IMPLANT STRAIN RELIEF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Application No. 63/152,698 filed February 23, 2021, the disclosure of which is hereby incorporated in its entirety by reference herein.

BACKGROUND

[0002] Some implantable devices can be positioned adjacent to, or extend at least partially around, a feature of the body to provide treatment to a location on or near the feature. An implantable device may include various components coupled to each other. By way of example, a cuff electrode assembly can include a cuff body to be positioned at least partially around a feature (e.g., nerve, vein, or muscle), where the cuff electrode assembly includes one or more conductors coupled to electrodes in the cuff body to provide electrical stimulation to the feature.

[0003] Forces of motion may impact a coupling (e.g., between conductors and a cuff body of a cuff electrode assembly), subjecting the coupling to strain. Additionally, tissue growth (e.g., growth of the feature, and/or tissue growth around the feature, and/or tissue growth around the implant) may further subject the coupling to strain. Over time, such strain can cause failure of the coupling.

[0004] Accordingly, there is an unmet need for improved techniques to reduce or relieve the strain between components.

SUMMARY

[0005] Methods, assemblies, and devices are described herein for providing strain relief for implants. In an embodiment, an implant is a cuff electrode. In an embodiment, an implant assembly includes a cuff electrode including a cuff body, and the implant assembly also includes at least one conductor. The cuff body may include at least one electrode, and the cuff body includes a strain relief construct. The strain relief construct is defined by one or more guides. One or more conductors may be arranged within the strain relief construct to define a strain relief pattern for the conductor(s).

[0006] In an embodiment, a method may include placing a cuff body around a target nerve. The cuff body may include one or more electrodes, and the cuff body includes a strain relief construct. The strain relief construct is defined by one or more guides. The method may also include arranging one or more conductors within one or more of the guide(s) to define a strain relief pattern for the conductor(s). The method may further include electrically coupling the conductor(s) to the electrode(s).

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1 is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0008] FIG. 2 is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0009] FIG. 3 is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0010] FIG. 4 is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0011] FIG. 5A is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0012] FIG. 5B is an embodiment of an assembly for providing strain relief for one or more conductors coupled to a cuff electrode.

[0013] FIG. 6 is a flow chart of an embodiment of a method of using an assembly that provides strain relief in a cuff electrode.

[0014] FIG. 7 illustrates an example of placement of a cuff electrode having a strain relief construct.

DETAILED DESCRIPTION

[0015] Non-limiting examples of various aspects and variations of the invention are described herein and illustrated in the accompanying drawings.

[0016] Numerous types of devices are implantable within a body of a subject. The strain relief devices and techniques as illustrated and described herein are applicable to various implantable devices in which it is desirable to reduce strain between the implantable device and one or more cables. The term "cable" as used herein refers to an electrical conductor, a fluidic tubing, a mechanical cabling, or other elongate construct directly or indirectly (e.g., through an intermediary connector) coupled to the implant. For ease of discussion, cuff electrodes are described herein by way of an implant example. [0017] A cuff electrode may deliver an electrical signal to a feature (e.g., nerve, vein, or muscle) of a body of a subject. A cuff electrode includes a cuff body and one or more electrodes. Each electrode is formed of an electrically conductive material. The electrode(s) are positioned on, or exposed from, an inner surface of a non-conductive casing (e.g., cuff body) so that the electrodes will contact tissue of a target feature when placed around the target feature. A cuff electrode wraps at least partially around a target feature and offers several advantages, such as secured contact with and selective stimulation of the target feature. For example, if a cuff electrode is wrapped around a nerve, electrical signals delivered from the electrodes may stimulate the nerve.

[0018] As implanted, each electrode is electrically coupled to an electrical conductor either directly, or indirectly by way of an intermediary conductive contact. There may be multiple conductors coupled to respective electrodes, and/or multiple electrodes coupled to a conductor. The conductors may be disposed within a lead. The lead may be coupled to circuitry such as an implantable pulse generator. When the cuff electrode is disposed on or around a target feature, the circuitry may control a stimulating electrical signal which is delivered by the electrode(s) to the target feature.

[0019] A coupling between an electrode and a conductor is often subject to strain when implanted, for example, due to motion of the body, growth around the cuff electrode, and/or growth around the conductor.

[0020] Some existing techniques provide strain relief by a complicated and difficult process. For example, the cuff body may be spread open by pulling two opposite edges of the cuff body away from each other (e.g., using bars or tweezers). A syringe needle may be pierced into the cuff body and a conductor may be inserted into the cuff body through the syringe needle. The conductor may then be pulled with a holding device (e.g., tweezer, tweezer scissors, or forceps) and flipped such that the conductor defines a loop. The inserted syringe needle may then be removed. The conductor may be coupled to an electrode within the cuff (e.g., directly, or indirectly using conductive contacts) before or after defining the loop. A suture (e.g., a knotted suture) may then be used over the loop to tighten the loop. Once the loop is tightened, an adhesive (e.g., a silicone adhesive) may be applied to permanently affix the loop to the cuff body. When the adhesive is cured, the suture may be removed. This process may be repeated for each electrode conductor coupling of the cuff electrode. For instance, consider a cuff electrode that includes three electrodes in the cuff body. The process described above is repeated for each of three electrode-conductor couplings.

[0021] The technique described above may require multiple people working simultaneously on the cuff electrode. For example, one person may have to define the loop that provides strain relief while another person may have to prepare the suture to tighten the loop. This process not only requires multiple operators but may also make it challenging to consistently perform the coupling for multiple electrodes in a single cuff electrode and across multiple cuff electrodes. Furthermore, coupling an electrode to a conductor using such a technique may require training, such as in using a syringe, holding a device, and suturing to create the loop without damaging the cuff body. [0022] Accordingly, fabrication of the cuff electrode with strain relief in a consistent manner may be time consuming and difficult. Furthermore, such fabrication may require numerous applications of adhesive.

[0023] The technology described herein provides strain relief for various implants, such as for a coupling between electrode(s) and conductor(s) of a cuff electrode. The methods, assemblies, and devices described herein facilitate fabricating assemblies in a consistent and repeatable manner. The technology described herein provides strain relief in implants in a reliable and consistent manner. Additionally, the technology is intuitive to use and does not require extensive training.

