiTi. In certain examples, the one or more reinforcement bands 234 may extend laterally (e.g., along the lateral direction 236) partially or completely across the neural stimulation lead 208. Additionally or alternatively, the one or more reinforcement bands 234 may extend longitudinally (e.g., along the longitudinal direction 238) partially or completely along the neural stimulation lead 208. Additionally or alternatively, the one or more reinforcement bands 234 may extend partially or completely across the neural stimulation lead 208 at a non-zero angle relative to the lateral direction 236 and / or the longitudinal direction 238. In some examples, the reinforcement bands 234 may be retracted during delivery of the neural stimulation lead 208 and extended during deployment of the neural stimulation lead 208. In certain examples, one or more reinforcement bands 234 can be inserted into one or more pockets 240 located on the back of the neurostimulation lead 208, as shown in Figure 5. In some examples, the reinforcement bands 234 can be disengaged from the pockets 240 and retracted again after deployment of the neurostimulation lead 208.

[0093] According to certain embodiments, the neural stimulation lead 208 can additionally or alternatively be expandable. Expanding the neural stimulation lead 208 can transition the neural stimulation lead 208 from a collapsed delivery configuration to an expanded, deployed configuration. In certain aspects, the neural stimulation lead 208 can be expanded pneumatically and / or hydraulically, for example, using a hydrogel. In certain embodiments, de-expanding the neural stimulation lead 208 can transition the neural stimulation lead 208 from the expanded, deployed configuration to the collapsed delivery configuration.

[0094] According to certain embodiments, the neural stimulation lead 208 may include a sclerosing agent such that when the neural stimulation lead 208 is in the expanded, deployed configuration, the sclerosing agent secures the neural stimulation lead 208 in the expanded, deployed configuration and reduces the likelihood of the neural stimulation lead 208 compressing and / or expanding and / or migrating when the subject 108 moves, bends, twists, etc. In certain embodiments, the sclerosing agent may be injected into the neural stimulation lead 208.

[0095] According to certain embodiments, the neural stimulation lead 208 may include one or more anchors (e.g., anchors 130) for securing the neural stimulation lead 208 to a portion of the spinal column, including, for example, a vertebra and / or another structure of the spinal column or a soft tissue structure, to prevent migration and / or displacement of the neural stimulation lead 208. According to certain embodiments, the neural stimulation lead 208 may include one or more anchors (e.g., anchors 130) for securing the neural stimulation lead 208 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or displacement of the neural stimulation lead 208.

[0096] 6A-6B are perspective views of an exemplary neural stimulation lead, according to at least some embodiments of the present disclosure. In particular, FIG. 6A illustrates a delivery device 302 including a neural stimulation lead 304 in a collapsed delivery configuration, and FIG. 6B illustrates a delivery device 302 including the neural stimulation lead 304 in an expanded, deployed configuration. According to certain embodiments, the neural stimulation lead 304 has a wider width when the neural stimulation lead 304 is in the expanded, deployed configuration than when the neural stimulation lead 304 is in the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 304 has a larger cross-sectional thickness when the neural stimulation lead 304 is in the collapsed delivery configuration than when the neural stimulation lead 304 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 304 may be defined the same as the width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B. Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 304 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 304 may be curved during deployment in the same or similar manner as the neurostimulation lead 106. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0097] As shown in FIG. 6A , the delivery device 302 is a tubular sheath that surrounds and confines the neurostimulation lead 304 in a collapsed delivery configuration to prevent the neurostimulation lead 304 from expanding prematurely. In some embodiments, the neurostimulation lead 304 can be folded within the delivery device 302. For example, the neurostimulation lead 304 can include multiple folds 306, and when compressed laterally 308 along the folds 306, the neurostimulation lead 304 collapses into the delivery configuration shown in FIG. 6A . According to certain embodiments, the delivery device 302 and the neurostimulation lead 304 can be percutaneously positioned within the subject 108 while the neurostimulation lead 304 is in the collapsed delivery configuration. For example, the neurostimulation lead 304 can be positioned at an implantation procedure site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 within the epidural space. Once the neurostimulation lead 304 is positioned at the implantation site, the delivery device 302 can be removed (e.g., withdrawn), allowing the neurostimulation lead 304 to unfold and expand to the expanded, deployed configuration shown in FIG. 6B . The wider coverage of the neurostimulation lead 304 allows the neurostimulation lead 304 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Furthermore, the neurostimulation lead 304 can be implanted percutaneously (unlike some conventional embodiments having a larger surface area) while the neurostimulation lead 304 is in the collapsed delivery configuration due to the smaller profile of the neurostimulation lead 304. Additionally or alternatively, the neurostimulation lead 304 can be transitioned from the expanded, deployed configuration to the collapsed delivery configuration by placing a device 302 over the neurostimulation lead 304.

[0098] According to certain embodiments, the neural stimulation lead 304 can have the same or similar characteristics as the neural stimulation lead 106 shown in FIGS. 1-2B and / or the neural stimulation lead 208 shown in FIGS. 3A-5. For example, the neural stimulation lead 304 can have an electrode array 310 that is the same or similar to the electrode array 112 and / or electrode array 216 disposed on the neural stimulation lead 304 and coupled to the IPG 104. Additionally or alternatively, the neural stimulation lead 304 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 304 can include a frame formed from a shape-memory material, such as NiTi, such that when the delivery device 302 is removed and no longer constrains the neural stimulation lead 304, the neural stimulation lead 304 expands to the expanded, deployed configuration shown in FIG. 6B. Thus, when the neural stimulation lead 304 is in the expanded, deployed configuration, the frame is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 304 can be expandable to transition the neural stimulation lead 304 from a collapsed delivery configuration to an expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 304 can include a stiffening agent that can be added and / or applied to the neural stimulation lead 304 to secure the neural stimulation lead 304 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 304 compressing and / or expanding and / or migrating when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 304 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 304 can include one or more anchors (e.g., anchor 130) to secure the neural stimulation lead 304 to a portion of the spinal column (e.g., see FIG. 2A , which shows a cross section of the spinal column), including, for example, vertebrae and / or other structures and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neural stimulation lead 304. For example, the one or more anchors are configured to secure the neurostimulation lead 304 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 304.

[0099] 7A is a distal end view of an exemplary neural stimulation lead, and FIG. 7B is a side view of the exemplary neural stimulation lead, in accordance with at least some embodiments of the present disclosure. In particular, FIG. 7A illustrates a delivery device 402 including a neural stimulation lead 404 in a collapsed delivery configuration, and FIG. 7B illustrates a delivery device 402 including the neural stimulation lead 404 in an expanded, deployed configuration. According to certain embodiments, the neural stimulation lead 404 has a wider width when the neural stimulation lead 404 is in the expanded, deployed configuration than when the neural stimulation lead 404 is in the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 404 has a larger cross-sectional thickness when the neural stimulation lead 404 is in the collapsed delivery configuration than when the neural stimulation lead 404 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 404 can be defined the same as the width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 404 is smaller in the collapsed delivery configuration than in the expanded deployed configuration. Additionally or alternatively, the neural stimulation lead 404 may be curved while being expanded and deployed in the same or similar manner as the neural stimulation lead 106 is curved. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0100] As shown in FIG. 7A , the delivery device 402 is a sheath that surrounds and confines the neural stimulation lead 404 in a collapsed delivery configuration to prevent the neural stimulation lead 404 from expanding prematurely. In some embodiments, the neural stimulation lead 404 can be folded within the delivery device 402. For example, the neural stimulation lead 404 can include at least one fold 406, and when compressed along the at least one fold 406, the neural stimulation lead 404 collapses into the delivery configuration shown in FIG. 7A . Additionally or alternatively, the neural stimulation lead 404 can include one or more first portions that are thicker than second portions of the neural stimulation lead 404. In these embodiments, the neural stimulation lead 404 can be arranged in a pattern such that at least one location of the first portion does not longitudinally and / or laterally overlap another first portion of the plurality of first portions when the lead is in the collapsed configuration. For example, the electrodes 408 on the neural stimulation lead 404 can be arranged in a pattern such that the positions of two electrodes do not overlap longitudinally and / or laterally when the lead is in a folded configuration. In other words, the electrodes 408 on the neural stimulation lead 404 can be arranged in a pattern such that the positions of two electrodes do not correspond to the same longitudinal and lateral positions when the lead is in a folded configuration.

