Nerve conduit system

Abstract

The invention relates to a nerve conduit system connecting two nerve endings in an end-to-end manner. In particular, the present invention relates to a nerve conduit system that supports the repair of nerve injury by promoting proper placement and orientation of nerve endings and enabling attachment of nerve endings of the same or different diameters. Thus, a nerve conduit system (10) for connecting two nerve endings in an end-to-end manner is provided, comprising a first component (12) and a second component (14), each component (12, 14) comprising an insertion portion (16, 26) for receiving one of the two nerve endings and a connection portion (22, 24), where each component (12, 14) comprises a through-hole (20, 30), the through-holes (20, 30) are defined at least by the respective insertion portions (16, 26) and extend between longitudinally opposite ends of the respective portions (12, 14), and wherein the connection portions (22, 24) are configured to engage each other and arranged such that the through-holes (20, 30) are in fluid communication with each other in a connected condition (i.e. When the connection portions (22, 24) of the first component (12) and the second component (14) engage each other).

Description

Technical Field

[0001] The present invention relates to a nerve conduit system for connecting two nerve endings in an end-to-end manner. In particular, the present invention relates to a nerve conduit system that supports the repair of nerve damage by promoting the correct placement and orientation of nerve endings and enabling the connection of nerve endings, preferably with different diameters. Background Art

[0002] When injured, tissue damage may involve damage to one or more nerves of the peripheral nervous system, resulting in partial loss of sensation and / or impaired motor skills. Such injuries involving nerve damage are particularly common in the upper extremities (e.g., a person's hands or fingers), such that if the nerve damage is not properly treated, the person may experience, for example, a loss of touch or tactile feedback and / or difficulty controlling fine motor skills in the injured area.

[0003] Current methods for treating nerve damage include joining nerve endings by various suturing techniques to provide connections between individual nerve endings in a substantially tension-free manner. In the presence of more severe defects (wherein nerve endings are not directly adjacent to each other), reconstruction may be required to overcome the corresponding gap. For example, reconstruction can be provided by autologous or allogeneic nerve transplantation. Alternatively, reconstruction can be achieved by providing a tubular structure to provide nerve guidance. For example, this tubular structure can be provided by an autologous or allogeneic venous structure, or by providing an artificial nerve conduit made of biocompatible material. Regardless of whether there is a gap, the use of the tubular structure can promote the repair of the injury, for example, by providing further mechanical support and structural stability, providing tension-free repair, reducing the inflammatory response at the injury site and / or limiting the extent of fibrous tissue development.

[0004] Tubular structures, particularly nerve conduits, are typically formed into a substantially cylindrical shape, extending longitudinally and defining an inner cavity or through-hole from one end to the opposite end. The size and shape are selected so as to be compatible with the affected microstructure of the damaged nerve tissue and surrounding tissue. Therefore, in order to treat nerve damage, a nerve ending is inserted into the nerve conduit from one end of the nerve conduit, and another corresponding nerve ending is inserted into the nerve conduit from the opposite end of the nerve conduit. Then, the two ends are fixed or coupled to the nerve conduit by means of, for example, suturing techniques or by applying or depositing a medical adhesive. Alternatively, the nerve endings can be fixed or coupled to the nerve conduit by a system combining a movable contact member and a pressing member, wherein the pressing member applies a mechanical force to the contact member to push and move the contact member in the radial direction of the nerve (WO2012133019). In the implanted state, the nerve conduit thus forms a nerve guide, wherein the continuous cylindrical shape of the nerve conduit and the inner cavity provides a directional path during neurogenesis.

[0005] Another potential complication resulting from nerve injury is an increased risk of neuromas, which can grow at the ends of severed nerves. Such neuromas may develop from disorganized axons growing outside the epineurium that was severed at the end of a transected nerve, for example after severe trauma or surgery, where axonal sprouting may form a bundle of disorganized and overexcitable nerve tissue without the original nerve structure. Neuromas are often accompanied by neuropathic pain, numbness, and tingling, and may also interfere with rehabilitation, functional recovery, and sensory deficits. Treatment or prevention of neuromas may be based on suturing the proximal end of the damaged nerve to the intact, newly denervated muscle's specific motor nerve. This treatment approach may be particularly suitable for situations where there is a large gap between the proximal and distal nerve endings, or where the distal nerve endings are lost due to amputation or tissue removal. Suturing techniques can reduce the risk of neuroma development while at least partially restoring muscle control. Summary of the Invention

[0006] Based on the known existing technologies, it is necessary to further promote the repair of nerve damage.

[0007] According to the present invention, it has been recognized that it may be difficult to insert and attach nerve endings to the corresponding ends of a nerve conduit, particularly in situations where a larger gap between the nerve endings needs to be bridged by the nerve conduit. It has been found that this is, on the one hand, caused by the limited flexibility of the nerve conduit in situ. Once a nerve ending is introduced and fixed to the corresponding end of the nerve conduit, the insertion and alignment of another nerve ending may be particularly impaired, and the further operation of the nerve conduit may be restricted. On the other hand, the continuous structure of the nerve conduit and the lack of visual feedback make it difficult for the surgeon to assess whether the corresponding nerve ending has been correctly inserted and whether it is correctly maintained in place after attachment (e.g., by using a medical adhesive). Therefore, potential necessary modifications are usually impossible.

[0008] In addition, it has been found that there may be differences in the diameters of the corresponding nerve endings to be connected, particularly in the case of larger gaps and / or when the proximal nerve endings are connected to different nerve endings (e.g., different motor nerves), wherein the latter may have a significantly smaller or larger diameter. In order to provide a connection for nerve endings that exhibit such diameter differences, the size of the nerve conduit needs to be increased accordingly, which, however, is disadvantageous for the correct insertion and fixation of nerve endings with smaller diameters. In particular, this may require a larger amount of medical adhesive to correctly fix at least the nerve endings with smaller diameters, which further complicates the implementation and operation of the nerve conduit. Larger diameters and large amounts of medical adhesives may also lead to abnormal axonal growth, damage repair, and may even induce the development of neuromas.

[0009] Therefore, the object of the present invention is to further improve and / or promote the repair of nerve damage. In particular, the object of the present invention is to promote the correct fixation and alignment of nerve endings with nerve conduits. A particular object of the present invention is to promote such repair of nerve endings with different diameters.

[0010] Said object is achieved by the independent claim. Preferred embodiments are described in the dependent claims, the description and the drawings.

[0011] Therefore, a nerve catheter system for connecting two nerve endings in an end-to-end manner is provided, comprising a first component and a second component, each component comprising an insertion portion and a connection portion, the insertion portion being adapted to receive one of the two nerve endings, wherein each component comprises a through-hole defined at least by the respective insertion portion and extending between longitudinally opposite ends of the respective components, and wherein the connection portions are configured to engage with each other and are arranged such that the through-holes are in fluid communication with each other in a connected state (i.e., when the connection portion of the first component engages with the connection portion of the second component).

[0012] It is worth noting that when the first component and the second component are joined, the connecting portion preferably does not act as a pressing member that applies a force in the radial direction of the nerve ending. More specifically, the connecting portion of the first component does not act as a pressing member that applies a force to the connecting portion of the second component in the radial direction of the nerve ending, and the connecting portion of the second component does not act as a pressing member that applies a force to the connecting portion of the first component in the radial direction of the nerve ending.

[0013] In other words, the nerve conduit system of the present invention comprises or consists of two separate (independent) components (a first component and a second component) that can be connected to each other (via their connection portion) to bring two nerve endings closer together and, in extreme cases, connect the two nerve endings. Thus, each component and its corresponding insertion portion receives a respective one of the two nerve endings to be connected, such that the nerve ending is accommodated in the through-hole of the corresponding component. By virtue of the connection and fluid communication through the through-hole, the nerve endings can thus be brought into an end-to-end relationship with each other.

[0014] As used herein, connecting nerve endings in an "end-to-end manner" includes direct connection of (two) nerve endings, i.e., without a gap between the nerve endings, and connection of (two) nerve endings with a gap or longitudinal distance of at most about 20 mm, preferably at most about 15 mm, more preferably at most about 10 mm, and particularly preferably at most about 5 mm. In some embodiments, (two) nerve endings are thus directly connected, i.e., without a gap between the nerve endings. In other embodiments, (two) nerve endings are connected with a gap or longitudinal distance of at most about 20 mm, preferably at most about 15 mm, more preferably at most about 10 mm, and particularly preferably at most about 5 mm between (two) nerve endings.

[0015] The advantage of providing two independent components is that, since each nerve ending can be individually fixed or attached to the corresponding (first or second) component before the two components are connected by means of the corresponding connecting portion, the operation of the nerve catheter system can be particularly facilitated. As a result, the surgeon's operational flexibility is improved. In addition, this further facilitates the insertion of the corresponding nerve ending into the corresponding insertion portion, while ensuring that the medical adhesive or other means for fixing the corresponding nerve ending to the corresponding (first or second) component has been correctly used. Therefore, the nerve endings can be optionally fixed or attached to the corresponding components before being connected to each other.

[0016] Furthermore, the two separate components advantageously enable each component to be selected according to the specific size (diameter) of each nerve ending. This is particularly advantageous for the connection of nerve endings having different diameters, since each component of the nerve catheter system can be selected according to the different sizes of the nerve endings. In particular, the individual components can include an insert defining a portion of the through-hole and having an inner diameter corresponding to the respective nerve ending to be inserted into the insert and accommodated within the through-hole. In contrast, conventional single-component nerve catheters are typically selected based on nerve endings having a larger diameter, such that the selected nerve catheter is typically too large for nerve endings having a smaller diameter and requires special fixation.

[0017] The first component may include an insertion portion and a corresponding portion of a through hole, the corresponding portion of the through hole having an inner diameter suitable for nerve endings with a larger diameter (compared to the (another) nerve ending to be connected thereto). Correspondingly, the second component may include an insertion portion and a corresponding portion of a through hole, the corresponding portion of the through hole having an inner diameter suitable for nerve endings with a smaller diameter (compared to the (another) nerve ending to be connected thereto). Therefore, the configuration of the first component and the second component can be optimized for a specific nerve ending diameter. By means of the connecting portion and the fluid-connected through hole, the nerve endings can then be connected to each other in an end-to-end manner. Preferably, the connecting portion is standardized for various sizes of the insert portions of the various components.

[0018] Thus, a nerve catheter system having two combinable but independent first and second components allows the insertion portions of the respective components to each include an internal through-hole having a different diameter and / or cross-sectional area. For example, a mismatch in the diameter of a nerve ending of 1.1 to 10 times, particularly more than 2 times, can be bridged by correspondingly adapting the respective first and second components of the nerve catheter system. For example, at least the insertion portion of one component can be configured to receive nerve endings having a diameter of 1 mm to 12 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm or 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm), while the insertion portion of the other component can be configured to receive nerve endings having a diameter of 1 mm to 12 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm or 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm).

[0019] However, it must be understood that the two nerve endings to be connected may have the same diameter, the first and second insertion parts and the corresponding parts of the through-hole then being adjusted accordingly.

[0020] Another advantage of equipping each nerve ending with a separate component is that, after the nerve ending is inserted into the corresponding insertion portion (entering the through hole), it can be observed or inspected. In particular, the corresponding nerve ending can be received in the through hole via the corresponding insertion portion. The nerve ending can extend from one longitudinal end (of the insertion portion) toward the opposite longitudinal end through the through hole. The insertion method of the nerve ending can make the nerve ending not extend beyond the insertion portion, but terminate in the through hole in the junction area between the insertion portion and the adjacent portion and / or at the junction area. Thus, the nerve ending can be observed via the relative longitudinal end of the through hole. Therefore, before applying the medical adhesive and / or the connecting component, it can be monitored whether it is correctly inserted.

