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WO2025250441A1 - Conduits pour une procédure de réparation nerveuse - Google Patents

Conduits pour une procédure de réparation nerveuse

Info

Publication number
WO2025250441A1
WO2025250441A1 PCT/US2025/030605 US2025030605W WO2025250441A1 WO 2025250441 A1 WO2025250441 A1 WO 2025250441A1 US 2025030605 W US2025030605 W US 2025030605W WO 2025250441 A1 WO2025250441 A1 WO 2025250441A1
Authority
WO
WIPO (PCT)
Prior art keywords
conduit
suture
separators
separator
nerve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/030605
Other languages
English (en)
Inventor
John Pepper
Steven S. Smith
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Epineurial Coaptation Technology LLC
Original Assignee
Epineurial Coaptation Technology LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Epineurial Coaptation Technology LLC filed Critical Epineurial Coaptation Technology LLC
Publication of WO2025250441A1 publication Critical patent/WO2025250441A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Definitions

  • the present disclosure relates to conduits for a nerve repair procedure. More specifically, the disclosure relates to conduits having separators configured to provide a gap utilized to separate a first and a second nerve stump during a nerve repair procedure.
  • Nerves consist of many individual nerve cells, axons, grouped together in a funiculus, wrapped in perineurium, which are grouped with other grouped axons, and blood vessels, all contained in an outer sheath called the epineurium.
  • the severed epineurium and nerves are referred to herein as proximal and distal nerve stumps.
  • the proximal nerve stump is positioned closer to the skeleton relative to the distal nerve stump.
  • Nerve cells, such as axon nerve cells generally grow from the proximal nerve stump.
  • the distal nerve stump generally receives the out growing nerve cells from the proximal nerve stump.
  • the nerve stumps may also be referred to herein generally as a first and a second nerve stump.
  • the epineurium is thin, flexible, and nearly translucent. When a nerve is cut, a scar will form over the end.
  • a conduit in accordance with one or more aspects of the present disclosure includes a conduit body.
  • the conduit body includes opposing first and second open end portions and a hollow conduit interior extending therebetween.
  • the conduit interior is configured to receive a first nerve stump through the first open end portion and a second nerve stump through the second open end portion during a nerve repair procedure on a patient.
  • a separator structure is positioned within the conduit interior of the conduit body. The separator structure is configured to provide a predetermined regeneration gap between the first and the second nerve stumps inserted into the conduit during the nerve repair procedure.
  • FIG. 1 depicts an example of a partial cut away perspective view of a conduit with a solid tab for a separator structure, according to aspects described herein;
  • FIG. 2 depicts an example of a partial cut away perspective view of the conduit of FIG. 1 with a first and a second nerve stump inserted into opposing open ends of the conduit, according to aspects described herein;
  • FIG. 3 depicts an example of a side view of a conduit carrier having a first and a second jaw in a closed position, according to aspects described herein;
  • FIG. 4 depicts an example of a side view of the conduit carrier of FIG. 3 having the first and the second jaw in an open position, according to aspects described herein;
  • FIG. 6 depicts an example of a front view of a conduit, wherein the separator structure includes a first and a second set of parallel suture separators disposed therein, according to aspects described herein;
  • FIG. 7 depicts an example of a side view of the conduit of FIG. 6, according to aspects described herein;
  • FIG. 8 depicts an example of a partial cut away perspective view of the conduit of FIG. 6, according to aspects described herein;
  • FIG. 9 depicts an example of a front view of a conduit, wherein the separator structure includes a first and a second set of crossed suture separators disposed therein, according to aspects described herein;
  • FIG. 10 depicts an example of a partial cut away perspective view of the conduit of FIG. 9, according to aspects described herein;
  • FIG. 11 depicts an example of a front view of a conduit, wherein the separator structure includes a first and a second set of networked suture separators disposed therein, according to aspects described herein;
  • FIG. 12 depicts an example of a partial cut away perspective view of the conduit of FIG. 11, according to aspects described herein;
  • FIG. 13 depicts an example of a front view of a conduit, wherein the separator structure includes a first and a second set of looped suture separators disposed therein, according to aspects described herein;
  • FIG. 14 depicts an example of a partial cut away perspective view of the conduit of FIG. 13, according to aspects described herein;
  • FIG. 15 depicts an example of a partial cut away perspective view of a conduit, wherein the separator structure includes having a first and a second set of suture separators spaced apart by a solid spacer that extends between, and is connected to, the first and second set of suture separators, according to aspects described herein;
  • FIG. 16 depicts an example of a perspective view of a conduit with a solid tab for a separator structure and further having an intersecting tube integrally connected to the conduit body of the conduit, according to aspects described herein;
  • FIG. 18 depicts an example of a perspective view of a conduit without a separator structure and having an intersecting tube integrally connected to the conduit body of the conduit, according to aspects described herein;
  • FIG. 19 depicts an example of a perspective view of the conduit of FIG. 16 with a first and second nerve stump about to be inserted into opposing ends of the conduit, according to aspects described herein;
  • FIGS. 1 and 2 an example is depicted of a partial cut away perspective view (FIG. 1) of a conduit 100 with a separator structure 102; and a partial cut away perspective view (FIG. 2) of the conduit 100 of FIG. 1 with a first nerve stump 104 and a second nerve stump 106 inserted into opposing open end portions 108, 110 of the conduit 100, according to aspects described herein.
