Nerve conduit

Abstract

The invention relates to a nerve conduit for connecting an impaired nerve ending to a target site. In particular, the present invention relates to nerve conduits that support nerve injury repair and motion control and / or reduce the risk of developing a neuroma at an impaired nerve ending. Thus, a nerve conduit (10) for connecting a nerve ending to a target site is proposed, comprising an elongated body (12) formed by a wall (22) defining an internal cavity (16), and comprising: a central portion (14) wherein the internal cavity (16) extends through the central portion (14); and two end portions (18, 19) defining respective openings (20, 21) to the lumen (16), one end portion (18) being an insertion portion configured for insertion into a respective nerve ending and the other end portion (19) being a nerve ending exit portion. According to the invention, the end portions (18, 19) are arranged such that the cross-sections of the openings (20, 21) are oriented at an angle to one another.

Description

Technical Field

[0001] This invention relates to a nerve conduit for connecting damaged nerve endings to a target site. Specifically, this invention relates to a nerve conduit that supports nerve injury repair and motor control or sensory function and / or reduces the risk of neuroma development at damaged nerve endings. Background Technology

[0002] When a person is injured, tissue damage may involve one or more nerves in the peripheral nervous system, resulting in partial loss of sensation and / or impaired motor skills. Such injuries involving nerve damage occur particularly in the lower and upper limbs, such as the human hand, so that if the nerve damage is not treated properly, a person may experience, for example, loss of tactile or tactile feedback and / or difficulty controlling fine motor skills in the injured area.

[0003] Current treatments for nerve injuries involve aligning nerve endings using various suturing techniques to provide connections between corresponding nerve endings in a largely tension-free manner. If more severe defects exist, where nerve endings are not directly adjacent, reconstruction may be necessary to overcome the corresponding gaps. Reconstruction can be provided, for example, via autologous or allogeneic nerve grafts. Alternatively, reconstruction can be performed by providing tubular structures to offer luminal guidance for nerves, providing directional pathways during neurogenesis. These tubular structures, which accommodate the corresponding nerve endings, can be provided, for example, via autologous or allogeneic venous structures or via artificial nerve conduits made of biocompatible materials. The use of tubular structures can also facilitate repair of the injury, regardless of the presence of gaps, for example by providing further mechanical support and structural stability, offering tension-free repair, reducing inflammation at the injury site, and / or limiting the extent of fibrous tissue development.

[0004] However, in clinical situations where distal nerve endings are lost, such as due to amputation or tissue removal, such connections between nerve endings are impossible. This not only complicates treatments that at least partially restore motor control or sensory function but may also increase the risk of neuromas, which can form at the site of the severed nerve ending. Such neuromas may form from disordered axonal growth that extends beyond the severed epineurium sheath of the transverse nerve ending, attempting to re-innervate distal muscles or skin, for example, after severe trauma or surgery. In such cases, axonal germination may form a bundle of disordered and overexcited neural tissue (called a neuroma) lacking the original neural structure. Neuromas are commonly associated with neuropathic pain, numbness, and tingling, and may also interfere with rehabilitation, functional recovery, and sensory deficits. Treatment or prevention attempts for neuromas may be based on suturing the proximal end of the damaged nerve to a specific motor nerve that is now fully denervated into a muscle. This suturing technique can at least partially restore muscle control while reducing the risk of neuroma development.

[0005] Alternative surgical procedures have been proposed for repairing peripheral nerve injuries where the distal nerve stump is unavailable, there is a significant nerve gap, or the nerve is transversely cut too far from the target organ, muscle, or skin. For example, end-lateral (ETS) nerve repair, in which the distal stump of the damaged nerve is sutured to the side of the undamaged nerve (Lykissas, 2011, World Journal of Orthopaedics, Vol. 2, No. 11, pp. 102-106).

[0006] Another surgical procedure called targeted muscle nerve re-innervation (TMR) is a surgical nerve transfer. In TMR, residual nerves from the amputated limb are transferred to a new muscle target. As part of the nerve transfer, the target muscle is decoupled from its original motor nerve inputs, allowing the newly transferred nerves to re-innervate them. (Bergmeister et al., 2021, Clinical Hand Surgery, Vol. 37, No. 3, pp. 415-424; Janes et al., 2021, Clinical Hand Surgery, Vol. 37, No. 3, pp. 345-359.) Summary of the Invention

[0007] Based on existing technologies, there is a need to further promote the repair of nerve damage, especially after amputation, where nerve damage has led to nerve endings that can form neuromas or cause phantom limb pain.

[0008] According to the present invention, it has been recognized that attaching proximal or distal nerve endings of a nerve (particularly a damaged nerve) to the side of a target muscle tissue, target organ, or target nerve can be difficult and / or may not provide satisfactory results, for example, to restore (partial) motor control and / or sensory function and / or avoid neuroma development and / or lead to regeneration of the damaged nerve. Suturing nerve endings may result in undesirable tissue damage and / or may complicate the proper orientation of the proximal nerve ending's terminal portion, resulting in impaired expected restoration of motor control or nerve occlusion. Furthermore, in the case of attachment to target muscle tissue, the suturing technique entering the muscle tissue may complicate effective fixation of the nerve endings. Alternative fixation methods using, for example, medical adhesives have been found to have limited success rates because the surface available for application is small. The required curing time may also lead to loss of proper positioning of the corresponding nerve endings and / or overall failure of attachment.

[0009] Therefore, the object of this invention is to further promote the repair of nerve injuries, and in particular to promote the proper fixation and positioning of nerve endings to target tissues (e.g., muscles, bones, or skin) or the lateral aspect of target organs or target nerves (collectively, the target site). A specific object of this invention may be to promote the connection of proximal nerve endings to target muscles or skin in an effective and efficient manner to restore motor control and / or sensory feedback and / or prevent neuroma development. Another object of this invention may be to promote the connection of proximal nerve endings to the lateral aspect of target (undamaged) donor nerves using an effective and efficient end-to-side (ETS) nerve repair method. Another object of this invention may be to promote the connection of nerve endings to organs (e.g., transplanted organs such as the heart, liver, and kidneys). The nerve conduit according to the invention is able to provide adequate support for damaged nerve endings along its natural longitudinal extension.

[0010] The objective is achieved by the independent claims. Preferred embodiments are described in the dependent claims, the specification, and the drawings.

[0011] Accordingly, a nerve conduit for connecting nerve endings (e.g., damaged nerve endings) to a target site (e.g., target tissue, target organ, or side of a target nerve) has been proposed, comprising an elongated body formed by a wall defining an inner lumen. The elongated body includes: a central portion through which the inner lumen extends; and two end portions defining respective openings into the inner lumen, one end portion being an insertion portion configured for inserting a respective nerve ending, and the other end portion being a nerve ending exit portion. According to the invention, the end portions are arranged such that the cross-sections of the openings are oriented at an angle to each other.

[0012] The nerve conduit typically includes a tubular shape, wherein the walls form an inner chamber or lumen with openings to provide a continuous channel or through-hole. In other words, the walls form a longitudinally extending elongation, wherein a (fluid) connection or communication between the exterior and the lumen is provided via corresponding openings at the end portions before insertion of a nerve ending and connection of the nerve conduit to a target site. According to a preferred embodiment, the walls are continuous between the end portions, such that the nerve conduit includes only the two openings. Therefore, the nerve conduit preferably does not include further openings, and / or the lumen does not include bifurcations or additional branches between the two end portions. This allows for a more uniform lumen and can facilitate directional nerve growth from the insertion portion to the exit portion. The exit portion is preferably understood to define an opening remote from a nerve ending that can be inserted at the proximal insertion portion, wherein the exit portion allows a nerve ending inserted at the same proximal end to grow to or extend beyond the level of the exit opening.

[0013] The planes of the end faces of the elongated bodies are also arranged at an angle to each other due to the angle between the cross-sections of the openings, so that they are not parallel. Therefore, it is advantageous to provide that nerve endings housed within the lumen (preferably within the central portion via the insertion portion) can connect to a target site, wherein the angle at the exit portion provides improved mechanical stability for the nerve conduit to attach to the target site. For example, the exit portion can be provided as a portion of the elongated body extending at an angle relative to the central portion, or it can be provided as a truncated portion of the elongated body. Thus, the corresponding end face of the elongated body at the exit portion can define a support surface that provides horizontal structural support at least in a direction substantially perpendicular to the direction defined by the insertion portion and / or the central portion.

[0014] To at least partially facilitate the recovery of motor control and / or sensory feedback and / or prevent neuroma development, the outlet portion is preferably configured to connect to muscle tissue. The muscle tissue may be, for example, a denervated target muscle adjacent to or near the corresponding damaged nerve endings, and facilitates motor control of the injured anatomical structure (e.g., the arm). Therefore, the outlet portion may be specifically configured to attach to the top of the muscle tissue. Alternatively, the muscle tissue may provide effective tissue for reducing the occurrence of neuroma development, where embedding the corresponding nerve endings within the muscle may be particularly advantageous. In this arrangement, the outlet portion may, for example, be inserted into an internal recess or slit within the muscle tissue, or placed on top of the muscle tissue.

[0015] Alternatively, the outlet portion can be configured to connect to the lateral side of the nerve. This alternative is the end-lateral (ETS) nerve repair known in the art, in which the distal stump of the transected nerve is occluded to the lateral side of the undamaged donor nerve. It provides a technique for repairing peripheral nerve injuries where proximal nerve stumps are unavailable or where significant nerve gaps exist.

[0016] Therefore, the angle at the exit portion not only provides improved fit to the target anatomy, but also, in particular, allows for the provision of a guiding surface to direct nerve endings through the central portion to the exit portion, where the angle enables the nerve endings to connect to the target site at a corresponding angle. Thus, nerve endings can connect to adjacent target sites, for example, in a substantially side-by-side manner, without requiring the bending of damaged nerve endings.

[0017] To facilitate attachment to the target site, the angle between the cross sections is preferably between 30 and 90 degrees. Specifically, the angle between the cross sections can be between 50 and 90 degrees, or between 70 and 90 degrees, or approximately 90 degrees, such that the cross sections of the opening are oriented substantially perpendicularly to each other. As mentioned above, this angle not only provides improved fit to the target site but also reduces the load applied to the nerve conduit and the damaged nerve endings housed therein. Furthermore, the preferred angle facilitates attachment to the target site without requiring bending of the nerve endings.

[0018] In this regard, the outlet portion can be provided, for example, as a truncated portion of an elongated body, wherein the plane of the end face of the elongated body at the level of the outlet opening can be at an angle of 30 to 70 degrees (e.g., 50 degrees) relative to the plane or cross-section defined by the opening of the insertion portion. While a larger angle can also be provided by a corresponding truncation, an angle of 70 degrees (or less than 70 degrees) to 90 degrees is preferably formed by the elongated body as an extension at an angle relative to the central portion. This larger angle can also facilitate lateral attachment of the nerve ending to the target site, wherein a substantially 90-degree angle or vertical orientation is particularly advantageous.

[0019] Preferably, the insertion portion is arranged adjacent to the central portion, and the outlet portion is arranged on the opposite side of the central portion. This arrangement adjacent to the central portion is advantageous for the insertion of nerve endings and particularly facilitates the insertion and / or accommodation of nerve endings in the central portion. The insertion portion and the central portion may, for example, define a common longitudinal axis of the elongated body, such that the nerve endings can be accommodated in an extended and substantially continuous manner.

[0020] The arrangement of the outlet portion on the opposite side of the central portion helps to guide nerve endings from the central portion to the outlet portion. However, the outlet portion does not necessarily have to be adjacent to the central portion, but can be arranged, for example, in the middle portion of the elongated body connecting the central portion and the outlet portion.

[0021] To facilitate the angular orientation of the cross-sections or planes of the openings relative to each other, the elongated body may include a transition portion adjacent to the central portion and forming an outlet portion, wherein the transition portion defines a curved portion of the elongated body and / or extends at an angle relative to the central portion. Thus, the transition portion may form an intermediate portion between the outlet opening and the central portion, wherein the transition portion includes the outlet portion on the side opposite to the central portion.

[0022] Due to the bend or angle defined by the transition portion (which preferably also defines the angle between the cross-sections or planes of the insertion portion and the outlet portion), the outlet opening and the insertion opening are not arranged at opposite longitudinal ends of the elongated body. However, this arrangement can be provided in a configuration where the outlet portion is formed as a truncated portion of the elongated body.

[0023] To promote the growth of damaged nerve endings toward the target site, the cross-section of the portion of the lumen defined by the transition section can gradually increase in the direction away from the central portion. For example, the walls can be formed and their dimensions designed such that the cross-section of the lumen gradually increases from the central portion toward the exit portion. Thus, ensuring that the cross-section or diameter of the transition section is always larger than the diameter of the central portion, the growth of nerve endings is not impaired and is promoted toward the exit portion.

[0024] Alternatively, the walls defining the transition portion may be specified to converge at least partially toward the exit portion. Thus, the transition portion may define a cross-section that gradually decreases inward toward the central portion, which can be configured to guide nerve ending growth toward or beyond the exit portion, for example, to reduce neuroma incidence without restoring nerve ending functionality. For example, a portion of the transition portion may extend at an angle relative to the central portion, while the opposing portion extends substantially linearly. Therefore, the longitudinal extension of the transition portion relative to the central portion and / or the insertion portion may also be specified to be reduced. In particular, the exit portion and / or the transition portion may include a conical or funnel shape.