[0021] The nerve conduit component may typically comprise a basic tubular shape with a through hole having longitudinally opposite openings and one or more (side) walls. Thus, a continuous channel or through hole is provided in each individual component, in particular when the connecting portion of the first component and the connecting portion of the second component are engaged, i.e. in the connected state, (by connecting the (single) through holes of the individual components to form a continuous (single) through hole in the connected state). Although the nerve conduit component may have a basically tubular shape, the diameter of the tubular shape may vary along the longitudinal direction. In the connected state, i.e. when the connecting portion of the first component and the connecting portion of the second component are engaged, the component may thus form a longitudinally extending elongated body, wherein the respective through holes are fluidically connected to each other, for example, by being arranged directly adjacent or by accommodating the end of the through hole of one component and not being used for inserting the respective nerve ending into the through hole of the other component.

[0022] According to another embodiment, the tubular shape may include structures with specific geometric shapes or surface irregularities that are formed as retaining surfaces on the outer surface (more preferably on the outer surface of the insert), such as protrusions, slits, threads, grooves, or holes. In particular, such external structures can advantageously (i) increase the contact between the surface of the insert and the medical adhesive; and (ii) create anchor points for the medical adhesive. Such external structures are disclosed, for example, in patent application WO2022229207, the contents of which are incorporated herein by reference.

[0023] The cross-section of the through hole is preferably circular or elliptical. The tubular or cylindrical structure can substantially correspond to the shape of the through hole so that a continuous guiding structure for tissue repair or support (protection) (such as neurogenesis or nerve growth) is generally provided without providing undesirable bias. The structure can provide sufficient structural stability and prevent sharp bending or kinking during tissue movement (i.e. compression, extension or nerve growth). The tubular shape can also accordingly provide a homogeneous structure that reacts in a predetermined manner along its entire longitudinal extension, in particular when forces act on a part of the nerve conduit system (e.g., when subjected to impact).

[0024] Thus, the through-hole of each component can be continuous and defined by open end faces at longitudinally opposite ends. In some embodiments, for one or both components of the system, preferably for the second component (but not for the first component), the through-hole can be defined solely by the insert. In other embodiments, for one or both components of the system, preferably for the first component (but not for the second component), the through-hole can be defined by the insert, or alternatively, by portions of the respective components connected to and / or extending from the respective insert (e.g., connecting portions and / or transition portions).

[0025] The insertion portion can define the proximal end and the longitudinally opposite distal end of the corresponding part of the through hole. That is, the proximal end (or the proximal opening) can be used to insert the corresponding nerve ending into the insertion portion and the corresponding part of the through hole. The distal end can be arranged so that the corresponding nerve ending preferably does not leave or protrude from the end. In the connected state, that is, when the connecting portion of the first component and the connecting portion of the second component are engaged, the distal end of the insertion portion of the first component and the distal end of the insertion portion of the second component can be relative to each other. Other parts of the corresponding parts can extend from the distal end, for example, to promote connection and / or promote the axonal growth of one nerve ending to be guided to another nerve ending to be connected, thereby limiting the risk of neuroma while supporting nerve regeneration and repair.

[0026] Preferably, at least one component (more preferably the first component and the second component) further includes a transition portion, which is arranged between the corresponding insertion portion and the corresponding connecting portion of the component, or extends between the corresponding insertion portion and the corresponding connecting portion of the component. The transition portion can extend from the insertion portion toward the connecting portion, or from the connecting portion toward the insertion portion, thereby forming a bridge portion. Extension here should be understood to mean longitudinal and / or radial extension. Providing such a transition portion is particularly advantageous if the diameters of the insertion portion and the connecting portion of the same component are different. Preferably, the diameter of the insertion portion of one component (e.g., the first component) can be larger than the diameter of the corresponding connecting portion of the component. Additionally or alternatively, the other component (e.g., the second component) preferably includes a connecting portion with a diameter larger than the diameter of the corresponding insertion portion. In particular, the transition portion "bridges" the insertion portion and the connecting portion of the same component of different diameters, allowing the (first and / or second) component to be formed as a single piece, preferably without abrupt changes or sharp-edged steps (in its outer shape).

[0027] Therefore, the transition portion preferably has a substantially conical or conical shape, for example as shown in a longitudinal cross section. Thus, a gradual transition from the diameter of the insert portion to the diameter of the connecting portion can be provided, preferably in a stepless manner. Thus, the transition portion preferably comprises a substantially circular cross section.

[0028] In some embodiments, the outer surface of the transition portion and / or the connecting portion can also facilitate handling of the respective components, for example, by forming an outer grip and / or support surface toward the connecting portion. This is particularly true when the transition portion comprises a substantially conical shape or other gradually transitioning shape.

[0029] The transition portion of the second component can be preferably configured to connect and arrange a corresponding connection portion outside the insert portion, for example, to attach the insert portion to a connection portion having a larger diameter, preferably in a surrounding and concentric manner. The transition portion of the first component can be configured to attach the insert portion to the connection portion, preferably in an adjacent and radially inward or outward extending manner.

[0030] In (at least) one component, preferably the first component, the connecting portion and the optional transition portion may also define corresponding parts of the through-hole (in addition to the insert portion defining (another) part of the (same) through-hole). This can be achieved by a configuration in which the insert portion and the connecting portion of (at least) one component (preferably the first component) are arranged adjacent to each other in the longitudinal direction, or are arranged directly adjacent to each other, or have a transition portion between the insert portion and the connecting portion. In such a configuration, the shape of the through-hole defined by the transition portion preferably comprises a shape corresponding to the entire transition portion, such that the outer diameter and the inner diameter extend substantially in parallel. The shape of the transition portion may not only provide a transition between through-holes of different diameters that have been determined, but may also facilitate the handling of the corresponding components, for example by forming an external grip and / or a support surface (even if no transition is required between the different diameters of the insert portion and the connecting portion, in particular if said diameters are the same).

[0031] In (at least) one component, preferably the second component, the transition portion and the connecting portion are arranged so that they do not define corresponding parts of the through hole. For example, as described below, the transition portion and / or the connecting portion may at least partially surround the insert portion.

[0032] The insertion portion and / or the connection portion of at least one component (preferably each component) may also include a substantially cylindrical (or tubular) shape. As described above, this can improve the stability and operability of the overall structure. In addition, such a shape allows for optimization of the radial dimensions based on the diameter of the corresponding nerve catheter. Furthermore, the cylindrical shape reduces or avoids the occurrence of sharp edges and / or unintended clamping or compression of surrounding tissue when the nerve catheter system is implanted.

[0033] As described above, the insertion portion of the first component and / or the insertion portion of the second component can have a basic tubular shape. Therefore, the insertion portion of the first component and / or the insertion portion of the second component can extend along the longitudinal axis. In addition, the connecting portion of the first component and / or the connecting portion of the second component can have a basic tubular shape. Therefore, the connecting portion of the first component and / or the connecting portion of the second component can extend along the longitudinal axis. Preferably, the longitudinal axes of the insertion portion and the connecting portion of the same component correspond to each other (for example, the longitudinal axis can be the same, or the longitudinal axis of the insertion portion is a longitudinal extension of the longitudinal axis of the connecting portion of the same component). In other words, for each component, the insertion portion, the connecting portion and the optional transition portion can preferably extend along the same longitudinal axis.

[0034] In the connected state, i.e., when the connecting portion of the first component and the connecting portion of the second component are engaged, preferably, the insert portion of the first component and the insert portion of the second component extend along the same longitudinal axis. Similarly, preferably, the connecting portion of the first component and the connecting portion of the second component extend along the same longitudinal axis. More preferably, when the connecting portion of the first component and the connecting portion of the second component are engaged, i.e., in the connected state, the insert portion, the connecting portion, and the optional transition portion of the first and second components all extend along the same longitudinal axis.

[0035] The connecting portion of (at least) one component (preferably the second component) can at least partially surround the insertion portion of the component. This can be direct or, preferably, with a transition portion arranged between the insertion portion and the connecting portion. The transition portion preferably provides a spacing between the insertion portion and the connecting portion (the connecting portion at least partially, preferably completely surrounds the insertion portion). The transition portion is preferably arranged so that the transition portion can (also) at least partially surround the insertion portion. This "surrounding" configuration may be particularly advantageous if the insertion portion of one component (preferably the second component) is configured for nerve endings with a smaller diameter than the nerve endings to be inserted into (and accommodated in) the insertion portion of another component. Thus, while maintaining the connectability of the various connecting portions, the overall longitudinal dimensions of the component can be reduced. In particular, the insertion portion and the connecting portion of at least one component can be arranged concentrically. In the configuration where the connecting portion partially or completely surrounds the corresponding insertion portion, the connecting portion preferably does not define the corresponding part of the through-hole.

[0036] The insert and the connecting portion of (at least) one component, preferably the first component, can be arranged adjacent to each other in the longitudinal direction. This can be direct or with a transition portion arranged between the insert and the connecting portion. In contrast to a concentric arrangement, such a sequential arrangement in the longitudinal direction may be particularly advantageous if the insert of the respective component comprises a diameter which is substantially the same or larger than the diameter of the connecting portion. In this arrangement, the connecting portion preferably defines a corresponding portion of the through-hole. Therefore, it can have similar dimensions or smaller dimensions than the portion of the through-hole defined by the insert. In the case of a diameter difference between the insert and the connecting portion to be bridged, a transition portion which accommodates said difference can be provided between the connecting portion and the insert, wherein the transition portion preferably also defines a corresponding portion of the through-hole.

[0037] According to one embodiment, the two components (i.e. the first component and the second component) can have the same (surrounding or sequential) configuration with respect to the arrangement of the connection portion and the insert portion relative to each other, i.e. (i) in both components, the connection portion can at least partially surround the insert portion of the component ("surrounding configuration"), or (ii) in both components, the insert portion and the connection portion can be arranged adjacent to each other in the longitudinal direction ("successive" configuration). According to a preferred embodiment, in only one of the components, preferably the first component, the insert portion and the connection portion can be arranged adjacent to each other in the longitudinal direction ("successive" configuration), while in the other component, preferably the second component, the connection portion at least partially surrounds the insert portion of the component ("surrounding configuration").

[0038] In order to facilitate the connection of the nerve endings in an end-to-end manner, the connecting portion can be configured so that, when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in a connected state), the insertion portion is arranged at longitudinally opposite ends of the nerve catheter system. Depending on the desired configuration, when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in a connected state), any optional available other portions defining the through-hole (e.g., a transition portion) are therefore arranged between the insertion portions. The arrangement of the longitudinally opposite ends can be such that: when the connecting portion of the first component and the connecting portion of the second component are engaged, the openings of the portions of the through-hole defined by the corresponding insertion portion (configured to receive the corresponding nerve ending and insert it into the corresponding insertion portion, i.e., configured as nerve ending entrances into the insertion portion) face away from each other.

[0039] Preferably, when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in a connected state), the (single) through hole of the first component and the (single) through hole of the second component define a single longitudinal axis of the nerve catheter system. By inserting the nerve endings into the corresponding insertion portions, the terminal end faces of the nerve endings can therefore be directly opposite each other, and radial offsets or angles in the end-to-end connection provided by the nerve catheter system can be avoided to promote more efficient and more direct repair of damaged nerves. Preferably, in the connected state, the through holes are arranged and aligned in a concentric or adjacent manner so that the nerve endings to be connected can be connected accordingly in an effective manner.

[0040] The through holes of the two components can be arranged in a sequential and adjacent manner in the longitudinal direction. Preferably, when the connecting portion of the first component and the connecting portion of the second component are engaged, that is, in the connected state, the connecting portion is configured so that the through hole of one component (particularly the second component) is at least partially accommodated in or near the through hole of the other component (for example, the first component).

[0041] By accommodating a portion of a through-hole (e.g., a through-hole of the second component) within the through-hole of the first component, the overall longitudinal dimensions of the nerve catheter system can be reduced. Furthermore, this configuration can improve the structural stability of the nerve catheter system and / or the sealing of nerve endings to be connected to the outside of the nerve catheter system, for example, by corresponding configurations of at least the respective connecting portions. In particular, the connecting portion of the first component can define a corresponding portion of the through-hole of the first component. Preferably, the connecting portion of the first component is adapted to accommodate the insertion portion of the second component and a corresponding portion of its through-hole.

[0042] Housing the nerve endings within or near the through-holes of the first component may also promote regeneration of damaged nerve endings by ensuring that the individual nerve endings to be connected are closer to each other. Thus, axonal growth may be supported, for example, from a nerve ending housed within the through-holes of the first component toward a nerve ending housed within the through-holes of the second component.

