Systems and methods for laparoscopic delivery and deployment of neural interfaces

Abstract

A nerve delivery device (1500) for delivering a nerve interface device (1504) into an abdominal cavity for implantation into a patient, wherein the nerve delivery device is configured to be inserted through a sealed port of an insertion tube, and wherein the nerve delivery device includes an opening for the nerve interface device at a distal end of the nerve delivery device.

Description

[0001] Brief description

[0002] This invention relates to a delivery tool for electrodes used in neuromodulation. The delivery tool may include a neural delivery device or tube having an open distal end and a sealed proximal end, the tube being configured to be inserted into a sealed port (in other words, a sealable port) and introduced into a cannula port. It should also be understood that the neural delivery device may be referred to as a neural interface delivery device or an electrode delivery device.

[0003] The delivery tool may also include a retaining mechanism positioned within the neural delivery device for retaining the neural interface such that the guide of the neural interface extends toward the distal end of the tube, and the outer diameter of the neural interface is mounted on or within a retainer that is smaller than the inner diameter of the tube. The retaining mechanism can hold the neural interface, thus maintaining alignment within the tube to manage and / or prevent excessive friction and / or premature release. In one embodiment, the retaining mechanism may be positioned at the end of the delivery tool. In another embodiment, the retaining mechanism may be configured to move the neural interface from the end of the tube proximal to the operator to the end of the tube distal to the operator, from which the neural interface can be removed for deployment around one or more nerves. Background Technology

[0004] Neural interfaces (or neural interface devices), such as clamp devices, include electrodes. Various challenges can arise when delivering and deploying neural interface devices, especially when these steps are performed laparoscopically.

[0005] For example, during deployment, it may be necessary to trim or remove sutures attached to the neural interface for deployment. During such trimming or removal, the target tissue or anatomical structures in or near the target tissue may be at risk of damage. Residual portions of the sutures left after trimming may also cause histological damage.

[0006] As another example, silicone-molded neural clamps may rub against the sides of deployment tubes (such as cannulas) and become stuck. The resulting friction can cause difficulty in advancement, and at least some parts of the neural interface (e.g., the arm) may become tangled, posing a risk of damaging the electrodes.

[0007] The inventors have devised various solutions for delivering and deploying neural interface devices while minimizing any electrode damage during such delivery and deployment. Attached Figure Description

[0008] Figure 1 This is a perspective view of a deployment protrusion for a nerve clamp according to one embodiment.

[0009] Figure 2 According to one embodiment Figure 1 A perspective view of the deployment protrusion, which is sutured to the nerve band and positioned to be deployed around the target.

[0010] Figure 3 According to one embodiment Figure 1 A perspective view of the deployment protrusion being used to pull open the nerve clamp and being pulled below the target.

[0011] Figure 4 According to one embodiment Figure 1 The remote view of the deployment protrusion.

[0012] Figure 5 According to one embodiment Figure 1 A perspective view of a neural band deployed around a target before the release of the deployment protrusion.

[0013] Figure 6 According to one embodiment Figure 1 A perspective view of the deployment protrusion, which has been cut to release the suture thread.

[0014] Figure 7 According to one embodiment Figure 1 A perspective view of the deployed protrusion, which is being pulled away from the nerve clamp.

[0015] Figure 8 This is a perspective view of a fully deployed neural bandage according to one embodiment.

[0016] Figure 9 This is a perspective view of one embodiment of a deployed protrusion having a series of lateral ridges and valleys.

[0017] Figure 10 yes Figure 9 The proximal view of the deployment protrusion.

[0018] Figure 11 According to one embodiment Figure 9 A perspective view of the deployment protrusion, which is sutured to the nerve band.

[0019] Figure 12A It is a perspective view of the ridges and valleys where the protuberances are deployed, showing the suture channel below and the more tapering proximal end.

[0020] Figure 12B yes Figure 12A A perspective solid view of the deployment protrusion.

[0021] Figure 12C yes Figure 12A Side view of the deployment protrusion.

[0022] Figure 13A It is a perspective view of the deployment of protrusions with longitudinal ridges and valleys on one side.

[0023] Figure 13B-1 , 13B-2 13B-3 is a perspective view of the deployment of the protrusion.

[0024] Figure 13C-1 , 13C-2 Figure 13C-3 is a perspective view of the deployment protrusion, in which the deployment protrusion is used as a measuring tool.

[0025] Figure 13C-4 It is a top view of the deployment tools and the corresponding dimension table.

[0026] Figure 13D These are top and bottom views of the deployment according to one embodiment, and a perspective view of the same deployment protrusion stitched to the nerve band.

[0027] Figure 14A This is a perspective view of a delivery tool for a neural interface according to one embodiment.

[0028] Figure 14B According to one embodiment Figure 14A A magnified perspective view of the delivery tool.

[0029] Figure 15A This is a perspective and cross-sectional view of a delivery tool according to one embodiment.

[0030] Figure 15B According to one embodiment Figure 15A A perspective view of the delivery tool, which is partially inserted into the cannula port.

[0031] Figure 15C According to one embodiment Figure 15A A perspective view of the delivery tool, which is fully inserted into the cannula port.

[0032] Figure 15D From Figure 15A A perspective view of the delivery tool removing the nerve bandage.

[0033] Figure 15E These are two perspective views of a delivery tool according to one embodiment.

[0034] Figure 15F yes Figure 15E Side view and cross-sectional view of the delivery tool.

[0035] Figure 16A This is a perspective view of a push rod according to one embodiment, with an enlarged view of the far end.

[0036] Figure 16BThis is a perspective view and a cross-sectional distal view of a nerve band and a deployment protrusion attached to and rolled up within the nerve band, according to one embodiment.

[0037] Figure 16C This is a perspective view of a push rod according to one embodiment, with a nerve clamp mounted at the distal end.

[0038] Figure 16D This is a perspective view of a push rod inserted into a delivery tube according to one embodiment.

[0039] Figure 16E This is a perspective view of a push rod and delivery tube partially inserted into the cannula port and the inlet tube according to one embodiment.

[0040] Figure 16F This is a perspective view of a push rod and delivery tube fully inserted into the cannula port and the inlet tube according to one embodiment.

[0041] Figure 17 This is a perspective view of a delivery tube according to one embodiment.

[0042] Figure 18 This is a side view of a delivery tool with a holding tool according to one embodiment.

[0043] Figure 19A This is a side view of a delivery tool with a retaining tool in the unreleased position, according to one embodiment.

[0044] Figure 19B This is a side view of a delivery tool with a holding tool in the release position, according to one embodiment.

[0045] Figure 20 It is a series of proximal and side views of three different cannula ports.

[0046] Figure 21A This is a perspective cross-sectional view of half of the neural interface retention feature of a trocar cannula according to one embodiment.

[0047] Figure 21B yes Figure 21A A perspective cross-sectional view of the other half of the neural interface that retains its characteristics.

[0048] Figure 22A yes Figure 21A A side view cross-sectional view of the entire cannula needle.

[0049] Figure 22B yes Figure 22A A side view of the cannula.

[0050] Figure 23A yes Figure 21A A perspective view of the proximal end of the cannula.

[0051] Figure 23B yes Figure 23A End view of the proximal end of the cannula.

[0052] Figure 24A It is a perspective cross-sectional view of the proximal end of the cannula, including retaining features and guiding members.

[0053] Figure 24B yes Figure 24A A perspective cross-sectional view of the proximal end of the cannula.

[0054] Figure 25A This is a perspective view of the neural interface preservation features according to one embodiment.

[0055] Figure 25B yes Figure 25A The end view that retains the characteristics.

[0056] Figure 26 This is a side cross-sectional view of a neural delivery device according to one embodiment.

[0057] Figure 27 This is a side cross-sectional view of a neural delivery device according to one embodiment, the neural delivery device having a proximal aperture.

[0058] Figure 28 This is a side cross-sectional view of a neural delivery device according to one embodiment, the neural delivery device having perforations along the length of the device. Detailed Implementation

[0059] This disclosure relates to embodiments of extravascular neural interface devices comprising electrodes for neural modulation of targets such as neurovascular bundles or nerves. In one embodiment, for example, a neural cuff comprises three arms open at both ends, each arm being shaped as an open-ended loop (referred to herein as a "neural cuff" or "clamp"). Figure 1 An embodiment of this clamp 100 is shown. The open ends of the two outer arms 102 and 104 may be opposite to the open end of the intermediate arm 106. In other words, the two outer arms 102 and 104 extend (or bend) in a direction opposite to the direction in which the intermediate arm 106 extends (or bends). Electrodes may be positioned in the two outer arms 102, 104, but may also be positioned in the intermediate arm 106. The molding material of the clamp and arms is typically silicone, surrounding all electrodes except for the exposed surfaces where the electrodes will contact the target tissue. The exact nature of the electrodes is not relevant to this disclosure and is therefore not shown, but the electrodes may be flexibly attached within the arms such that each arm can be planarized without damaging the precision electrodes or any connections within the arms or between the electrodes and the guide body 108.

