Nerve conduit

Abstract

The invention provides a nerve conduit, which comprises a sleeve, one end of the sleeve is provided with an opening, and the other end of the sleeve is provided with a fixing part; the supporting frame comprises one or more supporting plates; when the supporting frame is assembled in the sleeve, the interior of the sleeve is divided into a plurality of axial limiting channels by the supporting plates, and the limiting channels are configured to provide a preset growth path; a plurality of through holes are formed in the side wall of the sleeve, and the through holes are configured to provide passages for permeation of tissue fluid. According to the nerve conduit provided by the invention, a protective envelope is formed through the sleeve, replaces an adventitia, coats and limits the growth of nerve tracts, and nerves can be subjected to the action of relative mechanical stress along with the narrowing of the surrounding growth environment, so that the formation of neuroma is more quickly and stably prevented, the extrusion of surrounding muscles in a body is resisted, and the terminal nerves are protected. The nerve conduit is simple in structure and has good mechanical properties, and industrial mass production can be achieved.

Description

Technical Field

[0001] This disclosure relates to the field of medical device technology, and more specifically, to a nerve conduit. Background Technology

[0002] Peripheral nerve injury (PNI) caused by factors such as natural disasters, traffic accidents, and iatrogenic nerve damage can lead to severe sensory disturbances and impaired motor function. Traumatic painful neuroma (TPN) is a common complication following peripheral nerve injury. It often occurs in patients who ultimately undergo amputation due to traumatic finger amputation, car accidents, or late-stage diabetes. The amputated nerve not only fails to function in controlling distal extremities but also causes prolonged and severe pain. This is because the peripheral nerves continue to regenerate within the stump. Lacking proper guidance and hindering the continuous regeneration of collagen fibers, nerve regeneration is impeded, eventually leading to the development of a traumatic painful neuroma, inducing abnormal pain sensation (i.e., tenderness to touch) in the stump and causing immense suffering for the patient.

[0003] The most common prevention and treatment method is the cannulation method, used for the repair of damaged nerves. Existing nerve caps include natural polymer caps, such as chitosan and collagen. However, they have been found to have poor mechanical properties and are prone to collapse in vivo, failing to stably provide the support barrier environment needed for the regeneration of damaged nerves. Summary of the Invention

[0004] The purpose of this disclosure is to provide a neural conduit that can solve at least one of the technical problems mentioned above. The specific solution is as follows:

[0005] According to specific embodiments of this disclosure, in one aspect, this disclosure provides a nerve conduit, the nerve conduit comprising: a cannula, one end of which has an opening and the other end has a constricting portion; a support frame, the support frame comprising one or more support plates; when the support frame is assembled inside the cannula, the support plates divide the inside of the cannula into multiple axial limiting channels, the limiting channels being configured to provide a preset growth path; wherein, the sidewall of the cannula has multiple through holes, the through holes being configured to provide a pathway for the permeation of tissue fluid.

[0006] In an optional embodiment, the nerve conduit further includes a baffle, which is disposed at one end of the support plate; when the support frame is assembled inside the sleeve, the baffle is located at one end near the retractable portion, for closing the limiting channel.

[0007] In an alternative embodiment, the edge of the baffle is provided with a snap fastener configured to engage with the end of the sleeve away from the opening.

[0008] In an optional embodiment, the support frame further includes a limiting channel that extends axially along the support frame, and a plurality of support plates are disposed outside the limiting channel; when the support frame is assembled inside the sleeve, the axis of the limiting channel is substantially parallel to or coincides with the axis of the sleeve.

[0009] In an optional embodiment, the end of the sleeve away from the opening is provided with a slot, configured to engage with the snap fastener.

[0010] In one alternative embodiment, the end of the sleeve away from the opening has a plurality of foldable protrusions, which converge toward the axial direction of the sleeve to form the converged portion.

[0011] In an alternative embodiment, the plurality of foldable protrusions are circumferentially spaced along one end of the sleeve away from the opening.

