Systems and methods for laparoscopic delivery and deployment of neural interfaces

The deployment tab for nerve cuffs addresses issues of tissue injury and electrode damage by providing a safe and precise deployment mechanism, ensuring minimal trauma and effective laparoscopic delivery of neural interfaces.

JP7771056B2Active Publication Date: 2025-11-17GALVANI BIOELECTRONICS LTD
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Patent Information

Application Number
JP2022530674
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-11-27
Filing Date
2020-11-27
Publication Date
2025-11-17
Estimated Expiration
2040-11-27

AI Technical Summary

Technical Problem

Challenges arise during the delivery and deployment of neural interface devices, particularly neural interfaces such as cuff devices, due to issues like suture cutting causing tissue injury, suture remnants, and electrode tangling or damage during laparoscopic procedures.

Method used

The deployment tab for nerve cuffs, with features like transverse ridges and valleys, a tapered proximal end, and a suture design that allows for safe removal, minimizes tissue damage and electrode protection by providing a go/no-go indicator and facilitating smooth deployment through trocar ports.

Benefits of technology

The solution reduces tissue injury and electrode damage by ensuring safe deployment and minimizes friction, allowing for precise sizing and orientation of neural interfaces, thereby enhancing the safety and efficacy of laparoscopic neural interface procedures.

✦ Generated by Eureka AI based on patent content.

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Abstract

1. A deployment tab (110) for deploying a neural interface device (106), the deployment tab comprising: a first portion configured to be positioned proximate the neural interface device in use; and a connector for releasably coupling the first portion to the neural interface device, the connector secured to the first portion.
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Description

[Technical Field]

[0001] Short description A deployment tab for a nerve cuff is disclosed that has a thickness and / or width slightly greater than the thickness and / or width of the nerve cuff. The deployment tab can include a secured suture threaded through the deployment tab and removably attached to the nerve cuff. The deployment tool can be completely separated from the nerve cuff by cutting through at least a portion of the deployment tab. The deployment tab can include a series of transverse (or lateral, along the width of the deployment tab) ridges and valleys on one side that can serve as a cutting guide and can allow the deployment tab to be rolled to a smaller size for delivery. The deployment tab can include a series of longitudinal ridges and valleys on the opposite side that can serve to minimize or at least reduce the contact surface (including when the deployment tab is rolled). The deployment tab can include a tapered proximal end and can be configured to act as both an instrument (e.g., a go / no-go gauge) to confirm that the incision opening is large enough for the cuff and as a blunt dissection tool. If the thickness and / or width of the deployment tab is not such that it will fit through the incision, a slightly smaller nerve cuff may not fit easily. An anchored suture is positioned within the deployment tab such that when at least a portion of the deployment tab is cut open, the suture is severed, thereby releasing the deployment tab from the previously attached portion of the nerve cuff. [Background technology]

[0002] background Neural interfaces (or neural interface devices), such as cuff devices, include electrodes. Various challenges can arise during the delivery and deployment of neural interface devices, especially when the delivery and deployment steps are performed laparoscopically. Summary of the Invention [Problem to be solved by the invention]

[0003] For example, sutures attached to a neural interface for deployment may need to be cut or removed during deployment. During such cutting or removal, target tissue or anatomical structures near the target tissue may be at risk of injury. Remnants of sutures left behind after cutting may also cause damage to tissue structures.

[0004] As another example, a silicone molded nerve cuff may rub or get caught on the sides of a deployment tube (such as a trocar), resulting in friction making advancement difficult and causing at least some portions of the neural interface (e.g., arms) to become tangled, which poses a risk of damaging the electrodes. [Means for solving the problem]

[0005] The inventors of the present invention have devised various solutions for delivering and deploying neural interface devices while reducing electrode damage during such delivery and deployment. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 10 is a perspective view of a deployment tab for a nerve cuff, according to one embodiment. [Figure 2] FIG. 2 is a perspective view of the deployment tab of FIG. 1 sutured to a nerve cuff and positioned for deployment around a target, according to one embodiment. [Figure 3] 2 is a perspective view of the deployment tab of FIG. 1 being used to pull open the nerve cuff, with the deployment tab being retracted under the target, according to one embodiment. [Figure 4] FIG. 2 is a distal end view of the deployment tab of FIG. 1 according to one embodiment. [Figure 5] 2 is a perspective view of the nerve cuff of FIG. 1 deployed around a target prior to release from the deployment tab, according to one embodiment. [Figure 6]FIG. 2 is a perspective view of the deployment tab of FIG. 1 being cut to release the suture, according to one embodiment. [Figure 7] FIG. 2 is a perspective view of the deployment tab of FIG. 1 being pulled away from the nerve cuff, according to one embodiment. [Figure 8] FIG. 1 is a perspective view of a fully deployed nerve cuff, according to one embodiment. [Figure 9] FIG. 1 is a perspective view of one embodiment of a deployment tab having a series of lateral ridges and valleys. [Figure 10] FIG. 10 is a proximal end view of the deployment tab of FIG. 9. [Figure 11] FIG. 10 is a perspective view of the deployment tab of FIG. 9 sutured to a nerve cuff, according to one embodiment. [Figure 12A] FIG. 10 is a see-through perspective view of the ridges and valleys of the deployment tabs, showing the underlying suture channel and the more tapered proximal end. [Figure 12B] FIG. 12B is a solid perspective view of the deployment tab of FIG. 12A. [Figure 12C] FIG. 12B is a solid side view of the deployment tab of FIG. 12A. [Figure 13A] FIG. 1 is a perspective view of a deployment tab having longitudinal ridges and valleys on one side. [Figure 13B-1] FIG. 10 is a perspective view of a deployment tab. [Figure 13B-2] FIG. 10 is a perspective view of a deployment tab. [Figure 13B-3] FIG. 10 is a perspective view of a deployment tab. [Figure 13C-1] FIG. 10 is a perspective view of the deployment tab in use as a measurement tool. [Figure 13C-2] FIG. 10 is a perspective view of the deployment tab in use as a measurement tool. [Figure 13C-3] FIG. 10 is a perspective view of the deployment tab in use as a measurement tool. [Figure 13C-4] 1 is a top view of a deployment tool and a corresponding table of dimensions. [Figure 13D] 10A-10C show top and bottom views of deployment and a perspective view of the same deployment tab sutured to a nerve cuff, according to one embodiment. [Figure 14A]FIG. 1 is a perspective view of a delivery tool for a neural interface, according to one embodiment. [Figure 14B] FIG. 14B is a perspective view of the delivery tool of FIG. 14A including an elongated section, according to one embodiment. [Figure 15A] 1A-1C are perspective and cross-sectional views of a delivery tool, according to one embodiment. [Figure 15B] 15B is a perspective view of the delivery tool of FIG. 15A partially inserted into a trocar port, according to one embodiment. [Figure 15C] 15B is a perspective view of the delivery tool of FIG. 15A fully inserted into the trocar port, according to one embodiment. [Figure 15D] FIG. 15B is a perspective view of the nerve cuff being removed from the delivery tool of FIG. 15A. [Figure 15E] 1A-1C are two perspective views of a delivery tool, according to one embodiment. [Figure 15F] 15E and 15F show side and cross-sectional views of the delivery tool of FIG. 15E. [Figure 16A] FIG. 1 is a perspective view of a pusher rod, including a blown-up view of the distal end, according to one embodiment. [Figure 16B] 1A-1C are perspective and distal cross-sectional views of a nerve cuff and a deployment tab attached to the nerve cuff and rolled into the cuff, according to one embodiment. [Figure 16C] FIG. 1 is a perspective view of a pusher rod with a nerve cuff attached to its distal end, according to one embodiment. [Figure 16D] FIG. 10 is a perspective view of a pusher rod inserted into a delivery tube, according to one embodiment. [Figure 16E] FIG. 10 is a perspective view of a pusher rod and delivery tube partially inserted into a trocar port and introducer tube, according to one embodiment. [Figure 16F] FIG. 10 is a perspective view of a pusher rod and delivery tube fully inserted into a trocar port and introducer tube, according to one embodiment. [Figure 17] FIG. 1 is a perspective view of a delivery tube, according to one embodiment. [Figure 18] FIG. 10 is a side view of a delivery tool having a holding tool, according to one embodiment. [Figure 19A] FIG. 10 is a side view of a delivery tool with a holding tool in an unreleased position, according to one embodiment. [Figure 19B] FIG. 10 is a side view of a delivery tool with a holding tool in a released position, according to one embodiment. [Figure 20] 1A-1C are a series of proximal end and side views of three different trocar ports. [Figure 21A] FIG. 10 is a perspective cross-sectional view showing one half of a neural interface retaining feature of a trocar cannula, according to one embodiment. [Figure 21B] FIG. 21B is a perspective cross-sectional view showing the other half of the neural interface retaining feature of FIG. 21A. [Figure 22A] FIG. 21B is a general cross-sectional side view of the trocar cannula of FIG. 21A. [Figure 22B] FIG. 22B is a side view of the trocar cannula of FIG. 22A. [Figure 23A] FIG. 21B is a perspective view of the proximal end of the trocar cannula of FIG. 21A. [Figure 23B] FIG. 23B is an end view of the proximal end of the trocar cannula of FIG. 23A. [Figure 24A] FIG. 1 is a perspective cross-sectional view near the proximal end of a trocar cannula including a retaining feature and a guide member. [Figure 24B] 24B is a perspective cross-sectional view of the proximal end of the trocar cannula of FIG. 24A. [Figure 25A] FIG. 10 is a perspective view of a neural interface retaining feature, according to one embodiment. [Figure 25B] FIG. 25B is an end view of the retention feature of FIG. 25A. [Figure 26] FIG. 1 is a side cross-sectional view of a neural delivery device, according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0007] The present disclosure relates to embodiments of an extravascular neural interface device including electrodes for neural modulation of a target, such as a neurovascular bundle or nerve. For example, in one embodiment, a nerve cuff includes three open-ended arms (referred to herein as a "nerve cuff" or "cuff"), each shaped in the form of an open-ended ring. One embodiment of such a cuff 100 is shown in FIG. 1. The open ends of the two outer arms 102 and 104 can be located opposite the open end of the central arm 106. In other words, the two outer arms 102 and 104 extend (or curve) in a direction opposite to the direction in which the central arm 106 extends (or curves). Electrodes can be located on the two outer arms 102, 104, but can also be located on the central arm 106. Typically, the cuff and arms are molded from silicone, which surrounds the entire electrode except for the exposed surface where the electrode will contact the target tissue. The exact nature of the electrodes is not relevant to this disclosure and therefore not shown, but the electrodes may be flexibly connected within the arms so that each arm can be flattened without damaging the delicate electrodes or the connections within the arms or between the electrodes and the lead body 108.