[0060] Furthermore, while a neural ferrule comprising three arms with open ends has been discussed as an example, the deployment protuberance or delivery tool described herein can be used to deploy or deliver other types of neural interfaces with different shapes or arrangements. For example, the deployment protuberance or delivery tool can be used in cases where the neural ferrule comprises only one arm with open ends, two arms with open ends, or more than three arms with open ends.

[0061] Figure 1 The diagram illustrates the deployment of a protrusion 110. The protrusion 110 and the nerve clamp 100 are shown as positions that can be located within a patient's cavity when ready to be positioned around a target, such as a neurovascular bundle or nerve. The protrusion 110 may include attachment to the base of the clamp 100 via suture 112 (also referred to herein as suture or thread), the suture 112 being formed of a non-absorbable suture material, such as braided or monofilament polyester, nylon, polyvinylidene fluoride (PVDF), and polypropylene. The suture 112 may be molded or adhered to the protrusion 110 to form a suture loop 120 during manufacturing.

[0062] The path of the suture 112 through the protrusion 110 can be illustrated using the end 114 of the protrusion 110 as the starting point. The end 114 is referred to as the proximal end 114 because it is closer to the operator who manipulates the protrusion 110 during surgery. Therefore, the distal end of the protrusion 110 would be the end further away from the operator, which could contact or be positioned proximally to the nerve clamp 100. Starting from the starting point, the suture 112 can be movably passed through a first channel, such as a first tunnel 116 formed in the protrusion 110. Movable passage through a channel means that the suture 112 is able to move within and slide through (or along) the channel. The cross-sectional shape of the channel can be a circular hole, an elliptical or oblong groove, or other shapes. The first tunnel 116 passes through the central region, which is further described below. The suture 112 can then exit the first tunnel 116 at the distal end 117 of the protrusion 110 and movably pass through a first eyelet 118 in the first outer arm 102. The eyelet 118 may be formed by a hole extending through the distal end of the outer arm (beyond the position of any electrode positioned in the outer arm), wherein the proximal end of the outer arm is a ridge 304 coaxial with the guide body 108. The eyelet 118 may be a circular hole, an elliptical or oblong groove, or other shapes.

[0063] Once the suture thread 112 passes through the eyelet, it can be movably passed back through the opening in the protrusion 110 to form a suture loop 120 anchored to the protrusion 110 in some form (e.g., molded in during its formation or by adhesive). In other words, the portion of the suture thread 112 anchored in the protrusion 110 (e.g., the suture loop 120) is immovable and fixedly attached to the protrusion 110. The suture thread 112 can extend further from the suture loop 120 to exit the protrusion 110, then movably pass back through the second eyelet 122 in the second outer arm 104, movably pass through the second channel (e.g., the second tunnel 124 formed in the protrusion 110 extending from the distal end 117 of the protrusion to the proximal end 114 of the protrusion), and exit the protrusion 110. The two ends of the suture thread 112 can then be knotted into a knot 126. For simplicity, the knot 126 is depicted as a loop. In one embodiment, the knot 126 can be used as a gripping point for a surgical instrument. It should be understood that although the suture loop 120 is formed in this embodiment to use a single suture thread 112, two separate suture threads 112 can be used, such that each suture thread 112 passes through a different channel and is individually anchored in the protrusion 110.

[0064] Figure 2 The diagram shows a protrusion 110 and a collar 100 positioned near the target 200 for deployment. Figure 2 In the illustrated embodiment, target 200 may be a neurovascular bundle, although the clamp 100 may also be used on nerves that do not contain blood vessels. However, for ease of reference here, target 200 will be referred to as target tissue 200. The spacing between the positions of the two tunnels relative to the outer arm of the clamp also serves to maintain proper positioning of the outer arm when pulled under the target tissue. Furthermore, additional structural stability is provided when manipulating the clamp due to the spacing provided by the presence of a portion of the protrusion.

[0065] like Figure 3 As shown, the first surgical instrument 300 can be used to dissect or separate the area beneath the target tissue 200, grasping the suture knot 126 or proximal end 114 of the protrusion 110 (closest to the surgical instrument 300) and pulling the proximal end 114 of the protrusion 110 beneath the target tissue 200. The second surgical instrument 302 can also be used to grasp a portion of the intermediate arm 106 of the clamp 100 to create counter-traction between the arms of the clamp 100. When the protrusion 110 is pulled beneath the target tissue 200, the tapered portion of the proximal end 114 can facilitate further dissection of the tissue beneath the target tissue 200 as needed. The tapered proximal end 114 may be at least partially triangular. Figure 3As shown, the proximal end 114 can taper from the wider central portion of the protrusion 110 toward the narrower portion near the suture knot 126. Between the first surgical instrument 300 that pulls the suture knot 126 or the proximal end 114 and the suture loop 120 anchored within the protrusion 110, the second surgical instrument 302 can apply sufficient tensile force on the outer arms 102 and 104 to pull the outer arms 102 and 104 away from the ridge 304 of the collar 100.

[0066] like Figure 4 As further shown, the protrusion 110 can also serve as a pass / fail indicator during deployment. The thickness 400 of the protrusion 110 can be greater than the thickness of any one of the clamp arms 102, 104, or 106. In one embodiment, the protrusion can be approximately 0.5 mm thicker than the clamp arm. The width 402 of the protrusion 110 can also be greater than the width of the clamp 100 when measured from the outside of the outer clamp arms 102 and 104 deployed around the target tissue 200. In one embodiment, the width of the protrusion can be approximately 0.5 mm larger than the width of the clamp deployed around the target tissue, taking into account tissue compliance. In other embodiments, the protrusion can be, for example, approximately 0.5-2 mm thicker or wider than the clamp. The difference in size between the protrusion and the neural interface is based on the tissue compliance of the target tissue. The different thicknesses and widths of the protrusion 110 serve as a pass / fail feature because if the protrusion 110 cannot be pulled through without causing tissue damage when it is pulled through the anatomy, the clamp 100 cannot be safely deployed. Removing the protrusion 110 midway through deployment will result in less tissue damage and potential damage to the target tissue 200, as in the following scenario: when the arm is deployed at least partially around the target tissue 200, an attempt is made to push or pull the clamp 100 into place, but it is found that there is not enough space for the clamp and the arm must be pulled away from the target tissue.

[0067] Once the clamp 100 is positioned at the target tissue 200, and the extended arms 102, 104, and 106 have been released, they can wrap around the target tissue, such as Figure 5 As shown, it is necessary to safely and completely remove the protrusion 110 and suture 112 from the clamp 100. This safe and complete removal can be achieved by partially cutting through the protrusion at one or more locations in the central region, each of which is at a safe distance from the target tissue 200. Figure 5 and 6As shown, the cutting location in the central region can be indicated by the cutting window 500, such as a recessed area in the protrusion 110, which the surgeon can easily identify during deployment. Cutting through the protrusion 110 at the cutting window 500 along the length of the dotted line 602 with the cutting tool 600 will result in tunnels 116 and 124 (as shown). Figure 1 The suture thread 112 (as shown) was cut through. For example, as... Figure 7 As shown, the suture loop 120 is anchored within the protrusion 110 at approximately one-third of the length of the protrusion 110, starting from the distal end of the protrusion 110. Thus, the suture loop 120 does not extend as far within the protrusion 110 as the cutting window 500. Therefore, cutting the suture 112 at the cutting window 500 will allow the strands of the suture 112 within the tunnel to be released, but the suture 112 as part of the suture loop 120 will remain.

[0068] Then, as the protrusion 110 is fully and safely pulled away from the collar 100 in the direction of arrow 700, the released strands of the suture thread 112 can be pulled out from the eyelets 118 and 122. Apart from removing the protrusion 110, because the ends of the suture thread strands are still molded to or adhered to the protrusion 110 at the suture loop 120, all sutures are fully pulled away from the collar 100 upon removal of the protrusion 110. Figure 8 The image shows the complete deployment of the hoop 100 around the target organization 200.

[0069] Figure 9 Another embodiment of the protrusion 900 is shown. In this embodiment, the protrusion 900 includes a series of ridges 902 (which may also be referred to as ridges or protrusions) and valleys 904 (which may also be referred to as depressions), which may extend substantially perpendicular to one side of the protrusion 900 along a length 906 (i.e., along the width of the protrusion). Within each valley 904, tunnels 908 and 910 are exposed, such that the tunnels transition between tunnels through the ridge 902 and tubes through the valley 904. The channels 908, 910 may be substantially the same as the tunnels 116, 124 of the protrusion 110, because the suture 112 ( Figure 9(Not shown) A ferrule (near the operator or surgical instrument) can be movably passed through each channel 908, 910 from a tapered proximal end 912 (closest to the operator or surgical instrument) to a ferrule positioned at the distal end 914. Where channels 908, 910 pass through ridge 902, the channel will be a tunnel, and where the channel passes through valley, the channel will be a tube. Making a cut sufficiently far through either valley 904 (in some embodiments, the protrusion is completely cut in two, and in some embodiments, the cut is made just far enough not to cut the protrusion 110 in two) to cut through both channels 908, 910 will release sutures without completely cutting through the protrusion 900, thus allowing the protrusion 900 to be completely removed along with all sutures. By making a tunnel through valley 904 and channels 908, 910 near the bottom of ridge 902 where it meets valley 904, the sharpness of the resulting bends and edges can be reduced, thereby minimizing potential tissue irritation during removal.