[0012] In an alternative embodiment, the cannula has a notch in the wall at one end of the opening, the notch being configured to facilitate connection and fixation of nerve endings.

[0013] In an optional embodiment, the outer wall of the sleeve is provided with at least one fixing part for fixing the sleeve.

[0014] In an alternative embodiment, the cannula has a notch in the wall at one end of the opening, the notch being configured to facilitate connection and fixation of nerve endings.

[0015] In one alternative embodiment, the sleeve is a circular or polygonal tubular structure.

[0016] In one optional embodiment, the cannula is made of a biomedical material.

[0017] In one optional embodiment, the support frame is made of biomedical material.

[0018] In one optional embodiment, the baffle is made of a biomedical material.

[0019] In an alternative embodiment, the length of the support frame from the baffle to the end away from the baffle is less than the minimum length of the sleeve from the opening to the closing portion.

[0020] Compared with the prior art, the above-described solutions of this disclosure have at least the following beneficial effects:

[0021] The nerve conduit provided in this disclosure forms a protective capsule through a cannula, replacing the epineurium, covering and restricting the growth of the nerve bundle. This allows the nerve to be subjected to relative mechanical stress as the surrounding growth environment narrows, thereby preventing neuroma formation more quickly and stably, resisting compression from surrounding muscles, and protecting the terminal nerves. Furthermore, the nerve conduit of this disclosure has a simple structure and good mechanical properties, enabling industrial mass production. Attached Figure Description

[0022] Figure 1 A schematic diagram of the structure of a nerve conduit according to an embodiment of the present disclosure is shown.

[0023] Figure 2 An exploded view of a nerve conduit according to an embodiment of the present disclosure is shown.

[0024] Figure 3 A schematic diagram of the sleeve according to a first embodiment of the present disclosure is shown.

[0025] Figure 4 A schematic diagram of a support frame according to one embodiment of the present disclosure is shown.

[0026] Figure 5 A schematic diagram of the sleeve according to a second embodiment of the present disclosure is shown.

[0027] Figure 6 A schematic diagram of the sleeve according to a third embodiment of the present disclosure is shown.

[0028] Figure 7 A schematic diagram of the sleeve according to the fourth embodiment of the present disclosure is shown.

[0029] Figure label:

[0030] 100: Sleeve; 110: Opening; 120: Through hole; 130: Notch; 140: Slot; 150: Foldable protrusion;

[0031] 210: Retractable part; 220: Fixing part;

[0032] 300: Support frame; 310: Support plate; 320: Limiting channel; 330: Baffle; 331: Buckle; 340: Limiting channel. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of this disclosure clearer, the disclosure will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0034] The terminology used in the embodiments of this disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of this disclosure. The singular forms “a,” “the,” and “the” as used in the embodiments of this disclosure and the appended claims are also intended to include the plural forms, and “multiple” generally includes at least two unless the context clearly indicates otherwise.

[0035] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0036] It should be understood that although the terms first, second, third, etc., may be used to describe structures in the embodiments of this disclosure, these structures should not be limited to these terms. These terms are only used to distinguish different structures. For example, without departing from the scope of the embodiments of this disclosure, a first component may also be referred to as a second component, and similarly, a second component may also be referred to as a first component.

[0037] Depending on the context, the words “if” or “suppose” as used here can be interpreted as “when” or “in response to determination” or “in response to detection.” Similarly, depending on the context, the phrases “if determination” or “if detection (of the stated condition or event)” can be interpreted as “when determination” or “in response to determination” or “when detection (of the stated condition or event)” or “in response to detection (of the stated condition or event).”

[0038] It should also be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that an article or device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such an article or device. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the article or device that includes said element.