Assembly for providing strain relief

[0024] In an embodiment, an assembly for providing strain relief includes a cuff body including at least one electrode and at least one guide. The guide(s) define a strain relief construct on the cuff body, such as an arrangement that provides strain relief to a coupling between an electrode and a conductor when the conductor is positioned in the strain relief construct.

[0025] FIG. 1 is an embodiment of an assembly 100 for providing strain relief for a cuff electrode. The assembly 100 includes a cuff body 120 with a first arm 101 and a second arm 102. The cuff body 120 may include one or more conductive components, such as electrodes 135a, 135b shown in FIG. 1. The cuff body 120 includes a guide 140. Conductors 121, 122 may be electrically coupled to the respective electrodes 135a, 135b either directly or via respective conductive contacts 131, 130. In an embodiment, the conductors 121, 122 are disposed within a lead 110.

[0026] Strain relief of the couplings between the conductors 121, 122 and the respective electrodes 135a, 135b or the respective conductive contacts 131, 130 may be desirable to minimize or prevent strain (e.g., forces propagating along the conductors 121, 122 causing strain on the couplings) from weakening or disengaging one of the couplings, which could open an electrical path facilitated by the coupling and thereby cause the cuff electrode to be at least partially inoperative or operating outside of its intended design parameters.

Cuff electrode

[0027] The cuff body 120 may wrap around a target feature and/or may securely engage a target feature within a cavity of the cuff body 120. For instance, the cuff body 120 may loop around a target feature securely holding or otherwise wrapping the target feature. A first surface 112a of the cuff body 120 (e.g., an inner surface) may contact the target feature. A second surface 112b of the cuff body 120 (e.g., an outer surface opposite the first surface 112a) may face away from the target feature. In an embodiment, the electrode 135a and/or the electrode 135b is located on the first surface 112a of the cuff body 120. In an embodiment, the electrode 135a and/or the electrode 135b is embedded in the cuff body 120 and exposed from the first surface 112a. The guide 140 and the conductive contacts 131, 132 may be located on the second surface 112b of the cuff body 120. [0028] In an embodiment, the cuff body 120 may include a non-conductive material (e.g., including a silicone elastomer, polyethylene, or polyimide, or a combination thereof). For instance, the cuff body 120 may be a silicone sheath. The first surface 112a of the cuff body 120 defines an opening along a longitudinal axis 136. In an embodiment, the cuff body 120 may be in the shape of a split-ring (e.g., having a c-shaped profile in cross-section).

[0029] In an embodiment, an inner dimension (e.g., diameter) of the cuff body 120 measured with respect to its first surface 112a may be sized to receive a target feature, such as being about the same as an outer dimension of the feature, or being slightly less than an outer dimension of the feature.

[0030] In the embodiment of FIG. 1, the cuff body 120 defines an opening along its length (parallel to the longitudinal axis 136) between the first arm 101 and the second arm 102. The opening allows edges of the cuff body 120 to be spread apart so that the cuff body 120 can be placed on a target feature. Once placed on a target feature, the cuff body 120 may be closed. The cuff body 120 may be self-closing (e.g., biased to a closed configuration). In an embodiment, a self-closing structure may include a wire, rib, or other suitable preformed biasing element that is coupled to the cuff body 120 and urges the cuff body 120 toward a closed or coiled configuration. In an embodiment, the cuff body 120 includes one or more stretched layers of non-conductive material fused with one or more non- stretched layers of non-conductive material. The fused stretched and non-stretched layers may cause the resulting cuff body 120 to wrap (e.g., around the longitudinal axis 136), and thus self-close around a target feature when released from an open configuration.

[0031] Multiple techniques may be used to form a cuff body 120 having a bias toward a particular configuration, such as using the stretched and non-stretched layering technique described above in combination with the preformed biasing element technique described above, or using the stretched and non-stretched layering technique and/or the preformed biasing element technique in combination with another technique.

[0032] Although a bias towards self-closing has been discussed, a bias towards self-coiling or self-opening, or no bias, may be implemented instead.

[0033] The first arm 101 and the second arm 102, which are optional, can be included to facilitate opening the cuff body 120 from a closed configuration for placement around a target feature, and/or to facilitate maintaining the cuff body 120 in a closed configuration after placement. For example, the first arm 101 and the second arm 102 may each define a lumen; in an embodiment, prongs of a tool (not shown) can be inserted into the lumens to apply a spreading force within the lumens to open the cuff body 120 for placement. In another embodiment, a thread-like material (not shown) can be disposed within each lumen and used to pull the first arm 101 and the second arm 102 away from each other to open the cuff body 120, and/or to tie the first arm 101 to the second arm 102 to inhibit the cuff body 120 from opening after placement on the target feature. [0034] The first arm 101 and the second arm 102 may be integrally formed with, or attached to, the cuff body 120. For example, a tube, hollow cylinder, or duct may be affixed to the cuff body 120. For another example, the first arm

101 and the second arm 102 can be molded or otherwise concurrently formed in the material used to form a remainder of the cuff body 120. For a further example, the first arm 101 and the second arm 102 may be formed by removing material from the cuff body 120. Although shown as protrusions in FIG. 1, one or both of the first arm 101 and the second arm 102 may instead be a lumen or a recess formed between the first surface 112a and the second surface 112b of the cuff body 120. In a closed configuration of the cuff body 120, the first arm 101 and the second arm

102 may be adjacent to, or may contact, each other, or may be separated from each other with a gap between.

[0035] The cuff body 120 can include one or more layers of non-conductive materials. For example, the cuff body 120 may include one or more layers of silicone elastomer. The electrodes 135a, 135b and the conductive contacts 131, 130 may be attached to or embedded in the layers. In an embodiment, the conductive contacts 131, 130 are electrically coupled to the electrodes 135a, 135b, respectively, either by direct contact or through an intermediary electrically conductive material. In an embodiment, the conductive contacts 131, 130 are omitted.

[0036] In an embodiment, the conductors 121, 122 are electrically coupled to the electrodes 135a, 135b, respectively such that electrical signals can be passed through the conductors 121, 122 to the respective electrodes 135a, 135b to provide electrical stimulation to a target feature. In an embodiment, the conductors 121, 122 are electrically coupled to the conductive contacts 131, 130 and the conductive contacts 131, 130 are coupled to the respective electrodes 135a, 135b such that electrical signals can be passed through the conductors 121, 122 to the respective conductive contacts 131, 130 and thereby to the respective electrodes 135a, 135b to provide electrical stimulation to a target feature.