[0070] In other embodiments, the deployment protrusion 900 can be cut closer to a first region, which is closer to the neural interface, such as a tapered proximal end 912. A tapered portion implies a narrower width, meaning fewer incisions are needed to cut through the desired portion of the deployment protrusion 900.

[0071] The positions of channels 908 and 910 relative to the proximal end 912 of protrusion 900 are... Figure 10 Further illustrated below. The projection 900 has similar thickness and width dimensions and a tapering section to the projection 110, which allows the projection 900 to provide similar through / non-through features and aids in dissection. However, the ridges and valleys allow the projection 900 to be rolled up into smaller spaces, making it more suitable for insertion into smaller clamps, as further described below. In other words, the lateral ridges and valleys provide longitudinal flexibility that allows the deployed projection to be rolled up, while providing lateral stiffness when the deployed projection is deployed.

[0072] Figure 11An embodiment of the protrusion 1100 is shown, wherein the suture loop is not anchored within the protrusion 1100, but rather adhered to the outside of the protrusion 1100. For example, the suture thread 1101 may pass through the suture knot 1102 at the proximal end 1103 through channels 1105, 1107 to reach the eyelet (not shown) of the collar 100. After passing through the eyelet of the collar 100, the suture thread 1101 may return to the protrusion 1100 and pass through extensions / openings 1104, 1106, where the suture thread may be adhered to the protrusion 1100. In embodiments of the protrusion 1100, the suture thread 1101 may be adhered (non-molded) to the protrusion 1100. Small extensions or openings 1104, 1106 may be formed on or in the distal end of the protrusion 1100, such that an adhesive 1108 (e.g., silicone adhesive) may be applied to the suture thread 1101 to secure it to the protrusion 1100. If openings 1104 and 1106 are used, the suture thread 1101 can be inserted into the openings 1104 and 1106, and then adhesive can be applied to hold the suture thread 1101 in place. If extensions 1104 and 1106 are used, the suture thread 1101 can be at least partially wrapped around the extension, and then adhesive can be applied to further hold the suture thread 1101 in place. Adhesion (or adhesive) 1108 can also be applied at the suture knot 1102 to further secure the suture thread 1101 to the proximal end 1103 of the protrusion 11000. It should also be understood that the suture can be adhered (rather than molded) to the protrusion 1100.

[0073] Regarding where the processes can be cut for removal, using ridges and valleys in the central region to expose the suture tunnels in processes 900 and 1100 provides surgeons with more options than a single cutting window. Because the tubes are visible within the valleys, the location of the cuttable portion of the process is more clearly defined, allowing the surgeon to ensure that both strands of the suture have been cut before beginning removal of the process. The different designs used to identify the cuttable portions of the processes (i.e., the cutting windows and ridges and valleys) allow processes 110, 900, and 1100 to be used with different sized clamps. For example, process 110 works well with larger clamps that may not require as much flexibility, and processes 900 and 1100 work well with smaller clamps because the ridges and valleys make the processes more flexible longitudinally while maintaining lateral stiffness. Although further explained below, either design can be used for different sized neural devices.

[0074] In other embodiments, the protrusions 110, 900, or 1100 may include only a single channel (e.g., such as 116, 124, 908, or 910), wherein a suture 112 or 1101 is movably passed through the channel device, exits the protrusion, passes through the eyelet of a nerve clamp (which may have only a single arm), and returns into the protrusion to be anchored or adhered to it. Once the protrusion is cut along a valley at a central portion where a cutting window can be set, or simply at a distance sufficiently from the distal end, the suture can be released and pulled out of the eyelet of the clamp, allowing for clean and safe removal of both the suture and the protrusion. The single channel may be centrally located within the protrusions 110, 900, or 1100, or may be positioned centrally away from the protrusion.

[0075] Figure 12A and Figure 12B An embodiment of a protrusion 1200 similar to the embodiment of protrusion 1100 is shown. Figure 12A A perspective view of ridge 1202 and valley 1204 is provided, making the suture suture channels 1206 and 1208 visible from below. Figure 12B The same perspective view of the protrusion 1200 is shown, but as a solid view rather than a through-view. In this embodiment, the proximal end 1210 may have a more tapered profile and a softer transition 1212 from the proximal end 1210 to the central region 1214, where the protrusion 1200 is more likely to be cut during surgery. As mentioned above regarding Figure 3 The surgical instrument can be used to dissect the area of ​​tissue beneath the target tissue, grasp the proximal end of the suture knot or protrusion, and pull the protrusion completely beneath the target tissue, allowing for the deployment of neural devices. The tapered proximal end 1210 of the protrusion 1200 can also serve as a gripping point for the surgical instrument, which can be used to pull the protrusion 1200. A gripping opening 1216 at the proximal end 1210 of the protrusion 1200 allows the surgical instrument to better grip the protrusion 1200 near the gripping point. The more tapered profile of the proximal end 1210 makes it easier to dissect the tissue beneath the target and begin pulling the protrusion 1200 through the dissected area, reducing tissue irritation. Similarly, the softer transition 1212 between the proximal end 1210 and the central region 1214 makes it easier to pull the protrusion 1200 through the dissected tissue and reduces tissue irritation.

[0076] Figure 12B The transition portion 1212 and the central region 1214 of the protrusion 1200 are shown more fully. Figure 12C yes Figure 12A and Figure 12B The right-side solid view of the deployment protrusion shows the ridge 1202, valley 1204 and suture suture channel 1208 more fully.

[0077] Although the above-described deployment protrusions 110, 900, 1100, and 1200 have been described as including two channels or tunnels, deployment protrusions 110, 900, 1100, and 1200 may include only one channel or more than two channels.

[0078] Figure 13A This is a perspective view of an embodiment of the deployment of the protrusion 1300, which has a plurality of longitudinal ridges 1302 and valleys 1304 on a side 1306 opposite to a side 1308 of the protrusion 1300 that includes an indicator of a suture suture channel and a cutable portion, such as a bottom side (or vice versa), and a side 1308 that is, for example, a top side (or vice versa). The plurality of longitudinal ridges 1302 and valleys 1304 may be formed by longitudinal grooves formed in the side 1306. The protrusion 1300 may also be more tapered than in the previously discussed embodiments, such that some of the longitudinal grooves extend from a first region through a central region between the first and second regions to the second region, near the first region, the protrusion is held close to the implantable device, the second region is at the tapered end of the protrusion, while other longitudinal grooves begin at the first region and terminate at the central region due to the tapering.

[0079] The protrusions disclosed herein can be made of silicone resin, which may become sticky in some cases due to cleaning and sterilization, a condition that may worsen during long-term storage. Adding barium sulfate to the silicone resin can partially reduce its stickiness, which can also make the protrusion radiopaque, offering additional benefits. The stickiness can be further reduced by adding ridges 1302 and valleys 1304 to the base 1306 of the protrusion 1300. Since the base 1306 of the protrusion 1300 faces the silicone-covered nerve conduit when the conduit is rolled up inside the protrusion 1300, the longitudinal ridges 1302 and valleys 1304 of the base 1306 help minimize the contact area between the silicone resin of the protrusion 1300 and the nerve conduit. Additionally, the longitudinal ridges 1302 and valleys 1304 can have the added benefit of reduced surface contact with the dissected tissue, making it easier to pull the protrusion under the target tissue / bundle compared to a flat (without grooves) surface.

[0080] In some embodiments, the protrusions may 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 may depend on the desired flexibility or stiffness.

[0081] In some embodiments, such as Figure 13DAs further shown, the deployment protrusion disclosed herein includes rounded edges to reduce damage to patient tissues when the implantable device is positioned around a target within the patient's body. Figure 13D Additional illustrations are provided showing the deployment of protrusions with ridges and valleys on both sides.

[0082] The protrusions disclosed herein offer advantages beyond the delivery, localization, and deployment of the neural interface 100. For example, in some embodiments, the protrusions can be used as measuring tools. In one embodiment, reference... Figure 13B-1 , 13B-2 The 13B-3 allows for the measurement of a gap of length L between the end of the protrusion body 850 and the ridge portion of the neural interface 100 (which can also be referred to as the diameter or radial gap of the neural interface when deployed onto the target tissue) to determine the degree or amount of stretching of the neural interface 100 around the target tissue. This also characterizes the radial length of the electrode arm opening. Understanding these characteristics is useful for medical professionals when determining whether an appropriately sized neural interface 100 has been selected for the target tissue. Figure 13B-1 , 13B-2 In 13B-3, the radial gaps of L1, L2 and L3 are shown respectively, and can be evaluated by medical professionals during the delivery and deployment of the neural interface 800.