[0025] While the opening of the outlet portion can have various shapes, such as circular, it is preferably formed as an ellipse. This elliptical shape has been found to be advantageous for attachment to the target site, for example, by providing improved fit for the longitudinal extension of the nerve. In other words, the ellipse is preferably arranged such that its maximum diameter extends in the growth direction of the nerve ending. Furthermore, the elliptical shape of the outlet portion opening can promote nerve growth towards the target site.

[0026] Preferably, the ratio between the maximum and minimum diameters of the opening in the outlet portion is 1:1 to 4:1, more preferably 1.1:1 to 2.5:1. This elliptical extension of the opening has been found to be particularly advantageous for promoting growth toward the target site. Furthermore, this extension can provide improved fit to the target site (e.g., undamaged nerve endings or muscle tissue).

[0027] The minimum diameter of the opening of the outlet portion can substantially correspond to the diameter of the lumen defined by the central portion. Since the diameter of the lumen can be adapted to the diameter or size of the damaged nerve ending to be accommodated, the opening does not restrict the growth of the nerve ending.

[0028] The wall of the elongated body is preferably a single tubular wall comprising a substantially continuous thickness. Therefore, any variation in the cross-sectional area of ​​the lumen and / or opening is preferably defined by the extension and dimensional design of the wall, rather than by varying thickness. This provides improved structural stability and integrity throughout the elongated body and also provides similar material properties, such as a certain level of flexibility or rigidity, along the (longitudinal) extension of the elongated body, thus facilitating manipulation during nerve conduit implantation. Furthermore, continuous thickness facilitates fabrication and can reduce the total amount of material required for the nerve conduit.

[0029] While the central portion can be provided in various shapes, the lumen defined by the central portion preferably comprises a continuous cross-section. In particular, the central portion may comprise a substantially cylindrical shape. Thus, the central portion can form a substantially straight section for the nerve ending housed therein, defining a longitudinal axis. Therefore, the housing and support of the nerve ending can be improved, especially when the diameter of the lumen is adapted to the corresponding diameter of the nerve ending to be connected to the target site. A constant inner diameter also provides an improved guiding surface for axonal growth during nerve regeneration. Preferably, the central portion comprises a continuous wall thickness in both the circumferential and longitudinal directions, such that the inner and outer diameters of the central portion are preferably substantially continuous.

[0030] The cross-section of the inner cavity of the central portion, and preferably the cross-section of the opening of the insertion portion, is preferably circular or elliptical. A tubular or cylindrical shape can provide improved structural stability and prevent sharp bending or kinking during tissue movement (i.e., compression or stretching). Therefore, a tubular shape can also provide a uniform structure that responds in a predefined manner along the entire central portion when forces are applied (e.g., during impact).

[0031] To accommodate the corresponding diameter of nerve endings, the diameter of the lumen defined by the central portion is preferably from 1 mm to 12 mm, more preferably from 1.5 mm to 6.5 mm. Therefore, the nerve conduit is particularly advantageous for accommodating nerve endings, for example, in the upper or lower limbs of a patient, and for restoring fine motor control and / or sensory feedback and / or preventing neuroma development.

[0032] Therefore, the lumen can be adapted and its dimensions designed to accommodate the corresponding diameter of the nerve or nerve ending. For example, the diameter of the lumen can be 1 mm and 12 mm, depending on the diameter of the nerve (ending). To accommodate smaller nerves, the diameter of the lumen can be, for example, 1.5 mm and 6.5 mm. These dimensions have been found to be particularly advantageous for providing the necessary support for the growth or repair of nerve endings and / or nerves. The extension of the walls and the lumen in the longitudinal direction (which may be defined by the central portion and / or the insertion portion, and / or along the overall path defined by the lumen) is greater than 2.5 mm, preferably 5 mm and 30 mm, and more preferably 5 mm and 25 mm. These dimensions may also be particularly advantageous for bridging nerve defects or injuries. Thus, desired or predefined dimensions can provide a continuous guiding structure for internal anatomy, which is particularly advantageous for guiding and / or promoting neurogenesis and / or preventing neuromas.

[0033] According to one embodiment, to promote the growth of the accommodated nerve endings and their connection to the target site, the cross-sectional area of ​​the opening of the outlet portion can be larger than the cross-sectional area of ​​the lumen of the central portion. As described above regarding the transition portion, this enlargement ensures that the diameter of the opening of the outlet portion is greater than or equal to the diameter of the central portion, thereby minimizing unintentional damage to growth, such as unintentional obstruction or directional bias of nerve endings. Therefore, this increase in the cross-sectional area of ​​the outlet opening is preferably provided by a corresponding increase in the cross-sectional area of ​​the transition portion extending from the central portion, i.e., when the portion of the wall defining the transition portion does not converge. By providing an enlarged cross-sectional area of ​​the outlet opening, the outer diameter of the wall defining the outlet portion can be larger than the outer diameter of the wall defining the central portion, and preferably also larger than the outer diameter of other portions of the elongation.

[0034] Depending on the configuration of the nerve conduit, such as having a bend or a truncated elongation at the outlet portion, providing a suitably enlarged outlet opening can have the advantage of allowing observation or examination of nerve endings after insertion into the lumen via the insertion portion. Specifically, the corresponding nerve ending can be accommodated within the lumen via the corresponding insertion portion and can extend through the lumen toward the corresponding outlet portion. Although the nerve ending preferably terminates at the junction between the outlet opening or transition portion and the lumen defined by the central portion, the nerve ending can alternatively be inserted all the way into the outlet portion, terminating there, thereby allowing for better observation of the nerve ending through the outlet portion. Therefore, proper insertion of the nerve ending can be monitored before connection to the target site, and medical adhesive can be optionally applied.

[0035] More preferably, the cross-sectional area of ​​the opening of the outlet portion can increase in the direction away from the central portion. This extension can lead to adaptation to improved target site anatomy, especially when the outlet opening is formed as an ellipse.

[0036] The maximum diameter of the outlet opening can be 1 mm to 23 mm larger than the diameter of the inner cavity defined by the central portion, preferably 1.5 mm to 17 mm larger. The maximum diameter of the outlet can simply correspond to the maximum diameter of the opening in the case of a circular opening, but particularly it can correspond to the maximum diameter of an opening with an elliptical shape, while the inner cavity defined by the central portion preferably includes a circular cross-section. Therefore, improved directional growth can be facilitated in the direction corresponding to the extension of the elliptical opening.

[0037] The cross-sectional area of ​​the opening of the outlet portion is preferably larger than that of the opening of the insertion portion. Therefore, directional growth of nerve endings toward the outlet portion and its opening can be promoted, and the insertion and outlet portions can be appropriately indicated by the corresponding dimensions based on the cross-sectional area, thereby facilitating the manipulation of the nerve conduit.

[0038] To facilitate attachment of the exit portion of the nerve conduit to the target site, the outer diameter of the wall defining the exit portion is preferably larger than the outer diameter of the wall defining the central portion, and preferably also larger than the outer diameter of other portions of the elongated body. Therefore, a flange portion can be formed from the wall at the exit opening, wherein the flange portion extends radially outward from the exit opening. In particular, the flange portion can extend substantially within a plane defined by the cross-section of the exit opening.

[0039] In other words, the wall can extend radially outward from the outlet opening. Preferably, the wall can extend substantially perpendicular to the central axis defined by the elongator at the level of the outlet opening or at the corresponding end face of the elongator. However, in the case of a truncated portion of the elongator forming the outlet portion, the angle can be adapted accordingly such that the extension of the radially outward projecting wall portion is substantially within the plane defined by the end face of the wall of the outlet portion.

[0040] The flange portion at the outlet opening is substantially perpendicular to the cross-section of the outlet opening. As used herein, the expression "substantially perpendicular" includes a slight deviation from perpendicularity (90°), wherein the deviation is preferably no more than 10°, preferably no more than 7°, more preferably no more than 5°, and even more preferably no more than 3°. In some embodiments, the deviation angle is 0.5° to 10°, preferably 1° to 5°, and more preferably 1.5° to 3°.

[0041] According to another embodiment, the flange portion may extend along a curved surface defined by an angle of a central axis defined by the elongator at the level of the outlet opening or at a corresponding end face of the elongator, the angle decreasing in the radial direction. This embodiment may be particularly suitable for end-side applications.

[0042] While a generally vertical arrangement of the flange portions is particularly advantageous for attaching the nerve conduit to the target site, lower angles, such as 40 to 70 degrees or 45 to 65 degrees, can also be provided to offer a more gradual increase in the outer diameter at the outlet portion. Thus, a variety of angles (including angles greater than 90 degrees) can be provided, which may depend on a predefined or desired longitudinal and maximum radial extension of the outlet portion relative to the central portion or its lumen. This longitudinal and radial extension may depend on the target site and surrounding tissues, particularly on the contact or retaining surfaces required for proper attachment to the target site.

[0043] The wall defining the flange portion is preferably continuous with the adjacent wall portion defining the outlet portion or transition portion, and may be rounded at the respective interface. Therefore, the wall portions may be aligned or flush with the respective outer surfaces, and preferably have no steps or edges.

[0044] The flange portion facilitates connection to the target site due to the correspondingly increased surface area. This not only enhances the potential retention force between the outlet portion and the target site but also promotes the correct application of, for example, medical adhesives by indicating and / or defining a more prominent target application surface for medical adhesives. The increased end-face surface provided by the flange portion also makes it easier to correctly position and orient the nerve conduit and the nerve endings contained therein relative to the target site (e.g., denervated muscle or muscle segment (e.g., muscle flap), nerve side, bone, or organ), while providing enhanced stability and support during nerve conduit placement.

[0045] The flanged portion further facilitates the identification of the corresponding end portion, allowing surgeons to easily understand which end portion is used to insert the nerve ending and accommodate it within the insertion section and lumen. In this regard, after the nerve ending is properly inserted into the corresponding insertion section, the nerve ending corresponding to the nerve injury can be secured to the nerve conduit, ensuring that the medical adhesive or other means used to secure the nerve ending to the nerve conduit have been correctly applied. Therefore, the nerve ending can be secured or attached to the nerve conduit before it is connected to the target site.

[0046] Furthermore, the wall portion (or its material) defining the flange portion and / or outlet portion can also be flexible to provide an adaptive level of adaptation to the target site anatomy. In this regard, according to a preferred embodiment, "target site" in the present invention generally refers to tissue, such as muscle, preferably denervated muscle or muscle portion (e.g., muscle flap), nerve side, bone, or organ. In some aspects, target muscle tissue is used for amplification of outgoing signals controlled by the prosthesis. Therefore, flexibility of the flange portion may be particularly advantageous when applied over undamaged nerve or muscle tissue, as it provides a certain level of adaptation to the outer surface of the target site and the corresponding anatomy.

[0047] Similarly, flexibility may be advantageous for (partially) inserting the flange portion and / or the outlet portion into a slit in the muscle tissue, wherein the slit in the muscle tissue may extend, for example, substantially perpendicular to the plane of the outlet opening, such that at least the flange portion may extend at least partially into the slit. Thus, the flange portion may alternatively be configured to be received within the slit and at least partially covered by the muscle tissue, thereby providing an interference fit or positive locking.

[0048] The flange portion preferably at least partially surrounds the outlet opening. Specifically, the flange portion may completely surround the outlet opening, or preferably surround at least half of the circumference of the outlet opening. The configuration where the flange portion completely surrounds the outlet opening has the advantage of providing a continuous support surface in the circumferential direction, with no gaps along the circumference. This configuration can be advantageous for operational purposes and for improving structural stability. Furthermore, this configuration can improve the external sealing function of the outlet portion relative to the axonal growth of nerve endings housed within the lumen. Similarly, this configuration substantially prevents surrounding tissue from potentially impairing nerve growth.

[0049] The flange portion may include a basic rectangular portion, preferably a basic rectangular portion with rounded corner edges. The orientation of the rectangular shape can advantageously correspond to the orientation of the outlet opening extension, particularly when the outlet opening has an elliptical shape. Thus, the maximum extension of the rectangular shape can correspond to the maximum extension of the elliptical outlet opening diameter. Therefore, the size of the flange portion can be reduced while ensuring a substantially continuous flange portion along the circumference of the outlet opening. The rounded corner edges can also reduce unintentional friction or engagement with the target area, and / or the size of the flange portion can be further reduced and made to conform to the elliptical shape of the outlet opening.

[0050] The flange portion may further include a triangular portion oriented in the direction toward the insertion portion. This triangular portion may have the advantage of providing a level of flange portion flexibility, enabling improved adaptability and / or fit of the flange portion to the target site. Furthermore, the arrangement of the triangular portion, which may be substantially parallel to the longitudinal axis defined by the central portion and / or the insertion portion and extend in the direction of the insertion portion, ensures that the insertion and manipulation of nerve endings are not impaired by the flange portion, because the dimensions of the triangular portion can be designed so that it does not extend beyond the insertion portion, and its radial dimension relative to the insertion portion and the central portion is reduced due to its triangular shape. The triangular portion may particularly extend from the rectangular portion of the flange portion.