[0008] Additionally, although a nerve cuff with three open arms is discussed as an example, the deployment tabs or delivery tools described herein can be used to deploy or deliver other types of neural interfaces having different shapes or configurations. For example, the deployment tabs or delivery tools can be used with nerve cuffs that have only one open arm, only two open arms, or more than three open arms.

[0009] 1 shows a deployment tab 110. The tab 110 and nerve cuff 100 are shown as being capable of being placed within a patient's body cavity when ready to be placed around a target, such as a neurovascular bundle or nerve. The tab 110 may comprise a base attached to the cuff 100 by a suture 112 (also referred to herein as a suture or suture wire) formed from a non-absorbable suture material, such as braided or monofilament polyester, nylon, polyvinylidene difluoride (PVDF), and polypropylene. During manufacture, the suture 112 may be molded into or glued to the tab 110 to form a suture loop 120.

[0010] The end 114 of the tab 110 can be used as a starting point to describe the path of the suture 112 through the tab 110. The end 114 may be the end closer to an operator manipulating the tab 110 during a procedure, and is therefore referred to as the proximal end 114. The distal end of the tab 110 is therefore the end farther from the operator and may be in contact with or positioned near the nerve cuff 100. From this starting point, the suture 112 may movably pass through a first passageway, such as a first tunnel 116, formed in the tab 110. Movably passing through a passageway means that the suture 112 can move within and pass through (or slide along) the interior of the passageway. The cross-sectional shape of the passageway may be a circular hole, an oval or oblong slot, or other shape. The first tunnel 116 runs through a central area, which will be described further below. The suture 112 may then exit the first tunnel 116 at the distal end 117 of the tab 110 and movably pass through a first eyelet 118 of the first outer arm 102. The eyelet 118 may be formed by a hole formed through the distal end of the outer arm (beyond the point of any electrode disposed in the outer arm), the proximal end of which is a spine 304 on the same axis as the lead body 108. The eyelet 118 may be a circular hole, an oval or oblong slot, or other shape.

[0011] After passing through the eyelet, the suture 112 may movably pass back through the opening in the tab 110 to form a suture loop 120 that is fixed to the tab 110 in some manner, such as by being molded into the tab 110 when it is formed or by being secured with an adhesive. In other words, the portion of the suture 112 that is fixed in the tab 110, such as the suture loop 120, is not movably attached to the tab 110. The suture 112 may extend further from the suture loop 120 and out of the tab 110, then movably pass back through a second eyelet 122 in the second outer arm 104, movably pass through a second passageway, such as a second tunnel 124 formed in the tab 110 that extends from the distal end 117 to the proximal end 114 of the tab, and exit the tab 110. The two ends of the suture 112 may then be tied into a knot 126. For simplicity of illustration, knot 126 is shown as a loop. In one embodiment, knot 126 can serve as a grasping point for grasping a surgical tool. In this embodiment, suture loop 120 is formed so that a single suture 112 is used, although it is understood that two separate sutures 112 could also be used, with each suture 112 passing through a different passageway and secured separately within tab 110.

[0012] As will be understood by those skilled in the art, the length of the deployment tab will be measured from the end of the tab connected to the cuff to the knot 126 at the opposite end of the tab (i.e., from the distal end to the proximal end of the tab). Similarly, the width of the deployment tab can be understood to be the widest part of the tab transverse to that length (in an axis parallel to the axis passing through the two eyelets 118, 122 of the cuff).

[0013] FIG. 2 shows the tab 110 and cuff 100 positioned near the target 200 for deployment. In the embodiment shown in FIG. 2, the target 200 can be a neurovascular bundle, although the cuff 100 can also be used on nerves that do not contain blood vessels. However, for ease of reference herein, the target 200 will be referred to as the target tissue 200. The spacing between the locations of the two tunnels relative to the outer arms of the cuff can also serve to keep the outer arms properly positioned when they are pulled under the target tissue. Additionally, this spacing is provided by the presence of a portion of the tab, providing additional structural stability during manipulation of the cuff.

[0014] 3 , a first surgical tool 300 can be used to incise or separate an area beneath the target tissue 200 and to grasp the suture knot 126 or the proximal end 114 of the tab 110 (the end closest to the surgical tool 300) and pull the proximal end 114 of the tab 110 beneath the target tissue 200. Additionally, a second surgical tool 302 can be used to grasp a portion of the central arm 106 of the cuff 100 to create countertraction between the arms of the cuff 100. As the tab 110 is pulled beneath the target tissue 200, tapering of the proximal end 114 can aid in further dissecting tissue beneath the target tissue 200, if desired. The tapered proximal end 114 can be at least partially triangular shaped. 3, the proximal end 114 can taper from a wider central portion of the tab 110 to a narrower portion near the suture knot 126. Sufficient pulling pressure can be applied by a second surgical tool 302 on the outer arms 102 and 104 between a first surgical tool 300 pulling on the suture knot 126 or proximal end 114 and the suture loop 120 secured within the tab 110 to pull the outer arms 102 and 104 away from the spine 304 of the cuff 100.

[0015] As further shown in FIG. 4 , the tab 110 can also function as a go / no-go indicator during deployment. The thickness 400 of the tab 110 can be thicker than the thickness of any of the cuff arms 102, 104, or 106. In one embodiment, the tab can be approximately 0.5 mm thicker than the cuff arms. Additionally, the width 402 of the tab 110 can be wider than the width of the cuff 100 as measured from the outside of the outer cuff arms 102 and 104 deployed around the target tissue 200. In one embodiment, to account for tissue compliance, the width of the tab can be approximately 0.5 mm wider than the width of the cuff deployed around the target tissue. In other embodiments, the tab can be thicker or wider than the cuff by, for example, approximately 0.5-2 mm. The size difference between the tab and the neural interface is based on the tissue compliance of the target tissue. This difference in thickness and width of the tab 110 serves as a go / no-go feature. Because the tab 110 is pulled through the incision, if the tab 110 cannot be pulled without causing tissue damage, the cuff 100 cannot be safely deployed. Removing the tab 110 partway through deployment results in less tissue damage and potential injury to the target tissue 200 than would result from attempting to push or pull the cuff 100 into position and at least partially deploy the arms around the target tissue 200, only to find that there is insufficient space to pull the cuff and arms away from the target tissue.

[0016] After the cuff 100 is positioned over the target tissue 200 and the extended arms 102, 104, and 106 are released to allow them to wrap around the target tissue, as shown in FIG. 5 , the tab 110 and suture 112 must be safely and completely removed from the cuff 100. Safe and complete removal of the tab 110 and suture 112 can be accomplished by partially cutting the tab open at one or more locations in the central area, each of which is a safe distance from the target tissue 200. As shown in FIGS. 5 and 6 , the cutting location in the central area can be indicated by a cutting window 500, such as a sunken area of ​​the tab 110, that can be easily identified by the surgeon during deployment. Cutting the tab 110 along the length of the dashed line 602 at the cutting window 500 with a cutting tool 600 results in the severing of the suture 112 in both tunnels 116 and 124 (shown in FIG. 1 ). 7, the suture loop 120 is secured within the tab 110 approximately one-third of the length of the tab 110 from the distal end of the tab 110. As such, the suture loop 120 does not extend within the tab 110 all the way to the cutting window 500. Thus, cutting the suture 112 at the cutting window 500 can release the strand of suture 112 inside the tunnel, but the suture 112 that is part of the suture loop 120 remains intact.

[0017] Tab 110 can then be completely and safely pulled away from cuff 100 in the direction of arrow 700, pulling the released strand of suture 112 away from eyelets 118 and 122. In addition to removing tab 110, when tab 110 is removed, all of the suture is completely pulled away from cuff 100 because the ends of the suture strands are still molded into or adhered to tab 110 at suture loop 120. The cuff 100 is shown fully deployed around the target tissue 200 in FIG. 8.

[0018] An additional embodiment of a tab 900 is shown in FIG. 9. In this embodiment, the tab 900 includes a series of ridges 902 (sometimes called ridges or protrusions) and valleys 904 (sometimes called recesses), which may extend substantially perpendicular to a length 906 of one side of the tab 900 (i.e., along the width of the tab). Within each valley 904, tunnels 908 and 910 are exposed, alternating between being tunnels through the ridges 902 and pipes through the valleys 904. The passageways 908, 910 may be substantially similar to the tunnels 116, 124 of the tab 110 in that the suture 112 (not shown in FIG. 9) may movably pass through each passageway 908, 910 from a tapered proximal end 912 (the end closest to the operator or surgical tool) to a cuff arm disposed at a distal end 914. Where the passageways 908, 910 can pass through the ridges 902, the passageways will be tunnels, and where the passageways pass through the valleys, the passageways will be pipes. Cutting open either one of the valleys 904 enough to cut open both passageways 908, 910 (in some embodiments, cutting the tab completely in two, and in some embodiments, cutting just enough not to cut tab 110 in two) will release the suture without cutting the tab 900 completely open, thereby allowing the tab 900 to be completely removed along with all of the suture. Cutting the valleys 904 and passageways 908, 910 tunnels at a point close to where the bottom of the ridges 902 meets the valleys 904 can reduce the sharpness of any resulting corners and edges that may be created, thereby minimizing potential tissue irritation during removal.

