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CN-122028856-A - Nerve conduit

CN122028856ACN 122028856 ACN122028856 ACN 122028856ACN-122028856-A

Abstract

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

Inventors

  • Mary Maraphos
  • Esther Colin
  • Elise Devri
  • Sarah Rasolsontawo

Assignees

  • 蒂斯尤姆有限公司

Dates

Publication Date
20260512
Application Date
20241011
Priority Date
20231011

Claims (20)

  1. 1. A nerve conduit (10) for connecting nerve endings to a target site, the nerve conduit comprising an elongated body (12) formed by walls (22) defining a lumen (16), and the elongated body comprising: a central portion (14), wherein the lumen (16) extends through the central portion (14), and Two end portions (18, 19) defining respective openings (20, 21) to the lumen (16), one end portion (18) being an insertion portion configured for insertion of a respective nerve ending (26), the other end portion (19) being a nerve ending outlet portion, Wherein the end portions (18, 19) are arranged such that cross sections of the openings (20, 21) are oriented at an angle to each other.
  2. 2. The nerve conduit (10) of claim 1, wherein the angle between the cross sections is 30 degrees to 90 degrees.
  3. 3. The nerve conduit (10) of claim 2, wherein the angle between the cross sections is 50 degrees to 90 degrees, or 70 degrees to 90 degrees, or wherein the angle is about 90 degrees such that the cross sections of the openings (20, 21) are oriented substantially perpendicular to each other.
  4. 4. The nerve conduit (10) according to any one of the preceding claims, wherein the insertion portion (18) is arranged adjacent to the central portion (14) and the outlet portion (19) is arranged on an opposite side of the central portion (14).
  5. 5. The nerve conduit (10) of any one of the preceding claims, wherein the elongate body (12) comprises a transition portion (24) adjacent the central portion (14) and forming the outlet portion (19), wherein the transition portion (24) defines a bend of the elongate body (12) and/or extends at an angle relative to the central portion (14).
  6. 6. The nerve conduit (10) of claim 5, wherein a cross-section of a portion of the lumen (16) defined by the transition portion (24) increases progressively away from the central portion (14).
  7. 7. The nerve conduit (10) of claim 5, wherein the wall (22) defining the transition portion (24) at least partially converges toward the outlet portion (19).
  8. 8. The nerve conduit (10) according to claim 7, wherein the outlet portion (19) and/or the transition portion (24) comprises a conical or funnel shape.
  9. 9. The nerve conduit (10) according to any one of the preceding claims, wherein the opening (21) of the outlet portion (19) is formed as an ellipse.
  10. 10. The nerve conduit (10) according to claim 8, wherein the ratio between the maximum diameter and the minimum diameter of the opening (21) of the outlet portion (19) is 1:1 to 4:1, preferably 1.1:1 to 2.5:1.
  11. 11. The nerve conduit (10) according to claim 8 or 9, wherein the smallest diameter of the opening (21) of the outlet portion (19) substantially corresponds to the diameter of the lumen (16) defined by the central portion (14).
  12. 12. The nerve conduit (10) of any one of the preceding claims, wherein the wall (22) of the elongate body (12) is a single tubular wall comprising a substantially continuous thickness.
  13. 13. The nerve conduit (10) according to any one of the preceding claims, wherein the lumen (16) defined by the central portion (14) comprises a continuous cross-section, and/or wherein the central portion (14) comprises a substantially cylindrical shape.
  14. 14. The nerve conduit (10) according to any one of the preceding claims, wherein the diameter of the lumen (16) defined by the central portion (14) is 1-12 mm, preferably 1.5-6.5 mm.
  15. 15. The nerve conduit (10) according to any one of the preceding claims, wherein the cross-sectional area of the opening (21) of the outlet portion (19) is larger than the cross-sectional area of the lumen (16) of the central portion (14).
  16. 16. The nerve conduit (10) according to any one of the preceding claims, wherein the maximum diameter of the opening (21) of the outlet portion (19) is 1 to 15mm, preferably 4 to 12mm, larger than the diameter of the lumen (16) defined by the central portion (14).
  17. 17. The nerve conduit (10) according to any one of the preceding claims, wherein the cross-sectional area of the opening (21) of the outlet portion (19) is larger than the cross-sectional area of the opening (20) of the insertion portion (18).
  18. 18. The nerve conduit (10) according to any one of the preceding claims, wherein the cross-sectional area of the opening (21) of the outlet portion (19) increases in a direction away from the central portion (14).
  19. 19. The nerve conduit (10) according to any one of claims 1 to 14, wherein the cross-sectional area of the opening (21) of the outlet portion (19) is smaller than or equal to the cross-sectional area of the lumen (16) of the central portion (14) and/or the cross-sectional area of the opening (20) of the insertion portion.
  20. 20. The nerve conduit (10) according to any one of the preceding claims, wherein a flange portion (26) is formed by the wall (22) at the outlet opening (21), the flange portion (26) extending radially outwardly from the outlet opening (21).