[0051] The flange portion may include a generally circular or elliptical portion. The orientation of this shape can advantageously correspond to the orientation of the outlet opening extension, particularly when the outlet opening has an elliptical shape. Thus, the maximum extension of the elliptical shape can correspond to the extension of the maximum diameter of the elliptical outlet opening.

[0052] The outer surface of the flange portion may include one or more retaining surfaces, such as an external structure having at least a specific geometry or surface irregularity, configured to secure a medical adhesive to the flange portion. According to a particular embodiment, a plurality of holes (e.g., elliptical or circular), such as 2 to 20 holes, may be formed, wherein the holes may advantageously be spaced apart (equidistantly) on the flange portion.

[0053] In an alternative embodiment, the wall defining the flange portion can be formed as a plurality of radially outwardly extending arms spaced apart from each other in the circumferential direction. Therefore, gaps can be provided in the circumferential direction, allowing each arm to form an individual contact surface with the target tissue. This provides an improved level of flexibility and adaptability to the target tissue anatomy, while allowing the medical adhesive to be applied in such a manner that the number of edges covered by the medical adhesive and the contact surface with the target tissue can both be increased. Furthermore, providing individual arms facilitates the insertion of the end face of the flange portion into a slit or recess in the target tissue, or the placement of the flange portion on top of a muscle, if such a connection is preferred for the corresponding treatment and / or the anatomy of the target tissue.

[0054] Preferably, each of the arms has a circumferential extension of 10 to 150 degrees. This circumferential extension provides sufficient structural stability and connectivity while offering a favorable level of flexibility and adaptability to target tissue. The circumferential extension can be adapted to the number of arms and / or a predefined gap extension.

[0055] The arms are preferably equidistant from each other in the circumferential direction. This spacing also provides a uniform connection to the target tissue.

[0056] However, other arrangements of the arms may also be provided, in which pairs or multiple adjacent arms are arranged along corresponding radial axes, wherein the two or more radial axes may be provided at predefined angles to each other. This configuration may be advantageous for the corresponding extension of the target tissue anatomy, for example, when the target tissue has a more pronounced extension in a particular direction and / or when it is desired to connect to a specific portion of the target tissue.

[0057] An inner edge portion may also exist at the outlet opening, formed by a wall and extending radially inward into the outlet opening. Therefore, the inner edge portion may extend in or parallel to the plane of the outlet opening. The inner edge portion may provide structural support at the target site, preferably in addition to the flange portion. Alternatively, the inner edge portion may also provide adjustment for the diameter and / or cross-sectional area of ​​the outlet opening. Thus, the inner edge portion may allow the diameter of the outlet opening to be smaller than, for example, the diameter of the lumen defined by the central portion, to ensure that nerve endings housed in the nerve conduit grow in the correct direction, i.e., out of the outlet portion.

[0058] To improve support and / or adequately define the outlet opening, the inner edge portion may extend between one-third and two-thirds of the inner circumference of the wall. Specifically, the inner edge portion may extend in a semi-circular manner along approximately half of the inner circumference, or alternatively, it may extend along the entire inner circumference. The inner edge portion may have a reduced thickness compared to the wall thickness of the elongation, for example, compared to the wall thickness of the outlet portion, central portion, and / or insertion portion.

[0059] To facilitate the insertion of nerve endings via the insertion portion, the cross-sectional area of ​​the opening of the insertion portion can be increased in the direction away from the central portion. This configuration of the insertion portion can also exist in embodiments where the cross-sectional area of ​​the outlet opening is larger than that of the opening of the insertion portion.

[0060] The insertion portion and its opening can be formed into a rotationally symmetrical shape along a longitudinal axis, wherein the shape is preferably conical, concave, funnel-shaped, trumpet-shaped, or parabolic. The longitudinal axis is preferably defined by a central portion or its cavity. The increase in the opening is preferably gradual and uniform in all radial extensions. For example, the opening can have a circular cross-section along the entire longitudinal direction of the corresponding end portion, wherein the diameter of the circle gradually increases. This shape also has the advantage that, during implantation, the insertion of the nerve ending is uniformly guided by the inner surface of the wall defining the insertion portion. However, other shapes, such as ellipses, can also be provided, wherein the (gradual) increase in the opening is provided by an increase in at least one radial extension.

[0061] The rotationally symmetrical shape of the insertion portion also ensures that the mechanical properties of the exit portion are substantially the same in the circumferential direction. The preferred shape of the insertion portion and the gradually extending opening further facilitate the fixation of nerve endings to the nerve conduit by providing corresponding interface surfaces and recesses (e.g., for applying medical adhesives).

[0062] The walls forming the elongated body are preferably continuous in the circumferential direction. Therefore, as described above, the nerve conduit is preferably formed as a single continuous tubular structure, forming a closed structure.

[0063] Alternatively, the wall forming the elongated body may be discontinuous in the circumferential direction, wherein the nerve conduit is formed as a medical tissue wrapping. Thus, the wall is wound only in the circumferential direction and is at least partially unwound and rewound in the circumferential direction.

[0064] In other words, the walls of the overall defining elongated body can be discontinuous in the circumferential direction, allowing the elongated body to be opened and used to wrap around nerve endings. This configuration may be advantageous for operational purposes and to facilitate nerve insertion into the insertion portion.

[0065] To ensure that the elongated body forms a substantially closed structure while the wall is wound, the circumferential outer wall portion may at least partially overlap with the circumferential inner wall portion. Both the circumferential inner and outer wall portions may also have reduced wall thicknesses, such that the overlapping portions preferably together constitute the wall thickness corresponding to the remaining portion of the elongated body.

[0066] Therefore, the circumferential extension of the outer end preferably corresponds substantially to the circumferential extension of the inner end of the wall, such that the outer portion (completely) overlaps the inner portion. This avoids circumferential gaps around the wall, ensuring that nerve endings contained within the lumen are held within the nerve conduit and substantially completely covered and / or surrounded circumferentially.

[0067] The circumferential outer end is preferably formed by a single layer of wall overlapping the circumferential inner end. Therefore, the application of the nerve conduit can be significantly simplified compared to a configuration having multiple adjacent layers overlapping each other in the radial direction. According to a preferred embodiment, the circumferential outer end does not have any direct contact with the circumferential inner end.

[0068] Preferably, the wall can be fully unwound, such that in the unwound state, the wall can define a sheet-like structure extending only in the longitudinal direction. By ensuring that the wall is unwound, it can be wrapped around the internal nerve endings to be treated (e.g., damaged nerves) and can be rewound after the wall is correctly positioned.

[0069] The wall can be at least partially formed of an elastic or flexible material, preferably a three-dimensionally printable material. This elasticity not only facilitates providing the desired level of support and / or flexibility to accommodate the movement of surrounding tissue, but also promotes the unwinding and rewinding of the wall to apply the nerve conduit wrapping around the nerve to be treated. This elasticity can be provided, for example, through three-dimensional printing, where localized stresses in the material can provide corresponding biasing forces.

[0070] To securely attach nerve endings to the nerve conduit and to the target site, it may be necessary to use medical adhesives or similar methods at the respective insertion and exit portions. To facilitate attachment, the exit portion and / or the insertion portion preferably have a greater surface roughness at the outer surface of the wall than the outer surface of the defining central portion of the wall. Alternatively or additionally, the outer surface of the wall defining the insertion portion may include structured outer surface modifications.

[0071] Structured external surface modification and / or increased surface roughness have the advantage of improving the adhesive strength of optionally applied medical adhesives at the corresponding external surface, thereby enhancing the fixation and / or anchoring of the medical adhesive on the corresponding surface. For example, the external wall surface can provide an increased surface area and / or provide a form fit for the applied medical adhesive, and / or improve adhesion by changing surface tension. Therefore, medical adhesives applied to the external wall surface and adjacent tissues (i.e., nerve endings and target sites) can ensure that nerve endings and / or nerve conduits are held in place and fixed in place.

[0072] Compared to the wall thickness of the central portion, structured outer surface modifications can be formed on the thickened wall portions of the corresponding end portions. For example, the thickness of the thickened wall portions can be 1.1 to 5.0 times, preferably 1.5 to 2.5 times, the thickness of the central portion and / or the outlet portion. The thickened wall portions can be 100 μm to 600 μm, preferably 300 μm to 500 μm, while the unmodified wall portions can, for example, include a thickness of 50 μm to 400 μm, preferably 150 μm to 250 μm.

[0073] The wall portion of the flange may, for example, include a thickness of 50 μm to 400 μm, preferably 150 μm to 250 μm.

[0074] Alternatively, a continuous and substantially uniform wall thickness can be provided, in which a structured outer surface modification is embedded. In this case, the overall wall thickness can be adapted to the structured outer surface modification to ensure structural stability at the modified portion, for example, having a minimum wall thickness of about 50 μm, preferably (at least) 50 μm to 200 μm.

[0075] The structured external surface modification preferably forms one or more retaining surfaces, such as external structures at least partially having a specific geometry or surface irregularity, configured to secure the medical adhesive to the insertion portion. Thus, the medical adhesive already applied to the insertion portion and / or the adjacent tissue portion housing the damaged nerve ending can remain in situ without any significant movement, even after the medical adhesive has cured. In other words, by means of retaining surfaces, the medical adhesive can be fixed in place, preferably in a form-fitting manner with one or more retaining surfaces. The retaining surfaces can provide an increased contact surface with the medical adhesive. Furthermore, they can provide a predefined surface roughness, thereby improving the effectiveness of the adhesion between the medical adhesive and the insertion portion. Therefore, by the shape and / or surface of the retaining surfaces, loosening or slippage of the medical adhesive can be effectively prevented.

[0076] In other words, such an external structure can advantageously (i) increase the contact between the surface of the insertion portion and the adhesive; and / or (ii) create anchor points for the adhesive. Such an external structure is disclosed, for example, in patent application PCT / EP2022 / 061084, the contents of which are incorporated herein by reference in their entirety.

[0077] Preferably, the one or more retaining surfaces are formed as at least one groove extending in a helical direction along a longitudinal axis defined by the wall. The helical shape may define a thread extending along the outer surface of the insertion portion.

[0078] While the one or more grooves may define sharp edges, the at least one groove preferably includes rounded edges. Rounded edges should be understood to mean that there are no straight (angled) edges or steps at the interface between the top outer surface of the insertion portion and the opposite bottom surface of the groove, but rather a gradual transition at the corner surface of the groove. With the aid of rounded edges, stress within the wall material can be reduced, thereby reducing the occurrence of cracks or fractures. Therefore, providing rounded edges can also reduce the wall thickness required to support the groove, at least at the insertion portion.

[0079] For the rounded edges, alternatively or (preferably) additionally, the at least one groove may define at least one undercut. Providing an undercut can improve the anchoring of the medical adhesive to the insertion portion. The undercut may be formed such that the bottom of the groove is at least partially covered by the outer surface of the wall. That is, the outer wall surface may extend at least partially over the groove in the longitudinal direction. Preferably, this extension forms an angle of 45 to 90 degrees (between the bottom of the groove and the sidewall), preferably 60 to 85 degrees, more preferably 70 to 80 degrees, and even more preferably about 75 degrees. Therefore, the form fit or positive locking between the applied medical adhesive and the insertion portion can be improved.

[0080] To reduce the radial extension of the elongated body and the entire nerve conduit, the at least one groove may define the outermost edge of the insertion portion in the longitudinal direction of the wall. Therefore, the groove may terminate at the longitudinal end face of the wall and extend circumferentially at said end face, such that the radial extension can be reduced at said end. Thus, the overall size of the nerve conduit can be reduced. Alternatively, the groove may also terminate at a longitudinal offset from said longitudinal end face, which may be advantageous for further improving structural stability.

[0081] The depth or thickness of the groove can be substantially constant along the circumferential direction and along its entire longitudinal extension.

[0082] The extension and / or angle of the at least one groove may vary.

[0083] Preferably, the at least one groove extends 0.5 to 10 turns around the longitudinal axis defined by the wall, thus providing a helical structure. Preferably, the groove extends more than one turn around the longitudinal axis defined by the wall. In particular, the number of turns can be 2 to 6, preferably 3 to 5 or 4.

[0084] In some embodiments, the insertion portion may include a single groove. In other embodiments, the insertion portion may also include at least two grooves. Particularly when two or more grooves are provided in the same longitudinal end portion, each groove may extend 0.5 to 5 turns around the longitudinal axis. The at least two grooves may extend in parallel, for example, forming two or more parallel (non-intersecting) helices. Therefore, the arc length, curvature, and torsion of the parallel grooves / helices are preferably the same, such that they differ only in their position on the insertion portion. Preferably, the distance between the two or more parallel grooves / helices is regular (i.e., substantially the same).