[0037] The electrodes 135a, 135b can include any suitable conductive material. For example, the material can include one or more conductive metals (e.g., platinum, gold, silver, stainless steel, or a combination thereof), a conductive carbon, another material, or a combination of conductive materials. In an embodiment, the electrodes 135a, 135b include a conductive paste or gel. In an embodiment, the electrodes 135a, 135b are each an end portion of a respective conductor (e.g., and end portion of the conductor 121 or the conductor 122).

[0038] The conductive contacts 130, 131 can include any suitable conductive material. For example, the material can include one or more conductive metals (e.g., platinum, gold, silver, stainless steel, or a combination thereof), a conductive carbon, another material, or a combination of conductive materials.

[0039] Although FIG. 1 illustrates a cuff body 120 with two electrodes 135a, 135b, it should be readily understood that a cuff body in another embodiment may include any suitable number of electrodes. All electrodes in a cuff may be similar or different in terms of constituent materials, size, and shape. Additionally, although FIG. 1 illustrates a cuff body 120 in which the electrodes 135a, 135b are distributed longitudinally (e.g., parallel to longitudinal axis 136), it should be readily understood that a cuff body in another embodiment may alternatively include electrodes (and corresponding conductive contacts) that are distributed laterally (e.g., perpendicular to longitudinal axis 135). Furthermore, in some embodiments a cuff body may include electrodes that are distributed both longitudinally and laterally across the cuff body surface (e.g., in a two-dimensional array such as a rectangular array, or in a helical arrangement, or in an irregular or random array).

Guide

[0040] A cuff body may include one or more guides, and the guide(s) may be arranged in a variety of strain relief constructs. A conductor may be arranged within in a strain relief construct defined by the guide(s), either in a predefined strain relief pattern or in another strain relief pattern. For instance, one or more conductors may be introduced, guided, inserted, deployed, positioned, disposed, channeled, or otherwise routed into and/or through the guide(s) to form the strain relief pattern. The strain relief pattern formed by arrangement of the conductor within the strain relief construct may include at least one substantially curved portion (e.g., a curve, loop, sinusoidal wave, or sigmoid). Some variations of guides, strain relief constructs, and strain relief patterns of conductors positioned within strain relief constructs are illustrated by way of example in FIGS. 1-5B. Other variations will be apparent from the illustrations and descriptions herein.

[0041] In FIG. 1, assembly 100 includes one guide, a guide 140, that defines a strain relief construct. One or more conductors (e.g., one or both of the conductors 121, 122) may be arranged in a strain relief pattern within the strain relief construct. The guide 140 may hold the conductors in the strain relief construct on the cuff body 120.

[0042] The guide 140 may be integrated with, disposed on, affixed to, attached to, or otherwise coupled to the cuff body 120 (e.g., on the second surface 112b of the cuff body 120). The guide 140 may be formed of a non- conductive material. For example, the guide 140 may include the same non-conductive material as the cuff body 120. Alternatively, the guide 140 may include a non-conductive material different from the material of the cuff body 120.

[0043] In an embodiment, some or all of the guide 140 may be integrated with the cuff body 120 during the fabrication of the cuff body 120. For example, a silicone elastomer may be molded in a manner to include the guide 140. The mold may, for example, include a shape mimicking the guide 140, or the guide 140 may be defined in (e.g., by piercing, melting, or cutting) the cuff body 120 after the cuff body 120 is molded. In other variations, the guide 140 may be disposed on, affixed to, attached to, or otherwise coupled to the cuff body 120 after fabrication. For example, the guide 140 may be affixed to the cuff body 120 after fabricating the cuff body 120, using a polymer adhesive. In another example, the guide 140 may be attached to the cuff body 120 after fabricating the cuff body 120, using a clip, snap, or other fastening mechanism. [0044] The strain relief patterns of the conductors 121, 122 within the strain relief construct as illustrated in FIG. 1 may be implemented by inserting the conductor 121 into and through the guide 140, and inserting the conductor 122 into and through the guide 140. In the embodiment of FIG. 1, the conductors 121, 122 are shown inserted from opposite sides of the guide 140 so that they extend from opposite sides of the guide 140 with respect to each other; in other variations, the conductors 121, 122 may be inserted from a same side of the guide 140. The conductors 121, 122 are electrically connected to the respective conductive contacts 131, 130 or to the respective electrodes 135a, 135b either before or after arranging the conductors 121, 122 within the strain relief construct. The strain relief patterns shown in FIG. 1 include a first loop in the conductor 121 and a second loop in the conductor 122. In other embodiments, the strain relief patterns may omit the first loop or the second loop (e.g., one of the conductors 121, 122 is not inserted through the guide 140).

[0045] The first loop and the second loop are formed owing to the arrangement of the conductors 121, 122 within the strain relief construct defined by the guide 140 on the cuff body 120, and the conductors 121, 122 are held in position by the guide 140. Therefore, the first loop and the second loop need not be fixed to the cuff body 120 using adhesives, as was necessary for the techniques described above that did not have the use of a guide such as the guide 140.

[0046] In an embodiment, a conductor (e.g., the conductor 121 or the conductor 122) is inserted through the guide 140 twice to form two loops in a strain relief pattern for that conductor. More generally, a conductor may be introduced through the guide 140 any suitable number of times, to form consistent or varying sizes of loops.

[0047] An outer sheath of the lead 110 may be advanced towards the cuff body 120 and/or towards the guide 140 as indicated by the arrows, to cover an additional length of the conductors 121, 122.

[0048] An insulative and/or sealing material (e.g., epoxy) may be disposed over portions of the conductors 121, 122 exposed from the sheath of the lead 110, and/or may be disposed over the conductive contacts 131, 130, to avoid moisture and debris in the environment at the target site from interfering with the electrical coupling between the conductive contacts 131, 130 and the conductors 121, 122. The insulative and/or sealing material may also may be disposed over the strain relief pattern(s) to augment the strain relief provided by the strain relief construct and the strain relief pattern(s) (e.g., a strain relief pattern including the first loop in the conductor 121 and/or the strain relief pattern including the second loop in the conductor 122).