  • the conduit 100 includes a conduit body 112, which includes the opposing first and second open end portions 108, 110 and a hollow conduit interior 114 extending therebetween.
  • the conduit interior 114 is configured to receive the first nerve stump 104 through the first open end portion 108 and the second nerve stump 106 through the second open end portion 110 during a nerve repair procedure on a patient (not shown).
  • the separator structure 102 may be any appropriate structure that has an overall separator structure width 116 which defines a predetermined regeneration gap 116, i.e., a distance 116 that the first and second nerve stumps 104, 106 are to be spaced apart during a nerve repair procedure in order to promote optimal nerve growth between the nerve stumps 104, 106.
  • the separator structure is positioned within the conduit interior 114 of the conduit body 112.
  • the separator structure 102 includes a solid separator tab 118.
  • the tab extends radially across an inside diameter 120 of the conduit 100.
  • the separator tab 118 is integrally connected to opposing sides of a wall 122 of the conduit 100.
  • the separator tab 118 has a lateral thickness 124 that is at least an order of magnitude smaller than the inside diameter 120 of the conduit 100 in order to minimize any obstruction of nerve growth along a longitudinal axis 126 of the conduit 100.
  • the overall separator structure width 116 is equal to a longitudinal width of the separator tab 118, which extends parallel to the longitudinal axis 126 of the conduit 100 and defines the regeneration gap 1 16.
  • FIGS. 3 and 4 an example is depicted of a side view of a conduit carrier 200 having a first jaw 202 and a second jaw 204 in a closed position (FIG. 3); and an example of the side view of the conduit carrier 200 of FIG. 3 having the first and the second jaws 202, 204 in an open position (FIG 4), according to aspects described herein.
  • the conduit carrier 200 is designed to hold and support the conduit 100 during the nerve repair procedure.
  • the conduit carrier 200 includes a main housing 206.
  • a vacuum transferring cylinder 208 is attached to the main housing 206.
  • the vacuum transferring cylinder is connected to a vacuum source 210.
  • the vacuum source 210 is in fluid communication with the interior 114 of the conduit 100 through a vacuum port 128 (see FIG. 5).
  • the vacuum source 210 is configured to pull a vacuum on the conduit interior 114 to facilitate placement of the first and second nerve stumps 104, 106 through the open end portions 108, 110 of the conduit 110 and into the interior 114 of the conduit 100.
  • the conduit 100 may be released from the conduit holder 200.
  • conduit holders 200 that are configured to releasably engage with the conduit 100.
  • conduit holders are disclosed in International PCT Application No.: PCT/US2024/20669 to John Pepper et al., titled: “EPINEURIAL COAPTATION IMPLANTS, INSTRUMENTS AND METHODS”, filed on March 20, 2024, which is hereby incorporated herein by reference in its entirety.
  • conduit holders are disclosed in Provisional Application No.: 63/637976 to John Pepper et al., titled: “CARTRIDGE ASSEMBLY AND METHODS FOR PERIPHERAL NERVE REPAIR”, filed on April 24, 2024, which is also hereby incorporated herein by reference in its entirety.
  • FIG. 5 an example is depicted of a perspective view of the conduit 100 having a vacuum port 128 and one or more radial support structures 130, according to aspects described herein.