[0083] In another use of the protrusion, and referring to Figure 13C-1 , 13C-2 In some embodiments, as with 13C-3 and 13C-4, the rib and groove structure of the protrusion body 850 can be used as a “measuring tape” type measuring tool. The rib and groove structure of the body 850 can be flexible, allowing it to at least partially conform to the target tissue, and in doing so, it provides a medical professional user with another way to assess the size and fit of the neural interface 100 relative to the target tissue using the body 850. This can be achieved in several ways. In one embodiment, information can be provided to the medical professional user, who can then translate multiple ribs (or grooves) into usable information. For example, if 3-5 ribs cross the target tissue, the size of the clamp may be acceptable, while if 2 or fewer ribs cross the target tissue, it may mean the clamp is too large, and if 6 or more ribs cross the target tissue, it may mean the clamp is too small. Therefore, simply counting the number of ribs (or grooves) crossing the target tissue can directly provide fit information, such as… Figure 13C-1 (Ribs 1, 2, and 3 are shown), 13C-2 (ribs 1, 2, 3, and 4 are shown), and 13C-3 (ribs 1, 2, 3, 4, and 5 are shown). In another embodiment, a medical professional user can first, as shown... Figure 13C-1 , 13C-2The number of ribs (or grooves) shown in 13C-3, and as... Figure 13C-4 The diagram illustrates the use of known measurements between adjacent ribs (or grooves) to assess sizing and fit. Similarly, these known measurements can be converted into a table showing the clamp openings as fractions of the circumference and providing medical professionals with advice on which are suitable and unsuitable. Figure 13C-4 In the table, the third to seventh values ​​are optimal. The first two values ​​indicate that the clamp is too large for the target tissue, while the last two values ​​indicate that the clamp is too small for the target tissue.

[0084] In addition to improving the deployment of the trocar for ease of placement and implantation, the various protrusions disclosed herein can also improve delivery, which is the act of inserting the trocar into the patient's body, typically through the abdominal cavity. Laparoscopic surgery can be a preferred surgical approach in some cases for introducing neuromodulation or neurostimulation systems into the patient's body because it minimizes the risk of infection, reduces postoperative pain, and results in fewer complications. Laparoscopic surgery can be particularly suitable for neuromodulation applications where the target nerve or neurovascular bundle is located within the abdominal cavity. During laparoscopic surgery, the introduction of tools and devices into the body cavity can be achieved through a laparoscopic port, referred to as a "cannula port" or "cannula," which typically contains more than one flexible valve to prevent the escape of insufflation gas, an inert gas pumped into the body during surgery to create additional working and visual space. Figure 20 The diagram shows side views of three different cannula ports and corresponding proximal (i.e., closest to the operator / surgeon or patient) end views. The cannula may also be referred to as an insertion tube.

[0085] Neural interfaces, particularly neural clamps and their guides, can contain numerous fragile electrical connections. For example, allowing a neural clamp through a valve at the cannula port without a protective mechanism poses a high risk of electrode damage. Since electrode integrity is critical for the clamp's stimulatory effectiveness and safety, mitigation of the risk of electrode damage during laparoscopic introduction is necessary. The embodiments described herein enable the insertion device to interact with the cannula seal and provide careful guidance during the delivery of a delicate neural clamp into the peritoneum, including maintaining the clamp's orientation and position. The embodiments also allow for clamp release into the peritoneum and serve to protect the electrode surface on the inner side of the clamp until the "deployment" step. All embodiments provide a method for deploying a laparoscopic neural modulation clamp in a minimally risky and convenient manner, thereby minimizing damage to the clamp during delivery. This is useful because small tears occurring during the molding or necking of wires or electrodes can be difficult to detect, and because such damage can spread over time.

[0086] Figure 14A and 14B An embodiment of a delivery tube or nerve delivery device (also known as a cannula) including a push rod is shown. The entire device, including the delivery tube 1400, the push rod 1408, and the proximal seal, is... Figure 14B As shown in the image. Figure 14A and Figure 14B The disengagement section further illustrates details of the push rod 1408 and the neural clamp 1402. This design of the delivery tube can be adapted to a range of cannula port sizes, such as 12 mm and 15 mm, and therefore to different neural interface sizes, and can be compatible with neural clamps that include or exclude deployment protrusions, depending on the size of the mounting post. For example, a larger mounting post can be adapted to a larger clamp design or a smaller clamp design that does not include a protrusion rolled up inside the clamp during delivery, while a smaller mounting post can be adapted to a smaller clamp or a clamp that includes a rolled-up protrusion. As those skilled in the art will understand, when this application relates to a delivery tube, the tube can be a hollow tubular structure, or it can alternatively be provided by a solid cylinder with hollow ends or blind holes (i.e., such that there is a tubular structure at least surrounding the neural interface device). It is understood that "solid" means a structure that is completely filled internally or has no cavity. For example, an integral steel or polymer cylinder can be a solid cylinder. It should be understood that the use of the term "delivery tube" in the specification is intended to cover both embodiments. Furthermore, it should be understood that "delivery tube" refers to a neural delivery device.

[0087] This embodiment may also include a flanged push rod 1408 having a mounting post 1406, a suture loop management incision 1412, and a second flange 1414. Figure 12A The port for inserting the cannula needle is shown. Figure 20 As shown in the diagram, a portion of a delivery tube 1400, wherein a nerve clamp 1402 is located internally, and a guide 1404 extends toward the distal end of the delivery tube 1400. The nerve clamp 1402 may be mounted on a mounting post 1406 of a push rod 1408. The mounting post 1406 may be a cylindrical portion of the distal end of the push rod 1408. A deployment protrusion (with or without) that is rolled up within the nerve clamp 1402 is also present. Figure 12A or Figure 12B In the case of (not shown), the diameter of the mounting post 1406 can be set to match the inner diameter of the nerve clamp 1402.

[0088] The inner diameter of the delivery tube 1400 can be larger than the outer diameter of the nerve clamp 1402 when mounted on 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, together with the component's sizing, prevents the silicone of the nerve clamp and its guide 1404 from contacting the inner wall of the delivery tube 1400. This allows the clamp 1402 to advance smoothly through the interior of the delivery tube 1400 without the arm or other parts of the nerve clamp 1402 becoming entangled or damaged. The flange 1410 can work with the mounting post to control the orientation of the clamp 1402 as it is pushed through the delivery tube 1400. It should be noted that the clamp is mounted at the end of the push rod, while the guide extends toward the distal end of the delivery tube; that is, the guide body guides most of the clamp. Before the delivery tube with the clamp is introduced, the guide body of the clamp is inserted through the cannula needle port, as shown in some figures.

[0089] Figure 14B The incision 1412, further shown, allows surgical instruments to pull away a suture loop (not shown), which may have been used to hold the clamp on the mounting post 1406 and maintain the clamp's orientation. For example, suture thread may be wound around a portion of the clamp 1402, across the area of ​​the incision 1412, and around a portion 1418 of the push rod 1408 located between the incision 1412 and the flange 1414 to hold the clamp in a relatively fixed position until the suture thread is removed. The mounting post 1406 protects the electrodes of the clamp 1402, while the flange 1410 and the incision 1412 minimize friction between the clamp 1402 and the delivery tube.

[0090] like Figure 14B As further shown, the second flange 1414 allows the push rod 1408 to slide against the inner wall of the delivery tube 1400 in a stable, low-friction manner, and prevents the push rod 1408 from tilting in a way that allows the sleeve to contact the inner wall of the tube 1400. The proximal seal 1416 can close the proximal end of the delivery tube 1400, leaving only the distal end open and allowing the delivery tube to cooperate with the cannula needle port to maintain a tight seal of the abdominal opening. The seal 1416 is mounted around the push rod 1408, so that the push rod 1408 can be moved into and out of the delivery tube 1400 without allowing the inflated gas to escape.

[0091] Figure 15A , 15B Embodiments of different delivery mechanisms are shown in 15C and 15D, which are also applicable to a range of cannula port sizes and are compatible with nerve clamps, with or without deployment protrusions. This embodiment may include a delivery tube (or push tube) 1500, instead of... Figure 14A and 14BThe delivery tube and pusher described in the embodiments. As mentioned above, the delivery tube / pusher refers to a nerve delivery device. Figure 15A As shown in the perspective view of the cross-sectional view of the delivery tube 1500, the delivery tube 1500 includes a wall 1502 within the delivery tube 1500, which prevents leakage of inflated gas and can hold a clamp 1504 or other neural interface device at the distal end of the delivery tube (farthest from the cannula port once inserted). In some embodiments, the proximal cavity behind the wall 1502 may be solid. A clamp 1504, with or without a deployment protrusion, may be positioned within the delivery tube 1500, with a guide 1506 extending distally. Deployment protrusions such as deployment protrusions 110, 900, 1100, or 1200 may also be attached to the clamp and coiled within the clamp, as further described below and as... Figure 16B As shown. The inner diameter of the delivery tube 1502 can be customized based on the dimensions of the desired neural interface device 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 based on the outer diameter (or outer width) of the neural interface device to be delivered. The inner diameter of the delivery tube 1502 can be approximately equal to the outer diameter of the neural interface device to provide and maintain a certain level of friction with the clamp 1504 to provide a certain level of retention. In other words, the inner diameter of the opening of the delivery tube provides an interference fit with the neural interface device.

[0092] The delivery tube 1502 includes a flange-shaped delivery tube retaining feature disposed proximally to prevent the delivery tube from passing through the cannula (insertion tube) by a predetermined amount or completely through the cannula. The presence of the flange prevents the delivery tube 1502 from passing through the cannula beyond the flange.