[0043] Preferably, such accommodation within the through-hole of the component may be particularly advantageous if the respective component (e.g. the first component) is configured to accommodate a respective nerve ending having a larger diameter than the nerve ending to be accommodated within the through-hole of the other component. Thus, it is particularly advantageous if the connecting portion of the component (e.g. the first component) is arranged in a sequential or adjacent manner relative to the respective insertion portion (e.g. via a respective transition portion), wherein the dimensions of the connecting portion of the component and the corresponding portion of the through-hole may be larger than the dimensions of the insertion portion of the other component (e.g. the second component).

[0044] However, the connection portion of the respective component may have a predetermined size which is independent of the size of the insert of the respective component. Thus, the connection portion may be configured as a standardized connection portion for inserts of various sizes, for example in a modular kit of parts.

[0045] It should be understood that the embodiments described above can also be applied to configurations in which, for example, the second component is configured to receive nerve endings having substantially the same diameter or a larger diameter than the nerve endings to be received by the first component. In either configuration, the connecting portion of at least one component is preferably arranged in a sequential or adjacent manner relative to the corresponding insertion portion (e.g., via a corresponding transition portion), wherein the dimensions of the connecting portion and the corresponding portion of the through-hole of the component are larger than the dimensions of the insertion portion of the other component (e.g., the second component).

[0046] In the connected state, that is, when the connecting portion of the first component and the connecting portion of the second component are engaged, the nerve endings are preferably (only) accommodated in the corresponding insertion portion. Thereby, the nerve endings can be connected in an end-to-end manner without extending into the insertion portion of the corresponding other component. The connecting portion defining the through hole for accommodating the corresponding through hole of the other component (for example, the corresponding insertion portion of the other component) can be configured to accommodate only part of the insertion portion of the other component. In the accommodated and connected state, that is, when the connecting portion of the first component and the connecting portion of the second component are engaged, a predetermined gap can be provided between the end faces of each nerve ending.

[0047] The connecting portion may extend from a corresponding transition portion, the transition portion extending between the insert portion and the connecting portion to provide a bridge between different diameters. In this configuration, alternatively or additionally, the transition portion may also at least partially provide a predetermined gap.

[0048] Thus, the overall size of the nerve catheter system can be adjusted to the requirements of the individual nerve endings to be connected, eliminating the need to use oversized catheters.

[0049] In some embodiments, the through-hole of the first component may further include a longitudinal end portion that is arranged opposite the longitudinal end portion configured to receive the corresponding nerve ending and includes a cross-sectional area of ​​the through-hole that gradually increases in a longitudinal direction away from the insertion portion. For example, the local increase in the through-hole diameter may be provided at a distal longitudinal end portion of the first component defined by the corresponding connecting portion and / or the corresponding free longitudinal end portion.

[0050] Thus, the increase in diameter is not intended to facilitate insertion of the corresponding nerve ending, but may for example facilitate connection of the first component to the second component, in particular when the corresponding connection portion of the first component extends from the distal end of the insertion portion and is adapted to accommodate the connection portion of the second component.

[0051] In this configuration, the connecting portion of the second component preferably engages with the connecting portion of the first component at its outer surface. In other words, the connecting portion of the first component is preferably formed by a circumferential wall, wherein, for example, the circumferential wall of the second component can engage with the outer circumference of the connecting portion of the first component.

[0052] If the first component is provided with a transition portion, the transition portion of the first component is preferably configured so that when the connecting portion of the first component is engaged with the connecting portion of the second component (i.e., in a connected state), the transition portion at least partially receives and accommodates the radially expanded end portion of the insertion portion of the second component. Therefore, the second component may include at least one radially expanded end portion of the insertion portion. In some embodiments, the radially expanded end portion of the insertion portion is (only) located at the end that receives the nerve endings (the "entrance" where the nerve endings enter the insertion portion). In some embodiments, the radially expanded end portion of the insertion portion is (only) located at the end that is (longitudinally) opposite to the end that receives the nerve endings. Therefore, the radially expanded end portion may, for example, extend from the distal end of the insertion portion (i.e., the end that is not configured to insert the corresponding nerve ending). Preferably, both ends of the insertion portion of the second component may have radially expanded ends.

[0053] The radially flared end portion (located at the end of the insertion portion opposite the nerve entry end) is preferably configured so that a nerve ending housed in the through-hole does not extend through or beyond the end portion. Thus, the radially flared end portion can define the end face of the corresponding nerve ending. This provides a spacing or gap relative to the nerve ending housed in the portion of the through-hole defined by the corresponding insertion portion. Consequently, inadvertent extension of the nerve ending into the insertion portion of the corresponding other component can be avoided, allowing the nerve ending to be accommodated in a substantially tension-free manner.

[0054] Furthermore, the radial expansion of the end portion (e.g., a conical shape) can provide guidance for the growth or regeneration of axonal nerves from the nerve ending received in the through-hole of the first component toward the nerve ending (i.e., the target nerve ending) received in the through-hole of the second component. The radially enlarged end portion can, for example, abut an adjacent nerve ending or have a predetermined spacing therefrom, and / or its size can be designed to prevent growth along the periphery of the insertion portion of the second component, for example, if the second component is sized for a nerve ending having a smaller diameter.

[0055] Alternatively, when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in a connected state), the radially expanded end portion may also be accommodated within a portion of the through-hole defined by the connecting portion of the first component. Depending on the configuration of the first component, the longitudinal end face of the radially expanded end portion may, for example, be located at the junction of the connecting portion and an adjacent transition portion or insertion portion. The radially expanded end face may, for example, radially abut the through-hole of the first component in a frictionless manner, or it may be designed to define a predetermined gap between the through-hole and the radially expanded end face. Thereby, a guide surface and / or longitudinal boundary for accommodating the nerve ending within the through-hole of the first component may be provided. Such a guide surface provided by the radially expanded end face may, for example, be substantially continuous and / or flush with the adjacent transition portion or insertion portion of the first component.

[0056] The insertion portion of the second component and / or its optionally present radially expanded end portion preferably extend in the longitudinal direction (particularly in the distal direction) beyond the corresponding connecting portion. This configuration facilitates that the distal portion of the insertion portion can extend into the through-hole of the first component, typically beyond the connecting portion of the first component. In addition, this extension into the through-hole of the first component and toward the nerve endings accommodated in the insertion portion of the first component can minimize the gaps between the individual nerve endings connected in an end-to-end manner. Therefore, the extension from the insertion portion can provide a larger portion of the insertion portion, and the corresponding through-hole of the second component can be received and accommodated by the first component, i.e., within the corresponding through-hole, which can be beneficial for bringing the ends of the nerve endings close to each other.

[0057] At least a portion of the through-hole defined by (at least a portion of) the insertion portion of the first component and / or the second component may be defined by a tubular wall defining a substantially constant inner diameter. A constant inner diameter may be advantageous in view of the diameter and / or morphology of the nerve endings to be accommodated therein. Furthermore, this may facilitate the insertion of the corresponding nerve endings by avoiding shrinkage of the through-hole (which may be undesirable). The through-hole of the second component may be defined substantially (only) by the corresponding insertion portion. Thus, in the second component, the insertion portion preferably (only) substantially defines the longitudinal extension of the through-hole (whereas the connecting portion of the second component and optionally the transition portion of the second component may not define the through-hole when arranged in a "surrounding" configuration (i.e., the portion surrounds the insertion portion)). In some embodiments, the connecting portion of the second component is therefore preferably configured and arranged as not to define a portion of the through-hole, which can, for example, be provided in a configuration in which the connecting portion is arranged to surround the insertion portion.

[0058] The through-hole of the first component can also be essentially defined by the corresponding insertion portion, but is preferably also essentially defined by the corresponding connecting portion and the optional transition portion. In the connected state, i.e., when the connecting portion of the first component and the connecting portion of the second component of the nerve catheter system are joined, the through-hole of the system, i.e., the (single) continuous through-hole extending between the first component and the second component, can then be essentially (only) formed by the corresponding insertion portions of the two components. As a result, the nerve endings accommodated in the corresponding insertion portions are connected to each other or at least close to each other via the through-hole.

[0059] The connecting portion of the second component can extend from the longitudinal end of the corresponding insertion portion, which is configured to receive and / or insert the corresponding nerve ending, for example, from the entrance of the corresponding insertion portion. Alternatively, the connecting portion of the second component can extend from the insertion portion with a longitudinal offset from the longitudinal end of the corresponding insertion portion, which is configured to receive and / or insert the corresponding nerve ending. For example, the connecting portion can extend from the proximal end of the insertion portion or from a position between the proximal end and the distal end of the insertion portion. In general, the connecting portion of the second component can extend directly or indirectly from the insertion portion, preferably, wherein the transition portion can be arranged between the connecting portion of the second component and the insertion portion.

[0060] In the surrounding configuration described above, the connecting portion preferably extends along the outer surface of the insertion portion in the longitudinal direction towards the distal end of the insertion portion. Preferably, the wall of the connecting portion surrounds the wall of the insertion portion. Thus, preferably, substantially equal distances (in longitudinal and / or radial directions) are provided between the wall of the connecting portion and the wall of the insertion portion. Preferably, the radial spacing between the connecting portion and the insertion portion is provided by the transition portion. Thus, the transition portion can be configured to attach a connecting portion with a larger outer diameter to an insertion portion with a smaller diameter.

[0061] Thus, the connection portion can be formed as a circumferential wall, for example. The connection portion can be connected at one end to the wall defining the corresponding portion of the insertion portion and the through hole, in particular via the transition portion described above. The connection portion of the second component can include a "free" end or protrusion (in the longitudinal direction) that is configured to initiate connection with the first component. In other words, the free end or protrusion can provide a first contact with the connection portion of the other (first) component during the connection of the two components.

[0062] In particular, an offset of the connecting portion of the second component relative to, for example, the proximal end of the insertion portion of the second component may be advantageous, for example, when the overall longitudinal extension of the second component is large to bridge a correspondingly large nerve ending gap. In such cases, a longitudinal offset relative to the insertion portion may be advantageous for improving the structural stability and / or operability of the connecting portion of the second component.

[0063] The connecting portion of the first component is preferably arranged adjacent to a longitudinal end of the respective transition portion or the respective insertion portion, which is opposite to a longitudinal end of the respective insertion portion configured to receive and / or insert the respective nerve ending.

[0064] In some embodiments, the connection portion of the first component may be formed by a single circumferential wall defining a corresponding portion of the through hole. In addition, the wall may also be configured to accommodate and engage the connection portion of the second component. The connection portion of the second component may be formed as a circumferential wall.

[0065] Thus, the connection portion of the first component can be formed by a single circumferential wall, wherein the single wall accommodates the connection portion of the second component at its inner or outer surface. Thus, the connection portion of the second component can be received within the first component or at its outer surface, for example by means of a slidable device, wherein the wall of the first component can form a guide surface and engage with the connection portion of the second component, which is also preferably formed as a circumferential wall. In such an embodiment, the connection portion of the first component preferably defines a corresponding portion of the through-hole, which corresponding portion can in particular accommodate at least a portion of the through-hole of the second component.

[0066] The provision of a single circumferential wall facilitates connection because correct relative orientation of the two components in radial and longitudinal directions is simplified. Furthermore, receiving the wall of the connecting portion of the second component into the through-hole defined by the wall of the connecting portion of the first component, or along said wall of the connecting portion (e.g., by a sliding device), provides tactile feedback to the surgeon regarding the connection and can provide progressive engagement depending on the length of insertion.

[0067] In some embodiments, the connecting portion of the first component is formed as a double-walled portion, for example, two circumferential walls radially spaced apart to define a gap therebetween. Preferably, the two circumferential walls of the connecting portion are arranged in a substantially concentric manner. The two circumferential walls can be connected to each other at one (longitudinal) end, which is adjacent to the transition portion or insert portion of the first component. The (longitudinal) end opposite thereto is preferably a "free" end, which is configured to accommodate and engage the connecting portion of the second component. Therefore, the connecting portion of the second component, preferably a single (circumferential) wall, can be received in the gap provided between the two walls of the connecting portion of the first component. It should be understood that the size of the gap between the two walls of the connecting portion of the first component is generally designed to enable reception / accommodation of the connecting portion of the second component, which is preferably a single (circumferential) wall.