[0039] A neuroma is a tumor that forms in nerve tissue. It is usually caused by abnormal cell proliferation, which forms an abnormal mass in the nervous system. In some cases of peripheral nerve damage, where the nerve ends are too far apart or the ends are lost due to amputation, the newly formed axons cannot reach the distal target organs, leading to failure of nerve fiber repair. In this case, the nerve fibers grow into the surrounding scar tissue in a disordered manner, mixing into clumps to form a neuroma. Its internal structure is relatively chaotic, containing tangled axons, Schwann cells, endoderm cells, and endoderm cells, all within a dense collagen matrix surrounded by fibroblasts. Traumatic neuromas can cause spontaneous pain in patients, with varying degrees of pain, such as stabbing, burning, electric shock-like, or throbbing pain. Some patients describe it as a persistent dull pain that worsens with activity, touching the amputation site, or external pressure. This pain not only affects the patient's daily activities but may also lead to psychological problems such as sleep disorders, anxiety, and depression.

[0040] Among related technologies, there are numerous methods for treating neuromas, but the results are not ideal. For example, burying nerve endings in muscle can provide some buffering and isolation, but this procedure significantly increases surgical complexity, requiring additional surgical manipulation of healthy tissue, and is difficult to implement in amputations and other neurosurgical procedures. Suturing and ligating methods may lead to the formation of painful neuromas behind the ligation site, and the ligated nerve position is not conducive to reducing mechanical stimulation. Covering nerve endings with silicone or rubber tubes not only makes nerve insertion difficult but may also further damage the nerve and cause the neuroma to maintain a single, clumped structure, meaning even slight stimulation may trigger a reaction throughout the entire neuroma.

[0041] To address at least one of the aforementioned technical problems, this disclosure provides a nerve conduit comprising: a cannula with an opening at one end and a constriction at the other end; a support frame including one or more support plates; when the support frame is assembled within the cannula, the support plates divide the cannula into a plurality of axially confining channels configured to provide a predetermined growth path; wherein the cannula has a plurality of through holes on its sidewalls configured to provide pathways for the permeation of tissue fluid. This disclosure provides a device for alleviating discomfort associated with neuromas. More specifically, this disclosure relates to a device for limiting the size of a neuroma and physically surrounding the neuroma to prevent the occurrence of stimuli that induce neuropathic pain. This disclosure relates to a tissue-engineered scaffold that provides: a barrier limiting the size of the neuroma, subdividing the volume of the neuroma to reduce axonal communication, and mechanical isolation of the neuroma. Within the space created by the barrier, subdivision of the injured nerve restricts the amount of interaction between axons, thereby limiting signal cascades within the neuroma, which can be interpreted as pain during sensory nerve signal transduction. By providing mechanical isolation, the nerve conduit of this disclosure restricts stimulation of the neuroma, which is the primary cause of the signal cascade and subsequently the direct cause of pain. Another advantage is the ability of the device's material to remodel into natural tissue cushioning when combined with physical partitions of the axonal stump.

[0042] The optional embodiments of this disclosure are described in detail below with reference to the accompanying drawings.

[0043] Figure 1 A schematic diagram of the structure of a nerve conduit according to an embodiment of the present disclosure is shown. Figure 2 An exploded view of a nerve conduit according to an embodiment of the present disclosure is shown. Figure 3 A schematic diagram of the sleeve 100 according to a first embodiment of the present disclosure is shown. Figure 1 , Figure 2 and Figure 3As shown, according to a specific embodiment of this disclosure, in one aspect, a nerve conduit is provided, the nerve conduit comprising: a cannula 100, one end of which has an opening 110 and the other end has a closing portion 210; the opening 110 is configured to accommodate a nerve ending, and the closing portion 210 is configured to fix and block the nerve ending with (human) tissue; a support frame 300, the support frame 300 including one or more support plates 310; when the support frame 300 is assembled inside the cannula 100, the support plates 310 divide the inside of the cannula 100 into multiple axial limiting channels 320, the limiting channels 320 being configured to provide a preset growth path; wherein, the sidewall of the cannula 100 has multiple through holes 120, the through holes 120 being configured to provide a passage for the permeation of tissue fluid. The nerve conduit provided in this disclosure forms a protective capsule through the cannula 100, replacing the epineurium, covering and restricting the growth of the nerve bundle. This allows the nerve to be subjected to relative mechanical stress as the surrounding growth environment narrows, thereby preventing neuroma formation more quickly and stably, resisting compression from surrounding muscles, and protecting the terminal nerves. Furthermore, the nerve conduit of this disclosure has a simple structure and good mechanical properties, enabling industrial mass production.