[0093] Figure 15E and 15F It shows something similar to Figure 15A , 15B Another embodiment of those shown in 15C and 15D is also applicable to a range of cannula port sizes and is compatible with neural interfaces, with or without deployment protrusions. Although this is referred to hereinafter as a neural delivery device, it should be noted that such a device may also be referred to as a delivery tube because the neural delivery device has a tubular structure formed at the distal end (in order to hold the neural interface device). Figure 26 A side cross-sectional view of this embodiment is shown.

[0094] like Figure 26 As shown, the neural delivery device 3000 may include an opening 3001 (also referred to as an open end or hole) at the distal end of the neural delivery device for holding the neural interface device.

[0095] Figure 15E and15F Embodiments may include being formed as a solid cylinder (and) Figure 14A and 14B The hollow cylinder shown in the diagram forms a contrasting neural delivery device. It can also be said that... Figure 15E and 15F The neural delivery device has a tubular structure surrounding the neural interface device, while the rest of the axis of the neural delivery device is essentially solid.

[0096] The nerve delivery device can be long enough to protrude from the end of the insertion tube. This allows the nerve delivery device to be manually manipulated / held by the surgeon proximally. Alternatively, the nerve delivery device can be connected to a separate mechanical structure / plunger arrangement for controlling the movement of the nerve delivery device.

[0097] Figure 15E A neural delivery device made of stainless steel is shown. The open end can be formed by drilling a hole 3001 in a solid steel cylinder to fit the dimensions of the neural interface device to be delivered. The inner wall of the open end of the neural delivery device can provide friction using an interference fit as discussed above to hold the neural interface device in place near the opening until it is pulled out of the opening for deployment. The neural interface can be pulled via its guide body. Because the neural interface device to be delivered is positioned around the opening of the open end, the neural interface device only needs to travel a short distance (when pulled) until it is released. Therefore, tangling of the neural interface can be avoided while utilizing the friction between the neural interface device (such as a neural clamp) and the deployment tube. With this arrangement, the neural interface device does not make any contact with the cannula or external insertion tube, or minimizes contact, during insertion into the insertion tube. In other words, the neural interface device is protected from damage when positioned within the recessed portion of the neural delivery device. This means that any sensitive structures of the neural interface device are shielded from mechanical / electrical damage during the insertion process.

[0098] By using a solid cylinder as the base of the nerve delivery device, ease of manufacture can be improved. This device also avoids the need for any additional mechanical structures to prevent leakage of the filling gas, which might be necessary in some other embodiments, since the cannula needle valve can be used to maintain body pressure and no gas can escape through the solid body of the cannula.

[0099] Although Figure 15E and 15FThe embodiments can be formed of stainless steel, but it can alternatively be formed of a polymer material. In some embodiments, the polymer material can be, for example, polyoxymethylene resin (Delrin). In some embodiments, the delivery tube can be formed by injection molding using any suitable material. It is worth noting that this material and manufacturing method can also be applied to hollow tube embodiments (e.g., Figure 14A and 14B (The embodiment shown).

[0100] The materials used in the neural delivery device (in the solid cylindrical and hollow tube embodiments) should be biocompatible. Furthermore, polymeric materials (such as Delrin) are lightweight, which is beneficial for reducing the weight of the device. Where further weight reduction is required, the neural delivery device may include additional perforations, holes, or removal of a portion of the neural delivery device, as described below.

[0101] Neural delivery devices can be made by drilling a recess of the desired size into a solid cylinder of biocompatible material.

[0102] Figure 15E and 15F The nerve delivery device also includes a nerve delivery device retaining feature. An opening may be formed at the second end of the delivery tube in a direction perpendicular to the length of the nerve delivery device. The nerve delivery device retaining feature (e.g., a cord or suture thread or any other elongated tool) may be provided through the opening to prevent the delivery tube from passing through the cannula. Furthermore, the cord or suture thread may be used to retrieve the nerve delivery device and / or to provide tension to aid in the removal of the nerve delivery device, if necessary.

[0103] The nerve delivery device retaining feature may additionally or alternatively include a proximal cap (not shown), which is constructed and positioned to prevent accidental release of the delivery tube. This cap or handle may be positioned around the proximal end of the nerve delivery device and is provided to prevent the nerve delivery device from passing through the cannula or to assist in the operation of the nerve delivery device. Both the cord / suture and the proximal cap are capable of preventing accidental release of the delivery tube into the body, particularly when the length of the nerve delivery device is shorter than the length of the cannula. It should also be noted that the proximal cap may be a separate feature, or it may be integral with the nerve delivery device (e.g., an opening or increase in the diameter of the nerve delivery device at the proximal end such that the outer diameter of the nerve delivery device at the proximal end is larger than the inner diameter of the insertion tube or cannula).

[0104] In some embodiments, the proximal cover may be formed of a molded plastic material.

[0105] Although the above features of neural delivery devices are about Figure 15E and 15FThe neural delivery devices described herein, however, can also be clearly applied to hollow tube embodiments of neural delivery devices (e.g., Figure 14A and 14B (The embodiment shown).

[0106] Any of the aforementioned neural delivery devices may also include additional structural features, such as perforations and / or proximal holes. Adding perforations and / or proximal holes to a neural delivery device allows for the removal of additional weight from the device, which improves the ergonomics of manipulating it. An additional benefit is that a neural delivery device with reduced weight can cause less stress on the insertion cannula (and therefore the body) upon insertion.

[0107] Figure 28 The image illustrates such a neural delivery device, showing a neural delivery device 3200 having an opening 3201 at a distal end. These features are intended to be substantially similar to those of... Figure 26 Their counterparts 3000 and 3001 are shown. However, this embodiment also has multiple perforations 3203 along the length of the neural delivery device.

[0108] Perforations can be located along the length of the nerve delivery device, and they can take the form of notches or holes (either recessed into the side of the delivery tube or extending through the delivery tube to the other side). Holes can have any cross-section, including but not limited to circular, rectangular, oval, etc. Figure 28 The image shows a cross-section of this embodiment having multiple perforations along the length of the nerve delivery device.

[0109] In another embodiment, there exists such Figure 27 The nerve delivery device 3100 shown has an opening 3101 at its distal end. These features are intended to be substantially similar to those of... Figure 26 Their counterparts 3000 and 3001 are shown. However, this embodiment also includes a proximal hole 3103.

[0110] Incorporating a proximal foramen into the nerve delivery device allows for further weight reduction while still ensuring sufficient structural support from the surrounding walls to allow for efficient advancement of the delivery tube. A proximal foramen is a hole extending proximally along the length of the nerve delivery device (i.e., through the center of the solid cylinder). The proximal foramen can be used in conjunction with perforations as described above. Figure 27 The diagram shows a cross-section of this embodiment with a proximal aperture (but not a perforation). Proximal apertures can also be used in solid cylindrical delivery devices, allowing for the insertion of holding or retrieval structures into the neural delivery device.

[0111] Figure 15BThe illustration further illustrates how the push tube 1500 operates in conjunction with the cannula 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 push tube 1500 can be inserted through a port opening in the cannula port and into the insertion tube 1514. The outer diameter of the push tube 1500 may be smaller than the inner diameter of the port opening of the cannula port 1510 and the inner diameter of the insertion tube 1514. Figure 15C The diagram shows the push tube 1500 once fully inserted into the cannula needle port 1510, and Figure 15D The nerve clamp 1504 is shown once it is pulled out from the open end of the push tube 1500. Similarly, the push tube has a sealed proximal end and an open distal end.

[0112] exist Figure 16A , 16B Examples of different designs for the delivery tube and pusher are shown in 16C, 16D, 16E, and 16F. These embodiments can be adapted to custom-designed non-circular (or substantially oblong) trocar ports and are compatible with nerve clamps, with or without deployment protrusions. However, the specific shapes of the delivery tube and pusher are exemplary and can be shaped in a variety of different ways, such as circular, elliptical, etc. Figure 16A and 16B As shown, this embodiment may include a push rod 1600, which has a central post 1602 at its distal end (farthest from the cannula port once inserted). The central post 1602 may have a cross-section that matches the shape of the clamp 1604 when the deployment protrusion 1606 is already rolled up inside the clamp 1604. Although as Figure 16B The end view illustration shows that the internal space of the sleeve 1604, which has internally rolled-up deployment protrusions 1606, can be substantially circular, but the shape of the internal space is more likely to be similar to Figure 16A The central post 1602 shown has an elongated oval cross-section. The distal end of the push rod 1600 may also include one or more teeth or posts 1608, which can restrict the movement of the clamp 1604. (See above regarding...) Figure 14A and Figure 14B As described in mounting post 1406, the dimensions of the center post 1602 may vary depending on the dimensions of the sleeve and / or whether or not the deployment protrusion is included.