[0049] As discussed above, while the assembly 100 in FIG. 1 shows a single guide 140, an assembly (e.g., the assembly 100) may include any suitable number of guides. For example, additional guides may be disposed on the cuff body 120 at positions not visible in FIG. 1 to form an additional strain relief construct or constructs. For another example, two or more guides may be used to define one strain relief construct (e.g., as illustrated and described with respect to FIG. 2, FIG. 4, and FIGS. 5A and 5B).

Conductors

[0050] The conductors 121, 122 may be any suitable wires or cables made of conductive material, such as 35N LT ^® multi-phase nickel-cobalt-chromium-molybdenum alloy. In an embodiment, the conductor 121 and/or the conductor 122 may include an insulating cover (e.g., PVC (polyvinyl chloride), or PE (polyethylene)) encasing the conductive material. For example, the 35N LT ^® cables have an insulating coating of ETFE (ethylene tetrafluoro ethylene).

[0051] In an embodiment, the conductors 121, 122 are coupled to the conductive contacts 131, 130 before being arranged within the strain relief construct, and then the conductors 121, 122 are disposed in the lead 110. Alternatively, the conductors 121, 122 may be disposed in the lead 110, then arranged within the strain relief construct.

Lead

[0052] In an embodiment, the lead 110 includes one or more lumens through which the conductors 121, 122 are disposed. In an embodiment, a material is coated over the conductors 121, 122 to form a sheath, and the sheath with the conductors 121, 122 is the lead 110.

[0053] The conductors 121, 122 may extend through the lead 110 to electrically couple the electrodes 135a, 135b in the cuff body 120 to a remote power source (e.g., a power source connected to the conductors 121, 122 at an end of the lead 110 opposite the end adjacent to the cuff, the power source not shown in FIG. 1). In an embodiment, a length of the lead 110 may depend on a placement of the power source with respect to a placement of the cuff body 120. In an embodiment, the lead 110 may include non-conductive material (e.g., a polymer such as silicone).

[0054] The lead 110 may be attached to or otherwise coupled to the second surface 112b of the cuff body 120. In an embodiment, the lead 110 may be attached to or otherwise coupled to the cuff body 120 before the conductors 121, 122 are arranged within the strain relief construct. Alternatively, the lead 110 may be attached to or otherwise coupled to the cuff body 120 after the conductors 121, 122 are arranged within the strain relief construct.

[0055] In FIG. 1, the lead 110 is shown extending away from the cuff body 120 approximately perpendicular to the longitudinal axis 136 of the cuff body 120. In other variations, a lead may be attached to or otherwise coupled to a cuff body at an angle to the longitudinal axis of the cuff body. More generally, an assembly including a cuff body and a lead can be designed to fit within constraints at a target site within a body by orienting the lead at a desired angle with respect to the cuff body. Example Assemblies

[0056] FIG. 1 illustrates a cuff body 120 including the single guide 140, as discussed above. A cuff body in other embodiments may include multiple guides. In this manner, two or more guides may define a strain relief construct, and/or strain relief constructs may be defined in more than one location.

[0057] FIG. 2 illustrates an embodiment of an assembly 200 for providing strain relief for a cuff electrode. FIG. 2 is similar in many respects to FIG. 1, with a difference being that the embodiment of FIG. 2 includes two guides rather than one.

[0058] In FIG. 2, two guides 240, 241 (each of which may be similar to guide 140 in FIG. 1) are integrated into, disposed on, affixed to, attached to, or otherwise coupled to a cuff body 220 (e.g., an embodiment of the cuff body 120). As illustrated, the guides 240, 241 are oriented substantially parallel to each other and parallel to an axis 236 of the cuff body 220; in other embodiments, the guides 240, 241 are oriented at an angle with respect to each other and/or one or both of the guides 240, 241 are oriented at an angle with respect to the axis 236.

[0059] In the embodiment illustrated in FIG. 2, two conductors, namely conductors 221, 222 (e.g., similar to the conductors 121, 122 in FIG. 1) are disposed in a lead 210 (e.g., similar to the lead 110). The conductors 221, 222 may be electrically coupled to respective electrodes 235a, 235b (e.g., similar to the electrodes 135a, 135b in FIG. 1) in the cuff body 220 directly or via conductive contacts 231, 230 (e.g., similar to the conductive contacts 131, 130 in FIG. 1).

[0060] The guides 240, 241 define a strain relief construct. The conductors 221, 222 may be arranged within the strain relief construct. For example: the conductor 221 may be inserted into a top opening of the guide 240 and exited through a bottom opening of the guide 240, then inserted from a bottom opening of the guide 241 and exited through a top opening of the guide 241; and the conductor 222 may be inserted from a bottom opening of the guide 240 and exited through a top opening of the guide 240, then inserted from a top opening of the guide 241 and exited through a bottom opening of the guide 241. Accordingly, the conductors 221, 222 may be manipulated into a strain relief pattern defined by introducing the conductors 221, 222 through the guide 240 at a first location and through the guide 241 at a second location.

[0061] In an embodiment, the conductors 221, 222 may be coupled to the conductive contacts 230, 231 before being arranged within the strain relief construct. Alternatively, the conductors 221, 222 may be coupled to the conductive contacts 230, 231 after being arranged within the strain relief construct. The lead 210 may be attached to or otherwise coupled to the cuff body 220 before or after the conductors 221,222 are arranged within the strain relief construct.

[0062] In FIG 2, each or both of the guides 240, 241 may be used when arranging one or both of the conductors 221, 222 within the strain relief construct. For example, the guide 240 may be used for the conductor 221 and/or the conductor 222, the guide 241 may be used for the conductor 221 and/or the conductor 222, or both of the guides 240, 241 may be used for the conductor 221 and/or the conductor 222.

[0063] More generally, a guide on a cuff body may be used for none, all, or some of the conductors coupled to the cuff electrode.

[0064] FIG. 3 illustrates an embodiment of an assembly 300 for providing strain relief in a cuff electrode. In this embodiment, a single guide 340 diverges from a common portion into two different guide segments 340a, 340b. In the illustration of FIG. 3, the common portion of the guide 340 is on a side of the guide 340 towards a lead 310 (e.g., similar to the lead 110 in FIG. 1).