[0101] This may be done to maximize the packing density of the neurostimulation lead 404 in the collapsed delivery configuration and / or minimize the thickness and / or volume of the neurostimulation lead 404. According to certain embodiments, the delivery device 402 and neurostimulation lead 404 may be percutaneously positioned within the subject 108 while the neurostimulation lead 404 is in the collapsed delivery configuration. For example, the neurostimulation lead 404 may be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 in the epidural space. Once the neurostimulation lead 404 is positioned at the implantation site, the delivery device 402 may be removed (e.g., withdrawn), and the neurostimulation lead 404 may be deployed and expanded to the expanded, deployed configuration shown in FIG. 7B . The wider coverage of the neurostimulation lead 404 allows the neurostimulation lead 404 to contact the left and right sides of the spinal cord 133 and at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Additionally, the neurostimulation lead 404 may be implanted percutaneously (unlike some conventional embodiments having a larger surface area) due to the smaller profile of the neurostimulation lead 404 while the neurostimulation lead 404 is in the collapsed delivery configuration.

[0102] According to certain embodiments, the neural stimulation lead 404 can have the same or similar characteristics as the neural stimulation lead 106 shown in FIGS. 1-2B, the neural stimulation lead 208 shown in FIGS. 3A-5, and / or the neural stimulation lead 304 shown in FIGS. 6A-6B. For example, the neural stimulation lead 404 can have an electrode array 408 that is the same or similar to the electrode array 112, the electrode array 216, and / or the electrode array 310. Additionally or alternatively, the neural stimulation lead 404 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 404 can include a frame formed from a shape-memory material, such as NiTi, such that when the delivery device 402 is removed and no longer constrains the neural stimulation lead 404, the neural stimulation lead 404 expands to the expanded, deployed configuration shown in FIG. 7B. Thus, when the neural stimulation lead 404 is in the expanded, deployed configuration, the frame is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 404 can be expandable to transition the neural stimulation lead 404 from a collapsed delivery configuration to an expanded, deployed configuration. In certain embodiments, the neural stimulation lead 404 can be de-expanded to transition the neural stimulation lead 404 from the expanded, deployed configuration to the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 404 can include a sclerosing agent, which can be added and / or applied to the neural stimulation lead 404 to secure the neural stimulation lead 404 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 404 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., while the neural stimulation lead 404 is in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 404 may include one or more anchors (e.g., anchor 130) to secure the neurostimulation lead 404 to a portion of the spinal column (e.g., see FIG. 2A, which shows a cross section of the spinal column), including, for example, vertebrae and / or other structures and / or soft tissue structures of the spine, to prevent migration and / or movement of the neurostimulation lead 404.For example, the one or more anchors are configured to secure the neurostimulation lead 404 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 404. Additionally or alternatively, the neurostimulation lead 404 can be transitioned from an expanded deployed configuration to a collapsed delivery configuration by placing the device 402 over the neurostimulation lead 404.

[0103] 8A-8B are side views and FIG. 8C is a perspective view of an exemplary neural stimulation lead, according to at least some embodiments of the present disclosure. In particular, FIG. 8A illustrates a delivery device 502 including a neural stimulation lead 504 in a collapsed delivery configuration, and FIGS. 8B and 8C illustrate the neural stimulation lead 504 in an expanded, deployed configuration. According to certain embodiments, the neural stimulation lead 504 has a wider width when the neural stimulation lead 504 is in the expanded, deployed configuration than when the neural stimulation lead 504 is in the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 504 has a larger cross-sectional thickness when the neural stimulation lead 504 is in the collapsed delivery configuration than when the neural stimulation lead 504 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 504 can be defined the same as the width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B. Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 504 is smaller in the collapsed delivery configuration than in the expanded deployed configuration. Additionally or alternatively, the neural stimulation lead 504 may be curved while being expanded and deployed in the same or similar manner as the neural stimulation lead 106 is curved. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0104] 8A , the delivery device 502 is a sheath that surrounds the neurostimulation lead 504 and confines it in a collapsed delivery configuration to prevent the neurostimulation lead 504 from expanding prematurely. According to certain embodiments, the delivery device 502 and neurostimulation lead 504 can be percutaneously positioned within the subject 108 while the neurostimulation lead 504 is in the collapsed delivery configuration. For example, the neurostimulation lead 504 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 in the epidural space. Once the neurostimulation lead 504 is positioned at the implantation site, the delivery device 502 can be removed (e.g., withdrawn), and the neurostimulation lead 504 can be deployed and expanded to the expanded, deployed configuration shown in FIGS. 8B and 8C . The wider coverage of the neurostimulation lead 504 allows the neurostimulation lead 504 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Furthermore, the neurostimulation lead 504 can be implanted percutaneously (unlike some conventional embodiments having a larger surface area) while the neurostimulation lead 504 is in the collapsed delivery configuration due to the smaller profile of the neurostimulation lead 504. Additionally or alternatively, the neurostimulation lead 504 can be transitioned from the expanded, deployed configuration to the collapsed delivery configuration by placing the device 502 over the neurostimulation lead 504.

[0105] According to certain embodiments, the neural stimulation lead 504 may include a frame including multiple legs 506 extending from a proximal portion 508. In certain instances, the legs 506 may be coated, covered, and / or surrounded by a protective material 510, such as a high strength reinforced fluoropolymer (HSTF). Additionally or alternatively, the neural stimulation lead 504 may include an array of electrodes 512. In certain embodiments, an electrode of the array of electrodes 512 may be included at the end of each leg 506. Additionally or alternatively, one or more electrodes of the array of electrodes 512 may be positioned at an intermediate position 514 along one or more legs 506.

[0106] According to certain embodiments, neural stimulation lead 504 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, and / or neural stimulation lead 404 shown in Figures 7A-7B. For example, as described above, neural stimulation lead 504 can have an array of electrodes 512 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, and / or array of electrodes 408. Additionally or alternatively, neural stimulation lead 504 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 504 can include a frame made of a shape-memory material, such as NiTi, such that when the delivery device 502 is removed and no longer constrains the neural stimulation lead 504, the neural stimulation lead 504 expands to the expanded, deployed configuration shown in FIGS. 8B and 8C . Thus, the frame is in a relaxed shape when the neural stimulation lead 504 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 504 can include a stiffening agent, which can be added and / or applied to the neural stimulation lead 504 to secure the neural stimulation lead 504 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 504 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 504 is in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 504 can include one or more anchors (e.g., anchor 130) to secure the neurostimulation lead 504 to a portion of the spinal column (see, e.g., FIG. 2A , which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neurostimulation lead 504. For example, the one or more anchors can be configured to secure the neurostimulation lead 504 to the dura mater, ligamentum flavum, or other soft tissue structures to prevent migration and / or movement of the neurostimulation lead 504.