[0044] In practical use, the support frame 300 is assembled inside the sleeve 100, and then one end of the nerve cross-section is placed inside the sleeve 100 through the opening 110. The nerve conduit is fixed to the tissue by sutures, staples, clips, surgical adhesives, or sealants. The nerve conduit is remodeled within the host's own tissue and provides a cushioning pad for the neuroma. When host cells infiltrate the biomaterial, the nerve conduit is transformed into connective tissue, and axons and Schwann cells also permeate through the opening 120. When fibroblasts encounter other tissues (such as muscle, connective tissue layer, etc.), axonal regeneration stops; the nerve conduit will form a connective tissue layer surrounding the small neuroma with a vascular tissue capsule, and the sleeve 100 provides the necessary isolation and protection.

[0045] It should be noted that the gathering portion 210 and the sleeve 100 can be an integral structure, or the gathering portion 210 and the sleeve 100 can be detachably connected. In an optional embodiment, the gathering portion 210 is formed by extending or partially extending the sidewall of the sleeve 100 away from the opening 110 to form the foldable protrusion 150, and the foldable protrusion 150 is deflected towards the axial centerline of the sleeve 100 to form the gathering portion 210. In an optional embodiment, the gathering portion 210 is a hollow conical structure; the bottom sidewall of the hollow conical structure has the same shape and size as the end of the sleeve 100 away from the opening 110, and the bottom sidewall of the hollow conical structure is connected to the sleeve 100 away from the opening 110. The condensing portion 210 is mainly used to fix the tissue. After the sleeve 100 is set and the nerve end is successfully connected, the nerve conduit is fixed to the human tissue through the condensing portion 210. It can also play a blocking role, and the nerve end stops growing when it reaches the condensing portion 210.

[0046] Figure 4 A schematic diagram of a support frame 300 according to one embodiment of the present disclosure is shown. Figure 4 As shown, in some embodiments, the support frame 300 further includes a baffle 330, which is disposed at one end of the support plate 310; when the support frame 300 is assembled inside the sleeve 100, the baffle 330 is located at one end near the retracting portion 210, and is used to close the limiting channel 320. In an optional embodiment, the support frame 300 further includes a limiting channel 340, which extends axially along the support frame, and a plurality of the support plates 310 are disposed outside the limiting channel 340; when the support frame 300 is assembled inside the sleeve 100, the axis of the limiting channel 340 is substantially parallel to or coincides with the axis of the sleeve 100. The nerve conduit disclosed herein utilizes the support frame 300 to partition the nerve growth space, allowing the nerve to grow along the direction of the cannula 100 when entering the device, and supports the nerve through the support plate 310, providing support for the nerve while restricting the nerve growth direction, preventing the nerve from mixing into clumps and forming neuromas.

[0047] Figure 5 A schematic diagram of the sleeve 100 according to a second embodiment of the present disclosure is shown. Figure 6 A schematic diagram of the sleeve 100 according to a third embodiment of the present disclosure is shown. Figure 7 A schematic diagram of the sleeve 100 according to the fourth embodiment of this disclosure is shown. Figure 5 and Figure 7As shown, in some embodiments, the cannula 100 has a notch 130 on the wall at one end with the opening 110, the notch 130 being configured to facilitate connection and fixation of nerve endings. For example... Figure 6 and Figure 7 As shown, in some embodiments, the outer wall of the cannula 100 is provided with at least one fixing part 220, which is used to fix the cannula 100. The fixing part 220 is provided on the outer wall of the cannula 100, and the cannula 100 can be fixed in the tissue by sutures or the like to prevent the nerve conduit from falling out.