[0068] In other words, the connecting portion of the first component can be formed by a circumferential inner wall and an outer wall, which define a longitudinally extending groove (also referred to as a "gap" above) between the walls. In particular, the groove is configured to accommodate the connecting portion of the second component when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in the connected state). As a result, the inner wall and the outer wall of the connecting portion are radially spaced apart from each other. In some embodiments, the groove can also be formed in a single (thicker) wall portion (rather than in individual wall portions), thereby defining an inner wall / outer wall element or portion.

[0069] The inner and outer walls are preferably formed so as to extend from a longitudinal end of the connecting portion adjacent to the transition portion (or, if no transition portion is present, the insertion portion). Free ends of the inner and outer walls are provided at the other end of the connecting portion (in the longitudinal direction) and are configured to receive the connecting portion of the second component. The free ends typically face away from the corresponding insertion portion and / or the corresponding opening of the through-hole configured to receive the entrance of the nerve endings. In particular, the inner and outer walls are connected to each other at the (longitudinal) end of the connecting portion, which is adjacent to the transition portion (or insertion portion). The other longitudinal end of the wall is preferably a free end, forming a corresponding protrusion and a corresponding seat (or groove / gap) to (receive) the connecting portion of the second component. By means of the groove or double wall, the connecting portion of the second component (preferably also formed as a circumferential wall) can be inserted into the connecting portion of the first component, i.e., within the groove, so as to engage the outer and / or inner walls, for example, by an interference fit.

[0070] In addition, the outer wall may also include a radial flare or extension at its free end, for example in the form of a funnel, chamfer or bevel. Thus, the radius of the outer wall of the connecting portion of the first component may be increased at its free end compared to its other end (and compared to the main part of the connecting portion, wherein the inner wall and the outer wall preferably extend in a substantially concentric manner, preferably around the same longitudinal axis as the corresponding parts of the connecting portion and / or the through-hole of the second component). The radial flare may facilitate the insertion of the connecting portion of the second component. Such flaring may also be used to release the intermittent connection of the two components, for example, by facilitating the spacing between the outer wall and the receiving portion of the connecting portion of the second component.

[0071] As described above, each connecting portion may include at least one circumferential wall to facilitate connection of the two components via the corresponding connecting portion. Preferably, when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in a connected state), the circumferential walls are configured to engage with each other and be radially offset, and / or are sized and configured to couple with each other via an interference fit.

[0072] According to one embodiment, the outer diameter of the circumferential wall of the connecting portion of the second component can be adapted to (e.g., substantially corresponding to or slightly smaller than) the inner diameter of the (outer) circumferential wall of the connecting portion of the first component, preferably enabling a press-fit engagement of the circumferential walls. According to a preferred embodiment, the inner diameter of the circumferential wall of the connecting portion of the second component can be adapted to (e.g., substantially corresponding to or slightly larger than) the outer diameter of the (inner) circumferential wall of the connecting portion of the first component, preferably enabling a press-fit engagement of the circumferential walls. Typically, a certain amount of tolerance and / or flexibility can be provided for the diameters to enable a press-fit engagement of the circumferential walls. For example, the difference in the diameters of the circumferential walls can correspond to approximately 30% to 90% of the wall thickness, preferably approximately 40% to 60% of the wall thickness. One of the circumferential walls can also have a greater thickness so that the radial biasing force towards the circumferential wall having the smaller thickness can be increased, for example, to generate a biasing force in a radially outward direction.

[0073] Furthermore, the circumferential wall can be sized such that a wall of the connecting portion of the second component is slidably received by at least one wall of the connecting portion of the first component. Thus, the circumferential wall of the first component can provide a surface that facilitates connection and engagement of the two components. Thus, the circumferential wall of the second component can be received on either the outer or inner surface of the circumferential wall of the first component.

[0074] The slidable device can also provide initial retention prior to potential fixation of the two components, such as when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in the connected state), by using a medical adhesive or mechanical fixation. The guiding surface and the slidable device also promote correct orientation and alignment of the nerve guide components and the nerve endings contained therein.

[0075] Alternatively, or in addition to the press-fit engagement, the components can be fastened or secured to each other by positive locking. Such positive locking can reduce the need for medical adhesives and / or can facilitate the coupling of the components and the connection of the nerve endings to each other, thereby potentially reducing the occurrence of loose joints.

[0076] Thus, one of the connecting portions may comprise at least one radial protrusion and the other connecting portion may comprise at least one slit or groove, the slit or groove being configured to receive the protrusion and to secure the second component at least longitudinally to the first component when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e. in the connected state). Preferably, the at least one radial protrusion and the at least one slit are configured to form a snap-fit ​​engagement in the connected state (i.e. when the connecting portion of the first component and the connecting portion of the second component are engaged). It should be understood that at least one protrusion or slit may therefore refer to more than one protrusion or slit or groove, i.e. 2, 3, 4, 5, 6 or more, but may also refer to a single protrusion or slit or groove. In general, the number of protrusions and the number of slits or grooves may be the same or different.

[0077] By providing a form interlock, a predetermined connection state can be provided so that a required or predetermined distance or proximity between nerve endings in a contained state can be ensured. In addition, this form interlock mechanism, and in particular the snap-fit ​​engagement, provides tactile feedback to the surgeon to confirm the correct connection of the components to each other. Even if a medical adhesive is applied (for example for redundancy or special treatment requirements), there is no need to manually secure the components together during application and / or curing of the medical adhesive because the form interlock ensures that the components can remain in the predetermined connection state, i.e. when the connecting portion of the first component and the connecting portion of the second component are engaged.

[0078] Preferably, the at least one protrusion or the at least one slit of the connecting portion of the first component is located on the inner surface or the outer surface of the circumferential wall of the connecting portion. Alternatively or additionally, the at least one protrusion or the at least one slit of the connecting portion of the second component may be located on the opposite (i.e., outer or inner) surface of the circumferential wall of the connecting portion. For example, the at least one protrusion or the at least one slit of the connecting portion of the first component may be present on the connecting portion defined by a single circumferential wall, or may be arranged in a groove defined by two circumferential walls defining the connecting portion of the first component.

[0079] In particular, the circumferential wall of the connecting portion of the second component can thus be received within or accommodated by the circumferential wall of the connecting portion of the first component, i.e. inserted into a single circumferential wall or into a recess defined by the connecting portion of the first component. In the connected state, i.e. when the connecting portion of the first component and the connecting portion of the second component are engaged, the interface at the connecting portion of the second component can thus engage with a corresponding interface at the connecting portion of the first component.

[0080] At least one slit may comprise a larger circumferential extension than at least one protrusion. This allows a certain flexibility in the orientation of the components relative to each other in the circumferential direction. Thus, the larger extension of the slit allows a corresponding movement or rotation of the components corresponding to the difference in circumferential extension. This may be particularly advantageous in situations where, after the surgeon initially secures the components to each other, it is determined that relative rotation may be beneficial for treatment. In addition, this may also provide a certain degree of natural movement at the implant site and may, for example, absorb any torque forces that may impair nerve regeneration. In order to prevent such further rotation after correct alignment, a medical adhesive may also be additionally applied. As described above, during the application and / or curing of the medical adhesive, the shape interlocking secures the components to each other at least in the longitudinal direction.

[0081] Preferably, the nerve conduit system comprises a plurality of protrusions and a plurality of slits. Preferably, the number of slits and protrusions is equal. The protrusions and slits may be equally spaced in the circumferential direction.

[0082] Preferably, the nerve conduit component comprises at least two slits and / or at least two protrusions. Multiple protrusions and multiple slits can provide improved fixation of the nerve conduit components to each other and facilitate the surgeon to perform correct orientation and alignment during connection of the components. For example, the nerve conduit system can comprise 2 to 12 protrusions and slits, preferably 6 to 10 protrusions and slits. In addition, the slits can also be arranged as two rows of slits, wherein the rows of slits are spaced apart from each other in the longitudinal direction, and wherein each row of slits is arranged along a single straight line in the circumferential direction. Thus, the surgeon can choose between two different predetermined gaps between adjacent nerve endings in a connected state, and can select the desired gap based on the clinical state of the nerve endings and / or the required or preferred operation.

[0083] In addition to one or more slits, the nerve conduit system may also include one or more recesses configured to receive corresponding protrusions. In this case, the protrusions do not extend through or beyond the receiving recesses (as in the case of the slits), but are instead accommodated, seated, or retained by the recesses, e.g., in a form-fitting manner.

[0084] To facilitate insertion of the nerve ending into the corresponding insertion portion, the cross-sectional area of ​​the through-hole of the insertion portion of the first component and / or the cross-sectional area of ​​the through-hole of the insertion portion of the second component can be gradually increased at the longitudinal end portion for receiving the nerve ending and in the direction facing toward the end portion receiving the nerve ending (nerve entrance). In other words, the diameter of the through-hole can be increased in the longitudinal direction at the level or end face of the insertion portion (where the corresponding nerve ending is to be inserted into the through-hole, for example, at the entrance of the corresponding insertion portion).

[0085] This can be particularly advantageous for nerve catheter components sized to accommodate nerve endings with smaller diameters, as the smaller diameter can make it difficult to insert the corresponding nerve ending into the opening. For nerve endings with larger diameters, the difficulty of inserting a correspondingly sized insertion portion is significantly reduced. However, in this case as well, the increased diameter or opening can facilitate insertion and / or facilitate the application of a medical adhesive to secure the nerve ending to the corresponding insertion portion.

[0086] Preferably, the insert, and in particular the corresponding portion of the through-hole with an increased cross-sectional area, has a shape that is rotationally symmetrical along the longitudinal axis defined by the wall. In particular, the shape may be substantially U-shaped, S-shaped, conical, concave, funnel-shaped or parabolic. This avoids sharp edges that could hinder insertion, and a gradually extending guide surface can be provided to facilitate insertion. The preferred shape should be understood as a shape that extends substantially from the insert defining the corresponding portion of the through-hole, in particular from a portion having a substantially continuous diameter, as seen in a longitudinal cross-sectional view of the corresponding component. Due to their rotational symmetry, they are generally continuous in the circumferential direction, i.e., no gaps are formed.

[0087] According to some embodiments, the insert and, in particular, the corresponding portion of the through hole with an increased cross-sectional area may include structures having a specific geometry or surface irregularities that are shaped on their outer surfaces to form retaining surfaces, such as protrusions, slits, threads, grooves, or holes. In particular, such external structures can advantageously (i) increase the contact between the surface of the insert and the adhesive; and (ii) create anchor points for the adhesive. Such external structures are disclosed, for example, in patent application WO2022229207, the contents of which are incorporated herein by reference.

[0088] Therefore, providing a larger cross-sectional area at at least one end of the nerve catheter system significantly facilitates the insertion of the corresponding nerve ending of the nerve to be repaired. In particular, the larger cross-sectional area can provide a tolerance for (unexpected) offset of the insertion height of the nerve ending relative to the cross-sectional area of ​​the through-hole of the insertion portion during the repair process. Thus, even if such an offset is provided, it is ensured that the nerve ending is received in the nerve catheter and (minor) adjustments can be made without having to reinsert the nerve ending or take specific measures with respect to the nerve catheter. In addition, the larger cross-sectional area can serve as an optical guiding surface for the surgeon, thereby further facilitating the correct insertion of the corresponding nerve ending. Thus, it is possible to achieve in an easier and more efficient manner the correct insertion and placement of the nerve ending into the nerve catheter system, for example, into a through-hole whose size is specially designed to accommodate the nerve ending to be connected and will not have an adverse effect on the corresponding nerve ending.

[0089] In order to promote or guide proper axonal growth from a nerve ending having a larger diameter (e.g., received and housed in a first component) to a nerve ending having a smaller diameter (e.g., received in a through-hole in a second component), preferably, a guiding surface of a second diameter and / or insertion portion toward the other (second) component can be provided. This configuration may also be beneficial to the surrounding tissue by providing a soft edge or no edge at the interface with the adjacent part. The tapered shape is also easier to grip during surgery, thereby facilitating the operation of the first component. In addition, the tapered shape can improve the structural stability of the first component and the nerve catheter system as a whole in the connected state (i.e., when the connecting portion of the first component and the connecting portion of the second component are engaged).