[0107] 9 is a side view of a neural stimulation lead 602 according to at least some embodiments of the present disclosure. According to certain embodiments, the neural stimulation lead 602 has a wider width when the neural stimulation lead 602 is in the expanded, deployed configuration (as shown) than when the neural stimulation lead 602 is in the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 602 has a larger cross-sectional thickness when the neural stimulation lead 602 is in the collapsed delivery configuration than when the neural stimulation lead 602 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 602 can be defined as the same as width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 602 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 602 can be curved when the neural stimulation lead 602 is expanded and deployed in the same or similar manner as the neural stimulation lead 106 is curved. However, these diagrams are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0108] According to certain embodiments, the neurostimulation lead 602 can be inserted into a delivery sheath (not shown) to collapse the neurostimulation lead 602 into a collapsed delivery configuration and prevent the neurostimulation lead 602 from expanding prematurely. According to certain aspects, while the neurostimulation lead 602 is in the collapsed delivery configuration, the delivery device and neurostimulation lead 602 can be percutaneously positioned within the subject 108. For example, the neurostimulation lead 602 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 within the epidural space 132. Once the neurostimulation lead 602 is positioned at the implantation site, the delivery device can be removed (e.g., withdrawn), and the neurostimulation lead 602 can be deployed and expanded to the expanded, deployed configuration as shown in FIG. 9 . The wider coverage of the neurostimulation lead 602 allows the neurostimulation lead 602 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Additionally, the neurostimulation lead 602 allows the neurostimulation lead 602 to be implanted percutaneously (unlike some conventional embodiments which have a larger surface area) due to the smaller profile of the neurostimulation lead 602 while the neurostimulation lead 602 is in the collapsed delivery configuration.

[0109] According to certain embodiments, the neural stimulation lead 602 may include a frame 604 including multiple legs 606 extending away from a central portion 608. In certain examples, the frame 604 and legs 606 may be coated, covered, and / or surrounded by a protective material 610, such as HSTF. Additionally or alternatively, the neural stimulation lead 602 may include an array of electrodes 612. In certain embodiments, an electrode of the array of electrodes 612 may be included at one or more ends of each leg 606. Additionally or alternatively, at least one electrode of the electrode array 612 may be positioned along the periphery of the frame (e.g., at an intermediate location 614 along one or more legs 606) and / or at one or more locations 616 within the frame 604.

[0110] According to certain embodiments, neural stimulation lead 602 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 308 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, and / or neural stimulation lead 504 shown in Figures 8A-8C. For example, as described above, neural stimulation lead 602 can have an array of electrodes 608 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, array of electrodes 408, and / or array of electrodes 512. Additionally or alternatively, neural stimulation lead 602 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 602 can incorporate a frame formed from a shape memory material, such as NiTi, such that when the delivery device is removed and no longer constrains the neural stimulation lead 602, the neural stimulation lead 602 expands to the expanded, deployed state shown in FIG. 9 . Thus, the frame is in a relaxed shape when the neural stimulation lead 602 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 602 can include a stiffening agent that can be added and / or applied to the neural stimulation lead 602 to secure the neural stimulation lead 602 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 602 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 602 is in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 602 can include one or more anchors (e.g., anchor 130) to secure the neurostimulation lead 602 to a portion of the spinal column (see, e.g., FIG. 2A , which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spine, to prevent migration and / or movement of the neurostimulation lead 602. For example, the one or more anchors can be configured to secure the neurostimulation lead 602 to the dura mater, ligamentum flavum, or other soft tissue structures to prevent migration and / or movement of the neurostimulation lead 602.

[0111] FIG. 10 is a perspective view of a frame for a neural stimulation lead 702, and FIG. 11 is a cross-sectional view of a portion of the neural stimulation lead 702 shown in FIG. 10 , in accordance with at least some embodiments of the present disclosure. According to certain embodiments, the neural stimulation lead 702 has a wider width when the neural stimulation lead 702 is in an expanded, deployed configuration (as shown in FIG. 10 ) than when the neural stimulation lead 702 is in a collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 702 has a larger cross-sectional thickness when the neural stimulation lead 702 is in the collapsed delivery configuration than when the neural stimulation lead 702 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 702 can be defined the same as the width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 702 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 702 can be curved in the same or similar manner as the neural stimulation lead 106 is curved when the neural stimulation lead 702 is deployed. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0112] According to certain embodiments, the neural stimulation lead 702 can be inserted into a delivery sheath (not shown), which can collapse the neural stimulation lead 702 into a collapsed delivery configuration to prevent the neural stimulation lead 702 from expanding more quickly than desired. According to certain aspects, the delivery device and the neural stimulation lead 702 can be percutaneously positioned within the subject 108 while the neural stimulation lead 702 is in the collapsed delivery configuration. For example, the neural stimulation lead 702 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 within the epidural space 132. Once the neural stimulation lead 702 is positioned at the implantation site, the delivery device can be removed (e.g., withdrawn), allowing the neural stimulation lead 702 to unfold and expand to the expanded, deployed configuration as shown in FIG. 10 . The wider coverage of the neurostimulation lead 702 may provide better and / or more precise stimulation than narrower neurostimulation leads because the neurostimulation lead 702 may contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134. Additionally, the neurostimulation lead 702 may be implanted percutaneously because of the smaller profile of the neurostimulation lead 702 while the neurostimulation lead 702 is in the collapsed delivery configuration. (unlike some prior art embodiments which have a larger surface area).

[0113] According to certain embodiments, the neural stimulation lead 702 may include an expandable frame 704 including multiple channels and / or side supports 706 extending away from a central channel and / or central spine 708. In certain examples, the neural stimulation lead 702 is referred to herein as having a fishbone shape and / or a fishbone-spine arrangement. In certain examples, the neural stimulation lead 702 may include an array of electrodes 710. In certain embodiments, an electrode of the electrode array 710 may be included at an end of each channel and / or side support 706. Additionally or alternatively, one or more electrodes of the electrode array 710 may be positioned at an intermediate position 712 along one or more channels and / or side supports 706. In certain embodiments, the neural stimulation lead 702 may be de-expanded to transition the neural stimulation lead 702 from an expanded deployed configuration to a collapsed delivery configuration. According to certain embodiments, the neural stimulation lead 702 includes the features disclosed herein, but is not expandable and includes a shape memory material that facilitates the transition of the neural stimulation lead 702 from a collapsed delivery configuration to an expanded deployed configuration.