[0113] When the sleeve 1604 is installed on the push rod 1600, as Figure 16C As shown, column 1608 can hold clamp 1604 and protect clamp when it is pushed through delivery tube 1610, as... Figure 16DFurther illustrated, an O-ring 1612 or similar device can be installed in a distal block 1614, which has external dimensions designed to form a seal between the O-ring 1612 and the inner wall of the delivery tube 1610, whereby the delivery tube 1610 is open at its distal end and sealed at its proximal end. Moreover, as... Figure 16C As shown, the sleeve 1604 can be positioned on the central post 1602, as... Figure 16A As shown, the guide of the clamp extends in the distal direction.

[0114] Figure 16E The delivery tube 1610 and push rod 1600 of this embodiment are further shown. They can be inserted into the cannula seal of the cannula port 1620 outside the patient's body and into the inlet tube 1622 inside the abdominal cavity. Figure 16F The delivery tube 1610 and push rod 1600 are shown fully inserted into the cannula port 1620, allowing the nerve clamp 1604 to be successfully delivered to the distal end of the introduction tube 1622, where it can be removed for deployment.

[0115] Figure 17 An embodiment of a delivery tube or cannula is shown, which can be adapted to a circular cannula port and is similar to... Figure 15A , 15B The embodiments shown are 15C and 15D. However, in this embodiment, the delivery tube does not include, for example... Figure 15A , 15B The wall in the embodiments shown in 15C and 15D. This embodiment is compatible with nerve clamps, with or without a deployment protuberance. This embodiment may include a delivery tube (also referred to as a nerve delivery device) or a 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 to prevent the delivery tube from passing completely through the cannula needle. A nerve clamp 1708 may be positioned at a portion 1710 closer to the proximal end 1712 of the delivery tube 1700. The nerve interface is positioned further away from the open end, which allows a distance between the open end and the nerve interface to hold the nerve interface in place until it is pulled out of the delivery tube for deployment.

[0116] Figure 18 An embodiment of a retaining feature that can be used in any of the above embodiments (i.e., delivery tube, deployment tube, or push rod, with or without a mounting post or center post) is shown. In this embodiment, the retaining feature may be a basic double L-shaped or hook-shaped arm 1800 pivotally attached to the distal block 1614 of the push rod 1600. Figure 18Arm 1800 is shown in the closed position (left) and the open position (right). A nerve clamp is not shown, but when mounted on the central post 1602, arm 1800 can cover a portion of the distal end of the clamp and further restrain it. Arm 1800 can be used in place of the canine or post 1608, which can still be used on the opposite side, but may require the removal of a portion of the distal block 1614 to accommodate the operation of arm 1800, as further explained below.

[0117] Arm 1800 may be pivotally attached to distal block 1614 via pin 1802 or a similar device. When the nerve clamp is still within delivery tube 1610, the inner wall of delivery tube 1610 may force arm 1800 into a substantially closed position. As the nerve clamp approaches the end of delivery tube 1610, a second extension 1804 at the other end of arm 1800 (in the opposite direction to the first extension) may engage a release feature 1806 extending from the inner wall of delivery tube 1610, thereby forcing arm 1800 to pivot away from the clamp.

[0118] Figure 19A and 19B Another embodiment of the retaining feature 1900 is shown, which can be similarly pivotally attached to the distal block 1614. Instead of cutting off a portion of the distal block 1614, the retaining feature 1900 can be molded in the open position at the location of the teeth or posts 1608, as shown. Figure 19B As shown. The base 1902 of the retaining feature 1900 can be thinned to make the base flexible. When the retaining feature 1900 is within the delivery tube 1610, the retaining feature can be forced into a closed position through the extension. When the retaining feature 1900 leaves the distal end of the delivery tube 1610, the retaining feature will automatically pivot to its biased open position when the extension is no longer compressed by the delivery tube 1610.

[0119] Figure 21A and 21B This is a perspective cross-sectional view of different sides of a trocar cannula or delivery cannula according to one embodiment, showing the neural interface retention features. The cannula 2100 includes a sealed or insertion end 2102 and an open or delivery end 2104. The insertion 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... Figure 22A , Figure 22B It is shown more clearly in the middle, Figure 22A This is a cross-sectional view of the entire 2100mm cannula. Figure 22B An external view of the entire cannula 2100 is provided.

[0120] The inlet end 2102 may include two concentric rings, the smaller of which forms a retaining feature band 2106 and includes a series of flexible fins 2108. The flexible fins 2108 are triangular or serrated, with their wider ends attached to the inner wall of the retaining feature band 2106 and their narrower ends extending toward the center of the retaining feature band 2106. The narrower ends of the flexible fins 2108 do not contact each other, thus leaving a circular opening in the middle of the retaining feature band 2106. The flexible fins 2108 are evenly spaced around the inner wall of the retaining feature band, except that a large space is created between any two flexible fins to allow passage of a guide for the neural interface. The flexible fins 2108 are configured to hold the neural interface in a stable, centered position before it is further pulled along the sleeve 2100 toward the delivery end 2104 by the guide body of the neural interface. The retention feature can be configured to help keep the neural interface in alignment as it is inserted into the delivery tube and moved along the delivery tube toward the opening, and to reduce contact between the neural interface and the inner surface of the delivery tube.

[0121] The lead-in end 2102 of the cannula 2100 may also include a flange 2110 configured to prevent the cannula from sliding continuously through the cannula needle port during use. The lead-in end 2102 of the cannula may have a larger radius than the delivery end 2104 and may taper from the larger radius to a smaller radius near the location of the flange 2110. The tapered region 2112 may include a flat seat 2114 on which the retaining feature band 2106 may be positioned and held in place.

[0122] Figure 23A and Figure 23B They provided Figure 21A Perspective and end views of the proximal end of the cannula needle sleeve are shown, and the arrangement of the flexible fins 2108 is further illustrated. Figure 23B The most visible of the six fins are almost evenly spaced apart, except between two of the fins, which have a wider gap 2112 between them to accommodate the neural interface guide.

[0123] Figure 24A and Figure 24B Including towards the above Figures 21A-23B The image shows two different perspective cross-sectional views of the inlet end of the cannula, and also includes a guide member 2400. The guide member 2400 may be an additional concentric ring or band fitted inside the inlet end 2102 of the cannula, and may be configured to further reduce the radius of the inlet end, such that the neural interface is closely guided to and through the flexible fin 2108.

[0124] Another embodiment of retaining feature 2500 is in Figure 25AThe diagram shows a perspective view of the neural interface retention feature. The end view of retention feature 2500 is shown in... Figure 25B As shown in the diagram. The retaining feature 2500 may be a concentric band fitted within the inlet end 2102 of the cannula, but comprises only two flexible fins 2502 compared to six flexible fins 2108. The two fins 2502 may be gapped apart at their narrower ends 2504 toward the center of the inlet end, the gap extending toward the inner wall into a larger area within the rectangular region 2406. The rectangular region may be configured to accommodate guides for a neural interface.

[0125] Exemplary Example:

[0126] The following list of embodiments also forms part of this disclosure:

[0127] Example 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 inserting through the abdominal cavity, the insertion tube having a sealed port and an open end for positioning within the abdominal cavity upon insertion; and a delivery tube for inserting through the sealed port of the insertion tube, the delivery tube including an opening for the neural interface device at a first end.

[0128] Example 2: A tool or system as described in Example 1, wherein the delivery tube includes a retainer near an opening at an open end for holding the neural interface device in position at the opening of the delivery tube.

[0129] Example 3: A tool or system as described in Example 1 or 2, wherein the delivery tube includes a cross-sectional wall located near the open end of the delivery tube, and wherein the retainer is mounted on the wall.

[0130] Example 4: The tool or system as described in Example 1 further includes: a push rod having a first end for insertion into a 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 retainer for holding the neural interface device in place.

[0131] Example 5: A tool or system as described in Example 4, wherein the push rod includes a first flange directly below the retainer and a second flange positioned at a distance from the first flange along the length of the push rod, wherein the first flange and the second flange contact the inner surface of the delivery tube and slide along the inner surface to reduce contact between the neural interface device and the inner surface.

[0132] Example 6: A tool or system as described in Example 5, wherein the second flange is configured to seal the delivery tube.

[0133] Example 7: A tool or system as described in Example 5 or 6, wherein the distance is sufficient to prevent the push rod from tilting as the delivery rod moves from the sealable end of the delivery tube to the open end.

[0134] Example 8: A tool or system as described in any one of Examples 5 to 7, wherein the first flange includes an incision for accessing the sutures connected to the neural interface device.

[0135] Example 9: A tool or system as described in any one of Examples 5 to 8, wherein the retainer includes a mounting post, and wherein the neural interface device is configured to be positioned around the mounting post.

[0136] Example 10: A tool or system as described in Example 9, wherein the neural interface device has a central opening that allows the neural interface to be positioned around a target, wherein when the neural interface device is in the delivery tube, the neural interface device is attached to a deployment protrusion rolled up within the first central opening, and wherein the rolled-up deployment protrusion is configured to be positioned around the mounting post.

[0137] Example 11: A tool or system as described in Example 9 or 10, wherein the mounting post is shaped to match the shape of the neural interface device.

[0138] Example 12: A tool or system as described in any one of Examples 9 to 11, wherein the mounting post is a central post, and wherein the retainer further includes at least one side post positioned outside the neural interface device for holding the neural interface device when it is held on the mounting post.