[0048] In some embodiments, the sleeve 100 is a circular or polygonal tubular structure. In an optional embodiment, the end of the sleeve 100 away from the opening 110 has a plurality of foldable protrusions 150, which converge toward the axis of the sleeve 110 to form the converged portion 210. In an optional embodiment, the plurality of foldable protrusions 150 are circumferentially spaced along the end of the sleeve 100 away from the opening 110.

[0049] Specifically, the sleeve 100 is a polygonal prism-shaped tubular structure; the sleeve 100 has polygonal prism sides, meaning the tube wall of the sleeve 100 is composed of multiple side plates. The tube wall of the sleeve 100 extends away from the opening 110 at intervals of a first predetermined number of side plates, forming the foldable protrusion 150, and then bends towards the axial centerline of the sleeve 100, forming the closing portion 210. The side plates extending away from the opening 110 can be regularly spaced or irregularly spaced. In actual use, the closing portion 210 is fixed to the tissue by sutures, staples, clips, surgical adhesives, or sealants.

[0050] In some embodiments, the edge of the baffle 330 is provided with a buckle 331, and the end of the non-extended sidewall of the sleeve 100 away from the opening 110 is provided with a groove 140, through which the baffle 330 is connected to the sleeve 100. In an optional embodiment, when the sleeve 100 is a polygonal tubular structure, the groove 140 is formed by the sidewall that does not extend away from the opening 110. In an optional embodiment, the groove 140 is formed by the sidewall within the sleeve 100 that does not extend away from the opening 110 having a smaller axial length than the other sidewalls (excluding the foldable protrusion 150).

[0051] In some embodiments, the sleeve 100 is made of a biomedical material. In an optional embodiment, the support frame 300 is made of a biomedical material. In an optional embodiment, the baffle 330 is made of a biomedical material. In an optional embodiment, the biomedical material includes biodegradable materials such as animal-derived extracellular matrix materials and polymeric materials. Specifically, the biodegradable material can be high-density polyethylene (HDPE), polyethylene glycol (PEG) hydrogel, proteins purified from human or animal bodies (e.g., membranes of purified collagen or fibrin), and decellularized tissue frameworks (e.g., demineralized bone, amnion, SIS, dermis, or fascia). HDPE or PEG devices can include or consist of cylindrical porous HDPE or PEG surrounded by non-porous HDPE or PEG layers. Biomaterials capable of forming liquid materials, such as soluble purified collagen or particulate SIS and dermis, can be directly cast to form devices without the need for membranes as intermediates.

[0052] In some embodiments, the length of the support frame 300 from the baffle 330 to the end away from the baffle 330 is less than the minimum length of the sleeve 100 from the opening 110 to the closing portion 210. In actual use, when the baffle 330 and the support frame 300 are disposed inside the sleeve 100, the end of the support frame 300 away from the closing portion 210 is at a certain distance from the opening 110, forming a receiving groove. The nerve terminal is disposed in the receiving groove, and the cross-section of the nerve terminal is close to the side of the support frame 300 away from the closing portion 210.