[0114] According to certain embodiments, neural stimulation lead 702 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, neural stimulation lead 504 shown in Figures 8A-8C, and / or neural stimulation lead 604 shown in Figure 9. For example, as described above, neural stimulation lead 702 can have an array of electrodes 710 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, array of electrodes 408, array of electrodes 512, and / or array of electrodes 608. Additionally or alternatively, the neural stimulation lead 702 can include a stiffening agent that can be added to and / or applied to the neural stimulation lead 702 to secure the neural stimulation lead 702 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 702 compressing and / or expanding and / or migrating when the subject 108 moves, bends, twists, etc., while the neural stimulation lead 704 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 702 can include one or more anchors (e.g., anchors 130) that can secure the neural stimulation lead 702 to a portion of the spinal column (e.g., including a vertebra and / or another solid and / or soft tissue structure of the spinal column) to prevent migration and / or movement of the neural stimulation lead 702. For example, the one or more anchors are configured to secure the neural stimulation lead 702 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neural stimulation lead 702.

[0115] FIG. 12 is a side view of a neural stimulation lead transitioning from a collapsed delivery state to an expanded deployed state, and FIG. 13 is an enlarged view of a portion of the neural stimulation lead shown in FIG. 11 , in accordance with at least some embodiments of the present disclosure. In particular, FIG. 12 shows a delivery device 802 including a neural stimulation lead 804 transitioning from a collapsed delivery configuration (left side of FIG. 12 ) to an expanded deployed configuration (right side of FIG. 12 and FIG. 13 ). Additionally or alternatively, the neural stimulation lead 804 can be transitioned from the expanded deployed configuration to the collapsed delivery configuration by placing the device 802 over the neural stimulation lead 804. In certain aspects, the neural stimulation lead 804 has a serpentine shape (e.g., a sinusoidal shape). According to certain embodiments, the neural stimulation lead 804 has a wider width when the neural stimulation lead 804 is in the expanded deployed configuration (right side of FIG. 12 and FIG. 13 ) than when the neural stimulation lead 804 is in the collapsed delivery configuration (left side of FIG. 12 ). Additionally or alternatively, the neural stimulation lead 804 has a cross-sectional thickness that is greater when the neural stimulation lead 804 is in the collapsed delivery configuration than when the neural stimulation lead 804 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 804 may be defined the same as width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 804 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 804 may be curved in the same or similar manner as the neural stimulation lead 106 is curved when the neural stimulation lead 304 is expanded and deployed. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art will recognize many variations, alternatives, and modifications.

[0116] 12 , delivery device 802 is a tubular sheath that surrounds and confines neural stimulation lead 804 in a collapsed delivery configuration to prevent neural stimulation lead 804 from expanding prematurely. In some embodiments, neural stimulation lead 804 can include a non-bent and / or smooth bend 806 when neural stimulation lead 804 is within delivery device 802, as shown on the left side of FIG. 12 and in FIG. 13 . Then, when delivery device 802 is removed, neural stimulation lead 804 bends along bend 806 and assumes the expanded, deployed shape shown on the right side of FIG. 12 and in FIG. 13 .

[0117] According to certain aspects, the delivery device 802 and neurostimulation lead 804 can be percutaneously positioned within the subject 108 while the neurostimulation lead 804 is in a collapsed delivery configuration. For example, the neurostimulation lead 804 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 in the epidural space 132. Once the neurostimulation lead 804 is positioned at the implantation site, the delivery device 802 can be removed (e.g., withdrawn), and the neurostimulation lead 804 can be deployed and expanded to the expanded, deployed configuration shown on the right side of FIG. 12 and in FIG. 13 . The wider coverage of the neurostimulation lead 804 allows the neurostimulation lead 804 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Additionally, the neural stimulation lead 804 can be implanted percutaneously because the neural stimulation lead 804 has a smaller profile while in the collapsed delivery configuration (unlike some conventional embodiments which have a larger surface area).

[0118] According to certain embodiments, neural stimulation lead 804 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, neural stimulation lead 504 shown in Figures 8A-8C, neural stimulation lead 602 shown in Figure 9, and / or neural stimulation lead 702 shown in Figures 10 and 11. For example, neural stimulation lead 804 can have an array of electrodes 808 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, array of electrodes 408, array of electrodes 512, array of electrodes 608, and / or array of electrodes 710. Additionally or alternatively, neural stimulation lead 804 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 804 can be formed from a shape memory material, such as NiTi, such that when the delivery device 802 is removed and no longer constrains the neural stimulation lead 804, the neural stimulation lead 804 can expand to the expanded, deployed configuration shown on the right side of FIG. 12 and in FIG. 13 . Thus, when the neural stimulation lead 804 is in the expanded, deployed configuration, the neural stimulation lead 804 is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 804 can include a stiffening agent that can be added to and / or applied to the neural stimulation lead 804 to secure the neural stimulation lead 804 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 804 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 804 is in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 804 may include one or more anchors (e.g., anchor 130) to secure the neurostimulation lead 804 to a portion of the spinal column (e.g., see FIG. 2A, which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neurostimulation lead 804.For example, the one or more anchors are configured to secure the neurostimulation lead 804 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 804.

[0119] 14 is a side view of a neural stimulation lead transitioning from a collapsed delivery state to an expanded deployed state, according to an embodiment of the present disclosure. In particular, FIG. 14 shows a delivery device 902 including a neural stimulation lead 904 transitioning from a collapsed delivery configuration (left side of FIG. 14) to an expanded deployed configuration (right side of FIG. 14). Additionally or alternatively, the neural stimulation lead 904 can be transitioned from the expanded deployed configuration to the collapsed delivery configuration by placing the device 902 over the neural stimulation lead 904.

[0120] In certain aspects, the neural stimulation lead 904 has a coil shape. According to certain embodiments, the neural stimulation lead 904 has a wider width when the neural stimulation lead 904 is in the expanded, deployed configuration (right side of FIG. 14 ) than when the neural stimulation lead 904 is in the collapsed delivery configuration (left side of FIG. 14 ). Additionally or alternatively, the neural stimulation lead 904 has a larger cross-sectional thickness when the neural stimulation lead 904 is in the collapsed delivery configuration than when the neural stimulation lead 904 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 904 can be defined the same as width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B . Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 904 is smaller in the collapsed delivery configuration than in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 904 can be curved when the neural stimulation lead 904 is expanded and deployed in the same or similar manner as the neural stimulation lead 106 is curved. However, these diagrams are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0121] As shown in Figure 14, the delivery device 902 is a tubular sheath that surrounds the neural stimulation lead 904 and confines it in a collapsed delivery configuration to prevent the neural stimulation lead 904 from expanding prematurely. In some embodiments, the neural stimulation lead 904 can include a curve 906 that smooths out when the neural stimulation lead 904 is within the delivery device 902, as shown on the left side of Figure 14. Then, as the neural stimulation lead 904 is advanced through the delivery device 902, the neural stimulation lead 904 curves along the curve 906 and assumes the expanded, deployed configuration shown on the right side of Figure 14. After the expanded, deployed configuration is achieved, the delivery device 902 can be removed.

[0122] According to certain aspects, the delivery device 902 and neurostimulation lead 904 can be percutaneously positioned within the subject 108 while the neurostimulation lead 904 is in a collapsed delivery configuration. For example, the neurostimulation lead 904 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 in the epidural space 132. Once the neurostimulation lead 904 is positioned at the implantation site, the delivery device 902 can be removed (e.g., withdrawn), and the neurostimulation lead 904 can be deployed and expanded to the expanded, deployed configuration shown on the right side of FIG. 14 . The wider coverage of the neurostimulation lead 904 allows the neurostimulation lead 904 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Additionally, the neurostimulation lead 904 can be implanted percutaneously while the neurostimulation lead 904 is in the collapsed delivery configuration due to the smaller profile of the neurostimulation lead 904 (unlike some conventional embodiments which have a larger surface area).