[0019] In other embodiments, the deployment tab 900 can be cut closer to the first area closer to the neural interface, for example, at the tapered proximal end 912. This tapering means a narrower width, which means fewer cuts are required to slit the required portion of the deployment tab 900.

[0020] The location of channels 908, 910 relative to a proximal end 912 of tab 900 is further shown in FIG. 10 . Tab 900 has similar thickness and width dimensions and tapering as tab 110, which enable tab 900 to provide similar go / no-go characteristics and dissection aids, respectively. However, the ridges and valleys can allow tab 900 to be rolled into a smaller space, which can make tab 900 more suitable for insertion into smaller cuffs, as described further below. In other words, the lateral ridges and valleys can provide longitudinal flexibility that can enable the deployment tab to be rolled, while providing lateral stiffness when the deployment tab is unfolded.

[0021] 11 shows one embodiment of the tab 1100 in which the suture loop is not fixed within the tab 1100 but is instead glued to the outside of the tab 1100. For example, the suture 1101 can pass from the suture knot 1102 at the proximal end 1103 through passages 1105, 1107 to an eyelet (not shown) in the cuff 100. After passing through the eyelet in the cuff 100, the suture 1101 can return to the tab 1100 and pass through extensions / openings 1104, 1106 where the suture becomes glued to the tab 1100. In this embodiment of the tab 1100, the suture 1101 can be glued (not molded) to the tab 1100. Small extensions or openings 1104, 1106 can be formed on or in the distal end of the tab 1100 so that an adhesive 1108, such as a silicone adhesive, can be applied to the suture 1101 to secure the suture 1101 to the tab 1100. If openings 1104, 1106 are utilized, the adhesive can be applied after the suture 1101 is inserted into the openings 1104, 1106 to hold the suture 1101 in place. If extensions 1104, 1106 are utilized, the adhesive can be applied after the suture 1101 is at least partially wrapped around the extensions to further hold the suture 1101 in place. Glue (or adhesive) 1108 can also be applied at the suture knot 1102 to further secure the suture 1101 to the proximal end 1103 of the tab 1100. It will also be appreciated that the sutures may be glued (rather than molded) to the tabs 1100 described above.

[0022] The use of ridges and valleys to expose the suture tunnels in the central areas of tabs 900 and 1100 can provide surgeons with more options for where to cut the tab for removal than a single cutting window. Because the canal is visible in the valleys, the location of the cuttable portion of the tab may be more apparent, allowing the surgeon to ensure that both strands of suture have been cut before beginning tab removal. These different designs for indicating the cuttable portion of the tab (i.e., cutting windows and ridges and valleys) allow tabs 110, 900, and 1100 to be utilized with different sized cuffs. For example, tab 110 can function well with larger cuffs that may not require as much flexibility, while tabs 900 and 1100 can function well with smaller cuffs because the ridges and valleys allow the tabs to have more longitudinal flexibility while maintaining lateral stiffness. However, as will be further explained below, either design can be used with different sized neural devices.

[0023] In other embodiments, tab 110, 900, or 1100 can include only a single passageway (e.g., 116, 124, 908, or 910), in which case suture 112 or 1101 movably passes through the passageway, exits the tab, passes through an eyelet in the nerve cuff (which may have only a single arm), returns to the tab, and is secured or glued to the tab. After cutting the tab near its central portion, where a cutting window may be provided, or simply along one of the valleys far enough from the distal end, the suture can be released and pulled out of the eyelet in the cuff so that both the suture and tab can be completely and safely removed. This single passageway can be centrally located within tab 110, 900, or 1100, or can be located away from the center of the tab.

[0024] One embodiment of a tab 1200 similar to the embodiment of tab 1100 is shown in FIGS. 12A and 12B. FIG. 12A shows a see-through perspective of the ridges 1202 and valleys 1204 so that the suture channels 1206, 1208 underneath are visible. FIG. 12B shows the same perspective of the tab 1200 as a solid view instead of a see-through view. In this embodiment, the proximal end 1210 may have a more tapered profile and a more gradual transition 1212 from the proximal end 1210 to the central area 1214 where the tab 1200 is more likely to break during surgery. As described above with respect to FIG. 3, a surgical tool may be used to incise an area of ​​tissue beneath the target tissue, grasp the proximal end of the suture knot or tab, and pull the tab fully beneath the target tissue to allow the neural device to be deployed. The tapered proximal end 1210 of the tab 1200 can further serve as a gripping point for a surgical tool that can be used to pull the tab 1200. The gripping opening 1216 at the proximal end 1210 of the tab 1200 can provide a surgical tool with a better grip on the tab 1200 near the gripping point. The greater tapered profile of the proximal end 1210 can make it easier to incise tissue beneath the target and begin pulling the tab 1200 through the incision, which reduces tissue irritation. Similarly, the more gradual transition 1212 between the proximal end 1210 and the central area 1214 can make it easier to pull the tab 1200 through the incised tissue, reducing tissue irritation.

[0025] Figure 12B more fully illustrates the transition 1212 and central area 1214 of the tab 1200. Figure 12C is a solid right side view of the deployment tab of Figures 12A and 12B, more fully illustrating the ridges 1202, valleys 1204 and suture passages 1208.

[0026] Although the deployment tabs 110, 900, 1100, 1200 above are described as including two passageways or tunnels, the deployment tabs 110, 900, 1100, 1200 may include only one passageway or more than two passageways.

[0027] 13A is a perspective view of one embodiment 1300 of a deployment tab having a plurality of longitudinal ridges 1302 and valleys 1304 on a surface 1306, such as a bottom (or top) surface, opposite a surface 1308, such as a top (or bottom) surface, of the tab 1300 that includes the suture passageway and cuttable portion indications. The plurality of longitudinal ridges 1302 and valleys 1304 may be formed by longitudinal grooves formed on the surface 1306. The tab 1300 may further have a greater taper than previously discussed embodiments, such that some longitudinal grooves run from a first area near where the tab is held near the implantable device to a second area at the tapered end of the tab, through a central area between the first and second areas, while other longitudinal grooves begin at the first area and end at the central area due to the tapering.

[0028] The tabs disclosed herein can be manufactured from silicone. In certain instances, cleaning and sterilization can cause silicone to become sticky, which can worsen during long-term storage. The stickiness of silicone can be partially reduced by adding barium sulfate to the silicone, which can further make the tab radiopaque, which can be an additional benefit. The addition of ridges 1302 and valleys 1304 to the bottom surface 1306 of the tab 1300 can further reduce stickiness. When the bottom surface 1306 of the tab 1300 faces the silicone-covered nerve cuff when the cuff is rolled into the tab 1300, the longitudinal ridges 1302 and valleys 1304 of the bottom surface 1306 can help minimize the contact area between the silicone of the tab 1300 and the nerve cuff. Additionally, the longitudinal ridges 1302 and valleys 1304 can have the added benefit of reducing surface contact with the incised tissue, thereby making it easier to pull the tab under the target tissue / bundle than a flat (non-grooved) surface.

[0029] In some embodiments, the tabs can be formed from other biocompatible materials similar to silicone, such as styrene isoprene butadiene (SIBS), polyamide, parylene, liquid crystal polymer (LCP), polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), fluorinated ethylene propylene (FEP), ethylene-tetrafluoroethylene (ETFE), polyurethane, or other biocompatible polymers. The choice of material can depend on the desired flexibility or stiffness.

[0030] In some embodiments, the deployment tabs disclosed herein include rounded edges to reduce trauma to patient tissue when the implantable device is positioned around a target within the patient's body, as further shown in Figure 13D, which shows an additional view of a deployment tab with ridges and valleys on both sides.

[0031] The tabs disclosed herein provide other advantages for delivery, placement, and deployment of the neural interface 100. For example, in some embodiments, the tabs can be used as a measurement tool. In one embodiment, referring to FIGS. 13B-1, 13B-2, and 13B-3, the gap (sometimes referred to as the diameter or radial gap of the neural interface when deployed on the target tissue), having a length L, between the end of the tab body 850 and the spinal portion of the neural interface 100 can be measured to determine the degree or amount of extension of the neural interface 100 around the target tissue. This gap further characterizes the radial length of the electrode arm openings. Understanding these characteristics can be useful to a medical professional user when determining whether an appropriately sized neural interface 100 has been selected for the target tissue. FIGS. 13B-1, 13B-2, and 13B-3 illustrate radial gaps L1, L2, and L3, respectively, allowing a medical professional user to evaluate these gaps during delivery and deployment of the neural interface 100.

[0032] In another use of the tab, with reference to FIGS. 13C-1 , 13C-2, 13C-3, and 13C-4, in some embodiments, the rib-and-groove structure of the tab body 850 can be used as a “tape measure” type measuring tool. The rib-and-groove structure of the body 850 can be flexible such that it at least partially conforms to the circumference of the target tissue, thereby providing another way in which a medical professional user can use the body 850 to assess the size and fit of the neural interface 100 relative to the target tissue. This can be achieved in several ways. In one embodiment, information can be provided to a medical professional user that converts the number of ribs (or grooves) into usable information. For example, if 3-5 ribs are on the target tissue, the cuff size may be acceptable, if 2 or fewer ribs are on the target tissue, the cuff may be too large, and if 6 or more ribs are on the target tissue, the cuff may be too small. Thus, fit information can be provided directly by simply counting the ribs (or grooves) overlying the target tissue, as shown in FIG. 13C-1 (showing labeled ribs 1, 2, and 3), FIG. 13C-2 (showing labeled ribs 1, 2, 3, and 4), and FIG. 13C-3 (showing labeled ribs 1, 2, 3, 4, and 5). In another embodiment, a medical professional user can first count the ribs (or grooves) as shown in FIG. 13C-1, 13C-2, and 13C-3, and then use known measurements between adjacent ribs (or grooves) to assess size and fit, as shown in FIG. 13C-4. Similarly, known measurements can be converted into a table showing cuff opening as a percentage of circumference and providing advice to the medical professional user as to whether or not a cuff is suitable. In the table of FIG. 13C-4, values ​​3 through 7 are optimal, with the first two indicating the cuff is too large for the target tissue and the last two indicating the cuff is too small.