[0090] In some embodiments, the first diameter of the through hole of the insertion portion of the first component can be smaller than the second diameter of the corresponding connecting portion. Thus, the transition portion can define a through hole portion that expands radially outward. The connecting portion can be arranged to extend longitudinally relative to the insertion portion. For example, the through hole of the first component can be basically formed by the insertion portion, the transition portion and the connecting portion. The through hole expands radially outward in the transition portion. For example, this configuration can be provided when the diameter of the nerve ending of the first component is smaller than or equal to the diameter of the nerve ending to be accommodated in the second component. Similarly, this configuration can be provided when the nerve ending to be connected has a relatively small diameter (i.e., smaller than the connecting portion of the first component). Therefore, as long as the diameter of the nerve ending received by the first component is smaller than the corresponding connecting portion, this configuration can also be used to connect nerve endings of substantially the same size or nerve endings of the first component having a larger diameter than the nerve endings of the second component.

[0091] If the first diameter of the through hole of the insertion portion of the first component is greater than the second diameter of the corresponding connecting portion, the transition portion may define a portion of the through hole that tapers radially inwardly. Thus, the first component can accommodate a nerve ending having a diameter greater than that of a nerve ending accommodated in the second component.

[0092] In some embodiments, the connection portion may have a predetermined diameter.Such predetermined dimensions of one or more connection portions may be particularly advantageous in a kit of parts to accommodate corresponding connection portions of various second components, such as through-holes and / or inserts, having different sizes.

[0093] Thus, the connecting portion of the first component (and the second component) can be configured to have standardized, predetermined radial dimensions, for example within a kit of parts. Thus, at least the dimensions of the insertion portion and the through-hole can be variable. The transition portion of the first component and / or the transition portion of the second component can ensure that the distal end of a nerve ending housed in the respective insertion portion is gradually guided to the connecting portion of the other component and / or the adjacent insertion portion.

[0094] Preferably, the connecting portion is configured to connect the corresponding through-holes and the integral through-hole toward the exterior of the system in the connected state (i.e., when the connecting portion of the first component and the connecting portion of the second component are engaged). This can further promote axonal growth from one nerve ending to another through the nerve conduit system by preventing axonal escape and allowing nutrients and growth factors to concentrate. Thus, the risk of axonal growth, for example, around the insertion portion of the first component or the insertion portion of the second component, can be reduced or effectively avoided.

[0095] At least a portion of the transition portion adjacent to the insert portion (preferably the entire transition portion) may include or be formed by a wall, wherein the wall is arranged at a predetermined angle relative to the wall of the insert portion, and wherein the predetermined angle is based on the difference and distance between the first diameter (of the through hole) of the insert portion and the second diameter of the corresponding connecting portion. The wall of the transition portion preferably defines a portion of the through hole. It may also define a bridge portion between the insert portion and the connecting portion arranged along the exterior of the insert portion, for example in a concentric manner.

[0096] Thus, the length or extension of the transition portion in the longitudinal direction can increase as the difference between the first diameter and the second diameter increases. In order to shorten the overall length of the nerve catheter system, the longitudinal extension and / or the predetermined angle of the insertion portion of the first component and / or the insertion portion of the second component can be adjusted accordingly.

[0097] Preferably, in an arrangement where the transition portion surrounds the corresponding insert portion or extends over the corresponding insert portion, the predetermined angle is 10 to 60 degrees, preferably 30 to 60 degrees, and more preferably 30 to 50 degrees. In an arrangement where the transition portion is arranged adjacent to the insert portion, the predetermined angle may be 120 to 240 degrees, and more preferably 130 to 230 degrees.

[0098] This angle can define the conical shape of the transition portion and the funnel shape of the first component (and / or the second component) as a whole in longitudinal section.A predetermined gradual inclination is provided by the predetermined angle, wherein an angle of 120 to 240 degrees has been found to be particularly advantageous.

[0099] In an alternative, the transition portion (of the first component) can be formed by a wall defining a predetermined longitudinal extension, wherein the angle between the wall and the wall forming the insertion portion and / or its through hole is based on the difference between the first diameter and the second diameter. The predetermined longitudinal extension or axial length can make it possible for the total length of the first component to be standardized for various sizes of the insertion portion and the connecting portion. Such standardized length can also define a predetermined gap or spacing between the ends of the nerve endings connected via the nerve conduit system. For example, the nerve endings contained in the first component can be inserted into the interface of the transition portion or its vicinity, while the nerve endings contained in the second component can be inserted into the end face of the corresponding insertion portion, or into the interface with the optionally existing radially expanded end of the insertion portion.

[0100] Furthermore, the predetermined length may facilitate manipulation by a surgeon when implanting the nerve catheter system, for example during insertion of the corresponding nerve endings and / or connection of the first component and the second component.

[0101] To facilitate connection and provide tactile feedback to the surgeon, the connecting portion of the first component can define a stop, wherein when the connecting portion of the first component is engaged with the connecting portion of the second component, i.e., in the connected state, the stop is configured to abut the connecting portion of the second component. Thus, the stop can prevent the connecting portion of the second component from being inserted or extended beyond the stop in the longitudinal direction, i.e., preventing the second component from being inserted beyond the expected position. Preferably, the stop defines a predetermined relative arrangement between the first stop and the second stop. For example, the stop can establish a predetermined spacing or gap between the accommodated nerve endings, wherein the spacing or gap is optimized for end-to-end connection and nerve regeneration. The stop can also provide a predetermined connection, for example, by a corresponding interference fit and / or by ensuring a form interlocking or snap fit, wherein one or more protrusions of the first and second components engage with corresponding recesses or slits. The stop can, for example, be formed by a wall portion of the connecting portion and / or a wall portion of an adjacent transition portion (if such a transition portion is present).

[0102] Preferably, the stop portion is configured to at least partially receive the connecting portion of the second component and / or includes a longitudinally extending detent configured to radially secure the connecting portion of the second component when the connecting portion of the first component and the connecting portion of the second component are engaged (i.e., in the connected state). Thus, while abutment can be provided, for example, by radially extending protrusions of the walls of the connecting portion and / or the adjacent transition portion, the stop portion preferably also forms a directly adjacent end portion, such as a wall portion, that at least partially surrounds the connecting portion of the second component. The stop portion can, for example, be formed as a semicircular or parabolic recess or undercut, preferably comprising a circumferential wall portion extending in a radial direction along an adjacent end face of the connecting portion of the second component.

[0103] As described above, the connecting portion can be formed substantially as a circumferential wall extending in the longitudinal direction and configured to engage with a corresponding circumferential wall portion of the connecting portion of the second component. Thus, the stop portion can be formed as a wall portion or detent parallel to the circumferential wall, so that the end face of the connecting portion is radially fixed in the inward and outward directions and is received within the undercut.

[0104] In some embodiments, in addition to or as an alternative to the stop portion of the first component described above, the second component may (also) define a stop portion. The above description of the stop portion of the first component applies accordingly to the stop portion of the second component. It should be understood that when the connecting portion of the first component and the connecting portion of the second component are engaged, i.e., in the connected state, the stop portion of the second component is configured to abut the connecting portion of the first component. Therefore, the stop portion can prevent the connecting portion of the second component from being inserted or extended beyond the stop portion in the longitudinal direction, i.e., prevent the second component from being inserted beyond the intended position. In some embodiments, the first component and the second component each include a stop portion, for example in a complementary manner. For example, the stop portion of the first component may be located on the inner surface of the (circumferential) wall of the connecting portion of the first component, while the stop portion of the second component may be located on the outer surface of the (circumferential) wall of the connecting portion of the second component; or, preferably, the stop portion of the first component may be located on the outer surface of the (circumferential) wall of the connecting portion of the first component, while the stop portion of the second component may be located on the inner surface of the (circumferential) wall of the connecting portion of the second component.

[0105] During the process of inserting the nerve ending into the corresponding nerve conduit component and subsequently fixing the nerve ending using, for example, a medical adhesive, undesirable compression may occur to the corresponding nerve conduit component and the nerve ending, which may damage the integrity and repair of the nerve ending. For ease of operation, during the process of connecting the first component and the second component, at least one connecting portion and / or transition portion and / or insertion portion may also include one or more clamping ribs, which protrude radially outward from the outer surface of the wall of the connecting portion and preferably extend longitudinally on or along the outer surface of the connecting portion. By extending radially outward, the corresponding component can be more easily grasped and operated without directly interfering with the integrity of the insertion portion, the through hole and the connecting portion, and undesirable movements on the corresponding component can be absorbed or at least suppressed.

[0106] The connecting portion may include two or more clamping ribs. Thus, the connecting portion may include a single clamping rib or more than one clamping rib, such as two, three, four, five, six, seven, eight, nine, or more clamping ribs. Preferably, when two or more clamping ribs are present, the two or more clamping ribs may be equally spaced from one another along the circumference of the connecting portion. For example, the clamping ribs may be arranged as two or more pairs of ribs, wherein each pair of clamping ribs has the same predetermined circumferential spacing, and the pairs may have different predetermined circumferential spacings between each other.

[0107] The predetermined arrangement of the clamping ribs can facilitate orientation during alignment of the respective components and, for example, provide a degree of rotational symmetry and / or redundancy. Furthermore, if the two components include one or more ribs, the ribs can be positioned at predetermined locations, for example, relative to one or more protrusions or slots of the connecting portion, such that the ribs indicate the intended, predetermined arrangement of the components relative to one another. In other words, this arrangement of the ribs can facilitate proper alignment of the components.

[0108] The ribs can have a variety of shapes to facilitate handling and gripping of the corresponding component. Because these ribs can increase the radial dimension of the corresponding component and / or the entire nerve catheter system, they can protrude into the surrounding tissue during implantation. Therefore, to avoid or reduce potential tissue damage, each gripping rib can include at least one rounded end in the longitudinal cross-section of the corresponding connecting portion. This prevents sharp edges.

[0109] In addition, at least one wall of the connecting portion of the first component may also include a transparent window or opening, such as a radial opening, which may be arranged at a predetermined longitudinal offset from the free end of the connecting portion of the first component. By means of the window or opening, the insertion length or depth of the connecting portion of the second component can be monitored. Thereby, the surgeon can obtain visual feedback about the connection status (i.e. when the connecting portion of the first component and the connecting portion of the second component are engaged) and, for example, can insert the connecting portion of the second component so as to provide a predetermined gap for the nerve endings to be connected and / or according to treatment requirements. According to a specific embodiment, the first component and / or the second component of the nerve catheter system are made of a transparent material.

[0110] The window or opening may form an alternative to tactile feedback, such as provided by protrusions and grooves or stops of the connecting portion of the first component.However, the window or opening may also provide additional feedback to confirm correct orientation and coupling of the nerve guide components.

[0111] Preferably, the window or opening is formed in a wall defining the connecting portion, such as a circumferential wall extending in the longitudinal direction. To improve structural stability, a transparent window can be provided, eliminating the need for sealing with, for example, medical adhesives. By enabling such monitoring within the connecting portion and / or toward the through-hole, the surgeon can obtain direct visual feedback regarding the distance of the nerve endings received and accommodated by the second component relative to the nerve endings received and accommodated by the insertion portion of the first component.

[0112] In some embodiments, at least one component, in particular its respective lumen or through-hole, may contain a drug, e.g. by means of a coating or integration in the material of the respective component (e.g. wall), which may be released over time and may, for example, promote nerve growth.

[0113] The first component and / or the second component (preferably each component) are preferably formed of a biocompatible material, an inert material, a bioimplantable material, and / or a biodegradable material. The material can be selected to provide a predetermined structural stability while substantially avoiding or at least reducing an inflammatory response in the patient during treatment. For example, a biocompatible material can be selected that gradually degrades over time after implantation but initially provides sufficient structural support to fully repair nerve damage and ensure proper connection and sufficient stability of the corresponding nerve endings, such as during tissue movement.