  • the conduit 100 includes the conduit body 112 including opposing first and second open end portions 108, 110 and the hollow conduit interior 114 extending therebetween.
  • the conduit interior 114 is configured to receive the first nerve stump 104 (FIG. 2) through the first open end portion 108 and the second nerve stump 106 (FIG. 2) through the second open end portion 110, during a nerve repair procedure on a patient.
  • a vacuum port 128 extends through the wall 122 of the conduit body 112.
  • the vacuum port 128 is configured to connect to the vacuum source 210 (see FIG. 3) associated with the conduit holder 200 to pull a vacuum on the conduit interior 114 while inserting the nerve stumps 104, 106 into the first and second open end portions 108, 110.
  • the conduit 100 may also include one or more radial support structures 130 positioned on the outside of wall 122 of the conduit body 112.
  • the radial support structures 130 are configured to structurally support the conduit body 112 when the vacuum from the vacuum source 210 is being applied.
  • the one or more radial support structures 130 of the conduit 100 may be any appropriate support structure configured to structurally support the conduit body 112 when the vacuum is being applied.
  • the radial support structures 130 are retaining tabs 130.
  • several other examples of radial support structures may also be used, including any of the radial support structures disclosed in International PCT Application No.: PCT/US2024/20669 to John Pepper et al., titled: “EPINEURIAL COAPTATION IMPLANTS, INSTRUMENTS AND METHODS”, filed on March 20, 2024, which is hereby incorporated herein by reference in its entirety.
  • the vacuum source 210 is used to create a low pressure within the interior 114 of the conduit 100 in order to draw the first and second nerve stumps 104, 106 into the first and second open end portions 108, 110 of the conduit 100.
  • the conduit 100 is often composed of a flexible material to allow for added patient comfort and bending of the patient’s body part in which the conduit 100 is implanted. Problematically, when the vacuum is applied, the flexible body of the conduit 100 has a tendency to collapse before the nerve stumps 104, 106 can be inserted.
  • the radial support structures 130 such as the one or more retaining tabs 130 illustrated in FIG. 5, may be used to provide structural support to the conduit 100.
  • the retaining tabs 130 may also be designed to engage with the first and second jaws 202, 204 (see FIG. 3) of the conduit holder 200 to further maintain the shape of the conduit 100 when the vacuum is being applied to the interior 114 of the conduit 100.
  • the first and second jaws 202, 204 may be designed to clamp onto the retaining tabs 130 to hold the conduit body 112 in place while a vacuum is being applied.
  • one or more vacuum port flaps 132 are configured to close over the vacuum port 128 when the vacuum is not being applied. More specifically, the vacuum port flaps 132 can close over the vacuum port 128 when the nerve repair procedure is complete. When the vacuum port flaps 132 are closed over the vacuum port 128, the vacuum port flaps 132 prevent nerve cells from the first and second nerve stumps 104, 106 from growing through the vacuum port 128.
  • FIGS. 6, 7 and 8 an example is depicted of a front view (FIG. 6), a side view (FIG. 7) and a partial cut away perspective view (FIG. 8) of a conduit 100, wherein the separator structure 102 includes a first set 140 of one or more first suture separators 134 and a second set 142 of one or more second suture separators 136, according to aspects described herein.
  • the two sets 140, 142 of first and second suture separators 134, 136 are parallel to each other and extend substantially perpendicularly to the longitudinal axis 126 of the conduit 100.
  • the sets 140, 142 of first and second suture separators 134, 136 may include a single first suture separator 134 and a single second suture separator 136, wherein the first suture separator 134 and a second suture separator 136 may be attached to the wall 122 of the conduit 100.
  • the first and second suture separators 134, 136 are spaced apart a distance 116 that defines the predetermined regeneration gap 116.
  • first set 140 of first suture separators 134 may include a plurality of parallel first suture separator 134
  • the second set 142 of second suture separators 136 may include a plurality of parallel second suture separator 136.
  • first set 140 of first suture separators 134 includes three parallel first suture separators 134
  • the second set 142 of second suture separators 136 includes three parallel second suture separators 136.
  • each set 140, 142 of first and second suture separators 134, 136 may include any number of parallel suture separators.
  • the first and second suture separators 134, 136 may be attached to the wall 122, by extending through the conduit wall 122 to form at least a continuous suture loop 138 (see FIG.