[0139] Example 13: A tool or system as described in Example 13, wherein the at least one side post is retractable and includes a release element that is activated by not engaging the delivery tube.

[0140] Example 14: A tool or system as described in Example 12 or 13, wherein the delivery tube includes a portion extending from the inner surface near the open end of the delivery tube, wherein the at least one side post is retractable, and wherein the portion engages the at least one side post to retract the at least one side post when the first end of the push rod leaves the open end of the delivery tube.

[0141] Example 15: A tool or system as described in any one of Examples 4 to 14, wherein the push rod includes a block positioned near the first end, and wherein the block includes one or more O-rings to seal the delivery tube.

[0142] Example 16: A tool or system as described in any one of Examples 4 to 15, wherein the delivery tube and the push rod have circular cross-sections.

[0143] Example 17: A tool or system as described in any one of Examples 4 to 16, wherein the delivery tube and the push rod have non-circular cross sections.

[0144] Example 18: The tool or system as described in Example 17, wherein the non-circular cross section is one of an oblong, elliptical, square, rectangular, and polygonal shape.

[0145] Example 19: A tool or system as described in any of the preceding embodiments, wherein the sealable end of the delivery tube includes a retaining feature.

[0146] Example 20: A tool or system as described in Example 19, wherein the retaining feature includes a band positioned within the delivery tube, the band including a plurality of flexible fins extending from an inner wall of the band, the plurality of flexible fins being configured to retain alignment of the neural interface device when the neural interface device is inserted into the delivery tube.

[0147] Example 21: A tool or system as described in Example 20, wherein each of the plurality of flexible fins is triangular or toothed, having a wider end attached to the inner wall of the strip and a narrower end extending toward the center of the strip.

[0148] Example 22: A tool or system as described in Example 21, wherein the plurality of flexible fins are evenly spaced around the inner wall of the strip, except between two of the flexible fins, where a larger space allows the guide of the neural interface device to pass through.

[0149] Example 23: A tool or system as described in any one of Examples 19 to 22, wherein the sealable end of the delivery tube further includes a guide member configured to reduce the inner diameter of the delivery tube before the neural interface device passes through the retaining feature.

[0150] Example 24: A tool or system as described in any of the preceding embodiments, wherein the delivery tube is formed of stainless steel.

[0151] Example 25: A tool or system as described in 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, wherein the axis of the hole corresponds to the axis of the solid delivery tube.

[0152] Example 26: A tool or system as described in any of the preceding embodiments, wherein the delivery tube includes a delivery tube retaining feature configured to prevent the delivery tube from passing through the insertion tube beyond a predetermined amount.

[0153] Example 27: A tool or system as described in any of the preceding embodiments, wherein the delivery tube includes a second end having a hole at the second end that passes through the delivery tube in a direction perpendicular to the length of the delivery tube.

[0154] Example 28: A tool or system as described in any one of Examples 2 to 27, wherein the retainer is provided by friction between the inner surface of the opening of the delivery tube and the neural interface device.

[0155] Example 29: A tool or system as described in any one of Examples 2 to 28, wherein the retainer is provided for interference fit with the neural interface device to be delivered.

[0156] The delivery tool may include a tube having an open distal end and a sealed proximal end, the tube being configured for insertion into a sealed port and an inlet tube of a trocar. The delivery tool may also include a retainer positioned within the tube for holding a nerve, with its guide extending toward the distal end of the tube, and the outer diameter of the nerve clamp being mounted on the retainer, which is smaller than the inner diameter of the tube. In one embodiment, the retainer may hold the nerve clamp, thereby reducing contact with the inner surface of the tube, and the retainer is configured to move the nerve clamp from the proximal end of the tube to the distal end, where the nerve clamp can be removed to deploy around one or more nerves.

[0157] The following list of embodiments also forms part of this disclosure:

[0158] Example 1: A deployment protrusion for deploying a neural interface device, comprising: a first region configured to be positioned near the neural interface; and a connector for releasably coupling the first region to the neural interface, the connector being anchored to the first region.

[0159] Example 2: The deployment protrusion as described in Example 1, wherein the deployment protrusion has a flat shape.

[0160] Example 3: The deployment protrusion as described in Example 1 or 2, wherein the deployment protrusion at least partially comprises a triangular shape.

[0161] Example 4: The deployment protrusion as described in any of the preceding embodiments further includes a second region and a central region between the first region and the second region.

[0162] Example 5: Deployment of the protrusion as described in Example 4, wherein the first region is wider than the second region.

[0163] Example 6: A deployment protrusion as described in any of the preceding embodiments, wherein at least a portion of the connector is released through a cut in the deployment protrusion so that the first region can move away from the neural interface device.

[0164] Example 7: The deployment protrusion as described in any one of Examples 4-6 further includes: at least one channel extending from the first region through the central region to the second region, each channel including a first opening in the first region and a second opening in the second region.

[0165] Example 8: Deployment protrusion as described in Example 7, wherein the connector is a suture thread for passing through the at least one channel from the second opening to the first opening, and for holding the first region near the implantable device and anchoring it to the first region.

[0166] Example 9: A deployment protrusion as described in Example 7 or 8, including a cutable portion extending across the at least one channel and configured to release at least a portion of the connector within the at least one channel when the cutable portion is cut through, wherein the release of the at least a portion of the suture thread allows the first region to move away from the implantable device.

[0167] Example 10: A deployment protrusion as described in any one of Examples 7 to 9, wherein the connector includes a first portion extending from the second opening through the at least one channel to the first opening, wherein the connector includes a second portion removably attached to the implantable device, wherein the connector includes a third portion extending from the first opening through the at least one channel to the second opening, and wherein the first portion is connected to the second portion and the second portion is connected to the third portion.

[0168] Example 11: The deployment protrusion as described in any one of Examples 7 to 10, wherein the at least one channel includes a first channel and a second channel, wherein the first portion passes through the first channel and the third portion passes through the second channel.

[0169] Example 12: The deployment protrusion as described in any one of Examples 4 to 11, wherein at least the first region and the second region include rounded edges.

[0170] Example 13: The deployment protrusion as described in any one of Examples 9 to 12, wherein the cutable portion is a recessed region in the central region, the recessed region extending across at least the first channel and the second channel.

[0171] Example 14: Deployment protrusion as described in Example 13, wherein the recessed region in the central region extends only a portion of the width of the central region, such that when the recessed region is cut through to release the connector, at least a portion of the central region is not cut into two pieces.

[0172] Example 15: Deployment protrusion as described in Example 13, wherein the recessed region extends across the entire width of the central region such that when the recessed region is cut through to release the connector, the central region is cut into two pieces.

[0173] Example 16: A deployment protrusion as described in any one of Examples 4 to 15, wherein at least the central region includes a series of alternating lateral ridges and lateral valleys extending across the width of the central region to provide longitudinal flexibility that allows the deployment protrusion to be rolled up, while providing lateral stiffness when the deployment protrusion is deployed.

[0174] Example 17: Deployment protrusion as described in any one of Examples 4 to 16, wherein the first region and the second region include the alternating lateral ridges and lateral valleys extending across the width of the first region and the width of the second region.

[0175] Example 18: Deployment of the protrusion as described in Example 16 or 17, wherein the at least one channel is formed by a tunnel through each lateral ridge and a tube across each lateral valley.

[0176] Example 19: Deployment protrusion as described in any one of Examples 9 to 18, wherein the cutable portion is a lateral valley.

[0177] Example 20: Deployment protrusion as described in any of the preceding embodiments, wherein the connector is anchored to the first region by being molded into the first region.

[0178] Example 21: Deployment protrusion as described in any of the preceding embodiments, wherein the connector is anchored to the first region by an adhesive.

[0179] Example 22: The deployment protrusion as described in any one of Examples 4 to 21, wherein the first region, the second region and the central region are molded from silicone resin.

[0180] Example 23: The deployment protrusion as described in any one of Examples 7 to 22, wherein at least the second region tapers toward the second opening.

[0181] Example 24: Deployment of the protrusion as described in Example 23, wherein the tapered second region includes gripping points for manipulation.

[0182] Example 25: Deployment of the protrusion as described in Example 24, wherein the gripping point includes an opening.

[0183] Example 26: A deployment protrusion as described in any of the preceding embodiments, wherein the protrusion includes a first surface and a second surface opposite to the first surface, the first surface providing an indication of the location of the cutable portion, and the second surface including a plurality of longitudinal grooves along the length of the deployment protrusion for reducing contact.

[0184] Example 27: Deployment of the protrusion as described in Example 26, wherein at least the second region and the central region are tapered, wherein a first portion of the plurality of longitudinal grooves extends from the first region through the central region to the second region, and a second portion of the plurality of longitudinal grooves extends from the first region to the central region.

[0185] Example 28: Deployment protrusion as described in any one of Examples 4 to 27, wherein the second region tapers in thickness from the edge of the second region toward the central region.

[0186] Example 29: Deployment of the protrusion as described in Example 28, wherein the thickness increases from the edge of the second region toward the central region.

[0187] Example 30: Deployment protrusion as described in any one of Examples 4 to 27, wherein the second region includes a rounded edge.