[0033] In addition to improving deployment of the cuff for deployment and implantation, the various tabs disclosed herein can further improve delivery. Delivery is the act of implanting the cuff into a patient, typically through the patient's abdominal cavity. In some cases, laparoscopic surgery may be the preferred surgical method for introducing a neuromodulation or neurostimulation system into a patient's body because it minimizes the risk of infection, reduces postoperative pain, and results in fewer complications. Laparoscopic surgery may be particularly applicable for neuromodulation applications when the target nerve or neurovascular bundle is located within the abdominal cavity. Introduction of tools and devices into a body cavity during laparoscopic surgery can be performed through a laparoscopic port, also known as a "trocar port" or "trocar," which often includes two or more flexible valves to prevent the escape of insufflation gas, i.e., an inert gas pumped into the body to create additional working and visual space during surgery. A side view and corresponding proximal (i.e., closest to the operator / surgeon or outside the patient's body) end view of three different trocar ports are shown in Figure 20. A trocar may also be referred to as an insertion tube.

[0034] Neural interfaces, particularly nerve cuffs and nerve cuff leads, can contain many fragile electrical connections. Directing a nerve cuff, for example, through a valve in a trocar port, without a protective mechanism, carries a high risk of damaging the electrode. Because electrode integrity is critical to the stimulation efficacy and safety of the cuff, there is a need to mitigate the risk of electrode damage with laparoscopic introduction. The embodiments described herein allow an insertion device to interact with the trocar seal and provide careful guidance of the delicate nerve cuff, including maintaining the orientation and position of the cuff as it is delivered into the abdominal cavity. The embodiments further allow for release of the cuff into the abdominal cavity and serve to protect the electrode surface inside the cuff until the "unfolding" step. All embodiments provide a method for deploying a laparoscopic neuromodulation cuff in the most convenient manner with the lowest risk, thereby minimizing cuff damage during delivery. Such a method is useful because small cracks in the molding or necking of the wire or electrode can be difficult to detect, and such damage propagates over time.

[0035] One embodiment of a delivery tube or neural delivery device (also called a cannula) including a pusher rod is shown in Figures 14A and 14B. The entire device, including the delivery tube 1400, pusher rod 1408, and proximal end seal, is shown in Figure 14B. Additionally, the blown-out detail sections in Figures 14A and 14B show details of the pusher rod 1408 and nerve cuff 1402. A delivery tube of this design may be suitable for a range of trocar port sizes, such as 12 mm and 15 mm, and therefore different neural interface sizes, and may be compatible with nerve cuffs that may or may not include deployment tabs, depending on the size of the mounting post. For example, a larger mounting post may be suitable for larger cuff designs or smaller cuff designs that do not include tabs that are rolled inside the cuff during delivery, while a smaller mounting post may be suitable for smaller cuffs or cuffs that include rolled tabs. Those skilled in the art will understand that when the application concerns a delivery tube, the tube can be a hollow tubular structure, or alternatively, the tube can be provided by a solid cylinder with a hollow end or blind bore (i.e., such that there is at least a tubular structure around the neural interface device). "Solid" can be understood to refer to a structure that is completely filled or has no cavities. For example, a single steel or polymer cylinder would be a solid cylinder. It should be understood that when "delivery tube" is used herein, the term is intended to cover both of these embodiments. It should further be understood that "delivery tube" refers to a neural delivery device.

[0036] This embodiment may further include a mounting post 1406, a flanged pusher rod 1408 with a suture loop management cut out 1412, and a secondary flange 1414. FIG. 12A shows a portion of a delivery tube 1400 for insertion into a trocar port (shown in FIG. 20 ) with a nerve cuff 1402 disposed therein with a lead 1404 extending toward the distal end of the delivery tube 1400. The nerve cuff 1402 may be mounted on the mounting post 1406 of the pusher rod 1408. The mounting post 1406 may be a cylindrical portion of the distal end of the pusher rod 1408. The diameter of the mounting post 1406 may be sized to fit the inner diameter of the nerve cuff 1402 with or without a deployment tab rolled into the nerve cuff 1402 (not shown in FIG. 12A or 12B ).

[0037] The delivery tube 1400 can have an inner diameter that is larger than the outer diameter of the nerve cuff 1402 when attached to the mounting post 1406, but smaller than the outer diameter of the flange 1410. The flange 1410 can contact and slide against the inner wall of the delivery tube 1400, which, combined with the sizing of the components, can prevent the silicone of the nerve cuff and its lead 1404 from contacting the inner wall of the delivery tube 1400. This may allow the cuff 1402 to smoothly advance through the inside of the delivery tube 1400 without the arms or other portions of the nerve cuff 1402 becoming tangled or damaged. The flange 1410, together with the mounting post, can function to control the orientation of the cuff 1402 as it is pushed through the delivery tube 1400. It should be noted that the cuff is attached to the end of a pusher rod, with the lead extending toward the distal end of the delivery tube. That is, the lead body is anterior to the majority of the cuff. As shown in some of the figures, the lead body of the cuff is inserted through a trocar port before the delivery tube is introduced with the cuff.

[0038] 14B maintains the cuff on the mounting post 1406 and can allow a surgical tool to pull away a suture loop (not shown) that may have been used to maintain the orientation of the cuff. For example, a suture can be wrapped around a portion of the cuff 1402, passed over the area of ​​the notch 1412, and wrapped around the portion 1418 of the pusher rod 1408 between the notch 1412 and the flange 1414 to hold the cuff in a relatively fixed position until the suture is removed. The mounting post 1406 can protect the electrodes of the cuff 1402, while the flange 1410 and notch 1412 can minimize the cuff 1402 from rubbing against the delivery tube.

[0039] 14B , the secondary flange 1414 can allow the pusher rod 1408 to slide steadily and with low friction against the inner wall of the delivery tube 1400 and can prevent the pusher rod 1408 from tilting in a manner that would allow the cuff to contact the inner wall of the tube 1400. The proximal seal 1416 can close the proximal end of the delivery tube 1400 so that only the distal end is open and can allow the delivery tube to cooperate with the trocar port to keep the abdominal opening tightly sealed. The seal 1416 is fitted around the pusher rod 1408 so that the pusher rod 1408 can move in and out of the delivery tube 1400 without allowing insufflation gas to escape.

[0040] One embodiment of a different delivery mechanism is shown in FIGS. 15A, 15B, 15C, and 15D, which may further be suitable for a range of trocar port sizes and may be compatible with nerve cuffs with or without deployment tabs. This embodiment may include a delivery tube (or pusher tube) 1500 instead of the delivery tube and pusher rod described in the embodiment of FIGS. 14A and 14B. As noted above, this delivery tube / pusher tube relates to a neural delivery device. The delivery tube 1500, shown in perspective in FIG. 15A and also in cross section in FIG. 15A, includes a wall 1502 on the inside of the delivery tube 1500 that can prevent insufflation gas from escaping and can hold a cuff 1504 or other neural interface device at the distal end of the delivery tube (the end furthest from the trocar port after insertion). In some embodiments, the proximal cavity behind the wall 1502 can be solid. The cuff 1504 can be positioned within the delivery tube 1500 with or without a deployment tab, with the lead 1506 extending toward the distal end. Additionally, as described further below and shown in FIG. 16B , a deployment tab, such as deployment tabs 110, 900, 1100, or 1200, can be attached to the cuff and rolled inside the cuff. The inner diameter of the delivery tube 1502 can be adjusted based on the size of the neural interface device that needs to be delivered. The inner diameter of the delivery tube 1502 can be determined based on the neural interface device to be delivered, or more specifically, the outer diameter (or outer width) of the neural interface device to be delivered. To provide and maintain a level of friction with the cuff 1504 that provides a level of retention, the inner diameter of the delivery tube 1502 can be approximately equal to the outer diameter of the neural interface device. In other words, the inner diameter of the opening in the delivery tube provides an interference fit with the neural interface device.

[0041] The delivery tube 1502 includes a delivery tube retention feature in the form of a flange provided at the proximal end that is configured to prevent the delivery tube from passing through the trocar (insertion tube) more than a predetermined amount or from passing completely through the trocar. The presence of this flange prevents the delivery tube 1502 from passing through the trocar beyond the flange.

[0042] Another embodiment similar to that shown in Figures 15A, 15B, 15C, and 15D is shown in Figures 15E and 15F, which may further be suitable for a range of trocar port sizes and may be compatible with neural interfaces with or without deployment tabs. While this embodiment will be referred to below as a neural delivery device, it should be noted that because the neural delivery device is formed with a tubular structure at its distal end (to hold the neural interface device), such a device may also be referred to as a delivery tube. A side cross-sectional view of this embodiment is shown in Figure 26.

[0043] As shown in FIG. 26, the neural delivery device 3000 can include an opening 3001 (otherwise called an open end or hole) at the distal end of the neural delivery device for holding a neural interface device.

[0044] The embodiment of Figures 15E and 15F may include a neural delivery device formed as a solid cylinder (as opposed to the hollow cylinder shown in Figures 14A and 14B). The neural delivery device of Figures 15E and 15F may also be said to have a tubular structure around the neural interface device, while the remainder of the shaft of the neural delivery device is substantially solid.