  • first and second suture separators 134, 136 may be formed with a single suture that is threaded through the wall 122 to form multiple continuous suture loops 138, wherein each loop 138 includes one first suture separator 134 and one second suture separator 136.
  • the spaced apart distance 116 between the two sets 140, 142 of parallel first and second suture separators 134, 136 form the width of the separator structure 102.
  • the width 116 of the separator structure 102 provides the mechanical stop for the first and second nerve stumps 104, 106 (FIG. 2) during a nerve repair procedure.
  • the suture separators 134, 136 may have a diameter that is at least an order of magnitude smaller than the inside diameter 120 of the conduit. The small size of the suture diameter will reduce obstruction to nerve pathways available for nerve growth and, therefore, enhance the growth of nerves between the stumps 104, 106.
  • the suture separators 134, 136 may be composed of a bioabsorbable material that will be dissolved or absorbed over time. The removal of the bioabsorbable suture separators, may further enhance the growth of nerves between the nerve stumps 104, 106.
  • any separator structure 102 may also be fully or partially composed of a bioabsorbable material.
  • the solid separator tab 118 of FIG. 1 may be composed of a bioabsorbable material.
  • FIGS. 9 and 10 example is depicted of a front view (FIG. 9) and a partial cut away perspective view (FIG. 10) of a conduit 100, wherein the separator structure 102 includes a first set 144 of crossed first suture separators 134 and a second set 146 of crossed second suture separators 136 disposed therein, according to aspects described herein.
  • the first and second sets 144, 146 are spaced apart a distance 116 that defines the regeneration gap 116.
  • the first set 144 of crossed first suture separators 134 includes two crossed first suture separators 134 and the second set 146 of crossing second suture separators 136 includes two crossed second suture separators 136.
  • each set 144, 146 of first and second suture separators 134, 136 may include any number of crossed suture separators.
  • FIGS. 11 and 12 example is depicted of a front view (FIG. 11) and a partial cut away perspective view (FIG. 12) of a conduit 100, wherein the separator structure 102 includes a first set 148 of networked first suture separators 134 and a second set 150 of networked second suture separators 136 disposed therein, according to aspects described herein.
  • first suture separators 134 are connected together to form a netlike structure.
  • second suture separator 136 are connected together to form a netlike structure.
  • the first and second sets 148, 150 are spaced apart a distance 116 that defines the regeneration gap 116.
  • first suture separators 134 are stitched together within the interior of the conduit 100.
  • second suture separators 136 are also stitched together within the interior of the conduit 100.
  • the first and second sets 152, 154 are spaced apart a distance 116 that defines the regeneration gap 116.
  • the first set 152 of looped first suture separators 134 includes two looped first suture separators 134 and the second set 154 of looped second suture separators 136 includes two looped second suture separators 136.
  • each set 152, 154 of first and second suture separators 134, 136 may include any number of stitched suture separators.
  • FIG. 15 an example is depicted of a partial cut away perspective view of a conduit 100, wherein the separator structure 102 includes having a first set 156 of first suture separators 134 and a second set 158 of second suture separators 136 that are spaced apart by a solid spacer 160 that extends between, and is connected to, the first and second set 156, 158 of suture separators, according to aspects described herein.
  • the solid spacer 160 extends between, and connects to, a first suture separator 134 of the first set 154 of first suture separators 134 and a second suture separator 136 of the second set 154 of second suture separators 136.
  • the first and second sets 154, 156 may be any configuration, e.g., crossed, looped, parallel, networked or the like.
  • the solid spacer 160 spaces apart the first and second sets 156, 158 a distance 116 that defines the regeneration gap 116.
  • FIGS. 16 and 17 an example is depicted of a perspective view (FIG. 16) and a sectioned perspective view (FIG. 17) of a conduit 100 with a solid separator tab 118 for a separator structure 102 and further having an intersecting tube 170 integrally connected to the conduit body 112 of the conduit 100, according to aspects described herein.
  • the intersecting tube 170 of the conduit 100 may be integrally connected to the conduit body 112.
  • the intersecting tube 170 includes an intersecting tube body 172 having a hollow tube interior 174 that extends through the wall 122 of the conduit body 112.
  • the intersecting tube 170 may be composed of the same material as the conduit body 112.
  • the conduit body 112 and intersecting tube 170 may both be composed of collagen or small intestine submucosa tissue.