[0123] According to certain embodiments, neural stimulation lead 904 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, neural stimulation lead 504 shown in Figures 8A-8C, neural stimulation lead 602 shown in Figure 9, neural stimulation lead 702 shown in Figures 10 and 11, and / or neural stimulation lead 804 shown in Figures 12 and 13. For example, neural stimulation lead 904 can have an array of electrodes 908 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, array of electrodes 408, array of electrodes 512, array of electrodes 608, array of electrodes 710, and / or array of electrodes 808. Additionally or alternatively, the neural stimulation lead 904 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 904 can be formed in part from a shape-memory material, such as NiTi, such that when the delivery device 902 is removed and no longer constrains the neural stimulation lead 904, the neural stimulation lead 904 expands to the expanded, deployed configuration shown on the right side of FIG. 14 . Thus, when the neural stimulation lead 904 is in the expanded, deployed configuration, the neural stimulation lead 904 is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 904 can include a stiffening agent that can be added to and / or applied to the neural stimulation lead 904 to secure the neural stimulation lead 904 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 904 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 904 is in the expanded, deployed configuration. Additionally or alternatively, the neurostimulation lead 904 may include one or more anchors (e.g., anchor 130) to secure the neurostimulation lead 904 to a portion of the spinal column (e.g., see FIG. 2A, which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neurostimulation lead 904.For example, the one or more anchors are configured to secure the neurostimulation lead 904 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 904.

[0124] 15A-15H are side views of a neural stimulation lead transitioning from an expanded, deployed state to a collapsed delivery state, according to an embodiment of the present disclosure. In particular, FIG. 15A shows the neural stimulation lead 1002 in an expanded, deployed configuration. FIG. 15H shows the neural stimulation lead 1002 in a collapsed delivery configuration. FIGs. 15B-15G show the neural stimulation lead 1002 transitioning from the expanded, deployed configuration of FIG. 15A to the collapsed delivery configuration of FIG. 15H. In certain aspects, the neural stimulation lead 1002 can be transitioned from the expanded, deployed configuration to the collapsed delivery configuration by placing a delivery device over the neural stimulation lead 1002 that can collapse and / or crush the neural stimulation lead 1002.

[0125] According to certain embodiments, the neural stimulation lead 1002 can be inserted into a delivery sheath (not shown) to collapse the neural stimulation lead 1002 into a collapsed delivery configuration and prevent the neural stimulation lead 1002 from expanding more quickly than desired. According to certain aspects, the delivery device and the neural stimulation lead 1002 can be percutaneously positioned within the subject 108 while the neural stimulation lead 1002 is in the collapsed delivery configuration (shown in FIG. 15H ). For example, the neural stimulation lead 1002 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 within the epidural space 132. Once the neural stimulation lead 1002 is positioned at the implantation site, the delivery device can be removed (e.g., withdrawn), and the neural stimulation lead 1002 can be deployed and expanded to the expanded, deployed configuration as shown in FIG. 15A . The wider coverage of the neurostimulation lead 1002 allows the neurostimulation lead 1002 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Additionally, the neurostimulation lead 1002 may be implanted percutaneously while the neurostimulation lead 1002 is in a collapsed delivery configuration due to the smaller profile of the neurostimulation lead 1002 (unlike some conventional embodiments which have a larger surface area).

[0126] According to certain embodiments, the neural stimulation lead 1002 has the advantage of reducing the material of the neural stimulation lead 1002 disposed around the central portion 1004 of the delivery rod 1006. For example, if the wing portions 1008 are disposed around the delivery rod 1006 along the transverse axis 1010, the neural stimulation lead 1002 has more material disposed around the central portion 1004 of the neural stimulation lead 1002 than around the distal portion 1012 and the proximal portion 1014, resulting in a cross-sectional thickness of the central portion 1004 that is greater than the cross-sectional thicknesses of the distal portion 1012 and the proximal portion 1014.

[0127] To reduce the cross-sectional thickness around the central portion 1004, the wing portions 1008 are disposed (e.g., folded, bent, wrapped, collapsed, crushed, etc.) at a non-zero angle relative to the transverse axis 1010 and / or a non-perpendicular angle relative to the longitudinal axis 1016. For example, in at least one embodiment, the wing 1008A can be folded, wrapped, bent, collapsed, crushed, etc. along the line 1018A such that the angle 1020A between the line 1018A and the longitudinal axis 1016 is greater than 0 degrees and less than 90 degrees. Similarly, the wing 1008B can be folded, wrapped, bent, collapsed, crushed, etc. along the line 1018B such that the angle 1020B between the line 1018B and the longitudinal axis 1016 is greater than 0 degrees and less than 90 degrees. 15C, such positioning of wings 1008 positions wing 1008A adjacent distal portion 1012 and wing 1008B adjacent proximal portion 1014, thereby reducing the amount of material positioned adjacent central portion 1004. In Figures 15C-15H, the textured portion of neurostimulation lead 1002 represents the opposite side to the side of neurostimulation lead 1002 shown in Figures 15A and 15B.

[0128] In certain embodiments, the delivery rod 1006 can be positioned along the longitudinal axis 1016 of the neural stimulation lead 1002, as shown in Figure 15D. The neural stimulation lead 1002 can then be positioned (e.g., folded, wrapped, bent, collapsed, crushed, etc.) around the delivery rod 1006, as shown in Figures 15E-15H.

[0129] According to certain embodiments, neural stimulation lead 1002 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, neural stimulation lead 504 shown in Figures 8A-8C, neural stimulation lead 602 shown in Figure 9, neural stimulation lead 702 shown in Figures 10 and 11, neural stimulation lead 804 shown in Figures 12 and 13, and / or neural stimulation lead 904 shown in Figure 14. For example, neural stimulation lead 1002 can have an array of electrodes (not shown) that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, array of electrodes 408, array of electrodes 512, array of electrodes 608, array of electrodes 710, array of electrodes 808, and / or array of electrodes 908. Additionally or alternatively, the neural stimulation lead 1002 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 1002 can be formed in part from a shape-memory material, such as NiTi, such that when the delivery rod 1006 is removed, the neural stimulation lead 1002 expands to the expanded, deployed configuration shown in FIG. 15A . Thus, when the neural stimulation lead 1002 is in the expanded, deployed configuration, the neural stimulation lead 1002 is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 1002 can include a stiffening agent, which can be added to and / or applied to the neural stimulation lead 1002 to secure the neural stimulation lead 1002 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 1002 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 1002 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 1002 may include one or more anchors (e.g., anchor 130) to secure the neural stimulation lead 1002 to a portion of the spinal column (e.g., see FIG. 2A, which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neural stimulation lead 1002.For example, the one or more anchors are configured to secure the neurostimulation lead 1002 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neurostimulation lead 1002.