[0085] In some embodiments, at least two grooves may extend in opposite circumferential directions and intersect each other. The two embodiments may also be combined, i.e., two or more grooves extending in parallel, and two or more additional grooves extending in opposite circumferential directions, optionally also in parallel (such that the parallel intersecting grooves provide a "checkerboard" or "pineapple" pattern). The number of grooves in each circumferential direction may be 1 to 10, and preferably 6 to 8 or 7, depending on the longitudinal extension of the insertion portion and the angle of the grooves. Furthermore, the number of grooves in each circumferential direction is preferably equal. Moreover, at the insertion portion, the grooves / spirals preferably differ only in their orientation (and position on the insertion portion), but preferably not in other helical parameters. In other words, for all grooves / spirals at the insertion portion (except for the direction of intersecting spirals), the arc length, curvature, and torsion may be substantially the same. By providing multiple grooves (e.g., two or more grooves) in each circumferential direction, a rhomboid or diamond-shaped pattern, possibly resembling a pineapple surface, is provided at the outer surface of the corresponding longitudinal end portion. Therefore, multiple retaining surfaces with numerous edges can be provided, which may be advantageous for securing medical adhesives to the insertion portion.

[0086] In some embodiments, the one or more retaining surfaces may be formed as one or more circumferential ribs (elongated projections) extending from the outer surface of the wall. The extension of the one or more ribs may be linear with respect to the circumferential direction (e.g., parallel to the circumferential direction), or may include offsets in the longitudinal direction of the wall relative to the circumferential direction (e.g., diagonal, not parallel to the cross-section and forming an ellipse). Preferably, in the case of multiple ribs (e.g., 3 to 6) at the insertion portion, the ribs may be equidistant from each other and do not intersect, i.e., preferably arranged parallel to each other.

[0087] The one or more retaining surfaces can typically be provided on a thickened wall portion at the insertion portion, which is adapted to achieve the desired retaining surfaces and structural requirements at the insertion portion. Examples of preferred thicknesses or thickness ranges have been described above. If the insertion portion is arranged adjacent to the central portion, the thickened wall portion can be flush with the outer surface of the central portion by appropriate rounding or providing fillets.

[0088] Alternatively, the wall portion including one or more retaining surfaces may have a reduced thickness, wherein at least one of the one or more grooves or ribs extends radially beyond the adjacent wall portion. In other words, the radial retaining depth of the one or more grooves or ribs may be greater than the radial offset between the adjacent wall portion and the wall portion with reduced thickness, for example, by extending radially beyond the adjacent wall portion through the height of the one or more ribs. In this respect, the depth of the corresponding groove or the height of the corresponding rib may be formed by a thickened wall portion on the wall portion with reduced thickness that extends radially beyond the adjacent wall portion. Therefore, the amount of medical adhesive or medical bonding agent applied to the insertion portion can be increased without significantly increasing the radial extension of the insertion portion.

[0089] The retaining surface, or a portion of the longitudinal end face adjacent to the insertion portion of the retaining surface, may also include a reduced radial extension at its outer surface. In other words, when the inner diameter of the respective wall portions is the same, the radial outward extension of the retaining surface or a portion thereof can be reduced, for example, for the last groove or rib at the longitudinal end face. Therefore, it can be specified that the thickness of the medical adhesive or medical binder increases in the region of the wall with the reduced radial extension to further strengthen the connection between the nerve ending and the nerve conduit. Thus, unintentional reduction in the thickness of the medical adhesive or medical binder applied to the interface between the nerve ending and the insertion portion of the nerve conduit can be effectively avoided.

[0090] As a further alternative, the retaining surface of the insertion portion can be formed as a plurality of (e.g., elliptical or circular) holes, which can be arranged in at least one row in the circumferential direction of the wall. Thus, the holes can be positioned linearly along the circumference of the wall. The number of rows is preferably 1 to 10. Each row preferably includes 2 to 20 holes, wherein the holes can advantageously be equidistant in the circumferential direction of the elongation. Preferably, the holes are arranged in 2 to 4 rows, and / or each row includes 4 to 8 holes, wherein the holes in adjacent rows are preferably arranged in an alternating pattern. For example, two rows can be provided at the insertion portion, wherein each row can include, for example, six holes.

[0091] The one or more holes, particularly grooves, can also be provided as positive features on the outer surface of the wall, while other portions of the wall have other substantially continuous thicknesses. Thus, the wall may include positive protrusions or accumulations defining the corresponding grooves or holes at the insertion portion, while the remaining wall portions of the elongated body do not include such positive features. In this case, the outer surface of the wall preferably defines the inner radius of the corresponding groove or hole.

[0092] As described above, the target site can be, in particular, a denervated muscle or muscle portion (e.g., a muscle flap), a nerve side, bone, or organ. Therefore, in one embodiment, the exit portion of the nerve conduit can be configured to attach to / connect with muscle tissue. This configuration may be advantageous in at least partially promoting the recovery of motor control and / or sensory feedback and / or preventing neuroma development. The muscle tissue can be, for example, a denervated target muscle adjacent to or near the corresponding damaged nerve ending and facilitating motor control of the injured anatomy (e.g., the arm). The muscle tissue can also provide effective tissue for reducing the occurrence of neuroma development, where embedding the corresponding nerve ending within the muscle may be particularly advantageous. In some embodiments, the target muscle is used for amplifying the outgoing signals for prosthesis control.

[0093] Therefore, the outlet portion can be configured to attach to the top of the muscle tissue, or to attach within an internal recess or slit within the muscle tissue. As described above, the outlet portion, particularly the flange portion extending from it, can, for example, exhibit flexibility, which may be advantageous for inserting the outlet portion or flange portion (partially) into the slit of the muscle tissue, and / or provide a certain level of adaptability to the outer surface of the target site and the corresponding anatomical structures. The slit of the muscle tissue can, for example, extend substantially perpendicular to the central axis defined by the elongated body, such that the outlet portion or its flange portion can extend at least partially into the slit. Thus, the outlet portion or flange portion can be configured to be received within the slit and at least partially covered by the muscle tissue, thereby providing an interference fit or positive locking.

[0094] Alternatively, the outlet portion can be configured to connect to the side of the nerve. This alternative is the well-known end-lateral nerve repair, in which the distal stump of the transected nerve is occluded to the side of the undamaged donor nerve. It provides a technique for repairing peripheral nerve injuries where the proximal nerve stump is unavailable or where significant nerve gaps exist.

[0095] The elongated body, such as the integral or central portion and / or outlet and / or insertion portion, may contain one or more bioactive agents within its lumen, for example, through a coating or integrated into the material (e.g., the wall) of the respective portion, which may be released over time and may, for example, promote nerve growth. Similarly, its lumen may include pores, openings, grooves, or specific geometries or surface irregularities, and / or fillers that may promote the insertion, retention, and / or growth of nerve endings. Alternatively, the one or more bioactive agents may be cross-linked with a gel matrix within the nerve conduit of the present invention or injected directly into the lumen of the nerve conduit.

[0096] The nerve conduit is preferably formed of biocompatible, inert, bio-implantable, and / or biodegradable materials. Materials can be selected to provide predefined structural stability while substantially avoiding or at least reducing inflammatory responses in the patient being treated. For example, a biocompatible material can be selected that gradually degrades over time after implantation but initially provides sufficient structural support to adequately repair nerve damage and ensure that nerve endings are properly and stably connected, for example, during tissue movement.

[0097] Specific materials can also be selected to promote or support nerve growth, for example, by including or otherwise incorporating or comprising a corresponding coating, such as having one or more bioactive agents (including neurotrophic factors). Other examples of such bioactive surface functionality include, but are not limited to, anti-inflammatory agents, immunosuppressants, and neuroprotective agents. The bioactive agents can be surface-bound and / or trapped in the structure defining the elongated body, such as the wall described above.

[0098] Examples of bioactive agents are cytokines, nerve growth factor, hyaluronic acid, tacrolimus, cyclosporine A, melatonin, vitamin B12, methylprednisolone, riluzole, paclitaxel, cetuximab, brain-derived neurotrophic factor, laminin, nerve growth factor, glial cell-derived neurotrophic factor, glial growth factor, and α-fibroblast growth factor; preferred examples are tacrolimus.

[0099] Preferably, the nerve conduit is formed of a polymer-based material, more preferably an elastomer. This has the advantage that a variety of manufacturing methods can be applied, and / or that specific properties of the material can be provided based on, for example, polymer units. In particular, the polymer-based material can be a biocompatible material that also possesses elastic properties, allowing the nerve conduit to adapt to tissue movement around the repaired nerve injury in the implanted state.

[0100] The nerve conduit can be formed from polymeric units comprising ester and acid ester components, which are preferably polyols and acid ester components, respectively.

[0101] The materials used for the corresponding portions of the elongated body can be the same. This further facilitates manufacturing, and the structural properties of the nerve conduit can be substantially uniform along its longitudinal direction. In this case, if the nerve conduit system is configured accordingly, biodegradation (and / or bioabsorption) can also occur in a predefined or anticipated manner.

[0102] Preferably, the portion is integrally formed or formed from a single piece, for example, through material bonding and corresponding structural integration. Providing the nerve conduit as a single piece further improves its robustness, as it effectively avoids separate connections between portions.

[0103] Preferably, the nerve conduit is formed via a 3D printing process. This is particularly advantageous when the material of the nerve conduit is polymer-based, where curing of the material can be provided substantially instantaneously, for example, using (UV) light. Furthermore, this provides a level of precision that may not be easily achieved through extrusion and / or impregnation processes. In particular, the 3D printing process enables the acquisition of a specific shape for each nerve conduit, which is especially advantageous for preferred transition sections. Additionally, for example, the printing process can provide specific bioactive agents integrated into the 3D structure according to a predefined pattern, such as within a mesh structure and / or specific pockets or cavities formed by the 3D structure. Therefore, coordination and support for nerve repair can be further improved, and / or biodegradation can be achieved in a more controlled manner.

[0104] According to another aspect, a medical device for applying a medical adhesive material to a nerve conduit is proposed, comprising a body having two legs that extend at least partially from the body in a parallel manner, wherein the bottom surface of each of the legs is flush with the bottom surface of the body and includes a recess that forms a continuous reservoir between at least a portion of each leg and the body for receiving the medical adhesive material, and wherein the legs are arranged to at least partially cover the edge portion of a flange of an outlet portion of the nerve conduit.

[0105] A reservoir with a predefined depth or height is formed on the bottom surface of the medical device using a recess, extending from one leg through the body to the other. The predefined depth or height of the reservoir can be adapted to the predefined layer thickness of a medical adhesive, particularly a medical adhesive. Therefore, when the medical device with applied medical adhesive is placed on top of a nerve conduit, a layer of adhesive material of a predefined thickness is applied to the nerve conduit, at least along the edge portion of the flange at the nerve conduit's outlet. Thus, the medical device has the advantage that the medical adhesive material for connecting the nerve conduit and target tissue can be applied in a controlled manner, and that the medical adhesive material can be properly retained during any curing process.

[0106] When a medical device has been placed on a nerve conduit, the reservoir is preferably designed to extend along the edge portion of the flange along its entire length. Thus, if the nerve conduit has been placed on target tissue, the reservoir also covers the portion of the flange adjacent to the target tissue to facilitate connection between the exit portion of the nerve conduit and the target tissue.

[0107] The recess is preferably formed such that the top surfaces of the leg and the body are closed, so the reservoir does not contain any openings toward the top surface. In this way, adhesive material can be retained within the reservoir, providing improved control over applying sufficient amount of adhesive material to the reservoir, and such amount is maintained within the reservoir. Furthermore, this prevents unintentional leakage of adhesive material into surrounding tissue or accidental interlocking with, for example, the top surface of the leg after any curing. The closed configuration of the reservoir toward the top surface also improves the structural stability and stiffness of the leg and the entire medical device, thereby supporting the application of pressure to the nerve conduit and / or target tissue to facilitate the connection between the nerve conduit and target tissue.

[0108] The legs are arranged at least partially in a parallel and spaced-apart configuration. The spacing between the legs can be designed to accommodate the central and / or transitional portions of the nerve conduit, wherein at least partial coverage of the marginal portions is achieved by the respective extensions of each leg, particularly its radial and longitudinal extensions.

[0109] Preferably, the legs are configured to cover the edge portion of the flange of the nerve conduit as described above, wherein the flange is formed by a wall at the outlet opening of the nerve conduit, and wherein the flange portion extends radially outward from the outlet opening. Thus, the medical device can be supplied as a kit specifically with the nerve conduit, wherein the medical device is adapted to apply medical adhesive material to the edge portion of the flange of the nerve conduit according to the invention. Therefore, the spacing between the legs can be selected such that, when the medical device is placed on top of the flange portion and accommodates (at least) an adjacent portion of the nerve conduit, it accommodates, for example, a curved transition portion of the nerve conduit just above or at the joint with the flange portion.

[0110] The legs are preferably spaced apart from each other along their entire extension axis, particularly in their longitudinal extension, which may be perpendicular to the main extension direction of the body. Specifically, the body and legs may form a U-shape. In other words, the legs may extend substantially parallel to their extension axes. This spaced-apart configuration facilitates the placement of the medical device around the outlet transition portion and / or the central portion. Furthermore, the parallel extension of the legs allows for the facilitation of corresponding rectangular or parallel portions covering the flange and avoids excessive size and / or material.