[0045] The nerve delivery device can be of sufficient length to protrude beyond the end of the insertion tube, allowing the surgeon to manually manipulate / hold the proximal end of the nerve delivery device. Additionally or alternatively, the nerve delivery device can be connected to a separate mechanical structure / plunger arrangement to control the movement of the nerve delivery device.

[0046] FIG. 15E illustrates a neural delivery device formed from stainless steel. The open end can be formed by drilling a hole in a solid steel cylinder to fit the size of the neural interface device to be delivered. To hold the neural interface device in place near the opening until it is withdrawn through the opening for deployment, the inner wall of the open end of the neural delivery device can provide friction using the interference fit discussed above. The neural interface can be withdrawn via the neural interface lead body. Because the neural interface device to be delivered is provided near the opening in the open end, the neural interface device only needs to move a short distance before being released (when pulled). This allows for the neural interface device to avoid tangling while still utilizing friction between the neural interface device (e.g., nerve cuff) and the deployment tube. This configuration ensures that the neural interface device has little or no contact with the trocar or insertion tube during insertion of the neural delivery device into the external insertion tube. In other words, the neural interface device is protected from damage when positioned in the recess of the neural delivery device. This means that the sensitive structures of the neural interface device are protected from mechanical / electrical damage during the insertion process.

[0047] The use of a solid cylinder as the base of the neural delivery device can improve manufacturability. Such a device also avoids the need for additional mechanical structures to prevent the escape of insufflation gas, which may be necessary in some other embodiments. This is because the trocar valve can be used to maintain systemic pressure, and gas cannot escape through the solid body of the cannula.

[0048] While the embodiments of Figures 15E and 15F can be formed from stainless steel, they can instead be formed from a polymeric material. In some embodiments, the polymeric material can be, for example, Delrin. In some embodiments, the delivery tube can be formed by injection molding using a suitable material. Note that such materials and manufacturing methods can also be applied to hollow tube embodiments (e.g., the embodiment shown in Figures 14A and 14B).

[0049] The materials of the neural delivery device (both the solid cylindrical and hollow tube embodiments) should be biocompatible. Additionally, polymeric materials (such as Delrin) are lightweight materials, which can be beneficial in reducing the weight of the device. If further weight reduction is desired, the neural delivery device can further include perforations, holes, or removal of portions of the neural delivery device, as described below.

[0050] The neural delivery device can be fabricated by drilling a recessed hole of the required size into a solid cylinder of biocompatible material.

[0051] The nerve delivery devices of Figures 15E and 15F further include a nerve delivery device retention feature. A hole can be formed in the second end of the delivery tube, oriented perpendicular to the length of the delivery tube. A nerve delivery device retention feature, such as a string or suture, or other thin tool, can be threaded through the hole to prevent the nerve delivery device from passing through the trocar. The string or suture can also be used to remove the nerve delivery device and / or to provide pulling force to aid in removal of the nerve delivery device if necessary.

[0052] Additionally or alternatively, the neural delivery device retention feature can include a proximal cap (not shown) constructed and arranged to prevent accidental release of the delivery tube. This cap or handle can be located near the proximal end of the neural delivery device and can be provided to prevent the neural delivery device from passing through a trocar or to aid in handling the neural delivery device. The string / suture and the proximal cap together can prevent accidental release of the delivery tube into the body, particularly when the length of the neural delivery device is shorter than the length of the trocar. It should also be noted that this proximal cap can be a separate feature from the neural delivery device, or the proximal cap can be integral to the neural delivery device (e.g., flaring, i.e., increasing the diameter of the neural delivery device at the proximal end such that the outer diameter of the neural delivery device at the proximal end is larger than the inner diameter of the insertion tube or trocar).

[0053] In some embodiments, the proximal cap can be formed from a molded plastic material.

[0054] While the above neural delivery device retention features have been described with respect to the neural delivery device of Figures 15E and 15F, it will be apparent that they may also be applied to hollow tube embodiments of the neural delivery device (e.g., the embodiment shown in Figures 14A and 14B).

[0055] FIG. 15B further illustrates how the pusher tube 1500 operates in conjunction with a trocar port 1510, which may include a valve and seal 1512 outside the patient's body and an insertion tube 1514 inside the abdominal cavity. The pusher tube 1500 may be inserted into the insertion tube 1514 through a port opening in the trocar port. The outer diameter of the pusher tube 1500 may be smaller than the inner diameter of the port opening in the trocar port 1510 and the inner diameter of the insertion tube 1514. FIG. 15C illustrates the pusher tube 1500 after it has been fully inserted into the trocar port 1510, and FIG. 15D illustrates the nerve cuff 1504 after it has been withdrawn from the open end of the pusher tube 1500. Again, the pusher tube has a closed proximal end and an open distal end.

[0056] An embodiment of a different design for the delivery tube and pusher rod is shown in Figures 16A, 16B, 16C, 16D, 16E, and 16F. This embodiment may be suitable for custom non-round (or substantially obround) trocar ports and may be compatible with nerve cuffs with or without deployment tabs. However, this particular shape of the delivery tube and pusher rod is exemplary, and they may be shaped differently, such as round or oval. As shown in Figures 16A and 16B, this embodiment may include a pusher rod 1600 having a central post 1602 at its distal end (the end furthest from the trocar port after insertion). The central post 1602 may have a cross-section that matches the shape of the cuff 1604 when the deployment tab 1606 is rolled inside the cuff 1604. While the interior space of the cuff 1604 with the deployment tab 1606 rolled inward can be substantially circular as shown in the end view of FIG. 16B, the shape of the interior space is more likely to be oblong, as in the cross section of the central post 1602 shown in FIG. 16A. The distal end of the pusher rod 1600 can further include one or more tines or posts 1608 that can constrain movement of the cuff 1604. As discussed above with respect to FIGS. 14A and 14B and the mounting post 1406, the size of the central post 1602 can vary depending on the size of the cuff and / or the inclusion or exclusion of a deployment tab.

[0057] When the cuff 1604 is loaded onto the pusher rod 1600, as shown in FIG. 16C, the post 1608 can hold and protect the cuff 1604 when it is pushed into the delivery tube 1610, further shown in FIG. 16D. An O-ring 1612 or similar device can be attached to the distal block 1614, which has outer dimensions designed to form a seal between the O-ring 1612 and the inner wall of the delivery tube 1610, leaving the delivery tube 1610 open at its distal end and sealed at its proximal end. Also shown in FIG. 16C, the cuff 1604 can be positioned on the central post 1602 shown in FIG. 16A with the cuff's lead extending distally.

[0058] Additionally, Figure 16E shows the delivery tube 1610 and pusher rod 1600 of this embodiment as they are inserted into the trocar seal of the trocar port 1620 outside the patient's body and the introducer tube 1622 inside the abdominal cavity. Figure 16F shows the delivery tube 1610 and pusher rod 1600 fully inserted into the trocar port 1620, such that the nerve cuff 1604 has been successfully delivered to the distal end of the introducer tube 1622 where it can be removed for deployment.

[0059] FIG. 17 illustrates an embodiment of a delivery tube or trocar cannula similar to the embodiment shown in FIGS. 15A, 15B, 15C, and 15D that may be suitable for a round trocar port. However, unlike the embodiment shown in FIGS. 15A, 15B, 15C, and 15D, the delivery tube in this embodiment does not have a wall. This embodiment may be compatible with a nerve cuff with or without a deployment tab. This embodiment may comprise a delivery tube (also referred to as a neural delivery device) or cannula 1700. The delivery tube 1700 may be sealed by a cap 1704. The delivery tube 1700 includes a delivery tube retaining member 1706, which is a flange that prevents the delivery tube from passing completely through the trocar. A nerve cuff 1708 may be provided on a portion 1710 of the delivery tube 1700 closer to the proximal end 1712. Locating the neural interface further from the open end allows for a distance between the open end and the neural interface to hold it in place until it is withdrawn from the delivery tube for deployment.

[0060] FIG. 18 illustrates one embodiment of a retention feature that can be utilized in any of the above embodiments, i.e., the delivery tube, deployment tube, or pusher rod with or without a mounting post or central post. In this embodiment, the retention feature can be a substantially double L-shaped or hook-shaped arm 1800 pivotally attached to the distal block 1614 of the pusher rod 1600. FIG. 18 illustrates the arm 1800 in a closed (left) and an open (right) position. The nerve cuff is not shown; however, when a nerve cuff is mounted on the central post 1602, the arm 1800 will cover a portion of the distal end of the cuff, further restraining the cuff. The arm 1800 can be used in place of the tine or post 1608; however, a portion of the distal block 1614 may need to be cut away to accommodate the movement of the arm 1800, as described further below; the tine or post 1608 can still be utilized on the opposite side.

[0061] The arm 1800 may be pivotally attached to the distal block 1614 by a pin 1802 or similar device. When the nerve cuff is still within the delivery tube 1610, the inner wall of the delivery tube 1610 may urge the arm 1800 into a substantially closed position. As the nerve cuff approaches the end of the delivery tube 1610, a second extension 1804 on the other end of the arm 1800 (extending in the opposite direction from the first extension) engages a release feature 1806 extending from the inner wall of the delivery tube 1610, thereby pushing the arm 1800 and allowing it to pivot away from the cuff.

[0062] 19A and 19B show another embodiment of a retaining feature 1900 that can also be pivotally attached to the distal block 1614. Rather than cutting out a portion of the distal block 1614, the retaining feature 1900 can be molded in the open position at the location of the tine or post 1608, as shown in FIG. 19B. The base 1902 of the retaining feature 1900 can be narrowed so that the base is flexible. When the retaining feature 1900 is within the delivery tube 1610, the expanded portion can urge the retaining feature into the closed position. Once the retaining feature 1900 exits the distal end of the delivery tube 1610, the retaining feature will self-pivot to its biased open position when the expanded portion is no longer urged by the delivery tube 1610.