[0114] In addition, specific materials can be selected to promote or support nerve growth, for example, by including or otherwise incorporating or including a corresponding coating, such as a bioactive agent and / or one or more neurotrophic factors. Other examples of such bioactive surface functions include, but are not limited to, anti-inflammatory drugs, immunosuppressants, and neuroprotective agents. The bioactive agent can be surface-bound and / or embedded in the structure defining the elongated body, such as the wall described above.

[0115] Preferably, the first component and / or the second component (more preferably, each component) is formed from a polymer-based material, preferably an elastomer. This has the advantage that a variety of manufacturing methods can be applied and / or the material can be provided with specific properties based on, for example, polymer units. In particular, the polymer-based material can be a biocompatible material that also has elastic properties, so that in the implanted state, the nerve guide can adapt to tissue movement around the repaired nerve injury.

[0116] The first component and / or the second component (preferably each component) may be formed from polymerized and / or cross-linked polymer units comprising an ester-based component, preferably a polyol, and an acid ester-based component, preferably a polyacid.

[0117] The materials used for the various components can be identical. This further facilitates manufacturing, and the structural properties of the various components can be substantially uniform along the longitudinal direction of the nerve catheter system. In this case, if the nerve catheter system is configured accordingly, biodegradation (and / or bioresorption) can also occur in a predetermined or expected manner.

[0118] The first component and / or the second component (preferably each component) are preferably integrally formed (i.e., each component is formed as a single piece). Therefore, the connecting portion preferably does not require a specific connection to, for example, the transition portion or the insertion portion. Instead, the material bonding can be provided by the materials used for each component and the corresponding structural integration. By providing each component as a single piece, the robustness of the nerve catheter system can also be improved because separate connections between the components are effectively avoided.

[0119] Preferably, the first component and / or the second component (more preferably each component) is formed by a 3D printing process. This is particularly advantageous when the material of the nerve conduit is a polymer-based material, wherein curing of the material can be provided essentially instantaneously, for example using (UV) light. Furthermore, this provides a level of precision that may not (easily) be achieved by an extrusion process and / or an impregnation process. In particular, the 3D printing process enables a specific shape of each nerve conduit component to be obtained, wherein, for example, the printing process may provide for the integration of specific bioactive agents into the 3D structure according to a predetermined pattern, for example within a mesh structure and / or in specific pockets or cavities formed by the 3D structure. Thereby, the coordination and support of the nerve repair may be further improved, and / or biodegradation may be achieved in a more controlled manner.

[0120] The above-mentioned objects are also achieved by using the nerve conduit described above for repairing, supporting and / or guiding nerve tissue, in particular for repairing peripheral nerve damage and / or for connecting two nerve endings. In addition, the nerve conduit can also be used in combination with a medical adhesive. According to a preferred embodiment, the medical adhesive is based on a polymer unit comprising an ester component and an acid ester component, the ester component is preferably a polyol, and the acid ester component is preferably a polyacid; according to one embodiment, the medical adhesive is based on a photocurable elastomer from poly(glycerol co-sebacate), preferably based on poly(glycerol co-sebacate) acrylate (PGSA).

[0121] On the other hand, a kit of parts is provided, comprising a nerve catheter system according to the present invention, wherein the kit comprises two or more first parts suitable for different nerve ending diameters and / or two or more second parts suitable for different nerve ending diameters, wherein the connecting parts of the parts are adapted so that each first part of the kit can be connected to each second part of the kit.

[0122] In some embodiments, the kit includes two or more (different) first components and at least one second component that are suitable for different nerve ending diameters. In some embodiments, the kit includes at least one first component and two or more second components that are suitable for different nerve ending diameters. Preferably, the kit includes two or more (different) first components that are suitable for different nerve ending diameters and two or more (different) second components that are suitable for different nerve ending diameters. The two or more (different) first components and / or second components are generally different in (the size of) the insertion portion. In particular, in order to accommodate nerve endings with different diameters, the (inner) diameters of the insertion portions (through holes) of the two or more (different) first components are different. Similarly, in order to accommodate nerve endings with different diameters, the (inner) diameters of the insertion portions (through holes) of the two or more (different) second components are different. Thus, it is possible to select the appropriate size that best fits the nerve endings among the first components and / or second components (different insertion portions) of different sizes.

[0123] The inner diameter of the nerve ending is preferably selected from 1.5 mm to 12 mm. More specifically, for nerves above the wrist, the inner diameter of the nerve ending can be 1.5 mm to 12 mm; for nerves in the wrist and hand, the inner diameter of the nerve ending is 1.5 mm to 3 mm; and for nerves in the hand, the inner diameter of the nerve ending is 1.5 mm to 2 mm.

[0124] On the other hand, as described above, the connection portion of each component included in the kit is designed so that each first component in the kit can be connected to each second component in the kit. To this end, the connection portions are preferably of the same size. In other words, the connection portions (sizes) of the (different) first components are preferably the same, at least the portion of the connection portion involved in connecting to the second component is the same. In addition, the connection portions (sizes) of the (different) second components are preferably the same, at least the portion of the connection portion involved in connecting to the first component is the same. In this context, it is to be understood that the connection portion of the first component and the connection portion of the second component in the kit are configured to engage with each other.

[0125] By utilizing the specific configuration of inserts of varying sizes, nerve endings with varying diameters can be easily connected by selecting a first and / or second insert of appropriately sized dimensions, while still ensuring that the connecting parts are compatible with one another. Consequently, the appropriate first and second inserts can even be selected on-site (e.g., during surgery). This can avoid difficulties during and after surgery caused by improper catheter fit.

[0126] On the other hand, a kit of parts is provided, comprising a nerve catheter system according to the present invention as described herein, wherein the kit further comprises a medical adhesive. According to a preferred embodiment, the medical adhesive is based on a prepolymer unit comprising an ester component and an acid ester component, the ester component being preferably a polyol and the acid ester component being preferably a polyacid. According to one embodiment, the medical adhesive is based on a photocurable elastomer from poly(glycerol-co-sebacate), preferably based on poly(glycerol-co-sebacate) acrylate (PGSA). According to a preferred embodiment, the medical adhesive is a photocurable adhesive, i.e., it polymerizes or otherwise cures upon receipt of appropriate radiation energy, more particularly in the form of light from a light source. Preferably, the photocurable adhesive comprises a prepolymer and a photoinitiator, which is capable of initiating polymerization of the prepolymer upon exposure to light of a specific wavelength, such as ultraviolet (UV) radiation.

[0127] According to another aspect of the present invention, there is provided a method for connecting two nerve endings, comprising the following steps:

[0128] - providing a first component and a second component of a nerve catheter system as described above;

[0129] - inserting one of the nerve endings to be connected into the insertion portion of the first component, and inserting one of the nerve endings to be connected into the insertion portion of the second component;

[0130] - optionally, securing said nerve endings to said respective components; and

[0131] - connecting the first and second components in an end-to-end manner by connecting the connecting portion of the first component to the connecting portion of the second component, preferably by receiving at least a portion of the insert portion of the second component in the through hole of the first component.

[0132] The damaged nerve endings can be fixed by applying a medical adhesive to the exterior of the respective insertion portion. The first component and the second component are preferably connected by inserting and / or accommodating the connecting portion of the second component into or around the connecting portion of the first component until the two connecting portions engage with each other, preferably by interference fit and / or form interlocking. BRIEF DESCRIPTION OF THE DRAWINGS

[0133] The present disclosure may be more readily understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0134] Figure 1 A schematic diagram showing a longitudinal cross-section of a first component and a second component of an exemplary nerve catheter system according to the present invention in a connected state (ie, when a connecting portion of the first component and a connecting portion of the second component are engaged);

[0135] Figure 2 Shown according to Figure 1 The second component of Figure 1 Schematic diagram of the longitudinal section;

[0136] Figure 3 Shown according to Figure 2 Schematic diagram of a nerve guide with an alternative insertion portion;

[0137] Figure 4 Shown according to Figure 2 Schematic diagram of a nerve guide with an alternative insertion portion;

[0138] Figure 5 shows a schematic longitudinal cross-sectional view of a first component of a nerve catheter system according to another embodiment;

[0139] Figure 6 shows a schematic longitudinal sectional view of a first component according to another embodiment;

[0140] Figure 7 and Figure 8 Schematically shows the Figure 6 A first component having replaceable connecting portions and / or transition portions;

[0141] Figure 9 and Figure 10 Schematic diagram of a circuit according to an alternative embodiment with additional ribs Figure 4 a second component; and

[0142] Figure 11 and Figure 12 A schematic longitudinal cross-sectional view of a first component of a nerve catheter system with an alternative rib arrangement according to another embodiment is shown.

[0143] Figure 13 shows a schematic diagram of the first component and the second component of a nerve catheter system with shape interlocking according to an embodiment: (A) is a top view showing the two components in a separated state and in a connected state (shown by dotted lines); and (B) is a longitudinal cross-sectional view along the AA line shown in (A). DETAILED DESCRIPTION

[0144] Hereinafter, the present invention will be explained in more detail with reference to the accompanying drawings showing exemplary embodiments of the present invention. However, the scope of the present invention should not be limited by the specific embodiments described herein. The following embodiments are provided to enable those skilled in the art to more clearly understand and implement the present invention. In the accompanying drawings, identical elements are represented by identical reference numerals, and to avoid redundancy, their repeated description may be omitted.

[0145] Figure 1, a nerve catheter system 10 according to the present invention is schematically shown in longitudinal section. The nerve catheter system 10 includes a first component 12 and a second component 14, which are depicted here as being in a connected state, i.e., when a connecting portion of the first component and a connecting portion of the second component are engaged. Both the first component 12 and the second component 14 are configured to receive respective nerve endings (not shown), wherein one nerve ending constitutes a proximal nerve ending and the other nerve ending constitutes a distal or target nerve ending. In this example, the first component 12 is sized to accommodate nerve endings having a larger diameter than the nerve endings received by the second component 14, so that axonal growth from the first component 12 to the second component 14 can be promoted; conversely, the second component 14 is sized to accommodate nerve endings having a larger diameter than the nerve endings received by the first component 12, so that axonal growth from the second component 14 to the first component 12 can be promoted.

[0146] Both the first component 12 and the second component are substantially tubular and are formed by walls defining a lumen for receiving and accommodating the corresponding nerve endings. Thus, the first component 12 includes an insert portion 16 and a connecting portion 22, both of which are defined by walls. The insert portion 16 and the connecting portion 22 are connected via a transition portion 18 to form a continuous, homogeneous structure.

[0147] As shown, the insert portion 16 or its wall defines an open throughbore 20, which is depicted here as extending between longitudinally opposite ends of the first component 12 and is defined by the insert portion 16, the transition portion 18, and the connecting portion 22. The throughbore 20 is thus formed as a continuous passage from one end of the first component 12 to the opposite end.

[0148] As shown in the example, two circumferential walls 23 are provided at the connection portion 22 at radial intervals, which are configured to engage the corresponding connection portion 24 of the second component 14 in the connected state of the nerve catheter system 10 (i.e., when the connection portion 22 of the first component 12 and the connection portion 24 of the second component 14 are engaged). The outer wall 23 of the connection portion 22 is connected to the transition portion 18 and, together with the inner wall 23, defines a longitudinal groove for receiving the corresponding circumferential wall of the connection portion 24 of the second component 14. In order to facilitate the insertion of the connection portion 24 into the groove and thus facilitate the connection or engagement of the connection portions 22, 24, the wall of the connection portion 22 includes a radial flare at its free end, thereby providing an enlarged opening of the groove.

[0149] At the junction of the transition portion 18 and the connecting portion 22, a stop 32 is defined by a wall portion of the transition portion 18 and / or a wall 23 of the connecting portion 22. The stop 32 provides abutment for the connecting portion 24 of the second component 14 and ensures that the connection between the first component 12 and the second component 14 can be provided according to a predetermined connection state (i.e., when the connecting portion 22 of the first component 12 and the connecting portion 24 of the second component 14 are engaged). The double-walled feature formed by the connecting portion 22 thus provided radially fixes the second component 14 to the first component 12 and enables the first component 12 and the second component 14 to be in a predetermined relative position in the connection state (i.e., when the connecting portion 22 of the first component 12 and the connecting portion 24 of the second component 14 are engaged by the stop 32).