Description

Nerve conduit Technical Field The present invention relates to a nerve conduit for connecting a damaged nerve ending to a target site. In particular, the present invention relates to nerve conduits that support nerve injury repair and motor control or sensory function and/or reduce the risk of neuroma occurring at damaged nerve endings. Background When a person is injured, tissue damage may involve one or more nerve injuries to the peripheral nervous system, resulting in partial loss of sensation and/or impaired motor skills. Such injuries involving nerve damage occur particularly in the lower and upper limbs, such as the hands of a person, such that if the nerve damage is not properly treated, the person may experience loss of, for example, tactile or haptic feedback and/or may have difficulty controlling the fine motor skills of the injured area. Current treatment of nerve injury involves the apposition of nerve endings by various suturing techniques to provide connection between the respective nerve endings in a substantially tensionless manner. If there is a more severe defect in which nerve endings are not immediately adjacent, reconstruction may be required to overcome the corresponding gaps. For example, reconstruction may be provided by autologous or allogeneic nerve grafts. Alternatively, reconstruction may be performed by providing a tubular structure to provide nerve guidance in the form of lumens, providing a directional path during neurogenesis. Such a tubular structure accommodating the respective nerve endings may be provided, for example, by an autologous or allogenic venous structure or by an artificial nerve conduit made of biocompatible material. The use of tubular structures may also facilitate repair of the injury, whether or not there is a gap, such as by providing further mechanical support and structural stability, providing tension-free repair, reducing inflammatory responses at the site of the injury, and/or limiting the extent of fibrous tissue development. However, in clinical situations where distal nerve endings are lost, such as due to amputation or tissue resection, such connection between nerve endings is not possible. This not only complicates the treatment of at least partially restoring motor control or sensory function, but may also lead to an increased risk of neuroma, which may form at the severed nerve endings. Such neuroma may be formed by disordered axonal growth beyond the severed adventitial sheath that transects nerve endings in an attempt to re-innervate the distal muscle or skin, for example, after severe trauma or surgery, where sprouting of axons may form a bundle of disordered and hyperexcitable nerve tissue (called a neuroma) that does not have the original neural structure. Neuroma is often associated with neuropathic pain, numbness and tingling, and may also interfere with rehabilitation, functional recovery and sensory impairment. Treatment or prevention attempts for neuroma may be based on suturing the proximal end of the damaged nerve to a particular motor nerve of the intact newly denervated muscle. The suturing technique may at least partially restore muscle control while reducing the risk of neuroma development. Other alternative procedures have been proposed to repair peripheral nerve injuries where the distal nerve stump is not available or where there is significant nerve space or when the nerve is transected too far from the target organ or muscle or skin. For example, end-to-side (ETS) nerve repair, in which the distal stump of a damaged nerve is apposed to the side of an undamaged nerve (Lykissas, 2011, journal of world orthopaedics, volume 2, 11, pages 102-106). Another procedure known as targeted muscle innervation (TMR) is a surgical neurotransmission procedure. According to TMR, residual nerves from the amputated limb are transferred to a new muscle target. As part of the nerve transfer, the target muscles are separated from their original motor inputs so that newly transferred nerves can re-innervate them. (Bergmeister et al, 2021, manual surgery, volume 37, 3, pages 415-424; janes et al, 2021, manual surgery, volume 37, 3, pages 345-359.) Disclosure of Invention Starting from the known prior art, there is a need to further promote the repair of nerve damage, in particular after amputation, which results in nerve endings that can form neuroma or cause phantom limb pain. In accordance with the present invention, it has been recognized that attaching the proximal or distal nerve endings of a nerve (particularly a damaged nerve) to the side of a target muscle tissue or target organ or target nerve may be difficult and/or may not provide satisfactory results, e.g., to restore (partial) motor control and/or sensory function and/or to avoid the development of neuroma and/or to cause regeneration of the damaged nerve. Suturing nerve endings may lead to undesired tissue damage and/or may complicate proper orientation of the terminal ends of the p