[0063] 21A and 21B are perspective cross-sectional views of different sides of the neural interface retention feature of a trocar cannula or delivery tube, according to one embodiment. The cannula 2100 includes a closed or introducing end 2102 and an open or delivery end 2104. The introducing end 2102 is proximal to the trocar port (not shown) during use, and the delivery end 2104 is distal to the trocar port during use. This relationship is more clearly shown in FIG. 22A, a general cross-sectional view of the trocar cannula 2100, and FIG. 22B, a general external view of the trocar cannula 2100.

[0064] The introduction end 2102 can include two concentric rings, the smaller of which forms a retention feature band 2106 and includes a series of flexible fins 2108. The flexible fins 2108 are triangular or tooth-shaped, with their wider ends attached to the inner wall of the retention feature band 2106 and their narrower ends extending toward the center of the retention feature band 2106. The narrower ends of the flexible fins 2108 do not abut each other, thus leaving a circular opening in the center of the retention feature band 2106. The flexible fins 2108 are evenly spaced around the inner wall of the retention feature band 2106, except for between the two flexible fins, where a larger space is created to allow a neural interface lead to pass through. The flexible fins 2108 are configured to hold the neural interface in a stable, centered position before it is pulled (by the neural interface lead body) along the cannula 2100 toward the delivery end 2104. The retention feature can be configured to help hold the neural interface in an aligned position when inserted into the delivery tube and moved along the delivery tube towards the opening, and to reduce contact between the neural interface and the inner surface of the delivery tube.

[0065] The introducing end 2102 of the cannula 2100 can further include a flange 2110 configured to prevent the cannula from slipping completely through the trocar port during use. The introducing end 2102 of the cannula can have a larger radius than the delivery end 2104 and can taper from this larger radius to a smaller radius near the location of the flange 2110. The tapered area 2112 can include a flat seat 2114 onto which the retention feature collar 2106 can be placed and held in place.

[0066] Figures 23A and 23B show perspective and end views, respectively, of the proximal end of the trocar cannula of Figure 21A, better illustrating the placement of the flexible fins 2108. As best shown in Figure 23B, the six fins can be spaced approximately equally apart, except for two fins that have a wider gap 2112 between them to accommodate a neural interface lead.

[0067] 24A and 24B include two different perspective cross-sectional views near the introducing end of the trocar cannula described above in FIGS. 21A-23B, further including a guide member 2400. The guide member 2400 may be an additional concentric ring or band that fits snugly within the introducing end 2102 of the cannula, and may be configured to further reduce the radius of the introducing end so that the neural interface is tightly guided up to and through the flexible fins 2108.

[0068] An additional embodiment of a retention feature 2500 is shown in FIG. 25A, which shows a perspective view of the neural interface retention feature. An end view of the retention feature 2500 is shown in FIG. 25B. The retention feature 2500 can be a concentric ring that fits snugly within the introducing end 2102 of the cannula, but can include only two flexible fins 2502 versus the six flexible fins 2108. The two fins 2502 can be separated by a gap at the narrow end 2504 of the fins near the center of the introducing end, which widens toward the inner wall to form a rectangular area 2406. This rectangular area can be configured to accommodate a neural interface lead.

[0069] Illustrative Embodiments The following list of embodiments also forms part of this disclosure:

[0070] Embodiment 1: A deployment tab for deploying a neural interface device, the deployment tab comprising: a first area configured to be positioned near a neural interface; and a connector secured to the first area for releasably coupling the first area to the neural interface.

[0071] Embodiment 2: The deployment tab of embodiment 1, wherein the deployment tab comprises a flat shape.

[0072] Embodiment 3: The deployment tab of embodiment 1 or 2, wherein the deployment tab at least partially comprises a triangular shape.

[0073] Embodiment 4: The deployment tab of any of the preceding embodiments, further comprising a second area and a central area between the first and second areas.

[0074] Embodiment 5: The deployment tab of embodiment 4, wherein the first area is wider than the second area.

[0075] Embodiment 6: The deployment tab of any of the previous embodiments, wherein the slit in the deployment tab releases at least a portion of the connector to allow the first area to move away from the neural interface device.

[0076] Embodiment 7: The deployment tab of any one of embodiments 4 to 6, further comprising at least one passage extending from the first area through the central area to the second area, each passage including a first opening in the first area and a second opening in the second area.

[0077] Embodiment 8: The deployment tab of embodiment 7, wherein the connector is a suture secured to the first area that passes through at least one passage from the second opening to the first opening and holds the first area close to the implantable device.

[0078] Embodiment 9: The deployment tab of embodiment 7 or 8, comprising a cuttable portion extending across at least one passageway and configured to release at least a portion of the connector in the at least one passageway when the cuttable portion is cut open, wherein the release of at least a portion of the suture allows the first area to move away from the implantable device.

[0079] Embodiment 10: The deployment tab of any one of embodiments 7 to 9, wherein the connector includes a first portion that passes through at least one passage from the second opening to the first opening, the connector includes a second portion that is removably attached to the implantable device, and the connector includes a third portion that passes through at least one passage from the first opening to the second opening, the first portion being connected to the second portion and the second portion being connected to the third portion.

[0080] Embodiment 11: The deployment tab of any one of embodiments 7 to 10, wherein the at least one passage includes a first passage and a second passage, the first portion passing through the first passage, and the third portion passing through the second passage.

[0081] Embodiment 12: The deployment tab of any one of embodiments 4 to 11, wherein at least the first area and the second area include rounded edges.

[0082] Embodiment 13: The deployment tab of any one of embodiments 9 to 12, wherein the severable portion is a sunken area of ​​the central area that extends across at least the first passageway and the second passageway.

[0083] Embodiment 14: The deployment tab of embodiment 13, wherein the sunken area of ​​the central area extends across only a portion of the width of the central area so that at least a portion of the central area is not cut into two pieces when the sunken area is cut open to release the connector.

[0084] Embodiment 15: The deployment tab of embodiment 13, wherein the sunken area extends across the entire width of the central area so that when the sunken area is cut open to release the connector, the central area is cut into two pieces.

[0085] Embodiment 16: The deployment tab of any one of embodiments 4 to 15, wherein at least the central area includes a series of alternating lateral ridges and lateral valleys extending across the width of the central area to provide vertical flexibility that allows the deployment tab to be rolled up, while providing lateral rigidity when the deployment tab is unfolded.

[0086] Embodiment 17: The deployment tab of any one of embodiments 4 to 16, wherein the first area and the second area include alternating lateral ridges and lateral valleys extending across the width of the first area and the width of the second area.

[0087] Embodiment 18: The deployment tab of embodiment 16 or 17, wherein at least one passageway is formed by a tunnel through each lateral ridge and a tube across each lateral valley.

[0088] Embodiment 19: The deployment tab of any one of embodiments 9 to 18, wherein the severable portion is a lateral valley.

[0089] Embodiment 20: The deployment tab of any of the preceding embodiments, wherein the connector is secured to the first area by being molded into the first area.

[0090] Embodiment 21: The deployment tab of any of the preceding embodiments, wherein the connector is secured to the first area by adhesive.

[0091] Embodiment 22: The deployment tab of any one of embodiments 4 to 21, wherein the first area, the second area, and the central area are molded from silicone.

[0092] Embodiment 23: The deployment tab of any one of embodiments 7 to 22, wherein at least the second area is tapered toward the second opening.

[0093] Embodiment 24: The deployment tab of embodiment 23, wherein the tapered second area includes a gripping point for manipulation.

[0094] Embodiment 25: The deployment tab of embodiment 24, wherein the gripping point comprises an opening.

[0095] Embodiment 26: The deployment tab of any of the preceding embodiments, wherein the tab includes a first surface and a second surface opposite the first surface, the first surface providing an indication of the location of the severable portion, and the second surface including a plurality of longitudinal grooves along the length of the deployment tab to reduce contact.

[0096] Embodiment 27: The deployment tab of embodiment 26, wherein at least the second area and the central area are tapered, a first portion of the plurality of longitudinal grooves extends from the first area through the central area to the second area, and a second portion of the plurality of longitudinal grooves extends from the first area to the central area.

[0097] Embodiment 28: The deployment tab of any one of embodiments 4 to 27, wherein the thickness of the second area tapers from the edge of the second area toward the central area.

[0098] Embodiment 29: The deployment tab of embodiment 28, wherein the thickness increases from the edge of the second area toward the central area.

[0099] Embodiment 30: The deployment tab of any one of embodiments 4 to 27, wherein the second area has a rounded edge.

[0100] Embodiment 31: A system comprising a deployment tab according to any preceding claim and a neural interface comprising a cuff portion for placement at least partially around a target.

[0101] Embodiment 32: The system of embodiment 31, wherein the opening portion of the neural interface is configured to be removably coupled to the deployment tab.

[0102] Embodiment 33: A system of embodiment 31 or 32, wherein the cuff portion comprises a spine and at least two curved arms extending from the spine and carrying electrodes, each open end of the curved arms being removably coupled to a deployment tab.

[0103] Embodiment 34: The system of any one of embodiments 31 to 33, wherein the cuff portion has a first arm for moving in a first direction and one or more second arms for moving in a second direction substantially opposite to the first direction, and the second portion of the connector is removably attached to the one or more second arms.

[0104] Embodiment 35: The system of embodiment 34, wherein the one or more second arms include two arms arranged opposite the first arm, one of the two arms being aligned with the first opening of the first passage, and the other of the two arms being aligned with the first opening of the second passage.