[0065] Each guide segment 340a, 340b may guide a conductor into a strain relief pattern. For example, the guide segment 340a may be used for the conductor 321 (e.g., similar to the conductors 121, 122 in FIG. 1), where the conductor 321 may be introduced into the guide 340 at the common portion and exit from an opening in the guide segment 340a. Similarly, the guide segment 340b may be used for a conductor 322 (e.g., similar to the conductors 121, 122 in FIG. 1), where the conductor 322 may be introduced into the guide 340 at the common portion and exit from an opening in the guide segment 340b.

[0066] In an embodiment, when the conductor 321 is electrically connected to an electrical contact 331 (e.g., similar to the electrical contacts 131, 130 in FIG. 1) or to an electrode 335a (e.g., similar to the electrodes 135a, 135b in FIG. 1), a loop is formed in the conductor 321. In an embodiment, when the conductor 322 is electrically connected to an electrical contact 330 (e.g., similar to the electrical contacts 131, 130in FIG. 1), or to an electrode 335b (e.g., similar to the electrodes 135a, 135b in FIG. 1), a loop is formed in the conductor 322.

[0067] Although FIG. 3 illustrates the guide 340 diverging into a Y-shape, in other embodiments the guide 340 may diverge into any suitable shape with two or more diverging segments with each diverging segment functioning as a separate guide path.

[0068] In the embodiments shown in FIGS. 1-3, the guides include enclosed channels such as tubular structures through which one or more conductors are threaded. In other embodiments, a guide may include a lengthwise cut such that a conductor may be pressed through the cut and seated into the guide.

[0069] More generally, a guide may have any suitable form factor to engage with and guide one or more conductors.

[0070] FIG. 4, for example, illustrates an embodiment of an assembly 400 including a cuff body 420 (e.g., similar to the cuff body 120 of FIG. 1) and a guide 440 having recessed portions 440a, 440b, 440c, 440d, 440e (e.g., grooves, notches, carveouts, or slots) which define a strain relief construct. The guide 440 may be integrated into, disposed on, affixed to, attached to, or otherwise coupled to the cuff body 420. For example, the guide 440 may be a portion of the outer surface of the cuff body 420 that is modified (e.g., cut, melted, or scraped) to form one or more of the recessed portions 440a, 440b, 440c, 440d, and/or 440e. In an embodiment, the guide 440 is formed of a non-conductive material (e.g., silicone). In an embodiment, the guide 440 includes a relatively high-friction material or a surface treatment to improve engagement with one or more conductors.

[0071] Widths of the recessed portions of the guide 440 may be similar or may differ from one another. For instance, in FIG. 4, the recessed portions 440a, 440b, 440d, 440e have similar widths to each other, whereas a width of the recessed portion 440c is significantly greater. A number of conductors introduced into a particular recessed portion may depend on the width of that recessed portion. For example, in FIG. 4, the recessed portion 440c may guide both the conductors 421 and 422 in parallel whereas the recessed portions 440a, 440b, 440d, 440e may guide either the conductor 421 or the conductor 422. In an embodiment, a depth of one or more of the recessed portions (e.g., one or more of the recessed portions 440a, 440b, 440c, 440d, 440e) is sufficient to guide two or more conductors (e.g., the conductor 421 and the conductor 422) through the recessed portion.

[0072] The recessed portions 440a-440e may have any suitable cross-sectional shape, such as rectangular, hemispherical, or arcuate. In an embodiment, one or more of the recessed portions 440a-440e have a dimension (e.g., width or diameter) at an outer-facing surface where the conductor(s) are entered into the guide 440 that is less than a width of an internal dimension (e.g., width or diameter) where the conductor(s) are seated, such that the conductor(s) are forced past a smaller entry to reach a larger resting position (e.g., effecting a snap-fit of the conductor into the recess). In an embodiment, an internal periphery of at least one of the recessed portions 440a-440e are designed to mirror an external periphery of a conductor (e.g., one of the conductors 421, 422) so that the conductor fits snugly into that recessed portion. In an embodiment, a recessed portion may be sized and/or shaped such that a conductor may freely move axially within that recessed portion.

[0073] The guide 440 may include any number of recessed portions; five recessed portions 440a-440e are shown in FIG. 4. In an embodiment, the recessed portions are parallel to each other, as is illustrated for the embodiment of recessed portions 440a-440e. In an embodiment, one recessed portion may be at angle with respect to one or more other recessed portions. The recessed portions may be orientated to facilitate a desired strain relief pattern.

[0074] In an embodiment, a conductor may be introduced through one end of a recessed portion and may be pulled through the opposite end of the recessed portion using a suitable apparatus (e.g., tweezers or tweezer scissors). In an embodiment, a conductor may be placed or gently pressed into a recessed portion. In an embodiment, a conductor may be laterally locked in a recessed portion, such as by an interference between the conductor and the recessed portion. [0075] As discussed above, one or more conductors may be introduced into and/or through a recessed portion.

For example, in FIG. 4, both of the conductors 421, 422 may be introduced into and/or through the recessed portion 440c. Each conductor may be manipulated into a strain relief pattern defined by multiple recessed portions. For example, conductor 421 may be introduced through the recessed portions 440c, 440a, 440d to form a first loop; and conductor 422 may be introduced through the recessed portions 440c, 440e, 440b to form a second loop. In this manner, recessed portions 440a-440e define a strain relief construct to facilitate strain relief patterns such as for conductors 421, 422.

[0076] In an embodiment, the conductors 421, 422 may be coupled to the conductive contacts 430, 431 before or after being arranged within the strain relief construct. Similarly, the lead 410 may be attached to or otherwise coupled to the cuff body 420 before or after the conductors 421, 422 are arranged within the strain relief construct. In FIG. 4, the lead 410 may be attached to or otherwise coupled to the cuff body 420 such that the lead 410 may be perpendicular to the longitudinal axis 436 of the cuff body 420, although other orientations may be implemented instead.