[0130] 16A-16B are side views and FIG. 16C is a perspective view of an exemplary neural stimulation lead, in accordance with at least some embodiments of the present disclosure. In particular, FIG. 16A illustrates a delivery device 1102 including a neural stimulation lead 1104 in a collapsed delivery configuration. FIGS. 16B and 16C illustrate the neural stimulation lead 1104 in an expanded, deployed configuration. According to certain embodiments, the neural stimulation lead 1104 has a wider width when the neural stimulation lead 1104 is in the expanded, deployed configuration than when the neural stimulation lead 1104 is in the collapsed delivery configuration. Additionally or alternatively, the neural stimulation lead 1104 has a larger cross-sectional thickness when the neural stimulation lead 1104 is in the collapsed delivery configuration than when the neural stimulation lead 1104 is in the expanded, deployed configuration. According to certain embodiments, the width and cross-sectional thickness of the neural stimulation lead 1104 can be defined the same as the width 107 and cross-sectional thickness 109 shown in FIGS. 2A and 2B. Additionally or alternatively, in certain embodiments, the cross-sectional area of ​​the neural stimulation lead 1104 is smaller in the collapsed delivery configuration than in the expanded deployed configuration. Additionally or alternatively, the neural stimulation lead 1104 can be curved when the neural stimulation lead 1104 is in the expanded deployed configuration in the same or similar manner as the neural stimulation lead 106 is curved. However, these illustrations are merely examples and should not unduly limit the scope of the claims. One of ordinary skill in the art would recognize many variations, alternatives, and modifications.

[0131] 16A , the delivery device 1102 is a sheath that surrounds and confines the neural stimulation lead 1104 in a collapsed delivery configuration to prevent the neural stimulation lead 1104 from expanding prematurely. According to certain embodiments, the delivery device 1102 and the neural stimulation lead 1104 can be percutaneously positioned within the subject 108 while the neural stimulation lead 1104 is in the collapsed delivery configuration. For example, the neural stimulation lead 1104 can be positioned at an implantation site near the centerline of the spinal cord 133, the left and right sides of the spinal cord 133, and / or a portion of at least one dorsal root ganglion 134 within the epidural space 132. Once the neural stimulation lead 1104 is positioned at the implantation site, the delivery device 1102 can be removed (e.g., withdrawn), and the neural stimulation lead 1104 can be deployed and expanded to the expanded deployment configuration shown in FIGS. 16B and 16C . The wider coverage of the neurostimulation lead 1104 allows the neurostimulation lead 1104 to contact the left and right sides of the spinal cord 133 and / or at least one dorsal root ganglion 134, thereby providing better and / or more precise stimulation than narrower neurostimulation leads. Furthermore, the neurostimulation lead 1104 may be implanted percutaneously while the neurostimulation lead 1104 is in the collapsed delivery configuration due to the smaller profile of the neurostimulation lead 1104 (unlike some conventional embodiments which have a larger surface area). Additionally or alternatively, the neurostimulation lead 1104 may be transitioned from the expanded, deployed configuration to the collapsed delivery configuration by placing the device 1102 over the neurostimulation lead 1104.

[0132] According to certain embodiments, the neural stimulation lead 1104 may include a frame including multiple legs 1106 extending from a proximal portion 1108. In certain instances, the legs 1106 may be coated, covered, and / or surrounded by a protective material 1110, such as a high strength reinforced fluoropolymer (HSTF). Additionally or alternatively, the neural stimulation lead 1104 may include an array of electrodes 1112. In certain embodiments, an electrode of the array of electrodes 1112 may be included at the end of each leg 1106. Additionally or alternatively, one or more electrodes of the electrode array 1112 may be positioned at an intermediate position 1114 along one or more legs 1106.

[0133] According to certain embodiments, the neural stimulation lead 1104 can have the same or similar characteristics as the neural stimulation lead 106 shown in FIGS. 1-2B , the neural stimulation lead 208 shown in FIGS. 3A-5 , the neural stimulation lead 304 shown in FIGS. 6A-6B , and / or the neural stimulation lead 404 shown in FIGS. 7A-7B . For example, as described above, the neural stimulation lead 1104 can have an array of electrodes 1112 that is the same as or similar to the array of electrodes 112, the array of electrodes 216, the array of electrodes 310, and / or the array of electrodes 408. For example, the electrodes 1112 can include an enlarged region of conductive material at the end of each leg 1114. Additionally or alternatively, the neural stimulation lead 1104 can be formed from and / or coated with a biocompatible material, such as, for example, PE, ePE, PTFE, or ePTFE. Additionally or alternatively, the neural stimulation lead 1104 can include a frame portion 1103 made of a shape-memory material, such as NiTi, such that when the delivery device 1102 is removed and no longer constrains the neural stimulation lead 1104, the neural stimulation lead 1104 expands to the expanded, deployed configuration shown in FIGS. 16B and 16C . Thus, when the neural stimulation lead 1104 is in the expanded, deployed configuration, the frame is in a relaxed shape. Additionally or alternatively, the neural stimulation lead 1104 can include a stiffening agent, which can be added and / or applied to the neural stimulation lead 1104 to secure the neural stimulation lead 1104 in the expanded, deployed configuration to reduce the likelihood of the neural stimulation lead 1104 compressing and / or expanding and / or shifting when the subject 108 moves, bends, twists, etc., when the neural stimulation lead 1104 is in the expanded, deployed configuration. Additionally or alternatively, the neural stimulation lead 1002 can include one or more anchors (e.g., anchor 130) to secure the neural stimulation lead 1104 to a portion of the spinal column (see, e.g., FIG. 2A , which shows a cross section of the spinal column), including, for example, a vertebra and / or other solid and / or soft tissue structures of the spinal column, to prevent migration and / or movement of the neural stimulation lead 1104. For example, the one or more anchors can be configured to secure the neural stimulation lead 1104 to the dura mater, ligamentum flavum, or other soft tissue structures to prevent migration and / or movement of the neural stimulation lead 1104.

[0134] 17 is a perspective view of a neurostimulation lead 1202 according to an embodiment of the present disclosure. As shown, the lead 1202 can be delivered through a channel 1204 in a cannula, such as a needle 1206. An element, such as a spine wire 1208, can be used to push the lead 1202 through the needle 1206 when the lead 1202 is in its collapsed delivery configuration. After the lead 1202 exits the distal end of the needle 1206, the lead 1202 can expand to the expanded deployed configuration shown in FIG. 17. The spine wire 1208 can be, for example, a NiTi wire, and can provide longitudinal support and / or pushability for the delivery of the lead 1202.

[0135] As shown, the neurostimulation lead 1202 includes a body portion 1214, a plurality of rib wires 1216, and one or more stimulation contacts or electrodes 1212. In the illustrated embodiment, the body portion 1214 includes a central or base portion 1215 and a plurality of ribs 1218 extending from either side of the base portion. The lead 1202 can be characterized as having a fishbone array, or fishbone shape. Each of the rib wires 1216 is disposed on and extends along one of the ribs 1218 of the body portion 1214. In the illustrated embodiment, one or more electrodes 1212 are disposed at spaced locations on each rib 1218 and are shown attached to the rib wires 1216. In some embodiments, for example, the electrodes 1212 can be tubular elements that are slid into desired positions on the rib wires 1216. The electrodes 1212 can be formed of gold, platinum, or other conductive metals or materials. Lead wires (not shown in FIG. 17) are coupled to each electrode 1212 and extend therefrom to couple the electrodes to the implantable pulse generator 104 .