[0111] To maximize the potential for application of medical adhesive materials, the reservoir preferably extends to the corresponding end portion of each leg in a direction away from the body. Therefore, the reservoir may extend toward a closed end face at the corresponding longitudinal end portion. In particular, the reservoir may include a U-shape.

[0112] To provide improved structural stability for the medical device, the legs can be connected via bridging portions. Thus, the legs can define a generally open configuration between them, but may include connecting structures positioned away from the main body, for example, to stabilize the position of the legs relative to each other. For instance, bridging portions can be provided to prevent lateral movement or deflection of the legs when pressure is applied to the medical device (i.e., when placed on a nerve conduit).

[0113] Although the bridging portion can be arranged along the extension of the leg at any offset relative to the body, it is preferably positioned at the longitudinal end portion of the leg, away from the body. This provides improved visualization when placing the medical device on the nerve conduit or its flange. The location at the longitudinal end portion facilitates placement of the medical device relative to the nerve conduit or its outlet portion in a predefined location. For example, in the coupled state of the medical device and the nerve conduit, the bridging portion can abut against a portion of the outlet inlet portion.

[0114] The bridging portions can extend in a plane substantially perpendicular to each leg and in a direction toward each other. Therefore, based on the corresponding direct connection between the legs, this connection can also extend upwards away from the top surface of the leg, preventing lateral movement and / or deformation of the legs relative to each other when pressure is applied to facilitate the connection between the nerve conduit and the target tissue. Furthermore, this also reduces the overall extension of the bridging portions (in the longitudinal direction of the leg), thus enabling or maintaining a substantially open configuration of the medical device to facilitate visual examination when the medical device is placed on the nerve conduit and target tissue.

[0115] The bridging portion may include a convex curvature in a direction away from the top surface of the leg, wherein the bridging portion has a predefined interval relative to the exit portion, central portion, and / or transition portion of the nerve conduit. Preferably, the bridging portion is formed as a semi-circular arc or a U-shape. By means of the convex curvature, semi-circular arc, or U-shape, the bridging portion may, for example, surround a portion of the exit portion or transition portion, and may be specifically fitted to the exit portion or transition portion, thereby facilitating the positioning of the medical device relative to the nerve conduit or exit portion and the flange extending therefrom in a predefined location. When the medical device is placed and the bridging portion is fitted to the exit portion or transition portion, the reservoir can therefore be automatically positioned in a predefined location to cover at least a portion of the marginal portion and adjacent target tissue.

[0116] The bridging portion can also be tilted towards the main body and follow the curved contour of the nerve conduit to further aid in positioning. However, at the same time, the bridging portion can still be positioned at the longitudinal end portion to provide improved structural stability of the leg, or even improved structural stability of the leg towards its longitudinal end portion.

[0117] The top surface of the body can define a protrusion extending away from the reservoir. Therefore, the medical device can include a top portion extending from the body away from the legs and reservoir. This protrusion can be adapted to form a grasping element and can be shaped, for example, into a cylindrical, columnar, or rectangular rod shape. Thus, the operation of the medical device can be significantly facilitated, not only by using the protrusion to hold the medical device in orientation and expose the reservoir for applying medical adhesive materials to the reservoir, but also by allowing compressive forces to be applied to the medical device and transmitted through the protrusion to the legs and body. Therefore, the protrusion facilitates the loading of the medical device and the connection between the nerve conduit and the target tissue.

[0118] The protrusion may include a hole or cavity extending from its top surface toward the reservoir, which can be configured to receive a rod-shaped retaining element. Thus, instead of manually grasping the protrusion, it can engage the retaining element, such as a appropriately sized pin, which can facilitate placement on delicate tissues in confined areas and / or target sites by forming an extension narrower than one or more of a clinician's fingers.

[0119] The hole or cavity can be configured to engage the rod-shaped retaining element via frictional contact. To facilitate engagement with the rod-shaped retaining element, the hole or cavity is preferably tapered, with a decreasing diameter facing the reservoir. Thus, the rod-shaped retaining element can be easily inserted into the hole or cavity and can be pressed in until resistance is achieved based on the engagement between the outer wall surface of the retaining element and the inner wall surface of the hole or cavity. To further facilitate insertion or frictional engagement, the retaining element may have a corresponding tapered shape and / or may be formed of a resilient material. The hole or cavity can also be configured to receive the tip of the pliers in a compressed state.

[0120] To ensure that the medical adhesive material applied to the reservoir is retained within the reservoir, the hole or opening is preferably closed at a horizontal position above the reservoir. Therefore, the hole or opening can be configured as a blind hole with a predefined width and depth.

[0121] To facilitate the curing of the adhesive material, the medical device is preferably formed of a light-transmitting material. The light transmittance may be limited to one or more wavelength ranges. Preferably, the medical device is light-transmitting at least in the 380 nm to 550 nm range and / or in the ultraviolet (UV) range. Therefore, light in the blue and / or UV wavelength range can be transmitted through the medical device, which may be particularly advantageous for polymer-based adhesive materials containing a curing agent (e.g., a photoinitiator) that is sensitive to said wavelengths to initiate polymerization. In particular, such light-transmitting polymers may be advantageous for adhesive materials formed from or containing poly(glyceryl sebacate acrylate) (PGSA) or PGSAA.

[0122] Preferably, the medical device is formed of a transparent or translucent and / or colorless material, such as a transparent or translucent and / or colorless polymer. This material not only allows a broader spectrum of light to penetrate through the medical device, i.e., through the walls, and onto the adhesive material applied to the reservoir, but also allows for the use of a wider range of photosensitive adhesives or curing agents to initiate curing, enabling the connection between the nerve conduit and the target tissue to be adjusted accordingly based on the adhesive and / or curing agent. Furthermore, this allows for visual inspection, ensuring that the adhesive material is indeed correctly applied and / or has been adequately cured. The use of transparent or translucent materials also allows for monitoring the position of the nerve conduit relative to the target tissue, for example, before the adhesive material cures.

[0123] The body, legs, and optional bridging portions and / or optional protrusions are preferably formed as a single component, and therefore can be integrally formed, for example, through material bonding and corresponding structural integration and / or integral molding. By providing the medical device as a single piece, this not only simplifies manufacturing but also improves the robustness of the medical device as a whole, as it effectively avoids separate connections. In particular, this also improves the reliability and strength of the legs when pressure or force is applied to the medical device.

[0124] Preferably, the medical device may comprise, or be formed of, polymer-based materials and / or elastic materials. This has the advantage that a variety of manufacturing methods can be applied, and / or that specific properties of the material can be provided based on, for example, polymer units. In particular, polymer-based materials may be biocompatible materials that also possess elastic properties. These materials have previously been disclosed for nerve conduits. The medical device may preferably be formed of medical-grade silicone. Alternatively, it may be formed of polymerized and / or cross-linked polymer units, which may, for example, contain ester-based components and / or ester-based components, wherein the ester-based components are preferably polyols and the ester-based components are preferably polyacids, such as polyglycerol sebacate acrylate. The materials used for different parts of the medical device are preferably the same. Thus, manufacturing can be further facilitated, and the structural characteristics of the medical device can be substantially uniform.

[0125] Preferably, the medical device is manufactured using molding (e.g., injection molding) or 3D printing processes. This is particularly advantageous when the medical device's material is polymer-based, where the material can be cured virtually instantaneously, for example, using blue light. Furthermore, this provides a level of precision that may not be easily achievable through extrusion and / or impregnation processes.

[0126] According to another aspect, a kit is proposed comprising a nerve conduit according to the invention and a medical device according to the invention, wherein the medical device is adapted to be coupled to and / or placed on the nerve conduit, preferably by at least partially covering the outlet portion of the nerve conduit, and preferably at least partially covering a portion of the flange of the outlet portion of the nerve conduit.

[0127] The aforementioned objectives are also achieved through the use of the aforementioned nerve conduits to repair, support, and / or guide nerve tissue, particularly for connecting proximal or distal nerve endings of nerves (especially damaged nerves) to the side of target muscle tissue, target organs, or target nerves. The invention also relates to the use of the aforementioned nerve conduits to restore (partial) motor control and / or sensory function and / or prevent the development of neuromas and / or lead to the regeneration of damaged nerves. Targeted muscle tissue according to the Targeted Muscle Nerve Reinnervation (TMR) method should be understood as the target muscle tissue and the nerve endings present within it; the Targeted Muscle Nerve Reinnervation (TMR) method is well known in the art.

[0128] According to another aspect of the present invention, a method for treating peripheral nerve injury is provided, comprising the following steps:

[0129] - Provide the nerve conduit as described above;

[0130] - Inserting the nerve endings of the damaged nerve into the insertion portion of the nerve conduit; and

[0131] - Connect the outlet portion to the target site, preferably muscle tissue or nerve endings or undamaged nerves present in the muscle tissue.

[0132] Fixation of damaged nerve endings can also be achieved by applying medical adhesive through the corresponding opening to the outside of the insertion portion and / or within the opening. Furthermore, attachment to the target site is preferably performed at the outer surface of the target site, or by inserting at least a portion of the outlet portion or its flange portion into the slit of the target site, wherein the target site is preferably (denervated) muscle. Connection of the nerve conduit to the target site preferably includes circumferential contact along the outlet portion, preferably along the edge portion of the flange portion, and at least at the interface with the target site, with the application of medical adhesive.

[0133] The medical adhesive according to the invention, also referred to herein as a medical adhesive material, can be any medical adhesive in the art. In some embodiments, the medical adhesive is a medical adhesive material capable of polymerization upon exposure to light. Prior to such polymerization, the medical adhesive can be fluid or viscous. Preferably, the medical adhesive is a photocurable compound. In some embodiments, the medical adhesive material contains a photoinitiator that can induce polymerization, for example, a prepolymer, and may be sensitive to blue light or ultraviolet radiation. Preferably, the medical adhesive is or contains polyglycerol sebacate acrylate or PGSAA (e.g., as described in WO2021 / 078962).

[0134] According to another aspect of the invention, a method for treating peripheral nerve injury includes targeted muscle renervation. In some embodiments, the method maximizes the number of motor axons innervating the target muscle. In some embodiments, the method improves signal transduction from the target muscle. In some embodiments, the target muscle is used for amplification of efferent signals for prosthesis control.

[0135] It should be understood that the nerve conduit of the present invention can also be used in similar applications, such as for connecting tendon or ligament ends to target bone or bone portions. In this embodiment, the tendon or ligament ends replace the nerve endings described above, and the target site includes bone or bone portions, and the nerve conduit is referred to as a tendon conduit or ligament conduit. Therefore, in addition to (peripheral) nerve applications, the nerve conduit according to the present invention can also be used to provide a support structure for tendons, blood vessels (veins and / or arteries), muscle tissue, or small ligaments. Thus, such a support structure can be adapted to the appropriate size, tissue characteristics, and / or level of support to be provided. For example, the diameter of the lumen can be selected to ensure direct contact with the tissue contained therein, for example, for very fragile tissue structures, or a predefined radial spacing between the wall and the contained tissue can be provided, for example, to provide cushioning in the event of impact on adjacent tissue. Similarly, the wall thickness can be selected for the tissue to be treated based on the required structural support and the elasticity of the wall.

[0136] According to another aspect of the present invention, a method for applying a medical adhesive material to the exit portion of a nerve conduit is provided, comprising the following steps:

[0137] - Provides the medical device and nerve conduit according to the invention as described above;

[0138] - Apply medical adhesive material to the reservoir along its entire extension; and

[0139] - Position the medical device on the flange of the exit portion of the nerve conduit, which is placed on top of the target tissue, such that the applied medical adhesive material covers the edge portion of the flange and the adjacent target tissue, forming an interface between the nerve conduit and the target tissue.

[0140] During the application of medical adhesive material to the flange and adjacent target tissue, the nerve conduit can be held in place on top of the target tissue using a medical device. The target tissue is preferably muscle tissue.