[0077] FIG. 5A illustrates an embodiment of an assembly 500 for providing strain relief in a cuff electrode where four guides (guides 540, 541, 542, 543) define a strain relief construct. The four guides are provided in various orientations to define a rectangular-like outline of the strain relief construct. Although assembly 500 depicts four guides having a rectangular-like outline, the strain relief construct may include any suitable number of guides and have any suitable outline (e.g., circular, elliptical, triangular, or hexagonal outline), and one or more guides may be disposed within the outline. Furthermore, one or more of the guides may be curved or arcuate rather than substantially straight as shown in FIG. 5A, and/or one or more of the guides may diverge from a common portion to two or more guide segments.

[0078] One or more conductors may be manipulated into a strain relief pattern within a strain relief construct defined by the guides. Each conductor may be disposed in the set of guides that defines the strain relief construct, or in a subset of the guides. For example, the conductor 521 may be introduced through the guide 541, then through the guides 540, 543, 542 to define the strain relief pattern for the conductor 521 as illustrated in FIG. 5A, and the conductor 520 may be introduced through the guide 541, then through the guides 542, 543, 540 to define the strain relief pattern for the conductor 520 as illustrated in FIG. 5A. A conductor may be manipulated through all available guides or may be manipulated through one or more guides and not through one or more of the other guides.

[0079] Although the conductors 520, 521 are shown in FIG. 5A as introduced through the guides in the above- described manner (e.g., order), the conductors in an assembly may be introduced through all or some of the guides in any suitable manner (e.g., order) to form a strain relief pattern. In some embodiments, the manner in which the conductors are introduced through one or more guides may depend at least in part on the relative locations of the lead, guide(s) and/or conductive contacts. For example, FIG. 5B illustrates an embodiment of an assembly 500' for providing strain relief in a cuff electrode, where assembly 500' is similar to assembly 500 illustrated in FIG. 5A, except that the locations of the conductive contacts 530 and 531 are different in the assembly 500' than in assembly 500. In FIG. 5B, the conductive contacts 530, 531 are longitudinally distributed (e.g., approximately parallel to the longitudinal axis 536) on the cuff body, while the conductive contacts 530, 531 are circumferentially distributed around the cuff body. Thus, while assembly 500' illustrated in FIG. 5B includes guides 540, 541, 542, 543 that define an outline of a strain relief construct similar in shape to the strain relief construct in assembly 500 illustrated in in FIG. 5A, the conductors 530, 531 may be introduced through the guides in a different manner to traverse from the lead 510 to their respective conductive contacts. For example, in contrast to the example described above with respect to FIG. 5A, as shown in FIG. 5B, the conductor 521 may be introduced through guide 541, then through guides 540, 543, 542, and again through guide 541 to define the strain relief pattern for the conductor 521 to traverse to the conductive contact 530 as illustrated in FIG. 5B. Additionally, in contrast to the example described above with respect to FIG. 5A, as shown in FIG. 5B, the conductor 520 may be introduced through guide 540, then through the guides 541, 542, and 543 to define the strain relief pattern for the conductor 520 to traverse to the conductive contact 531 as illustrated in FIG. 5B. Similar to assembly 500, a conductor may be manipulated through all available guides or may be manipulated through one or more guides and not through one or more of the other guides.

[0080] Furthermore, the guide(s) forming the strain relief construct may be located on any suitable portion of the cuff body. For example, in contrast to assembly 500 (illustrated in FIG. 5A) that includes a strain relief construct located nearly opposite (e.g., nearly 180 degrees away from) the cuff body arms 501 and 502 (and opening therebetween), assembly 500' (illustrated in FIG. 5B) includes a strain relief construct located approximately 90 degrees from the cuff body arms 501 and 502 (and opening therebetween). The strain relief construct may be located any suitable arcuate distance from the cuff body arms and/or opening therebetween, such as adjacent, approximately 45 degrees, approximately 90 degrees, approximately 135 degrees, or approximately 180 degrees from the cuff body arms and/or opening therebetween.

[0081] In contrast to FIG. 1, FIG. 2, FIG. 3, and FIG. 4, where the leads 110, 210, 310, and 410, respectively, were illustrated extending approximately perpendicular to the longitudinal axis 136, 236, 336, and 436, respectively, the lead 510 in FIG. 5A and FIG. 5B is illustrated as being aligned (e.g., approximately parallel) with the longitudinal axis 536 of the cuff body 520. Flowever, in any embodiment, a lead (e.g., the lead 110, 210, 310, 410, or 510) may be oriented at any angle with respect to a longitudinal axis of the respective cuff body.

[0082] As has been described, one or more guides may be included on the cuff body to define at least one strain relief construct for one or more conductors. In FIG. 1, a single guide defines a strain relief construct. In FIG. 2, two guides define a strain relief construct. In FIG. 3, one guide diverges into two different guide segments and defines a strain relief construct. In FIG. 4, a guide includes one or more recessed portions to define a strain relief construct. In FIGS. 5A and 5B, multiple guides are oriented at various angles to define a strain relief construct. Each conductor may be manipulated into a strain relief pattern through multiple guides and/or multiple recessed portions of a guide. A conductor may be introduced into a guide (or a recessed portion of a guide) once, twice, or more times in accordance with the strain relief pattern. For example, in FIGS. 1-5A, for a sequence of guides (or recessed portions of a guide) through which a conductor is introduced, the conductor passes through each guide or recessed portion of a guide one time. As shown in FIG. 5B, for a sequence of guides through which a conductor is introduced, the conductor passes through at least one guide multiple times, following the outline of the strain relief construct. Although each of the assemblies 100, 200, 300, 400, 500, 500' are illustrated in FIG. 1, FIG. 2, FIG. 3, FIG. 4, FIG. 5A, FIG 5B, respectively, with two conductors arranged within the strain relief construct, more conductors may be arranged within a strain relief construct, or a single conductor may be arranged within the strain relief construct.

[0083] In an embodiment, a cuff body may include additional features (e.g., features not shown in FIGS. 1-5) to provide directions for defining a strain relief pattern using the strain relief construct. For instance, a cuff body may include one or more visual aids to provide directions for defining a strain relief pattern. For example, in the assembly 200 in FIG. 2, the cuff body 220 may include a visual aid providing directions to insert the conductor 221 through a top opening on the guide 240. The visual aid may include further directions to pull the conductor 221 through a bottom opening on the guide 240. The visual aid may include directions to then route the conductor 221 through a bottom opening on the guide 241 and to pull the conductor 221 from the top opening on the guide 241, thereby routing the conductor 221 into a strain relief pattern. In an embodiment, visual aids may be multiple incisions on a cuff body that may collectively define a path for a conductor to follow on a cuff body (e.g., the path previously described). In an embodiment, visual aids may be one or more colors included on an outer surface of a cuff body. For instance, the path for each separate conductor may be represented by a different color. In some variations, paths may be printed on the cuff body (e.g., as arrows).