[0150] In the second component 14, nerve endings having a smaller diameter can be received by means of the corresponding insert portion 26, which defines an opening to the through-hole 30 of the second component 14. A radially flared end portion 29 is also provided at a longitudinal end of the insert portion 26, opposite the longitudinal end configured as the entrance for the corresponding nerve ending. The radially flared end portion 29 is configured to guide nerve growth from the first component 12 (i.e., the insert portion 16 and / or the transition portion 18) into the through-hole 30. Preferably, the nerve ending to be received in the second component 14 is inserted into the through-hole 30 substantially defined by the insert portion 26, up to the radially flared end portion 29. Similarly, the nerve ending received in the through-hole 20 of the first component 12 is also inserted in such a manner that the nerve ending does not extend beyond the corresponding insert portion 16, i.e., does not extend into the transition portion 18. Thus, the nerve endings are proximate to one another in an end-to-end manner, wherein the transition portion 18 of the first component 12 and the radially expanded end portion 29 of the second component 14 provide a predetermined spacing or gap between the nerve endings.

[0151] The connecting portion 24 of the second component 14 shown in this example extends in the longitudinal direction from the insertion portion 26 along the outer surface of the wall of the corresponding insertion portion 26 and is configured to seal the through-hole 30 at the distal end of the first component 12. Therefore, nerve regeneration is contained within the nerve catheter system 10 and is effectively guided from the insertion portion 16 of the first component 12 to the insertion portion 26 of the second component 14. In other words, axonal growth outside the through-hole 30 between the first component 12 and the second component 14 is avoided to the greatest extent possible.

[0152] The radially spaced arrangement of the connecting portion 24 and the insert portion 26 of the second component 14 ensures that the connecting portion 24 can engage with the corresponding connecting portion 22 of the first component 12. At the same time, the difference in diameter between the connecting portion 24 and the insert portion 26 allows the insert portion 26 to be received and accommodated by the connecting portion 22 or a portion of the through-hole 30 defined by the connecting portion 22. Therefore, the insert portion 26 can extend toward or into the transition portion 18 of the first component 12, facilitating end-to-end connection of the corresponding nerve endings. Furthermore, this improves the structural stability of the second component 14 without significantly increasing the overall size of the entire nerve catheter system 10.

[0153] The connecting portion 24 of the second component 14 is connected to the insert portion 26 by a corresponding transition portion 28 that extends between the connecting portion 24 and the inlet end and / or proximal end of the insert portion 26. Thus, the transition portion 28 bridges a first diameter at the junction of the insert portion 26 and a second diameter at the junction of the connecting portion 24. The connecting portion 24 surrounds the insert portion 26 in a substantially concentric manner.

[0154] As shown, the sealing of the through hole 30, that is, the space between the inner surface of the inner wall 23 of the connecting portion 22 and the outer surface of the insert portion 26, is mainly performed at the distal end of the first component 12 and is completed by the transition portion 28. In addition, this space can also reduce potential undesirable friction and / or provide support for the second component 14, thereby inhibiting radial forces, such as during surgery or during movement of the implant site.

[0155] Likewise, the transition portion 18 extends between the insert portion 16 and the connecting portion 22 and bridges the respective portions 16, 22 of different diameters. In this adjacent arrangement, the transition portion 18 defines a respective portion of the through-hole 20. Furthermore, the transition portion 18 includes a substantially conical shape that provides a gradual guide surface toward the radially expanded end 29 and, therefore, promotes axonal growth toward nerve endings housed in the insert portion 26 of the second component 14.

[0156] exist Figure 2 In, according to Figure 1 The second component 14 is depicted in an uncoupled or disconnected state, indicating the free end of the connecting portion 24 that will be received and engaged with the connecting portion 22 of the first component 12. As is also apparent from this figure, a transition portion 28 extending from the insert portion 26 forms a seal between the longitudinally extending walls of the connecting portion 24 and the longitudinally extending walls of the insert portion 26 that define the through-hole 30.

[0157] exist Figure 3 and Figure 4 In the figure, it is schematically shown that Figure 2An alternative embodiment of the second component 14 is provided, wherein the insert 26 is configured substantially differently. Figure 3 As shown, the insertion portion 26 can be extended in the longitudinal direction, essentially forming an extension of the through-hole 30. Thus, the connecting portion 24 is arranged at a predetermined longitudinal offset from the entry end of the insertion portion 26. This embodiment may be advantageous for applications where a longer nerve injury gap needs to be bridged by the nerve catheter system 10, wherein the connecting portion 24 is provided in a substantially identical manner to reduce the overall (radial) size of the second component 14 and ensure that the connection between the first component 12 and the second component 14 is not compromised by the corresponding extension of the connecting portion 24. In other words, a predetermined flexibility or elasticity can be maintained for the connecting portion 24 while the second component 14 is adapted to bridge a longer nerve injury gap.

[0158] according to Figure 4 The embodiment corresponds essentially to Figure 3 However, in this configuration, the insertion portion 26 includes an opening and a cross-sectional area that increase in a direction away from the connection portion 24. The insertion portion 26 is formed as a conical portion, thereby facilitating insertion of the corresponding nerve ending into the insertion portion 26.

[0159] Figure 5 FIG. 1 shows a longitudinal cross-sectional view of a first component 12 according to another embodiment of the present invention. Figure 1 Compared to the embodiment of the present invention, an insert portion 16 is provided, which is correspondingly adapted to receive the Figure 1 The insertion portion 16 is formed as a substantially cylindrical portion, wherein a radially outwardly expanding opening is provided at the inlet end or proximal end, the opening being conical or parabolic. Thus, as described above, for example, according to Figure 4 The insertion portion 26 of the second component 14 can facilitate the insertion of nerve endings with a smaller diameter into the insertion portion 16 .

[0160] In accordance with the smaller-sized insertion portion 16 and through-hole 20, the transition portion 18 according to this example extends radially outward to connect the smaller through-hole 20 with the larger-sized connection portion 22. The connection portion 22 according to this example is formed as a single circumferential wall extending in the longitudinal direction of the first component 12 and away from the transition portion 18.

[0161] according to Figure 5 The embodiment of FIG. 1 also depicts a stop 32 defined as a semicircular wall extension or detent of the connecting portion 22 and / or transition portion 18, forming a recess to receive and radially secure a corresponding connecting element or wall of the connecting portion 24 of the second component 14. The stop 32 defines a longitudinal detent sized to prevent the end face of the connecting portion 24 of the second component 14 from being inadvertently advanced toward the transition portion 18 and thereby inserted beyond its intended position.

[0162] The connecting portion 22 is configured to receive the connecting portion 24 on an inner surface of a (single) circumferential wall defining the connecting portion 22 and form a guide surface by achieving slidable engagement with the connecting portion 24 of the second component 14 .

[0163] according to Figure 6 The embodiment depicts a first component 12 that is substantially identical to Figure 1 The depicted embodiment is similar but includes a smaller diameter portion of the through hole 20 defined by the insert 16. In this example, the longitudinal extension of the transition portion 18 has been predetermined so that the angle of the transition portion 20 is Figure 1 The angles are more gradual than those depicted in Figure 1 Compared to the depicted embodiment, the difference in diameter between the connecting portion 22 and the insert portion 16 is smaller, and the height or radial extension of the connecting transition portion 18 is therefore reduced.

[0164] In addition, according to Figure 1 The embodiment of the first component 12 shown is similar, according to Figure 6 The first component 12 is also configured to receive a nerve ending having a larger diameter than the nerve ending to be received in the second component 14. For example, Figure 5 The optional enlarged opening at the entrance of the illustrated insert 16 is not depicted in this embodiment.

[0165] Figure 7 and Figure 8 Schematically shows the Figure 6 A first component 12 having an alternative transition portion 18 and a connecting portion 22 .

[0166] Therefore, if Figure 7 As shown, the transition portion 18 and the connecting portion 22 may be as shown. Figure 5 However, in this embodiment, the insert portion 16 and the transition portion 18 are configured to accommodate nerve endings having a larger diameter than the nerve endings to be accommodated in the second component 14. Therefore, the insert portion 16 and the transition portion 18 are substantially arranged according to Figure 6 Thus, although the connection portion 22 is similarly configured to receive and / or engage the connection portion 24 at the inner surface of the wall defining the connection portion 22, the connection portion 24 is similar to the connection portion 22 according to the embodiment of the present invention. Figure 5 The portion of the through-hole 20 defined by the insert 16 is less pronounced than in the illustrated embodiment.

[0167] exist Figure 8 An alternative configuration is depicted in which the connection portion 24 is received and housed at the outer surface of the wall defining the connection portion 22. Figure 7In contrast to the embodiment shown, the free end surface of the wall is not radially expanded, but rather forms a linear extension parallel to the longitudinal axis of the first component 12, so as to facilitate coupling at the outer surface of the connecting portion 22. According to this embodiment, the transition portion 18 is provided with an increased wall thickness, which may be advantageous for increasing structural stability and / or improving the functionality of the stop 32 in order to weaken the longitudinal displacement of the connecting portion 24 of the second component 14 beyond the transition portion 18 towards the insert portion 16.

[0168] Figure 9 and Figure 10 Schematic depiction of Figure 4 The second component 14 has additional ribs 34 according to an alternative embodiment. As shown in these figures, a plurality of longitudinally extending ribs 34, for example, 4 to 10, or as shown in the figures, 6 or 8, can be provided at the outer surface of the connecting portion 24 of the second component 14, wherein the ribs 34 are equally spaced along the circumference of the wall defining the connecting portion 24. Figure 9 As shown, the rib 34 is rounded at one longitudinal end and rounded at the Figure 10 In the embodiment of the present invention, the ribs 34 are rounded at both longitudinal ends. The double rounded surface may be advantageous for the tissue around the target implant site and may provide a smaller overall size. However, a single rounded end may also be selected to increase the potential clamping force and operating surface.

[0169] Figure 11 and Figure 12 Schematic diagram showing a longitudinal section of the first component 12 according to another embodiment of the present invention, with an alternative arrangement of ribs 34 provided on the outer surface of the connecting portion 22. The configuration of the first component 12 corresponds substantially to Figure 5 and Figure 8 A combination of embodiments is shown in which the insert portion 16, through-hole 20 and transition portion 18 are sized to accommodate smaller diameter nerve endings, while the single circumferential wall also defines a connection portion 22, but wherein the connection portion 22 is adapted to accommodate a corresponding connection portion 24 of the second component 14 on the outer surface of the wall.

[0170] about Figure 9 and Figure 10 The first component 12 may further include a plurality of spaced-apart ribs 34, for example 4 to 10 ribs 34, which are rounded at one or both longitudinal ends depending on the patient's structure and anatomical requirements at the implantation site.

[0171] FIG13 shows a schematic diagram of a first component 12 and a second component 14 of a nerve catheter system 10, showing the two components in a separated state and a connected state (dashed lines), wherein the components 12 and 14 are designed so that they can also be fastened or fixed to each other by a form-locking method. This form-locking method can reduce the need for medical adhesives and / or can facilitate the connection of the components 12 and 14 and the connection of nerve endings to each other, thereby potentially reducing the occurrence of loose joints.

[0172] Thus, the connecting portion 24 of the second component 14 includes a plurality of radial protrusions 36, while the connecting portion 22 of the first component 12 includes (corresponding) slits or grooves 38 that are configured to receive the protrusions 36. Thus, when the connecting portion 22 of the first component 12 is engaged with the connecting portion 24 of the second component 14, i.e., in the connected state, the second component 14 can be at least longitudinally fixed to the first component 12. In particular, the at least one radial protrusion 36 and the at least one slit or groove 38 are configured to engage in a snap-fit ​​manner in the connected state (i.e., when the connecting portions of the first and second components are engaged).