[0141] As described above, medical adhesive materials are preferably cured by applying light. To promote curing, the medical device may be formed from a light-transmitting polymer, wherein curing is achieved by applying light in situ through the medical device. Medical adhesive materials are preferably polymer-based and / or include medical adhesives as described above. Attached Figure Description

[0142] This disclosure will be more readily understood in conjunction with the accompanying drawings and the following detailed description, wherein:

[0143] Figure 1 A schematic diagram of the nerve conduit according to the present invention is shown in longitudinal section;

[0144] Figure 2 The diagram is schematically shown in a three-dimensional view according to... Figure 1 The nerve conduit;

[0145] Figure 3 The diagram is schematically shown in a bottom view according to... Figure 1 The nerve conduit;

[0146] Figure 4 A schematic diagram of a nerve conduit according to an alternative embodiment of the present invention is shown in longitudinal section;

[0147] Figure 5 The diagram is schematically shown in a three-dimensional view according to... Figure 4 The nerve conduit;

[0148] Figure 6 The diagram is schematically shown in a bottom view according to... Figure 4 The nerve conduit;

[0149] Figure 7 The cross-sectional perspective view schematically illustrates the following based on Figure 4 The nerve conduit;

[0150] Figure 8 A schematic diagram of a nerve conduit according to an alternative embodiment of the present invention is shown in longitudinal section;

[0151] Figure 9 The diagram is schematically shown in a three-dimensional view according to... Figure 8 The nerve conduit;

[0152] Figure 10 The diagram is schematically shown in a bottom view according to... Figure 8 The nerve conduit;

[0153] Figure 11 The cross-sectional perspective view schematically illustrates the following based on Figure 8 The nerve conduit;

[0154] Figure 12 A schematic diagram of a nerve conduit according to an alternative embodiment of the present invention is shown in a bottom view, having an elongated body that is discontinuous in the circumferential direction;

[0155] Figure 13 The longitudinal section schematically illustrates the following based on Figure 12 The nerve conduit;

[0156] Figure 14 The diagram is schematically shown in a three-dimensional view according to... Figure 12 The nerve conduit;

[0157] Figure 15 A schematic diagram of a nerve conduit according to an alternative embodiment of the present invention is shown in a bottom view, having an elongated body that is discontinuous in the circumferential direction;

[0158] Figure 16 The longitudinal section schematically illustrates the following based on Figure 15 The nerve conduit;

[0159] Figure 17 The diagram is schematically shown in a three-dimensional view according to... Figure 15 The nerve conduit;

[0160] Figure 18 The medical device according to the present invention is shown in a three-dimensional side view;

[0161] Figure 19 The diagram is schematically shown in a bottom view according to... Figure 18 Medical equipment;

[0162] Figure 20 according to Figure 19 The longitudinal section schematically illustrates the following based on Figure 18 Medical equipment;

[0163] Figure 21 The top perspective view shows the contents of the medical adhesive material. Figure 18 Medical equipment;

[0164] Figure 22 The top perspective view shows the location on top of the nerve conduit and the element with retaining structure. Figure 21 The loaded medical equipment;

[0165] Figure 23 A stereoscopic side view shows the location on top of the nerve conduit without retaining elements. Figure 21 The loaded medical equipment;

[0166] Figure 24 The bottom view shows the location on the top of the flange of the nerve conduit. Figure 21 The loaded medical equipment; and

[0167] Figure 25 A longitudinal section is shown of the nerve conduit according to the invention, which, according to one embodiment, has a reduced wall thickness at the insertion portion. Detailed Implementation

[0168] The invention will be explained in more detail below with reference to the accompanying drawings. In the drawings, the same elements are denoted by the same reference numerals, and repeated descriptions may be omitted to avoid redundancy.

[0169] exist Figures 1 to 3 The image schematically illustrates one embodiment of the nerve conduit 10 according to the present invention, wherein... Figure 1 The nerve conduit 10 is shown in longitudinal section. As shown, the nerve conduit 10 includes an elongated body 12 comprising an insertion portion 18 and an exit portion 19. The insertion portion 18 is configured to receive a corresponding nerve ending (not shown), such as a proximal nerve ending of a damaged nerve, which will connect to a target site, particularly a (denervated) muscle, via the exit portion 19. Between the insertion portion 18 and the exit portion 19, a central portion 14 is provided, which is arranged directly adjacent to or successive to the insertion portion 18. At the opposite end of the central portion 14, a transition portion 24 extends away from the central portion 14 and forms the exit portion 19. The transition portion 24 and the central portion 14 together define a lumen 16, wherein the central portion 14 is adapted to accommodate the nerve ending received via the insertion portion 18.

[0170] Both the outlet portion 19 and the insertion portion 18 include corresponding openings 20, 21 toward the lumen 16. Thus, a continuous lumen or channel is provided for the nerve conduit 10 from the opening 20 of the insertion portion 18 to the opening 21 of the outlet portion 19. As shown, the elongated body 12 is essentially formed by a tubular wall 22 defining the lumen or channel of the nerve conduit 10, wherein the wall 22 preferably comprises a substantially constant thickness (t) along the extension of the elongated body 12.

[0171] The central portion 14 and the portion of the inner cavity 16 defined by the central portion are formed as a basically cylindrical portion having a constant inner diameter and outer diameter, which is adapted to accommodate received nerve endings having corresponding diameters. Starting from the central portion 14, the wall portion of the transition portion 24 extends such that its cross-sectional area increases toward the outlet opening 21, resulting in an enlargement of the opening 21 compared to the cross-sectional area or diameter of the inner cavity 16 of the central portion 14 and the diameter of the opening 20 of the insertion portion 18. Furthermore, the wall portion of the transition portion 24 defines a bend such that the cross-section of the outlet opening 21 is oriented at an angle relative to the cross-section of the insertion opening 20.

[0172] In this non-limiting example, the angle is approximately 90 degrees, such that openings 20 and 21 are oriented substantially perpendicular to each other. Combined with the gradually increasing cross-sectional area of ​​the transition portion 24 and the enlarged opening 21, this promotes the growth of the received nerve endings toward the exit portion 19 and, via the exit opening 21, toward the target site, as described above. This configuration may be particularly advantageous for connecting nerve endings to muscle tissue in a targeted muscle nerve re-innervation (TMR) manner or to undamaged nerves in an end-to-end manner.

[0173] To facilitate the insertion of nerve endings into the lumen 16 of the central portion 14, the insertion portion 18 includes an opening 20 that extends radially away from the central portion 14 and its cross-sectional area.

[0174] The nerve conduit 10 further includes a flange portion 26 at the level of the outlet opening 21 and a retaining surface 30 at the insertion portion 18, both of which facilitate the connection of the nerve ending to the target site. Figure 2 and Figure 3 Further details of these features were described.

[0175] Therefore, as Figure 1 and Figure 2 As shown, the flange portion 26 extends substantially within the plane of the cross-section of the outlet opening 21 and the portion defining the central portion 14 of the wall 22. Therefore, an enlarged surface area of ​​the elongated body 12 is provided at the outlet portion 19, which is advantageous for connection to the target site, for example, by increasing the connection surface and / or the surface for applying medical adhesive. Furthermore, providing the flange portion 26 ensures that no medical adhesive is unintentionally applied at or within the outlet opening 21, thus avoiding potential obstruction of nerve ending growth toward the target site.

[0176] like Figure 3As best shown in the bottom view, the outlet opening 21 is also formed as an ellipse, with the maximum diameter approximately twice the diameter of the inner cavity 16 of the central portion 14, and the minimum diameter substantially corresponding to the diameter of the inner cavity 16 of the central portion 14. Therefore, a directional bias for nerve ending growth can be achieved, i.e., in the direction of the maximum diameter. The flange portion 26 includes a rectangular shape with rounded edges and a triangular shape extending therefrom, resembling a top view with rounded block-shaped arrows or a simplified boat shape. The triangular portion points towards the insertion portion 18, which has the advantage that the flange portion 26 does not obstruct the operation of the insertion portion 18 and the central portion 14, such as... Figure 2 As shown.

[0177] The retaining surface 30 is formed as a single groove extending in a helical direction along a longitudinal axis defined by the defined insertion portion 18 of the wall 22 and the portion of the central portion 14. The helical extension comprises two to six turns, four turns in this example, providing an optimized balance between structural stability and increased surface area for applying, for example, medical adhesives.

[0178] The flange portion 26 at the outlet portion 19 and the retaining surface 30 at the insertion portion 18 facilitate a firm attachment to the target site. Furthermore, this allows medical professionals or surgeons to clearly define the corresponding function of the end portion during implantation and surgery.

[0179] exist Figures 4 to 7 The image schematically illustrates an alternative embodiment of the nerve conduit 10 according to the invention. (See image for details.) Figure 1 As shown in the longitudinal cross-section, the insertion portion 18 and the central portion 14 of the nerve conduit 10 substantially correspond to Figures 1 to 3 The illustrated embodiment. However, in this embodiment, the central portion 14 has a more significant longitudinal extension. Furthermore, the outlet portion 19 is arranged directly adjacent to the central portion 14 on the side of the central portion 14 opposite to the insertion portion 18. There is no transition portion in this embodiment. Instead, the outlet portion 19 is formed as a truncated portion of the elongation 12, such that the cross-section of the outlet opening 21, or the plane defined by the end face of the wall 22 defining the outlet opening 21, is oriented at an angle relative to the cross-section of the insertion opening 20. In this configuration, the elongation 12 defines the overall longitudinal extension, while the openings 20, 21 are arranged at an angle to each other, for example, as... Figure 4 The angle shown is approximately 50 to 70 degrees.

[0180] At the outlet portion 19, the outer diameter of the wall 22 is increased compared to the outer diameter of the wall portion defining the central portion 14. This increase is provided by the flange portion 26, similar to... Figures 1 to 3The illustrated embodiment. The flange portion 26 thus extends radially outward from the outlet portion 19 or its outlet opening 21, such that the flange portion 26 extends substantially in the same plane as the outlet opening 21 or its cross-section. Since this embodiment does not include the transition portion defining the bend of the elongated body 12, the angle of the flange portion 26 relative to the longitudinal axis and / or the adjacent wall portions of the outlet portion 19 and the central portion 14 is less than 90 degrees, for example in… Figure 4 The range is 40 degrees to 20 degrees as shown.

[0181] In addition, such as Figures 4 to 6 As shown, the flange portion 26 does not surround the entire outlet opening 21, which is consistent with... Figures 1 to 3 The depicted embodiment is the opposite. Instead, the flange portion 26 surrounds approximately half of the circumference of the outlet opening 21. The flange portion 26 is also formed as a rounded rectangular shape having a triangular portion extending from the rectangular portion, wherein the triangular portion converges with the wall portion surrounding the outlet opening 21 in the direction toward the insertion portion 18.

[0182] like Figure 4 and Figure 5 As best shown, although according to Figures 4 to 6 The embodiments can be laterally connected, but the configuration of the nerve conduit 10 is particularly suitable for connecting the nerve ending to the target site by placing the nerve ending on top of the target site or at the anterior surface of the target site.

[0183] The nerve conduit 10 may also include an optional inner edge portion 28, which is depicted in Figure 4 and Figure 7 In this example, the inner edge portion 28 extends in a semi-circular manner along the inner circumference of the outlet opening 21. The inner edge portion 28 can provide additional support at the target location, particularly in the portion of the outlet opening 21 not surrounded by the flange portion 26.

[0184] exist Figures 8 to 11 The image schematically illustrates yet another embodiment of the nerve conduit 10 according to the invention. In this embodiment, the transition portion 24 extends from the central portion 14, similar to... Figures 1 to 3 The illustrated embodiment. However, the transition portion 24 does not form a bend; instead, the wall portion of the transition portion 24 extends from the central portion 14 at an angle relative to the central portion 14. Figure 8 The bottom end of the transition portion 24 is depicted, with the bottom wall portion extending substantially linearly from the central portion 14, such that the transition portion 24 defines a converging geometry having a conical or funnel shape. Therefore, the cross-section of the transition portion 24 gradually decreases from the central portion 14.

[0185] As a result, the exit opening 19 formed by the transition portion 24 is correspondingly reduced, such that the diameter or cross-section of the exit opening 21 is smaller than the diameter of the lumen 16 defined by the central portion 14. Therefore, nerve endings contained in the central portion 14 may not extend through the exit opening 21, and nerve growth is effectively directed toward the exit opening, for example, to avoid the development of neuromas.

[0186] like Figures 8 to 11 As shown, the nerve conduit 10 also includes a flange portion 26 that extends in the plane of the outlet opening 21, and... Figures 1 to 3 as well as Figures 4 to 7 The depicted embodiment is similar. In this example, the entire outlet opening 21 is surrounded by a flange portion, similar to... Figures 1 to 3 The illustrated embodiment. However, since the outlet opening 21 includes a reduced diameter and is circular rather than elliptical, the size of the flange portion can be reduced, as... Figure 10 Best shown (see) Figure 3 contrast).

[0187] In addition, an inner edge portion 28 can be provided, which is depicted on Figure 11 In the middle. Although the inner edge portion 28 can provide additional support at the target site in addition to the adjacent flange portion 26, the inner edge portion 28 is specifically configured to reduce the diameter of the outlet opening 21.

[0188] exist Figures 12 to 17 The embodiments of the nerve conduit 10 according to the invention are depicted, wherein the elongated body 12 is discontinuous in the circumferential direction. Therefore, these embodiments depict the nerve conduit 10 as a configuration for medical tissue encapsulation. Figures 12 to 14 The described embodiments are substantially similar to Figures 8 to 11 The illustrated embodiment. However, in this embodiment, the wall is configured to be in a coiled state, wherein the wall is at least partially unwound and rewound in the circumferential direction. Therefore, the wall can be coiled and rewound only in the circumferential direction, such that in the unwound state, nerve endings can be placed on the wall surface of the portion defining the central portion 14 and the lumen 16 of the insertion portion 18. After proper placement, the wall can then be rewound to define... Figures 12 to 14 The shape depicted, in which nerve endings (not shown) are thus accommodated within the cavity 16 of the central portion 14 and the insertion portion 18.

[0189] During the winding of the wall, the circumferential inner wall portion 32 is at least partially covered by the circumferential outer wall portion 34 to form an overlapping structure. For example... Figure 13As best shown, a (small) gap may exist between the circumferential inner wall portion 32 and the circumferential outer wall portion 34. Due to the overlapping portion, the walls still form a sufficient external seal to retain nerve endings within the lumen 16 and to prevent external tissue from penetrating the elongated body 12.