[0188] Example 31: A system comprising: a deployment protrusion as described in any of the preceding claims; and a neural interface comprising a ferrule portion for placement at least partially around a target.

[0189] Example 32: The system as described in Example 31, wherein the opening portion of the neural interface is configured to be removably connected to the deployment protrusion.

[0190] Example 33: A system as described in Example 31 or 32, wherein the clamp portion includes a ridge and at least two curved arms extending from the ridge and including electrodes, wherein each open end of the curved arm is removably coupled to the deployment protrusion.

[0191] Example 34: The system as described in any one of Examples 31 to 33, wherein the clamp portion includes a first arm and one or more second arms, the first arm being for movement along a first direction, the one or more second arms being for movement along a second direction substantially opposite to the first direction, and wherein the second portion of the connector is removably attached to the one or more second arms.

[0192] Example 35: The system as described in Example 34, wherein the one or more second arms include two arms positioned on opposite sides of the first arm, one of the two arms being aligned with a first opening of the first channel, and the other of the two arms being aligned with a first opening of the second channel.

[0193] Example 36: The system as described in any one of Examples 31 to 35, wherein the one or more second arms include a first eyelet and the other arm includes a second eyelet, and wherein the second portion of the connector is removably attached to the sleeve by passing through the first eyelet and the second eyelet to hold the first region near the sleeve until at least one of the first portion or the third portion is cut through at the cutable portion, such that the second portion of the connector can be pulled away from the sleeve.

[0194] Example 37: The system as described in any one of Examples 31 to 35, wherein the thickness of the central region of the protrusion is equal to or greater than the thickness of the neural interface.

[0195] Example 38: The system as described in Example 37, wherein the one or more second arms have an arm height in a direction perpendicular to both the width and length of the protrusion, wherein the central region has a height extending substantially parallel to the arm height, and wherein the height of the central region is greater than the arm height.

[0196] Example 39: The system as described in any one of Examples 31 to 35, wherein the width of the first region of the protrusion is equal to or greater than the width of the neural interface.

[0197] Example 40: The system as described in any one of Examples 34 to 39, wherein the clamp has a width measured from the outside of one arm to the outside of the other arm, and the width extends substantially parallel to the width of the first region, and wherein the width of the first region is greater than the width of the clamp.

[0198] Example 41: The system as described in any one of Examples 31 to 40, wherein the deployment protrusion can be configured as a measuring tool for measuring the compatibility of the neural interface with a target.

[0199] Example 42: The system according to any one of Examples 41, wherein the measurement result of matching is determined based on the distance between the ridges or grooves or valleys of the deployed protrusions.

[0200] Example 43: The system according to Example 41 or 42, wherein the measurement result of matching is determined based on the distance between the first portion of the deployment protrusion and the second portion of the deployment protrusion.

[0201] Therefore, a deployment point for a nerve clamp may be provided with a thickness and / or width slightly larger than that of the nerve clamp. The deployment point may include anchoring sutures that are wound through the deployment point and removably attached to the nerve clamp. An incision through at least a portion of the deployment point can completely detach the deployment tool from the nerve clamp. The deployment point may include a series of transverse (or lateral, along the width of the deployment point) ridges and valleys on one side, which can serve as a cutting guide and allow the deployment point to be rolled into a smaller size for delivery. The deployment point may include a series of longitudinal ridges and valleys on the opposite side, which can be used to minimize the contact surface (including when the deployment point is rolled up). The deployment point may include a tapered proximal end and is configured to be operated on as an instrument (e.g., a through / through gauge) to check whether the anatomical opening is large enough for the clamp and as a blunt dissection tool. In other words, the deployment point may be configured to provide repeatable blunt dissection around a target (e.g., a neurovascular bundle). Blunt dissection may not damage the nerve bundle. For example, at least one of the following can help the deployment protuberance to function as a blunt dissection tool: various shapes of the deployment protuberance (basic triangle or tapered / variable width); the rounded edges or corners of the deployment protuberance; and / or the tapered thickness of the deployment protuberance. If the thickness and / or width of the deployment protuberance would not be suitable for passage through the dissection, a slightly smaller nerve clamp may not fit. Anchoring sutures are positioned within the deployment protuberance such that when at least a portion of the deployment protuberance is cut, the sutures are cut, thereby releasing the deployment protuberance from the pre-attached portion of the nerve clamp.

[0202] Furthermore, the deployment protrusion can be configured to keep the arms of the releasably attached neural interface parallel, particularly during deployment. Additionally, the deployment protrusion is releasably connected to the neural interface in at least two locations: e.g., around the first opening of the first channel in the first region of the deployment protrusion and around the first opening of the second channel in the first region of the deployment protrusion, wherein the connector is configured to pass through said channel. Therefore, the deployment protrusion can prevent the arms of the releasably attached neural interface from crossing over when they pass under the neurovascular bundle during deployment. In other words, the deployment protrusion can be configured to maintain the portion of the neural interface connected to the first region parallel to the edge of the first region. The deployment protrusion can be configured to maintain portions of the neural interface connected to the first region separated from each other by a predetermined distance. The predetermined distance can be at least a portion of the width of the first region of the deployment protrusion. The predetermined distance can be the distance between the first opening of the first channel and the first opening of the second channel.

[0203] A deployment protrusion may include a thickness and width slightly greater than the thickness and length of a nerve clamp. The deployment protrusion includes an anchoring suture wound through the deployment protrusion and removably attached to the nerve clamp, such that an incision through a portion of the deployment protrusion allows for complete separation of the deployment tool from the nerve clamp. The deployment protrusion may include a tapered proximal end and is configured to operate as a through / out-of-the-way gauge. A slightly smaller nerve clamp may be mismatched if the thickness and width of the deployment protrusion would not be suitable for passage through the anatomical portion. The anchoring suture is positioned within the deployment protrusion such that when the deployment protrusion is incised, the suture is cut, thereby releasing the deployment protrusion from the pre-attached portion of the nerve clamp.

[0204] Although embodiments of the present disclosure have been shown and described with reference to various examples, the embodiments of the present disclosure are not limited to the specific descriptions contained herein. Additional alternatives or equivalent parts and elements may be readily used to implement the present disclosure.

Claims

1. A neural delivery device for delivering a neural interface device into the abdominal cavity for implantation in a patient, wherein, The neural delivery device is configured to be inserted through a sealed port of an insertion tube, wherein the neural delivery device includes an opening for the neural interface device at a distal end of the neural delivery device, wherein the neural delivery device includes a retainer near the opening for holding the neural interface device in position at the opening of the neural delivery device, and wherein the retainer is (i) provided by friction between the inner surface of the opening of the neural delivery device and the neural interface device, or (ii) provided for an interference fit with the neural interface device to be delivered, wherein the neural delivery device includes a wall positioned within the neural delivery device, and wherein the wall extends in a plane transverse to the longitudinal axis of the neural delivery device.

2. The neural delivery device as claimed in claim 1, wherein, The nerve delivery device is a delivery tube.

3. The neural delivery device as claimed in claim 2, wherein, The delivery tube is a hollow tube.

4. The neural delivery device as claimed in claim 1, wherein, The neural delivery device is a solid delivery tube, and the opening at the distal end of the neural delivery device is a hole formed in the solid delivery tube, wherein the axis of the hole corresponds to the axis of the solid delivery tube.

5. The neural delivery device of claim 4, wherein, The solid delivery tube also includes a proximal end aperture that extends from the proximal end of the solid delivery tube toward the distal end of the solid delivery tube.

6. The neural delivery device according to any one of claims 1-5, wherein, The neural delivery device includes a neural delivery device retaining feature configured to prevent the neural delivery device from passing through the insertion tube beyond a predetermined amount.

7. The neural delivery device of claim 6, wherein, The neural delivery device retains a feature including a filament passing through a transverse hole in the proximal end of the neural delivery device, wherein the transverse hole passes through the neural delivery device in a direction perpendicular to the length of the neural delivery device.

8. The neural delivery device of claim 6, wherein, The neural delivery device retains a proximal portion having an outer diameter larger than the inner diameter of the insertion tube.

9. The neural delivery device according to any one of claims 1-5, wherein, The nerve delivery device includes a proximal end with a hole at the proximal end that passes through the nerve delivery device in a direction perpendicular to its length.

10. The neural delivery device according to any one of claims 1-5 and 7-8, wherein, The nerve delivery device is made of stainless steel.

11. The neural delivery device according to any one of claims 1-5 and 7-8, wherein, The nerve delivery device is formed of a polymer material.

12. The neural delivery device according to any one of claims 1-5, wherein, The nerve delivery device includes at least one perforation and / or hole along the length of the nerve delivery device, the at least one perforation and / or hole extending in a direction transverse to the length of the nerve delivery device.

13. The neural delivery device of claim 12, wherein, The perforation and / or hole extends across the diameter of the nerve delivery device.

14. An instrument 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 for positioning within the abdominal cavity during insertion; and The neural delivery device as claimed in any of the preceding claims, wherein the neural delivery device is for insertion through the sealed port of the insertion tube.

15. The tool as claimed in claim 14, wherein, The tool also includes a neural interface device.

Images