[0173] The slit or groove 38 of the connecting portion 22 of the first component 12 is located on the inner (circumferential) wall of the connecting portion 22. Furthermore, the protrusion 36 of the connecting portion 24 of the second component 14 is located on the outer (circumferential) wall of the connecting portion 24. Thus, the circumferential wall of the connecting portion 24 of the second component 14 can be received or accommodated by the circumferential wall of the connecting portion 22 of the first component 12, i.e., inserted into a single circumferential wall or into the groove 38 defined by the connecting portion 22 of the first component 12. In the connected state (i.e., when the connecting portion 22 of the first component 12 and the connecting portion 24 of the second component 14 are engaged), an interface located at the outer surface of the connecting portion of the second component can thus engage a corresponding interface located at the inner surface of the connecting portion of the first component.

[0174] 13 , both the first component 12 and the second component 14 include stoppers 32 in a complementary manner. Thus, the stoppers 32 of the first component 12 can be located on the inner surface of the (circumferential) wall of the connecting portion 22 of the first component 12, while the stoppers 32 of the second component 14 can be located on the outer surface of the (circumferential) wall of the connecting portion 24 of the second component 14.

[0175] It will be apparent to those skilled in the art that these embodiments and projects merely illustrate various possibilities. Therefore, the embodiments shown herein should not be construed as limiting these features and configurations. Any possible combination and configuration of the features described may be selected according to the scope of the present invention.

[0176] Reference numerals

[0177] 10 Neural catheter system

[0178] 12 First Part

[0179] 14 Second Part

[0180] 16 Insertion

[0181] 18 Transition

[0182] 20 through holes

[0183] 22 Connection

[0184] 23 wall

[0185] 24 Connection

[0186] 26 Insertion

[0187] 28 Transition

[0188] 29 Radially expanded end

[0189] 30 through holes

[0190] 32 stopper

[0191] 34 ribs

[0192] 36 radial protrusions

[0193] 38 Slits or grooves

Claims

1. A nerve catheter system (10) for connecting two nerve endings in an end-to-end manner, comprising a first component (12) and a second component (14), each component (12, 14) comprising an insert (16, 26) and a connecting portion (22, 24), each insert being adapted to receive one of the two nerve endings, in, Each component (12, 14) includes a through hole (20, 30) defined at least by the respective insert (16, 26) and extending between longitudinally opposite ends of the respective component (12, 14), and wherein the connecting portions (22, 24) are configured to engage with each other and are arranged so that when the connecting portions (22, 24) of the first component (12) and the second component (14) are engaged, the through holes (20, 30) are in fluid communication with each other, and optionally, wherein, when the first component (12) and the second component (14) are engaged, the connecting portions (22, 24) preferably do not act as pressing members that apply force in a radial direction of the nerve endings.

2. The nerve catheter system (10) according to claim 1, wherein At least one component (12, 14), preferably the first component (12) and the second component (14), further includes a transition portion (18, 28) extending between the corresponding insert portion (16, 26) and the corresponding connecting portion (22, 24).

3. The nerve catheter system (10) according to claim 2, wherein: The transition portion (18, 28) has a substantially conical shape.

4. The nerve catheter system (10) according to any one of the preceding claims, wherein The insert portion (16, 26) and / or the connection portion (22, 24) of at least one component (12, 14), preferably each component (12, 14), has a substantially cylindrical shape.

5. The nerve catheter system (10) according to any one of the preceding claims, wherein A connecting portion (22, 24) of at least one component (12, 14), preferably the second component (14), at least partially surrounds an insert portion (16, 26) of the component (12, 14).

6. The nerve catheter system (10) according to claim 5, wherein The insert portion (16, 26) and the connecting portion (22, 24) of at least one component (12, 14), preferably the second component (14), are arranged in a concentric manner.

7. The nerve catheter system (10) according to any one of the preceding claims, wherein The insertion portion (16, 26) and the connection portion (22, 24) of at least one component (12, 14) are arranged adjacent to each other in the longitudinal direction, and the at least one component (12, 14) is preferably the first component (12).

8. The nerve catheter system (10) according to claim 7, wherein A transition portion (18, 28) is arranged between the insert portion (16, 26) and the connecting portion (22, 24).

9. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portions (22, 24) are configured such that when the connecting portions (22, 24) of the first (12) and second (14) components are engaged, the inserts (16, 26) are arranged at longitudinally opposite ends of the nerve catheter system (10).

10. The nerve catheter system (10) according to any one of the preceding claims, wherein The through-holes (20, 30) of the first and second components (12, 14) define a single longitudinal axis of the nerve catheter system (10) when the connecting portions (22, 24) of the first and second components (12, 14) are engaged.

11. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portions (22, 24) are configured such that when the connecting portions (22, 24) are engaged, the through hole (30) of the second component (14) is at least partially received within the through hole (20) of the first component (12).

12. The nerve catheter system (10) according to any one of the preceding claims, wherein The transition portion (18) of the first component (12) is configured to at least partially receive and accommodate the radially expanded end portion (29) of the insert portion (26) of the second component (14) when the connecting portions (22, 24) of the first and second components (12, 14) are engaged.

13. The nerve catheter system (10) according to any one of the preceding claims, wherein The insert portion (26) of the second component (14) and / or the radially expanded end portion (29) of the insert portion (26) extend beyond the corresponding connecting portion (24) in the longitudinal direction.

14. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portion (24) of the second component (14) extends from a longitudinal end of the corresponding insertion portion (26) configured to receive and / or insert the corresponding nerve ending; or extends with a longitudinal offset from the longitudinal end of the corresponding insertion portion configured to receive and / or insert the corresponding nerve ending.

15. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portion (22) of the first component (12) is arranged adjacent to a longitudinal end of a corresponding transition portion (18) or a corresponding insertion portion (16), which is opposite to a longitudinal end of the corresponding insertion portion (16) configured to receive and / or insert a corresponding nerve ending.

16. The nerve catheter system (10) according to any one of the preceding claims, wherein At least a portion of the through-hole (20, 30) defined by the insert (16, 26) of the first and / or second component (12, 14) is defined by a tubular wall defining a substantially constant inner diameter.

17. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portion (22) of the first component (12) is formed by a single circumferential wall (23), and wherein the single wall (23) receives the connecting portion (24) of the second component (14) at an inner or outer surface of the wall (23).

18. The nerve catheter system (10) according to any one of claims 1 to 16, wherein: The connecting portion (22) of the first component (12) is formed by circumferential inner and outer walls (23) defining a longitudinally extending groove between the walls (23), wherein the groove is configured to receive the connecting portion (24) of the second component (14) when the connecting portions (22, 24) of the first and second components (12, 14) are engaged.

19. The nerve catheter system (10) according to any one of the preceding claims, wherein Each connection portion (22, 24) includes at least one circumferential wall (23), and the circumferential walls (23) are configured to engage one another and are radially offset, and / or are sized and configured to engage one another by an interference fit when the connection portions (22, 24) of the first component (12) and the second component (14) are engaged.

20. The nerve catheter system (10) according to claim 19, wherein The circumferential wall (23) is dimensioned so that, when the connecting portions (22, 24) of the first and second components (12, 14) are engaged, the wall (23) of the connecting portion (24) of the second component (14) is slidably received by at least one circumferential wall (23) of the connecting portion (22) of the first component (12).

21. The nerve catheter system (10) according to any one of the preceding claims, wherein One of the connecting portions (22, 24) includes at least one radially extending protrusion (36), and the other connecting portion (22, 24) includes at least one slit or groove (38) configured to receive the protrusion (36), and preferably, the slit or groove is configured to longitudinally secure at least the second component (14) to the first component (12) when the connecting portions (22, 24) of the first component (12) and the second component (14) are engaged.

22. The nerve catheter system according to claim 21, wherein The at least one protrusion (36) or the at least one slit or groove (38) of the connecting portion (22) of the first component (12) is located at the inner surface of the circumferential wall (23) of the connecting portion (22); and / or The at least one protrusion (36) or the at least one slit or groove (38) of the connecting portion (24) of the second component (14) is located at the outer surface of the circumferential wall (23) of the connecting portion (24).

23. The nerve catheter system (10) according to claim 21 or 22, wherein: At least one radially extending protrusion (36) and at least one slot or groove (38) are configured to be in snap-fit ​​engagement when the connecting portions (22, 24) of the first (12) and second (14) components are engaged.

24. The nerve catheter system (10) according to any one of claims 21 to 23, wherein: The at least one slit or groove (38) comprises a greater circumferential extension than the at least one protrusion (36).

25. The nerve catheter system (10) according to any one of claims 21 to 24, comprising a plurality of protrusions (36) and a plurality of slits or grooves (38), the protrusions and slits or grooves preferably being the same in number, wherein: The protrusions (36) and slits or grooves (38) are preferably equally spaced apart in the circumferential direction.

26. The nerve catheter system (10) according to any one of the preceding claims, wherein The cross-sectional area of ​​the through hole (20, 30) of the insertion portion (16, 26) of the first component (12) and / or the second component (14) gradually increases at the longitudinal end for receiving the nerve ending and in the direction away from the corresponding connection portion (22, 24).

27. The nerve catheter system (10) according to any one of the preceding claims, wherein The transition portion (18, 28) of the first component (12) and / or the second component (14) is configured to seamlessly connect a corresponding insertion portion (16, 26) having a first diameter to a corresponding connection portion (22, 24) having a second diameter different from the first diameter.

28. The nerve catheter system (10) according to claim 27, wherein At least a portion of the transition portion (18, 28) adjacent to the insert portion (16, 26) includes a conical or tapered shape in a longitudinal cross-section of the first component.

29. The nerve catheter system (10) according to claim 27 or 28, wherein At least a portion of the transition portion (18, 28) adjacent the insert portion (16, 26) includes a wall, wherein the wall is arranged at a predetermined angle relative to a wall of the insert portion (16, 26), wherein the predetermined angle is based on a difference and a distance between a first diameter and a second diameter.

30. The nerve catheter system (10) according to claim 29, wherein In an arrangement in which the transition portion (18, 28) surrounds the corresponding insertion portion (16, 26) and / or the transition portion (18, 28) extends over the corresponding insertion portion (16, 26), the predetermined angle is 30 to 60 degrees, preferably 40 to 50 degrees; or in an arrangement in which the transition portion (18, 28) is adjacent to the insertion portion (16, 26), the predetermined angle is 120 to 240 degrees, preferably 130 to 230 degrees.

31. The nerve catheter system (10) according to any one of the preceding claims, wherein The connecting portion (22) of the first component (12) defines a stop (32) configured to abut the connecting portion (24) of the second component (14) when the connecting portions (22, 24) of the first component (12) and the second component (14) are engaged.

32. The nerve catheter system (10) according to claim 31, wherein The stop portion (32) is configured to at least partially receive the connecting portion (24) of the second component (14) when the connecting portions (22, 24) of the first component (12) and the second component (14) are engaged and / or includes a longitudinally extending detent configured to radially secure the connecting portion (24) of the second component (14).

33. The nerve catheter system (10) according to any one of the preceding claims, wherein At least one component (12, 14) includes one or more clamping ribs (34) projecting radially outward from the outer surface of the wall of the connecting portion (22, 24), and the one or more clamping ribs (34) preferably extend longitudinally at or along the outer surface of the component (12, 14).

34. The nerve catheter system (10) according to claim 33, wherein The components (12, 14) include two or more clamping ribs (34), wherein the two or more clamping ribs (34) are preferably equally spaced apart from each other along the circumference of the components (12, 14).

35. The nerve catheter system (10) according to claim 33 or 34, wherein The one or more clamping ribs (34) include at least one rounded longitudinal end in a longitudinal cross-section of the corresponding connecting portion (22, 24).

36. The nerve catheter system (10) according to any one of the preceding claims, wherein The wall (23) of the connecting portion (22) of the first component (12) comprises a transparent window or opening, which is arranged at a predetermined longitudinal offset from the free end of the connecting portion (22) of the first component (12).

37. A kit of parts comprising a nerve catheter system (10) according to any one of the preceding claims, wherein The kit comprises two or more first components (12) adapted to different nerve ending diameters and / or two or more second components (14) adapted to different nerve ending diameters, wherein the connecting portions (22, 24) of the components are adapted so that each first component (12) of the kit can be connected to each second component (14) of the kit.

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