[0105] Embodiment 36: A system according to any one of embodiments 31 to 35, wherein one or more second arms include a first eyelet and the other arm includes a second eyelet, and the second part of the connector is removably attached to the cuff by passing through the first eyelet and the second eyelet so as to hold the first area close to the cuff until at least one of the first part or the third part is cut open with a cuttable portion to allow the second part of the connector to be pulled away from the cuff.

[0106] Embodiment 37: The system of any one of embodiments 31 to 35, wherein the thickness of the central area of ​​the tab is equal to or thicker than the thickness of the neural interface.

[0107] Embodiment 38: A system according to any one of embodiments 34 to 37, wherein one or more second arms have an arm height in a direction perpendicular to both the width and length of the tab, and the central area has a height running substantially parallel to the arm height, and the height of the central area is greater than the arm height.

[0108] Embodiment 39: The system of any one of embodiments 31 to 35, wherein the width of the first area of ​​the tab is equal to or wider than the width of the neural interface.

[0109] Embodiment 40: The system of any one of embodiments 34 to 39, wherein the cuff has a width measured from the outer side of one arm to the outer side of the other arm, running substantially parallel to the width of the first area, and the width of the first area is wider than the width of the cuff.

[0110] Embodiment 41: The system of any one of embodiments 31 to 40, wherein the deployment tab is configurable as a measurement tool to measure the fit of the neural interface to the target.

[0111] Embodiment 42: The system of any one of embodiments 41, wherein the fit measurement is determined based on the distance between the ridges or grooves or valleys of the deployment tabs.

[0112] Embodiment 43: The system of embodiment 41 or 42, wherein the fit measurement is determined based on the distance between the first portion of the deployment tab and the second portion of the deployment tab.

[0113] Thus, a deployment tab for a nerve cuff can have a thickness and / or width slightly greater than the thickness and / or width of the nerve cuff. The deployment tab can include a fixed suture threaded through the deployment tab and removably attached to the nerve cuff. The deployment tool can be completely separated from the nerve cuff by slicing open at least a portion of the deployment tab. The deployment tab can include a series of transverse (or lateral, along the width of the deployment tab) ridges and valleys on one side, which can serve as a slicing guide and allow the deployment tab to be rolled to a smaller size for delivery. The deployment tab can include a series of longitudinal ridges and valleys on the opposite side, which can serve to minimize contact surface area (including when the deployment tab is rolled up). The deployment tab can include a tapered proximal end and can be configured to operate as both an instrument (e.g., a go / no-go gauge) to confirm that the incision opening is large enough for the cuff and as a blunt dissection tool. In other words, the deployment tab can be configured to provide reproducible blunt dissection around a target, such as a neurovascular bundle. This blunt dissection can be non-damaging to the nerve bundle. For example, at least one of a variety of different shapes (substantially triangular or tapered / variable width), rounded edges or corners, and / or a tapered thickness of the deployment tab can aid in the deployment tab's function as a blunt dissection tool. If the thickness and / or width of the deployment tab does not fit into the incision, a slightly smaller nerve cuff may also not fit. An anchored suture is positioned within the deployment tab such that when at least a portion of the deployment tab is cut open, the suture is severed, thereby releasing the deployment tab from the previously attached portion of the nerve cuff.

[0114] Additionally, the deployment tabs can be configured to maintain the arms of the removably attached neural interface parallel, particularly during deployment. Furthermore, the deployment tabs are removably connected to the neural interface at at least two locations (e.g., near the first opening of the first passageway in the first area of ​​the deployment tab and near the first opening of the second passageway in the first area of ​​the deployment tab, with the connector configured to pass through these passageways). Thus, the deployment tabs can prevent the arms of the removably attached neural interface from crossing when they are threaded under the neurovascular bundle during deployment. In other words, the deployment tabs can be configured to maintain the portions of the neural interface coupled to the first area parallel to the edges of the first area. The deployment tabs can be configured to maintain the portions of the neural interface coupled to the first area at a predetermined distance from each other. This predetermined distance can be at least a portion of the width of the first area of ​​the deployment tab. This predetermined distance can be the distance between the first opening of the first passageway and the first opening of the second passageway.

[0115] The deployment tab can have a thickness and width slightly greater than the thickness and length of the nerve cuff. The deployment tab includes a fixed suture threaded through the deployment tab and removably attached to the nerve cuff in a manner that allows the deployment tool to be completely separated from the nerve cuff by cutting open a portion of the deployment tab. The deployment tab can include a tapered proximal end and can be configured to operate as a go / no-go gauge. If the thickness and width of the deployment tab do not fit into the incision, a slightly smaller nerve cuff may also not fit. The fixed suture is positioned within the deployment tab such that when the deployment tab is cut open, the suture is cut, thereby releasing the deployment tab from the previously attached portion of the nerve cuff.

[0116] The following list of embodiments also forms part of this disclosure:

[0117] Embodiment 1: A tool or system for delivering a neural interface device into the abdominal cavity for implantation in a patient, comprising: an insertion tube for insertion through the abdominal cavity, the insertion tube having a sealed port and an open end that is positioned within the abdominal cavity when inserted; and a delivery tube for insertion through the sealed port of the insertion tube, the delivery tube comprising an opening at a first end for the neural interface device.

[0118] Embodiment 2: The tool or system of embodiment 1, wherein the delivery tube includes a holder near the opening at the open end for holding the neural interface device in position at the opening of the delivery tube.

[0119] Embodiment 3: The tool or system of embodiment 1 or 2, wherein the delivery tube includes a transverse wall disposed near the open end of the delivery tube, and the holder is attached to this wall.

[0120] Embodiment 4: The tool or system of embodiment 1, further comprising a pusher rod having a first end for insertion into the sealable end of the delivery tube and a second end for extending from the sealable end of the delivery tube, the first end including a holder for holding the neural interface device in said position.

[0121] Embodiment 5: The tool or system of embodiment 4, wherein the pusher rod includes a first flange immediately below the holder and a second flange positioned a distance from the first flange along the length of the pusher rod, and the first flange and the second flange touch and slide along the inner surface to reduce contact between the neural interface device and the inner surface of the delivery tube.

[0122] Embodiment 6: The tool or system of embodiment 5, wherein the second flange is configured to seal against the delivery tube.

[0123] Embodiment 7: The tool or system of embodiment 5 or 6, wherein the distance is sufficient to prevent the pusher rod from tilting while moving the delivery rod from the sealable end to the open end of the delivery tube.

[0124] Embodiment 8: The tool or system of any of embodiments 5 to 7, wherein the first flange includes a cutout for accessing a suture connected to the neural interface device.

[0125] Embodiment 9: The tool or system of any of embodiments 5 to 8, wherein the holder includes a mounting post and the neural interface device is configured to be positioned around the mounting post.

[0126] Embodiment 10: The tool or system of embodiment 9, wherein the neural interface device has a central opening that allows the neural interface to be placed around a target, and the neural interface device is attached to a deployment tab that is rolled within the first central opening while the neural interface device is in the delivery tube, and the rolled deployment tab is configured to be positioned around the mounting post.

[0127] Embodiment 11: The tool or system of embodiment 9 or 10, wherein the mounting post is shaped to fit the shape of the neural interface device.

[0128] Embodiment 12: The tool or system of any of embodiments 9 to 11, wherein the mounting post is a central post and the holder further comprises at least one side post positioned outside the neural interface device, the at least one side post for holding the neural interface device while held on the mounting post.

[0129] Embodiment 13: The tool or system of embodiment 13, wherein at least one side post is retractable and includes a release mechanism actuated by disengagement from the delivery tube.

[0130] Embodiment 14: The tool or system of embodiment 12 or 13, wherein the delivery tube includes a portion extending from an inner surface near the open end of the delivery tube, wherein at least one side post is retractable, and wherein the portion engages with and retracts the at least one side post when the first end of the pusher rod exits the open end of the delivery tube.

[0131] Embodiment 15: The tool or system of any of embodiments 4 to 14, wherein the pusher rod includes a block disposed near the first end, the block including one or more O-rings for sealing the delivery tube.

[0132] Embodiment 16: The tool or system of any of embodiments 4 to 15, wherein the delivery tube and pusher rod have a circular cross section.

[0133] Embodiment 17: The tool or system of any of embodiments 4 to 16, wherein the delivery tube and pusher rod have a non-circular cross section.

[0134] Embodiment 18: The tool or system of embodiment 17, wherein the non-circular cross section is one of an obround, an ellipse, a square, a rectangle, and a polygon.

[0135] Embodiment 19: The tool or system of any of the preceding embodiments, wherein the sealable end of the delivery tube includes a retention feature.

[0136] Embodiment 20: The tool or system of embodiment 19, wherein the retention feature comprises a band ring disposed within the delivery tube, the band ring comprising a plurality of flexible fins extending from an inner wall of the band ring, the plurality of flexible fins configured to maintain alignment of the neural interface device when inserted into the delivery tube.

[0137] Embodiment 21: The tool or system of embodiment 20, wherein each of the plurality of flexible fins is triangular or tooth-shaped, with a wider end attached to the inner wall of the band ring and a narrower end extending toward the center of the band ring.

[0138] Embodiment 22: The tool or system of embodiment 21, wherein the flexible fins are equally spaced around the inner wall of the annulus except between two of the flexible fins, where a larger space allows the lead of a neural interface device to pass through.

[0139] Embodiment 23: The tool or system of any of embodiments 19 to 22, wherein the sealable end of the delivery tube further comprises a guide member configured to reduce the inner diameter of the delivery tube before the neural interface device passes through the retention feature.

[0140] Embodiment 24: The tool or system of any of the preceding embodiments, wherein the delivery tube is formed of stainless steel.

[0141] Embodiment 25: The tool or system of any of the preceding embodiments, wherein the opening at the first end of the delivery tube is a hole formed in the solid delivery tube, the axis of the hole coinciding with the axis of the solid delivery tube.