[0190] Although the insertion portion 18 may include a gradually increasing cross-section, for example to facilitate the application of medical adhesives, such increased radial extension may be particularly advantageous in a configuration where the walls of the elongated body 12 are continuous in the circumferential direction. This is because the insertion of nerve endings according to this embodiment is essentially based on placement on the inner wall surface of the elongated body 12 after unwinding. Therefore, Figures 12 to 14 The depicted embodiment includes a basic cylindrical insertion portion 18.

[0191] Figures 15 to 17 The described embodiments are substantially similar to Figures 1 to 3 The described embodiments. However, for Figures 12 to 14 In the depicted embodiment, the elongated body 12 is discontinuous in the circumferential direction and is arranged in a coiled state such that the circumferential inner wall portion 32 is at least partially covered by the circumferential outer wall portion 34 to form an overlapping structure.

[0192] for Figures 12 to 14 In the depicted embodiment, the elongated body 12 includes a generally cylindrical insertion portion 18 to facilitate rewinding and unwinding of the elongated body 12, and / or to provide a more compact design and to accommodate nerve endings received in the lumen 16.

[0193] In addition, such as Figure 16 As shown, the elongated body 12 may optionally include an inner edge portion 28. Therefore, the cross-sectional area of ​​the ellipse can be reduced such that the outlet opening 21 has a diameter less than or equal to that of the cavity 16 defined by the central portion 14.

[0194] like Figures 12 to 17 As shown, the flange portion 26 is similar to Figures 1 to 3 The described embodiments; except that they are discontinuous and non-overlapping.

[0195] Figure 18 A medical device 100 according to the invention is shown. The medical device 100 is adapted to facilitate the application of a medical adhesive material to a nerve conduit. Thus, the medical device 100 can be placed on top of the outlet portion of such a nerve conduit to at least partially cover a flange extending from the outlet portion, such as a flange extending radially outward from the outlet opening.

[0196] As shown in the perspective side view, the medical device 100 includes a body 110 having two legs 112 extending from the body 110 in a substantially parallel manner. The legs 112 are spaced apart to form a gap 114, and together with the body 110, form a U-shaped medical device 100. The gap 114 allows the legs 112 and the body 110 to cover edge portions of a flange, wherein the flange may include a rectangular shape such that the edge portions also extend at least partially in a parallel manner. Furthermore, the gap 114 may be adapted such that the legs 112 and the body 110 at least partially surround or accommodate the outlet portion, central portion, and transition portion of a nerve conduit.

[0197] At the longitudinal end portions 112, directed away from the body 110, bridging portions 116 are arranged between the legs 112, forming a connection between the legs 112. The bridging portions 116 extend substantially perpendicular to the top surface of the respective leg 112 and have a convex shape with a U-shaped arcuate configuration. The arcuate shape of the bridging portions 116 facilitates the reception of the outer surface of the central portion and / or transition portion of the nerve conduit, which may, for example, have a tubular shape. In this respect, the bridging portions 116 also include an inclination along the longitudinal direction toward the body 110. This inclination may be adapted to the geometry of the central portion and / or transition portion of the nerve conduit.

[0198] For operational purposes, the medical device 100 also includes a protrusion 118 extending from the body 110 toward the leg 112, substantially perpendicular to the top surface of the leg 112. The protrusion 118 can be grasped by a clinician or surgeon, making it easier to place the medical device 100 on nerve conduits and adjacent target tissues. Preferably, the height of the protrusion 118 together with the body 110 is 4 mm to 8 mm, more preferably 5 mm to 7 mm. Operation can be facilitated by a blind hole 120, which is tapered toward the body 110 and capable of engaging a retaining element (not shown), such as a rod-shaped retaining element or a forceps tip. Therefore, placement of the medical device 100 at delicate target tissues that do not allow for the presence of one or more fingers can be facilitated.

[0199] With the aid of the protrusion 118, the bottom surfaces of the leg 112 and the body 110 can also be more easily exposed and held in a preferred orientation for applying medical adhesive materials. For this purpose, the bottom surface of the medical device 100 includes a recess defining a reservoir 122, such as... Figure 19 Further details are shown below.

[0200] Therefore, as Figure 19As shown, the bottom surfaces of the body 110 and the legs 112 are arranged flush with each other, such that a recess in the bottom surface of the medical device 100 defines a continuous reservoir 122 from one leg 112 through the body 110 to the other leg 112, the height of which preferably defines the thickness of the medical adhesive layer to be applied. The reservoir 122 extends toward the longitudinal end portion of the leg 112 in a direction away from the body 110, such that the extension of the reservoir 122 substantially corresponds to the extension of the leg 112. Similarly, the width 126 of the reservoir 122 substantially corresponds to the width of each of the legs 112, such that the reservoir 122 at the leg 112 is defined only by a thin edge 124.

[0201] At the body 110, the reservoir 122 may optionally be offset from the outer surface of the device to provide improved structural stability of the medical device 100 and to facilitate pressure application via the protrusion 118 by providing a larger contact surface at the level of the body 110 and the corresponding protrusion 118.

[0202] The spacer 114 may be selected to accommodate the exit portion, central portion, and transition portion of the nerve conduit, and / or ensure that the leg 112, in its coupled state with the nerve conduit, covers the edge portion of the flange at the exit portion of the nerve conduit. Therefore, it not only ensures that medical adhesive material is applied to the edge portion of the flange and at the interface with the target tissue, but it also facilitates visual inspection of adequate placement and reduces the amount of material required for manufacturing. The leg 112, and particularly the portion of the leg 112 connected to the body 110, may include a rounded geometry or other geometry adapted such that, in the coupled state of the medical device 100 with the nerve conduit, the edge portion of the flange and the portion of the flange adjacent to the target tissue are covered by the reservoir 122.

[0203] The spacing 114 between the legs 112 can be based on the diameter of the nerve endings and the corresponding dimensions of the nerve conduit and its exit / central / transition portion. Therefore, the spacing 114 is preferably selected between 2 mm and 7 mm, wherein the spacing 114 can be selected to be as close as possible to the outer diameter of the nerve conduit, for example, 0 mm to 1 mm larger than the outer diameter of the nerve conduit to be connected to the target tissue, preferably 0 to 0.5 mm larger. For example, for a nerve conduit with an outer diameter of approximately 4.75 mm, the spacing 114 is preferably 4.75 mm to 5.25 mm, such that the outer surface of the exit / transition portion of the corresponding nerve conduit can be accommodated within the spacing 114 and can, for example, abut against the legs 112 and / or the bridging portion 116.

[0204] The width 126 of the reservoir 122 can be less dependent on the size of the nerve conduit or the nerve to be connected to the target tissue, because the width 126 defines the connection interface between the nerve conduit and the target tissue. Therefore, the width 126 can be substantially constant for different nerve conduit sizes, for example, from 2.4 mm to 3.2 mm.

[0205] exist Figure 20 In the middle, medical equipment 100 along Figure 19 A cross-sectional view along line AA is shown. Thus, it is shown that the hole 120 is preferably formed as a blind hole 120 that does not extend toward the reservoir 122 to prevent leakage of the medical adhesive material. However, the hole 120 may optionally extend to and be fluidly connected to the reservoir 122 to allow for filling of the reservoir by injection, for example, by injecting a medical adhesive material with reduced viscosity. The height or depth of the reservoir 122 is relatively small compared to the height of the leg 112 to ensure sufficient structural stability during pressure applied via the protrusion 118 (e.g., during the curing of the medical adhesive material). For example, the depth or height of the reservoir 122 may be from 0.1 mm to 0.5 mm, which has been found sufficient to provide adequate connection between the nerve conduit and adjacent target tissue.

[0206] Figure 21 A top perspective view shows the medical adhesive material 130 contained in the reservoir 122, according to... Figure 18 The medical device 100. As shown, medical adhesive 130 can be applied within the recess, leaving only the edge 124 of the leg 112 and the portion of the base 110 offset from the reservoir 122 uncovered. The application of the medical adhesive 130 can be facilitated by means of a retaining element 128, which engages with the hole 120 via an interference fit or friction fit, and allows for easier handling and placement of the medical device 100 without unintentionally interfering with the bottom surface of the medical device 100.

[0207] After applying medical adhesive material 130 (e.g., polymer-based medical adhesive), medical device 100 can be placed on nerve conduit 10, such as... Figure 22 As shown. Therefore, the medical device 100 is placed on top of the nerve conduit 10, facilitated by the retaining element 128. The nerve conduit 10 preferably corresponds to, as shown... Figures 1 to 3 The depicted nerve conduit can be supplied together in a kit. The medical device 100 at least partially houses the nerve conduit 10, particularly including an outlet portion 19 comprising a flange extending from an outlet opening. Figure 22 In this embodiment, the insertion portion 18 of the nerve conduit 10 is not covered or contained by the medical device 100. In this respect, the bridging portion 116 can be configured such that medical adhesive material 130 can be applied to the insertion portion 18 simultaneously to provide a connection between the insertion portion 18 or the connecting portion of the nerve conduit 10 and the damaged nerve ending at least partially contained within the nerve conduit 10.

[0208] However, preferably, this connection between the nerve ending and the insertion portion 18 of the nerve conduit 10 is performed as a first step. This facilitates the manipulation of the nerve conduit 10 and ensures that the nerve ending is properly held within the nerve conduit 10 before it is attached to the target tissue. An example is depicted in Figure 23 In this process, the medical device 100 is placed on the nerve conduit 10, and the cured medical adhesive 130 has covered the insertion portion and the adjacent portion of the nerve ending (not shown). Therefore, in the second step, the medical device 100 with the applied medical adhesive 130 is placed on the nerve conduit 10 to achieve connection between the nerve conduit 10 and the (adjacent) target tissue (not shown).

[0209] Figure 24 The advantageous configuration and size design of the medical device 100 are well illustrated, shown in a bottom view at the top of the flange 26 of the nerve conduit 10. Figures 21 to 23 The medical device 100 is loaded with this device. Thus, the edge portion of the flange 26, extending radially outward from the outlet opening of the outlet portion 19, is substantially covered along its entire circumference by the legs 112 and the corresponding reservoir 122 of the medical device 100. The triangular portion of the flange 26 pointing towards the insertion portion 18 is not completely covered by the reservoir 122 or the medical adhesive 130. However, based on the overall coverage of the edge portion of the flange 26, the medical adhesive 130 can provide a sufficient interface to distribute the compressive force of the flange 26 toward the target tissue to secure the nerve conduit to the target tissue.

[0210] like Figure 25 As shown, the wall portions including one or more retaining surfaces 30 can typically have a reduced thickness, wherein the grooves or ribs extend radially such that they extend beyond the adjacent wall portions forming the central portion 14. The grooves or ribs can thus define a radial retaining depth exceeding the difference between the wall portion with the reduced thickness and the adjacent wall portion. Therefore, the amount of medical adhesive or medical bonding material applied to the insertion portion 18 can be increased without significantly increasing the radial extension of the insertion portion 18.

[0211] Figure 25 The detailed view further shows that, in order to further increase the thickness of the medical adhesive or medical sealant at the interface between the nerve conduit 10 and the nerve ending, the groove or rib directly adjacent to the longitudinal end face (shown on the right) of the insertion portion 18 facing the opening 20 includes a reduced radial extension, which is optionally rounded toward the longitudinal end face. This further strengthens the connection between the nerve ending and the nerve conduit and avoids the medical adhesive or medical sealant applied to the interface between the nerve ending and the insertion portion 18 of the nerve conduit unintentionally having a reduced thickness.

[0212] It will be apparent to those skilled in the art that these embodiments and items depict only examples of a variety of possibilities. Therefore, the embodiments shown herein should not be construed as limiting these features and configurations. Any possible combination and configuration of the described features may be chosen according to the scope of the invention.

[0213] List of reference numerals

[0214] 10. Nerve conduits

[0215] 12 Elongated bodies

[0216] 14. Central Section

[0217] 16. Inner cavity

[0218] 18 Insertion section

[0219] 19 Export Portion

[0220] 20, 21 Opening

[0221] 22 wall

[0222] 24 Transition Section

[0223] 26. Flange or flange portion

[0224] 28 Inner edge portion

[0225] 30 Maintain surface

[0226] 32 circumferential inner wall portion

[0227] 34 Circumferential outer wall portion

[0228] 100 Medical Equipment

[0229] 110 Main Body

[0230] 112 legs

[0231] 114 intervals

[0232] 116 Bridging section

[0233] 118 protrusions

[0234] 120 holes

[0235] 122 storage

[0236] 124 Edge

[0237] 126 width

[0238] 128 Holding element

[0239] 130 Medical adhesive materials

Claims

1. A nerve conduit (10) for connecting nerve endings to a target site, the nerve conduit comprising an elongated body (12) formed by a wall (22) defining an inner lumen (16), and the elongated body comprising: Central portion (14), wherein the inner cavity (16) extends through the central portion (14), and The cavity (16) is defined by two end portions (18, 19) of corresponding openings (20, 21), one end portion (18) being an insertion portion configured for inserting a corresponding nerve ending (26), and the other end portion (19) being a nerve ending exit portion. The end portions (18, 19) are arranged such that the cross sections of the openings (20, 21) are oriented at an angle to each other.