[0084] In similar fashion as described with respect to the conductors 121, 122 in FIG. 1, the conductors in any of the embodiments in FIGS. 2-5B may be coupled to their respective conductive contacts before being manipulated into a strain relief pattern. Alternatively, the conductors may be coupled to the conductive contacts after being manipulated into a strain relief pattern. Additionally, the lead may be attached to or otherwise coupled to the cuff body before or after the conductors are manipulated into the strain relief pattern.

Method of using the assemblies

[0085] FIG. 6 is a flow chart of an embodiment of a method 600 of using the assemblies shown in FIGS. 1-5. At 602, the method 600 includes placing a cuff body around a feature. For example, the cuff body may be spread open by applying force to a first arm and a second arm on the cuff body. More specifically, force may be applied by pulling the arms away from each other. The cuff body in the open state may be placed on a feature such that at least a portion of an inner surface of the cuff body touches the feature. The arms may then be released (e.g., by removing the force).

The cuff body may self-close and wrap its inner surface around the feature.

[0086] At 604 _; the method 600 includes introducing at least one conductor through at least one guide of a strain relief construct to form a strain relief pattern. In an embodiment, multiple conductors may be introduced through one guide. One or more conductors may be inserted through a first opening of the guide such that they exit and extend out of a second opening of the guide. Once exited from the second opening, the conductors may be extended to form a loop. In an embodiment, multiple conductors may be introduced through multiple guides to define a strain relief pattern.

[0087] At 606, the method 600 may include electrically coupling the conductors to electrodes. For instance, the conductors may be coupled to conductive contacts that are disposed on a cuff body. The conductive contacts may electrically couple the conductors to the electrodes within the cuff body. Alternatively, the conductors may be directly coupled to the electrodes and the conductive contacts may be bypassed or omitted.

[0088] The steps 602-606 of the method 600 can be performed in any order. For instance, in one variation, step 604 may be performed before step 602. In another variation, step 606 may be performed after step 604 but before step 602. In still another variation, step 606 may be performed before step 604. In another variation, steps 604, 606 may be performed before step 602. Put differently, the sequence of the steps described in method 600 may be performed in any order.

[0089] FIG. 7 is an illustration of how the assemblies described in FIGS. 1-5 could be placed within a body for treatment. A cuff electrode 700 (e.g., structurally and/or functionally similar to one of the assemblies 100-500 in FIGS. 1-5, respectively) may be wrapped around a nerve 760 of a subject (e.g., a nerve in a pudendal branch). For example, the cuff electrode 700 may be placed around the nerve 760 using the method described at step 602 in FIG. 6. A lead 710 may couple the cuff electrode 700 to a stimulator 750. The stimulator 750 may deliver electrical signals to the nerve 760. In an embodiment, the electrical signals assist a subject with urinary control.

[0090] In an embodiment, the strain relief constructs and assemblies shown in FIGS. 1-5 may be incorporated onto (or into) the cuff electrode 700 to enhance an electrical coupling between components in the cuff electrode 700 and conductors disposed in the lead 710. In an embodiment, strain relief constructs and assemblies similar to those shown in FIGS. 1-5 may be incorporated onto (or into) the stimulator 750 to enhance an electrical coupling between components in the stimulator 750 and conductors disposed in the lead 710.

[0091] In general, embodiments of the present disclosure include without limitation one of, or a combination of, the following aspects: • An implantable cuff electrode includes a cuff body and a strain relief construct. The cuff body includes at least one electrode. The strain relief construct includes a guide disposed on the cuff body, and the strain relief construct defines a channel structured to engage at least one conductor.

• An assembly includes a cuff body, a strain relief construct, and a conductor. The cuff body includes at least one electrode. The strain relief construct includes a guide disposed on the cuff body, and the strain relief construct defines a channel. The conductor is arranged within the strain relief construct to form a strain relief pattern.

• A method includes placing a cuff body around a target nerve. The cuff body includes at least one electrode, and includes a strain relief construct including a guide. The method further includes introducing a conductor into the guide, and electrically coupling the conductor to one or more of the at least one electrode.

• One or more of the foregoing aspects include without limitation one of, or a combination of, the following features:

- The/a channel defined by the strain relief construct is a tubular opening through the guide.

- The/a channel defined by the strain relief construct is a portion of the guide that is recessed from an outer surface of the guide.

- The guide is affixed to an outer surface of the cuff body.

- The guide is integrally formed with the cuff body.

- The guide is a first guide and the strain relief construct includes multiple guides including the first guide.

The multiple guides may further include a second guide, where the first guide and the second guide are on a same side of the cuff body or on approximately opposite sides of the cuff body.

- The guide comprises a common portion and a diverging portion, where the diverging portion includes a first guide segment and a second guide segment.

- The cuff body is self-closing.

- The cuff body includes a conductive contact in or on the cuff body, and the conductive contact is electrically coupled to one or more of the at least one electrode.

- A conductive contact in or on the cuff body is electrically coupled to one or more of the at least one electrode, and the/a conductor is electrically coupled to the conductive contact.

- There are multiple conductors, and each of the guides is structured to guide at least one of the conductors into a strain relief pattern. The conductor is disposed in each of multiple guides defining the strain relief construct.

- The conductor is disposed in less than all of multiple guides defining the strain relief construct.

- The conductor can be introduced through the guide such that the conductor forms a strain relief pattern having a curved portion.

- The guide is a first guide and the strain relief construct includes multiple guides including the first guide and a second guide; the conductor is a first conductor and the/an assembly includes multiple conductors including the first conductor and a second conductor. The first conductor may be introduced into the first guide and the second conductor may be introduced into the second guide. The first guide may be the second guide, or the first guide may be different than the second guide.