[0136] 17, the ribs 1218 of the body portion 1214 are separate elements. For example, at least some of the adjacent ribs 1218 do not include a web, membrane, or other structure connecting the ribs along all or part of their length. Such separate ribs 1218 can exhibit an enhanced ability to conform to and engage the spine and / or nerve or other body part of a subject to which they are applied.

[0137] The body 1214 can be formed from and / or coated with a biocompatible material, such as PE, ePE, PTFE, or ePTFE. In some embodiments, for example, the body 1214 can be formed from a layer of such a biocompatible material that covers both sides of the electrode 1212 and / or rib wire 1216. The back side of the body 1214, opposite the side configured to engage a spine or other portion of the body to which the lead 1202 is attached, can be insulating. In some embodiments, the electrode 1212 can be effectively embedded within the body 1214, and a clearance hole can be placed in the body 1214 adjacent to the electrode 1212. For example, the electrode 1212 can be exposed by laser etching the material of the body 1214 or by localized hydrophilic treatment of the desired area. The goal is to reduce resistance / impedance through the conductive path, thereby reducing power consumption. In other embodiments, the electrode 1212 can be placed on the exterior surface of the body 1214.

[0138] According to certain embodiments, neural stimulation lead 1202 can have the same or similar characteristics as neural stimulation lead 106 shown in Figures 1-2B, neural stimulation lead 208 shown in Figures 3A-5, neural stimulation lead 304 shown in Figures 6A-6B, neural stimulation lead 404 shown in Figures 7A-7B, neural stimulation lead 602 shown in Figure 9, and / or neural stimulation lead 702 shown in Figure 10. For example, as described above, neural stimulation lead 1202 can have an array of electrodes 1212 that is the same as or similar to array of electrodes 112, array of electrodes 216, array of electrodes 310, and / or array of electrodes 408. Additionally or alternatively, neural stimulation lead 1202 can include a frame made from a shape memory material, such as NiTi, such that when a delivery device, such as needle 1206, is removed and no longer constrains neural stimulation lead 1202, the neural stimulation lead expands to the expanded, deployed shape shown in Figure 17. Thus, when the neural stimulation lead 1202 is in the expanded, deployed configuration, the frame has a relaxed shape. In yet another embodiment, the body 1214 is configured as a shape-memory material that provides expansion to the expanded, deployed configuration when the lead 1202 is not constrained by a delivery device, such as the needle 1206. Additionally or alternatively, the neural stimulation lead 1202 can include one or more anchors (e.g., anchors 130) to secure the neural stimulation lead 1202 to a portion of the spinal column (e.g., see FIG. 2A , which shows a cross section of the spinal column), including, for example, a vertebra and / or another solid and / or soft tissue structure of the spinal column, to prevent migration and / or movement of the neural stimulation lead 1202. For example, the one or more anchors are configured to secure the neural stimulation lead 1202 to the dura mater, ligamentum flavum, or other soft tissue structure to prevent migration and / or movement of the neural stimulation lead 1202.