2. The nerve conduit (10) according to claim 1, wherein, The angle between the cross sections is between 30 and 90 degrees.

3. The nerve conduit (10) according to claim 2, wherein, The angle between the cross sections is 50 to 90 degrees, or 70 to 90 degrees, or the angle is approximately 90 degrees, such that the cross sections of the openings (20, 21) are oriented substantially perpendicular to each other.

4. The nerve conduit (10) according to any one of the preceding claims, wherein, The insertion portion (18) is arranged adjacent to the central portion (14), and the outlet portion (19) is arranged on the opposite side of the central portion (14).

5. The nerve conduit (10) according to any one of the preceding claims, wherein, The elongated body (12) includes a transition portion (24) adjacent to the central portion (14) and forming the outlet portion (19), wherein the transition portion (24) defines a bend in the elongated body (12) and / or extends at an angle relative to the central portion (14).

6. The nerve conduit (10) according to claim 5, wherein, The cross-section of the portion of the inner cavity (16) defined by the transition portion (24) gradually increases in the direction away from the central portion (14).

7. The nerve conduit (10) according to claim 5, wherein, The wall (22) defining the transition portion (24) converges at least partially toward the outlet portion (19).

8. The nerve conduit (10) according to claim 7, wherein, The outlet portion (19) and / or the transition portion (24) include a conical or funnel shape.

9. The nerve conduit (10) according to any one of the preceding claims, wherein, The opening (21) of the outlet portion (19) is elliptical.

10. The nerve conduit (10) according to claim 8, wherein, The ratio between the maximum diameter and the minimum diameter of the opening (21) of the outlet portion (19) is 1:1 to 4:1, preferably 1.1:1 to 2.5:

1.

11. The nerve conduit (10) according to claim 8 or 9, wherein, The minimum diameter of the opening (21) of the outlet portion (19) substantially corresponds to the diameter of the inner cavity (16) defined by the central portion (14).

12. The nerve conduit (10) according to any one of the preceding claims, wherein, The wall (22) of the elongated body (12) is a single tubular wall comprising a substantially continuous thickness.

13. The nerve conduit (10) according to any one of the preceding claims, wherein, The cavity (16) defined by the central portion (14) includes a continuous cross section, and / or wherein the central portion (14) includes a generally cylindrical shape.

14. The nerve conduit (10) according to any one of the preceding claims, wherein, The diameter of the inner cavity (16) defined by the central portion (14) is 1 mm to 12 mm, preferably 1.5 mm to 6.5 mm.

15. The nerve conduit (10) according to any one of the preceding claims, wherein, The cross-sectional area of ​​the opening (21) of the outlet portion (19) is greater than the cross-sectional area of ​​the cavity (16) of the central portion (14).

16. The nerve conduit (10) according to any one of the preceding claims, wherein, The maximum diameter of the opening (21) of the outlet portion (19) is 1 mm to 15 mm larger than the diameter of the inner cavity (16) defined by the central portion (14), preferably 4 mm to 12 mm larger.

17. The nerve conduit (10) according to any one of the preceding claims, wherein, The cross-sectional area of ​​the opening (21) of the outlet portion (19) is greater than the cross-sectional area of ​​the opening (20) of the insertion portion (18).

18. The nerve conduit (10) according to any one of the preceding claims, wherein, The cross-sectional area of ​​the opening (21) of the outlet portion (19) increases in the direction away from the central portion (14).

19. The nerve conduit (10) according to any one of claims 1 to 14, wherein, The cross-sectional area of ​​the opening (21) of the outlet portion (19) is less than or equal to the cross-sectional area of ​​the cavity (16) of the central portion (14) and / or the cross-sectional area of ​​the opening (20) of the insertion portion.

20. The nerve conduit (10) according to any one of the preceding claims, wherein, A flange portion (26) is formed by the wall (22) at the outlet opening (21), and the flange portion (26) extends radially outward from the outlet opening (21).

21. The nerve conduit (10) according to claim 20, wherein, The flange portion (26) extends substantially within a plane defined by the cross-section of the outlet opening (21).

22. The nerve conduit (10) according to claim 20 or 21, wherein, The flange portion (26) at least partially surrounds the outlet opening (21), and the flange portion (26) preferably completely surrounds the outlet opening (21).

23. The nerve conduit (10) according to any one of claims 20 to 22, wherein, The flange portion (26) includes a rectangular portion, preferably a rectangular portion with rounded corner edges.

24. The nerve conduit (10) according to any one of claims 20 to 23, wherein, The flange portion (26) includes a triangular portion oriented toward the insertion portion (18).

25. The nerve conduit (10) according to claim 24, wherein, The triangular portion extends from the rectangular portion.

26. The nerve conduit (10) according to any one of the preceding claims, wherein, An inner edge portion (28) is formed by the wall (22) at the outlet opening (21), and the inner edge portion (28) extends radially inward into the outlet opening (21).

27. The nerve conduit (10) according to claim 26, wherein, The inner edge portion (28) extends from one-third to two-thirds of the inner circumference of the wall (22).

28. The nerve conduit (10) according to any one of the preceding claims, wherein, The cross-sectional area of ​​the opening (20) of the insertion portion (18) increases in the direction away from the central portion (14).

29. The nerve conduit (10) according to any one of the preceding claims, wherein, The insertion portion (18) and the corresponding opening (20) are formed in a rotationally symmetrical shape along the longitudinal axis, preferably wherein, The shape is selected from a group consisting of cone, concave, funnel, trumpet, or parabolic shapes.

30. The nerve conduit (10) according to any one of the preceding claims, wherein, The wall (22) forming the elongated body (16) is continuous in the circumferential direction.

31. The nerve conduit (10) according to any one of claims 1 to 29, wherein, The wall (22) forming the elongated body (16) is discontinuous in the circumferential direction, and the nerve conduit (10) is formed as a medical tissue wrapping, wherein the wall (22) is wound only in the circumferential direction, and wherein the wall (22) is at least partially unwound and rewound in the circumferential direction.

32. The nerve conduit (10) according to any one of the preceding claims, wherein, The outlet portion (19) and / or the insertion portion (18) have a greater surface roughness at the outer surface of the wall (22) than the outer surface of the wall (22) defining the central portion (14), and / or the outer surface of the wall (22) defining the insertion portion (18) includes a structured outer surface modification.

33. The nerve conduit (10) according to claim 32, wherein, The structured outer surface modification forms one or more retaining surfaces (30), which are configured to secure medical adhesive to the insertion portion (18).

34. The nerve conduit (10) according to claim 33, wherein, The one or more retaining surfaces (30) are formed as at least one groove extending in a helical direction along a longitudinal axis defined by the wall (22).

35. The nerve conduit (10) according to claim 34, wherein, The at least one groove includes a rounded edge, and / or wherein the at least one groove defines at least one undercut.

36. The nerve conduit (10) according to claim 34 or 35, wherein, The at least one groove extends 2 to 6 turns around the longitudinal axis defined by the wall (22).

37. The nerve conduit (10) according to claim 33, wherein, The one or more retaining surfaces (30) are formed as one or more circumferential ribs extending from the outer surface of the wall (22).

38. The nerve conduit (10) according to claim 37, wherein, The extension of one or more ribs is linear with respect to the circumferential direction, or includes an offset in the longitudinal direction of the wall (12) with respect to the circumferential direction.

39. The nerve conduit (10) according to any one of claims 34 to 38, wherein, The wall (22) portion including the one or more retaining surfaces (30) has a reduced thickness, and wherein at least one of the one or more grooves or the one or more ribs extends radially beyond the adjacent wall portion.

40. The nerve conduit (10) according to claim 39, wherein, The retaining surface (30) or the portion of the retaining surface (30) adjacent to the longitudinal end face of the insertion portion (18) includes a reduced radial extension.

41. The nerve conduit (10) according to any one of the preceding claims, wherein, The outlet portion (19) is configured to attach to / connect with muscle tissue.

42. The nerve conduit (10) according to claim 41, wherein, The outlet portion (19) is configured to attach to the top of the muscle tissue, or to attach to an internal recess or slit within the muscle tissue.

43. A medical device (100) for applying a medical adhesive material (130) to a nerve conduit (10), the medical device comprising a body (110) having two legs (112) extending at least partially in parallel from the body (110), wherein, The bottom surface of each of the legs (112) and the bottom surface of the body (110) are arranged flush with each other and include a recess that forms a continuous reservoir (122) between at least a portion of each leg (112) and the body (110) for receiving the medical adhesive material (130), and wherein the legs (112) are arranged to at least partially cover the edge portion of the flange (26) of the outlet portion (19) of the nerve conduit (10).

44. The medical device (100) according to claim 43, wherein, The leg (112) is configured to cover the edge portion of the flange (26) formed by the wall (22) at the outlet opening (21) of the nerve conduit (10), and wherein the flange (26) extends radially outward from the outlet opening (21).

45. The medical device (100) according to any one of claims 43 or 44, wherein, The legs (112) are spaced apart from each other over their entire longitudinal extension.

46. ​​The medical device (100) according to any one of claims 43 to 45, wherein, The main body (110) and the leg (112) form a U-shape.

47. The medical device (100) according to any one of claims 43 to 46, wherein, The storage unit (122) extends to the corresponding end portion of each of the legs (112) in a direction away from the body (110).

48. The medical device (100) according to any one of claims 43 to 47, wherein, The leg (112) is connected via a bridging portion (116).

49. The medical device (100) according to claim 48, wherein, The bridging portion (116) is located at the longitudinal end portion of the leg (112) in a direction away from the body (110).

50. The medical device (100) according to claim 48 or 49, wherein, The bridging portion (116) extends in a plane substantially perpendicular to each of the legs (112) and in a direction toward each other.

51. The medical device (100) according to any one of claims 48 to 50, wherein, The bridging portion (116) includes a convex curvature in a direction away from the top surface of the leg (112).

52. The medical device (100) according to claim 51, wherein, The bridging portion (116) is formed as a U-shaped arc.

53. The medical device (100) according to any one of claims 48 to 52, wherein, The bridging portion (116) is inclined toward the body (110) and is formed to follow the curved contour of the nerve conduit.

54. The medical device (100) according to any one of claims 43 to 53, wherein, The top surface of the body (110) defines a protrusion (118) extending in a direction away from the storage (122).

55. The medical device (100) according to claim 54, wherein, The protrusion (118) includes a hole or cavity (120) extending from the top surface of the protrusion (118) toward the reservoir (122), the hole or cavity (120) being configured to receive a rod-shaped retaining element (128).

56. The medical device (100) according to claim 55, wherein, The hole or cavity (120) is tapered and has a decreasing diameter toward the reservoir (122).

57. The medical device (100) according to claim 55 or 56, wherein, The hole or opening (120) is closed at the level above the reservoir (122).

58. The medical device (100) according to any one of claims 43 to 57, wherein the medical device is formed of a light-transmitting material.

59. The medical device (100) according to any one of claims 43 to 58, wherein the medical device is formed of a transparent or translucent material.

60. The medical device (100) according to any one of claims 43 to 59, wherein the medical device comprises or is formed of a polymer-based material and / or an elastic material.

61. A kit comprising a nerve conduit (10) according to any one of claims 1 to 42 and a medical device (100) according to any one of claims 43 to 60.

62. Use of a nerve conduit (10) according to any one of claims 1 to 42 and / or a medical device (100) according to any one of claims 43 to 60 for repairing, supporting and / or guiding nerve tissue, particularly for repairing peripheral nerve injuries.

63. A method for treating peripheral nerve injury, comprising the following steps: - Provide a nerve conduit (10) according to any one of claims 1 to 42; - Insert the nerve endings of the damaged nerve into the insertion portion (18) of the nerve conduit (10); - The nerve endings are fixed in the cavity (16) by applying medical adhesive to the outside of the wall (22) at the opening (20) of the insertion portion (18); as well as - Attach the outlet portion (19) to the target site, preferably muscle tissue.

64. A method for applying a medical adhesive material (130) to the outlet portion (19) of a nerve conduit (10), comprising the steps of: - Provides a medical device (100) according to any one of claims 43 to 60 and a nerve conduit (10) according to any one of claims 1 to 42; - Apply medical adhesive material (130) to the reservoir (122) along its entire extension; - Position the medical device (100) on the flange (26) of the outlet portion (19) of the nerve conduit (10) placed on top of the target tissue, such that the applied medical adhesive material (130) covers the edge portion of the flange (26) and the adjacent target tissue, and forms an interface between the nerve conduit (10) and the target tissue.

65. The method according to claim 64, wherein, During the application of the medical adhesive material (130) to the flange (26) and the adjacent target tissue, the nerve conduit (10) is held in the proper position on top of the target tissue by means of the medical device (100).

66. The method according to any one of claims 64 or 65, wherein, The medical adhesive material (130) is cured by applying light.

67. The method of claim 66, wherein, The medical device (100) is formed of a light-transmitting polymer and is cured by applying light in situ through the medical device (100).

68. The method according to any one of claims 64 to 67, wherein, The medical adhesive material (130) is polymer-based and / or includes medical adhesives.

69. The method according to any one of claims 64 to 68, wherein, The target tissue is muscle tissue.

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