- Multiple conductors may be introduced into one or more of, or each of, multiple guides disposed on the cuff body.

- The guide includes a common portion and a diverging portion, where the diverging portion includes a first guide segment and a second guide segment. The conductor may be introduced into the common portion to exit the first guide segment. Another conductor may be introduced into the common portion to exit the second guide segment.

- The conductor may be coupled to a conductive contact disposed in or on the cuff body.

- A lead may be coupled to the cuff body, and the conductor may be disposed in and extend out of the lead.

[0092] Thus has been described several embodiments of guides used to provide strain relief on an implant. Particular embodiments have been illustrated and described with respect to a cuff electrode and an assembly of the cuff electrode with one or more conductors, where one or more guides define a strain relief construct for engaging the conductors to the cuff electrode in a strain relief pattern. However, the strain relief construct is further applicable to other types of assemblies including electrical coupling of conductors to components, assemblies including mechanical cabling or fluidic lumens (e.g., catheters) coupled to a component, or other types of assemblies.

[0093] When used in the present disclosure, the terms "e.g.," "such as", "for example", "for an example", "for another example", "examples of", "by way of example", and "etc." indicate that a list of one or more non-limiting example(s) precedes or follows; it is to be understood that other examples not listed are also within the scope of the present disclosure.

[0094] As used herein, the singular terms "a," "an," and "the" may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more." [0095] As used herein, the term "set" refers to a collection of one or more objects. Thus, for example, a set of objects can include a single object or multiple objects.

[0096] The term "in an embodiment" or a variation thereof (e.g., "in another embodiment" or "in one embodiment") refers herein to use in one or more embodiments, and in no case limits the scope of the present disclosure to only the embodiment as illustrated and/or described. Accordingly, a component illustrated and/or described herein with respect to an embodiment can be omitted or can be used in another embodiment (e.g., in another embodiment illustrated and described herein, or in another embodiment within the scope of the present disclosure and not illustrated and/or not described herein).

[0097] The term "component" refers herein to one item of a set of one or more items that together make up a device, formulation or system under discussion. A component may be in a solid, powder, gel, plasma, fluid, gas, or other form. For example, a device may include multiple solid components which are assembled together to structure the device and may further include a liquid component that is disposed in the device.

[0098] The term "design" or a grammatical variation thereof (e.g., "designing" or "designed") refers herein to characteristics intentionally incorporated based on, for example, estimates of tolerances (e.g., component tolerances and/or manufacturing tolerances) and estimates of environmental conditions expected to be encountered (e.g., temperature, humidity, external or internal ambient pressure, external or internal mechanical pressure, stress from external or internal mechanical pressure, age of product, or shelf life, or, if introduced into a body, physiology, body chemistry, biological composition of fluids or tissue, chemical composition of fluids or tissue, pH, species, diet, health, gender, age, ancestry, disease, or tissue damage); it is to be understood that actual tolerances and environmental conditions before and/or after delivery can affect characteristics so that different components, devices, formulations, or systems with a same design can have different actual values with respect to those characteristics. Design encompasses also variations or modifications before or after manufacture.

[0099] The term "manufacture" or a grammatical variation thereof (e.g., "manufacturing" or "manufactured") as related to a component, device, formulation, or system refers herein to making or assembling the component, device, formulation, or system. Manufacture may be wholly or in part by hand and/or wholly or in part in an automated fashion.

[00100] The term "structured" or a grammatical variation thereof (e.g., "structure" or "structuring") refers herein to a component, device, formulation, or system that is manufactured according to a concept or design or variations thereof or modifications thereto (whether such variations or modifications occur before, during, or after manufacture) whether or not such concept or design is captured in a writing. [0100] The term "electrically coupled" or a grammatical variation thereof (e.g., "electrical coupling”) refers herein to conductive coupling between two or more components to facilitate an actual or expected flow of electrical current between the components, whether or not electrical current is presently flowing. Electrical coupling may be, for example, by physical contact alone, by the elements being physically attached to each other such as through soldering, arc welding, acoustic or other vibration welding, by other electrical coupling technique, or by coupling the elements through a conductive intermediary such as a wire or trace or a conductive paste.

[0101] The term "body" refers herein to an animalia body.

[0102] The term "subject" refers herein to a body into which an embodiment of the present disclosure is, or is intended to be, implanted. For example, with respect to humans, a subject may be a patient under treatment of a health care professional.

[0103] The terms "substantially" and "about" are used herein to describe and account for small variations. For example, when used in conjunction with a numerical value, the terms can refer to a variation in the value of less than or equal to +10%, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%.

[0104] The foregoing description of various embodiments has been presented for purposes of illustration and description. It is not intended to limit the invention to the precise forms disclosed. Many modifications, variations and refinements will be apparent to practitioners skilled in the art. For example, embodiments of the device can be sized and otherwise adapted for various pediatric and neonatal applications as well as various veterinary applications. Also, those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the present invention and are covered by the appended claims below.

[0105] While the present disclosure has been described and illustrated with reference to specific embodiments thereof, these descriptions and illustrations do not limit the present disclosure. It can be clearly understood that various changes can be made, and equivalent components can be substituted within the embodiments, without departing from the true spirit and scope of the present disclosure as defined by the appended claims. Also, components, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more components, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, components that are shown or described as being combined with other components, can, in various embodiments, exist as standalone components. Further, for any positive recitation of a component, characteristic, constituent, feature, step or the like, embodiments of the invention specifically contemplate the exclusion of that component, value, characteristic, constituent, feature, step or the like. The illustrations may not necessarily be drawn to scale. There can be distinctions between the artistic renditions in the present disclosure and the actual apparatus, due to variables in manufacturing processes and such. There can be other embodiments of the present disclosure which are not specifically illustrated. The specification and drawings are to be regarded as illustrative rather than restrictive. Modifications can be made to adapt a particular situation, material, composition of matter, method, or process to the objective, spirit and scope of the present disclosure. All such modifications are intended to be within the scope of the claims appended hereto. While the methods disclosed herein have been described with reference to particular operations performed in a particular order, it can be understood that these operations can be combined, sub-divided, or re-ordered to form an equivalent method without departing from the teachings of the present disclosure. Therefore, unless specifically indicated herein, the order and grouping of the operations are not limitations of the present disclosure.