[0139] The invention of this application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Therefore, it is intended that the embodiments cover the modifications and variations of the present invention provided they come within the scope of the appended claims and their equivalents. The present disclosure further includes the following aspects: <<Aspect 1>> a body portion configured to transition from a collapsed delivery configuration to an expanded, deployed configuration, wherein the expanded, deployed configuration is wider than the collapsed delivery configuration, and transitioning the neurostimulation lead from the collapsed delivery configuration to the expanded, deployed configuration includes an unfolding or unwrapping action that is not perpendicular to a central axis of the delivery system; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including <<Aspect 2>> a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the expanded deployed configuration is wider than the collapsed delivery configuration, the width of the body portion in the expanded deployed configuration being configured to extend across at least a portion of the spinal cord and one or more dorsal root ganglia; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 3 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the body portion is in a rolled configuration while the body portion is in the collapsed delivery configuration and wherein the body portion is in an unrolled configuration while the body portion is in the expanded deployed configuration, and wherein the body portion is configured to unroll to transition from the collapsed delivery configuration to the expanded deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 4 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, the body portion comprising one or more reinforcing members extending laterally across at least a portion of the body portion; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 5 a body portion configured to transition from a collapsed delivery configuration to an expanded, deployed configuration, wherein the body portion is in a folded configuration while the body portion is in the collapsed delivery configuration and wherein the body portion is in an unfolded configuration while the body portion is in the expanded, deployed configuration, and wherein the body portion is configured to unfold to transition from the collapsed delivery configuration to the expanded, deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 6 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the expanded deployed configuration is wider than the collapsed delivery configuration, and wherein the body portion has a non-zero curvature when in the expanded deployed configuration; and an array of electrodes disposed on the body portion, the array of electrodes electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 7 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the body portion has a winged shape when in the expanded deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 8 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, the body portion comprising a central spine and a plurality of side supports; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 9 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the body portion is in an uninflated configuration while the body portion is in the collapsed delivery configuration and wherein the body portion is in an expanded configuration while the body portion is in the expanded deployed configuration, and wherein the body portion is configured to be inflated to transition from the collapsed delivery configuration to the expanded deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 10 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the body portion has a serpentine shape when in the expanded deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 11 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, the body portion having a coil shape when in the expanded deployed configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 12 A neurostimulation lead described in any one of aspects 1 and 3 to 11, wherein the width of the main body portion in the expanded, deployed configuration is configured to extend across at least a portion of the spinal cord and one or more dorsal root ganglia. Aspect 13 13. The nerve stimulation lead of any one of aspects 1 to 12, wherein the width of the body portion is greater than 6 mm. Aspect 14 14. The nerve stimulation lead of any one of aspects 1 to 13, wherein the width of the main body portion is 6 mm to 15 mm. Aspect 15 A neurostimulation lead described in any one of aspects 1 to 5 and 7 to 14, wherein the body portion has a non-zero curvature when the body portion is in the expanded, deployed configuration. Aspect 16 A neurostimulation lead described in any one of aspects 1, 2 and 4 to 15, wherein the body portion is in a rolled configuration while in the collapsed delivery configuration, the body portion is in an unrolled configuration while in the expanded, deployed configuration, and the body portion is configured to unroll in order to transition from the collapsed delivery configuration to the expanded, deployed configuration. Aspect 17 A nerve stimulation lead described in any one of aspects 1 to 3 and 5 to 16, wherein the body portion includes one or more reinforcing members extending laterally across at least a portion of the body portion. Aspect 18 A neurostimulation lead described in any one of aspects 1 to 17, configured to be delivered via a catheter including a side slot, and wherein the body portion extends through the side slot to transition from the collapsed delivery configuration to the expanded deployment configuration. Aspect 19 A neurostimulation lead described in any one of aspects 1 to 4 and 6 to 18, wherein the body portion is in a folded configuration while in the collapsed delivery configuration, the body portion is in an unfolded configuration while in the expanded, deployed configuration, and the body portion is configured to be unfolded to transition from the collapsed delivery configuration to the expanded, deployed configuration. Aspect 20 A neurostimulation lead according to any one of aspects 1 to 7 and 9 to 19, wherein the body portion comprises a central spine and a plurality of side supports. Aspect 21 A neurostimulation lead described in any one of aspects 1 to 6, 8, 9 and 12 to 19, wherein the body portion has a coil shape when in the expanded, deployed configuration. Aspect 22 A neurostimulation lead described in any one of aspects 1 to 6, 8, 9 and 12 to 19, wherein the body portion has a serpentine shape when in the expanded, deployed configuration. Aspect 23 A neurostimulation lead described in any one of aspects 1 to 6, 8, 9 and 12 to 19, wherein the body portion has a winged shape when in the expanded, deployed configuration. Aspect 24 A nerve stimulation lead described in any one of aspects 1 to 23, wherein the main body portion incorporates a frame made of a shape memory material, and when the frame is in the expanded, deployed configuration, the shape memory material assumes a relaxed shape. Aspect 25 25. The neurostimulation lead of claim 24, wherein the shape memory material is nitinol. Aspect 26 Aspect 26. The neurostimulation lead of any one of aspects 1 to 25, wherein the body portion forms an elastomeric sleeve. Aspect 27 A neurostimulation lead described in any one of aspects 1, 2, 4, 6-8, 10-15, 17, 18, 20, 22-26, wherein the body portion is in an unexpanded configuration while in the collapsed delivery configuration, and the body portion is in an expanded configuration while in the expanded, deployed configuration, and the body portion is configured to be expanded to transition from the collapsed delivery configuration to the expanded, deployed configuration. Aspect 28 28. The neurostimulation lead of claim 27, wherein the body portion is pneumatically or hydraulically expanded. Aspect 29 A neurostimulation lead described in any one of aspects 1 to 28, comprising a stiffening agent for fixing the body portion in the expanded deployed shape. Aspect 30 Aspect 30. The neurostimulation lead of any one of aspects 1-29, wherein the expanded deployment configuration is thinner than the collapsed delivery configuration. Aspect 31 The neurostimulation lead of any one of aspects 1 to 30, further comprising an anchor for securing the body portion to a spine. Aspect 32 32. The neurostimulation lead of claim 31, wherein the anchor is a barb. Aspect 33 A neurostimulation lead as described in aspect 31, wherein the anchor is configured to promote attachment of tissue to the anchor. Aspect 34 Aspect 34. The neurostimulation lead of any one of aspects 1-33, wherein at least a portion of the neurostimulation lead comprises a material that promotes tissue ingrowth. Aspect 35 The neurostimulation lead of any one of aspects 1-34, further comprising an IPG. Aspect 36 36. The neural stimulation lead of embodiment 35, further comprising an external controller communicatively coupled to the IPG. Aspect 37 A neural stimulation lead described in any one of aspects 1 to 36, wherein the neural stimulation lead includes a plurality of first portions that are thicker than the second portions of the neural stimulation lead, and the neural stimulation lead is arranged in a pattern such that the position of at least one of the plurality of first portions does not overlap with another first portion of the plurality of first portions. Aspect 38 38. The neurostimulation lead of claim 37, wherein the plurality of first portions comprises an array of electrodes. Aspect 39 A neurostimulation lead according to any one of aspects 1 to 38, wherein the cross-sectional area of ​​the solid material of the neurostimulation lead is smaller in the collapsed delivery configuration than in the expanded deployment configuration. Aspect 40 A neurostimulation lead described in any one of aspects 2 to 39, wherein transitioning the neurostimulation lead from the collapsed delivery configuration to the expanded deployment configuration includes an unfolding or unwrapping operation that is not perpendicular to the central axis of the delivery system. Aspect 41 A neurostimulation lead as described in any one of aspects 2 to 40, wherein the neurostimulation lead is configured to transition from an expanded deployment configuration to a collapsed delivery configuration, and transitioning the neurostimulation lead from the expanded deployment configuration to the collapsed delivery configuration includes at least one of de-expanding, collapsing, wrapping, bending, or crushing the neurostimulation lead. Aspect 42 a body portion configured to transition from a collapsed delivery configuration to an expanded deployed configuration, wherein the expanded deployed configuration is wider than the collapsed delivery configuration; and an array of electrodes disposed on the body portion, wherein the array of electrodes is electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including Aspect 43 1. A method of implanting a neurostimulation lead in a subject, comprising: percutaneously inserting a catheter into a subject, wherein a distal end of the catheter is positioned adjacent to an implant treatment site within the subject located within the epidural space of the subject; delivering a neurostimulation lead to an implantation site via the catheter while the neurostimulation lead is in a collapsed delivery configuration, wherein the neurostimulation lead is described in any one of aspects 1-42; and transitioning the neurostimulation lead from the collapsed delivery configuration to an expanded deployed configuration; A method comprising:

Claims

1. Rods with slots, a body portion defined by a longitudinal axis releasably attached to the slot of the rod, including a left portion and a right portion opposite the left portion relative to the longitudinal axis, the left portion and the right portion extending from opposite sides of the slot, the body portion configured to transition from a collapsed delivery configuration to an expanded, deployed configuration, wherein while the body portion is in the collapsed delivery configuration, the body portion is in a wound configuration about the rod, wherein in the wound configuration both the left portion and the right portion are wrapped in a clockwise or counterclockwise direction relative to the longitudinal axis, and while the body portion is in the expanded, deployed configuration, the body portion is in an unwound configuration, and to transition from the collapsed delivery configuration to the expanded, deployed configuration, the body portion is configured to unwrap by unwrapping both the left portion and the right portion in opposite clockwise or counterclockwise directions; and an array of electrodes configured to be disposed on the body portion, wherein the array of electrodes is configured to be electrically coupled to an implantable pulse generator (IPG); , a neurostimulation lead, including

2. 2. The neurostimulation lead of claim 1, wherein the body portion is in a rolled configuration while in the collapsed delivery configuration, and the body portion is in an unrolled configuration while in the expanded, deployed configuration, and the body portion is configured to unroll to transition from the collapsed delivery configuration to the expanded, deployed configuration.

3. The neurostimulation lead of claim 1 , wherein the body portion comprises one or more stiffening members extending laterally across at least a portion of the body portion.

4. The neurostimulation lead of claim 1 , wherein the body portion comprises a central spine and a plurality of side supports.

5. The neurostimulation lead of claim 1 , wherein the body portion incorporates a frame made of a shape memory material, the shape memory material assuming a relaxed shape when the frame is in the expanded, deployed configuration.

6. The neurostimulation lead of claim 1 , wherein the body portion forms an elastomeric sleeve.

7. 2. The neural stimulation lead of claim 1, wherein the neural stimulation lead includes a plurality of first portions that are thicker than second portions of the neural stimulation lead, and the neural stimulation lead is arranged in a pattern such that a position of at least one of the plurality of first portions does not overlap another first portion of the plurality of first portions.

8. The neurostimulation lead of claim 7 , wherein the plurality of first portions comprises an array of electrodes.

9. The neurostimulation lead of claim 1 , including a stiffening agent for securing the body portion in the expanded, deployed configuration.

10. The neurostimulation lead of claim 1 , further comprising an anchor for securing the body portion to a spine.

11. 2. The neural stimulation lead of claim 1, further comprising a first delivery sheath having two slots positioned symmetrically along a longitudinal axis around the neural stimulation lead while the body portion is in the collapsed delivery configuration, wherein edges of the left and right portions of the neural stimulation lead extend into the two slots.

12. The neural stimulation lead of claim 11 , further comprising a second delivery sheath surrounding the neural stimulation lead and the first delivery sheath while the body portion is in the collapsed delivery configuration.

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