[0142] Embodiment 26: The tool or system of any of the preceding embodiments, wherein the delivery tube comprises a delivery tube retention feature configured to prevent the delivery tube from passing through the insertion tube more than a predetermined amount.

[0143] Embodiment 27: The tool or system of any of the preceding embodiments, wherein the delivery tube has a second end, at the second end having a hole extending through the delivery tube in a direction perpendicular to the length of the delivery tube.

[0144] Embodiment 28: The tool or system of any one of embodiments 2 to 27, wherein the holder is provided by friction between the inner surface of the opening of the delivery tube and the neural interface device.

[0145] Embodiment 29: The tool or system of any one of embodiments 2 to 28, wherein the holder is provided as an interference fit with the neural interface device to be delivered.

[0146] The delivery tool can include a tube having an open distal end and a sealed proximal end, the tube configured for insertion into the sealed port (or sealable port) of the trocar port and the introducer tube. The delivery tool can further include a retention mechanism disposed within the tube for retaining the neural interface, the neural interface's leads extending toward the distal end of the tube, and the neural interface mounted on or in a holder with an outer diameter smaller than the inner diameter of the tube. The retention mechanism can hold the neural interface to maintain alignment within the tube to manage and / or prevent excessive friction and / or premature release. In one embodiment, the retention mechanism can be located at the end of the delivery tool. In another embodiment, the retention mechanism can be configured to move the neural interface from an end of the tube proximal to the operator to an end of the tube distal from which the neural interface can be removed for deployment around one or more nerves.

[0147] Although embodiments of the present disclosure have been shown and described with respect to various embodiments, the embodiments of the present disclosure are not limited to the specific descriptions contained herein. Additional alternative or equivalent components and elements can readily be used to practice the present disclosure.

Claims

1. a deployment tab for deploying the neural interface device, a first area or portion configured to be positioned proximate the neural interface device in use; a connector for releasably coupling the first area or portion to the neural interface device, the connector being fixed to the first area or portion; Equipped with 1. A deployment tab comprising: a first surface that is a top surface; and a second surface that is a bottom surface opposite the first surface, the first surface providing an indication of the location of a cuttable or breakable portion; and the second surface including a plurality of longitudinal grooves along the length of the deployment tab to reduce contact.

2. The deployment tab of claim 1 , wherein the deployment tab at least partially comprises or consists of a flattened shape.

3. 3. The deployment tab of claim 2, wherein the deployment tab at least partially comprises or consists of a triangular, tapered and / or trapezoidal shape.

4. a second area or portion configured to be positioned more proximally than the first area or portion in use; a central area or portion between the first area and the second area; The deployment tab of any one of claims 1 to 3, further comprising:

5. The deployment tab of claim 4 , wherein the first area or portion is wider than the second area or portion.

6. 6. The deployment tab of claim 4 or 5, wherein the deployment tab is configured such that, in use, when the deployment tab is cut, at least a portion of the connector is released from coupling with the first area or portion to allow the first area or portion to be moved away from the neural interface device.

7. 7. The deployment tab of claim 4, further comprising at least one passageway extending from the first area or portion through the central area or portion to the second area or portion, each passageway including a first opening in the first area or portion and a second opening in the second area or portion.

8. 8. The deployment tab of claim 7, wherein the connector includes a first portion that passes through the at least one passageway from the second opening to the first opening, the connector includes a second portion that is removably attached to the neural interface device, and the connector includes a third portion that passes through the at least one passageway from the first opening to the second opening, the first portion connected to the second portion and the second portion connected to the third portion.

9. 9. The deployment tab of claim 8, wherein the at least one passageway includes a first passageway and a second passageway, the first portion passing through the first passageway and the third portion passing through the second passageway.

10. 10. The deployment tab of claim 7, wherein the connector is a suture that passes through the at least one passageway from the second opening to the first opening, and the suture is anchored to the first area or portion near the neural interface device to hold the first area or portion.

11. 11. The deployment tab of claim 7, comprising a severable or breakable portion extending across the at least one passageway, the severable or breakable portion configured, when cut open, to separate a portion of the connector in the at least one passageway proximal to the severable portion from another portion of the connector distal to the severable portion, wherein the separation of the portions of the connector allows the deployment tab to separate from the neural interface device.

12. The deployment tab of claim 4 , wherein at least the first area or portion and the second area or portion include rounded edges.

13. 12. A deployment tab according to claim 9 or any one of claims 10 or 11 which cite claim 9, wherein the cuttable or breakable portion is a sunken area of ​​the central area or portion that extends transversely across the length of the deployment tab across at least the first passage and the second passage.

14. 14. The deployment tab of claim 13, wherein the sunken area of ​​the central area or portion extends across only a portion of the width of the central area or portion such that at least a portion of the central area or portion is not cut into two pieces when the sunken area is slit open to release the connector, or the sunken area of ​​the central area or portion extends across the entire width of the central area or portion such that at least a portion of the central area or portion is cut into two pieces when the sunken area is slit open to release the connector.

15. 15. The deployment tab of claim 4, wherein at least the central area or portion includes a series of alternating lateral ridges and lateral valleys extending across the width of the central area or portion, the lateral ridges and lateral valleys configured to provide lateral stiffness when the deployment tab is unfolded and longitudinal flexibility for rolling up the deployment tab.

16. 16. The deployment tab of claim 15, wherein the first area or portion and the second area or portion include the alternating lateral ridges and lateral valleys extending across a width of the first area or portion and a width of the second area or portion.

17. 17. A deployment tab according to claim 15 or 16, when dependent on claim 7, wherein the at least one passageway is formed by a tunnel through each transverse ridge and a tube across each transverse valley.

18. 18. The deployment tab of any one of claims 15 to 17, wherein the cuttable or frangible portion is a lateral valley.

19. The deployment tab of any one of claims 1 to 18, wherein the connector is molded into the first area, portion, or secured to the first area or portion by adhesive.

20. The deployment tab of claim 4 , wherein the first area or portion, the second area or portion, and the central area or portion are molded from silicone.

21. A deployment tab according to claim 7 or any one of claims 8 to 19 which cites claim 7, wherein at least the second area or portion is tapered proximally in the direction of the second opening.

22. 22. The deployment tab of claim 21, wherein the tapered second area or portion includes a gripping point for manipulation.

23. The deployment tab of claim 22 , wherein the gripping point comprises an aperture.

24. 5. The deployment tab of claim 4, wherein at least the second area or portion and the central area or portion are tapered, a first portion or portions of the plurality of longitudinal grooves extending from the first area or portion through the central area to the second area or portion, and a second portion of the plurality of longitudinal grooves extending from the first area or portion to the central area or portion.

25. The deployment tab of claim 4 , wherein the thickness of the second area or portion tapers from a proximal edge of the second area toward the central area or portion.

26. 26. The deployment tab of claim 25, wherein the thickness increases from the proximal edge of the second area or portion toward the central area or portion.

27. A deployment tab according to any one of claims 1 to 26; a neural interface device comprising a cuff portion for placement at least partially around a target; A system comprising:

28. 28. The system of claim 27, comprising the deployment tab of any one of claims 4-18 or 20-26, wherein an open portion of the neural interface device is configured to be removably coupled to the deployment tab, and wherein a thickness of the central area or portion of the deployment tab is equal to or greater than a thickness of the neural interface device.

29. 29. The system of claim 28, wherein a thickness of the neural interface device is defined by a height of one or more second arms in a direction perpendicular to the width and length of the deployment tab, the thickness of the central area or portion of the deployment tab is defined by a height oriented substantially parallel to the height of one or more of the second arms, and the height of the central area or portion of the deployment tab is greater than the height of one or more of the second arms.

30. 30. The system of any one of claims 27 to 29, wherein the width of the first area or portion of the deployment tab is equal to or wider than the width of the neural interface device.

31. 31. The system of any one of claims 27 to 30, wherein the deployment tab is configurable as a measurement tool to measure the fit of the neural interface device to a target.

32. 32. The system of claim 31, comprising the deployment tab of any one of claims 15 to 18 or claims 19 or 21 to 23 that cite claims 15 to 18, wherein the distance between the lateral ridges, longitudinal grooves or lateral valleys of the deployment tab is set to a predetermined distance so as to act as a measurement tool.

33. 32. The system of claim 31, wherein the distance between the first portion of the deployment tab and the second portion of the deployment tab is set to a predetermined distance to act as a measurement tool.

34. The deployment tab of any one of claims 1 to 26, wherein the deployment tab comprises a cuff portion.

35. The deployment tabs are configured to hold a portion of the neural interface device relative to the first area or portion in an orientation parallel to the distal end of the first area or portion. The deployment tab of any one of claims 1 to 26 or 34 configured to function as a blunt dissection tool.

36. The deployment tab of any one of claims 1-26 or 34-35, wherein the deployment tab is configured to function as a blunt dissection tool.

37. 37. The deployment tab of any one of claims 1-14 or 34-36, wherein the deployment tab is configured to maintain portions of the neural interface device facing the first area or portion at a predetermined distance from each other.

38. 38. The deployment tab of claim 37, wherein the predetermined distance is at least a portion of the width of the first area or portion of the deployment tab.

39. 38. The deployment tab of claim 37, wherein the predetermined distance is the distance between the first opening of the first passageway and the first opening of the second passageway.

40. The system of any one of claims 27 to 34, wherein the deployment tab is at least partially rolled into the neural interface device.

Citation Information

Patent Citations

  • Electrode part and electrode system

    JP2011152204A

  • Pinch to open the cuff electrode

    JP2015528385A

  • Stimulation cuffs and implantable devices

    JP2016501686A

  • System, Method and Tool for Implanting Peripheral Nerve Electrode Cuff

    US20170266436A1

  • Electrode devices for neurostimulation

    WO2019020985A1