[0053] This disclosure aims to protect a nerve conduit comprising: a cannula 100 having an opening 110 at one end and a constriction portion 210 at the other end; a support frame 300 including one or more support plates 310; when the support frame 300 is fitted within the cannula 100, the support plates 310 divide the cannula 100 into a plurality of axially confining channels 320, the confining channels 320 being configured to provide a predetermined growth path; wherein the sidewall of the cannula 100 has a plurality of through holes 120, the through holes 120 being configured to provide pathways for the permeation of tissue fluid. This disclosure provides a device for relieving discomfort associated with neuromas. More specifically, this disclosure relates to a device for limiting the size of a neuroma and physically surrounding the neuroma to prevent the occurrence of stimuli that induce neuropathic pain. This disclosure relates to a tissue-engineered scaffold that provides: a barrier to limit the size of the neuroma, subdivision of the neuroma volume to reduce axonal communication, and mechanical isolation of the neuroma. Within the space created by the barrier, the subdivision of the injured nerve limits the amount of interaction between axons, thereby limiting the signal cascade within the neuroma, which can be interpreted as pain during sensory nerve signal transduction. By providing mechanical isolation, the nerve conduit of this disclosure restricts stimulation of the neuroma, which is the primary cause of the signal cascade and subsequently the direct cause of pain. Another advantage is the ability of the material of this device to be remodeled into a natural tissue cushion when combined with physical partitioning of the axonal stump. The nerve conduit provided by this disclosure forms a protective capsule through the sheath 100, replacing the epineurium, covering and restricting the growth of the nerve bundle. This allows the nerve to be subjected to relative mechanical stress as the surrounding growth environment narrows, thereby preventing neuroma formation more quickly and stably, resisting compression from surrounding muscles, and protecting the terminal nerve. Furthermore, the nerve conduit of this disclosure has a simple structure and good mechanical properties, enabling industrial mass production.

[0054] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the systems or apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the descriptions are relatively simple, and relevant parts can be referred to the method section.

[0055] The above embodiments are only used to illustrate the technical solutions of this disclosure, and are not intended to limit it. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this disclosure.

Claims

1. A nerve conduit, characterized by, The nerve conduit comprises: a sleeve, one end of which is provided with an opening and the other end of which is provided with a retracted portion; a support frame, which comprises one or more support plates; when the support frame is assembled in the sleeve, the support plates divide the sleeve into a plurality of axial limiting channels, which are configured to provide a preset growth path. The sleeve has a plurality of through holes in the side wall, which are configured to provide a path for the infiltration of tissue fluid.

2. The nerve conduit of claim 1, wherein, The support frame further comprises: a baffle plate, which is arranged at one end of the support plate; when the support frame is assembled in the sleeve, the baffle plate is located at one end close to the retracted portion, and is used to close the limiting channel.

3. The nerve conduit according to claim 2, wherein the edge of the baffle plate is provided with a buckle, which is configured to be clamped with the end of the sleeve away from the opening.

4. The nerve conduit of claim 1, wherein, The support frame further comprises: a limiting channel, which extends axially along the support frame, and a plurality of support plates are arranged outside the limiting channel; when the support frame is assembled in the sleeve, the axis of the limiting channel is substantially parallel to or coincides with the axis of the sleeve.

5. The nerve conduit of claim 3, wherein, The end of the sleeve away from the opening is provided with a clamping groove, which is configured to be clamped with the buckle.

6. The nerve conduit according to claim 1, wherein the end of the sleeve away from the opening has a plurality of foldable protrusions, which are retracted in the direction of the axis of the sleeve to form the retracted portion.

7. The nerve conduit according to claim 6, wherein the plurality of foldable protrusions are arranged at intervals along the circumference of the end of the sleeve away from the opening.

8. The nerve conduit according to claim 1, wherein the tube wall of the end of the sleeve provided with the opening is provided with a notch, which is configured to facilitate the connection and fixation of the nerve end.

9. The nerve conduit according to claim 1, wherein the outer wall of the sleeve is provided with at least one fixing portion, which is used to fix the sleeve.

10. The nerve conduit according to claim 1, wherein the material of the sleeve is a biomedical material; and / or the material of the support frame is a biomedical material; and / or the material of the baffle plate is a biomedical material.

11. The nerve conduit according to claim 1, wherein the length of the support frame from the baffle plate to the end away from the baffle plate is less than the minimum length of the sleeve from the opening to the retracted portion.

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