  • the intersecting tube 170 is configured to connect to a vacuum source 210 associated with a conduit carrier 200 (see FIG. 2) to pull a vacuum on the conduit interior 114 while inserting first and second nerve stumps 104, 106 (see FIGS. 19 and 20) into the first and second open end portions 108, 110 of the conduit body 112.
  • the intersecting tube body 172 of the intersecting tube 170 may have a centerline 176 which intersects the separator structure 102.
  • the intersecting tube 170 makes it easy to provide a simple and leak free seal of the interior 114 of the conduit 100 to a vacuum source 210.
  • the intersecting tube 170 may have multiple shapes such as oval, rectangular, circular or the like.
  • the diameter of a circular intersecting tube 170 may be about one half of the conduit’s diameter.
  • the intersecting tube 170 may be made of the same material as the conduit 100 and may be manufactured at the same time. Alternatively, the intersecting tube 170 may be a combination of multiple components composed of multiple materials that are different from that of the conduit 100.
  • the centerline 176 of the intersecting tube 170 may intersect the conduit 100 in the center of the region that will become the regeneration zone 116 (see FIG. 1).
  • the conduit 100 may include an integral separator structure 102 for keeping nerve stumps 104, 106 from contacting one another.
  • the intersecting tube 170 may be closed off by use of, for example, an enveloping suture, or a blood vessel occlusion clip, so that the hollow tube interior 174 no longer extends through the wall 122 of the conduit body 112. This may be done as close to the wall 122 of the conduit 100 as possible. The remainder of the intersecting tube 170 may then be cut off.
  • the hollow tube interior 174 of the intersecting tube 170 may have a diameter that ranges from 1mm to 6 mm.
  • the overall length of the intersecting tube 170 may have a length of from 5 to 100 mm, with 15 mm being an approximate length of most use.
  • FIG. 18 an example is depicted of a perspective view of a conduit 100 without a separator structure 102 and having an intersecting tube 170 integrally connected to the conduit body 112 of the conduit 100, according to aspects described herein.
  • the embodiment is an alternative design to that of the conduits of FIGS. 16 and 17, which include a separator structure 102.
  • the conduit 100 includes a conduit body 112 including opposing first and second open end portions 108, 110 and a hollow conduit interior 114 extending therebetween.
  • the conduit interior 114 is configured to receive a first nerve stump 104 (see FIG. 19) through the first open end portion 108 and a second nerve stump 106 through the second open end portion 110 during a nerve repair procedure on a patient.
  • An intersecting tube 170 is integrally connected to the conduit body 112.
  • the intersecting tube 170 includes an intersecting tube body 172 having a hollow tube interior 174 that extends through a wall 122 of the conduit body 112.
  • the intersecting tube 170 is configured to connect to a vacuum source 210 (see FIG. 2) associated with a conduit carrier 200 (see FIG. 2) to pull a vacuum on the conduit interior 114 while inserting the nerve stumps 104, 106 into the first and second open end portions 108, 110 of the conduit body 112.
  • the regeneration gap 116 may be formed by a separator (not shown) that is integral to the conduit holder 200.
  • a separator not shown
  • FIG. 1 Several examples of such conduit holders with integral separators are disclosed in International PCT Application No.: PCT/US2024/20669 to John Pepper et al., titled: “EPINEURIAL COAPTATION IMPLANTS, INSTRUMENTS AND METHODS”, filed on March 20, 2024, which is hereby incorporated herein by reference in its entirety.
  • the centerline 176 of the intersecting tube 170 is configured to intersect the region of space wherein the regeneration gap 116 will be formed within the conduit 100.
  • FIGS. 19 and 20 an example is depicted of a perspective view (FIG. 19) and a sectioned perspective view (FIG. 20) of the conduit 100 of FIG. 16 with a first and second nerve stump 104, 106 about to be inserted into opposing ends 108, 110 of the conduit 100, according to aspects described herein.
  • An anti -collapse tool 180 may be utilized to keep the intersecting tube 170 from collapsing when a vacuum is applied by the vacuum source 200.
  • the anti-collapse tool 180 may have a hollow interior 182 through which the vacuum path 184 created by the vacuum source 200 extends.
  • the tool 180 provides a convenient connection to the vacuum source 200.
  • the anticollapse tool 180 enables a full vacuum to be pulled on the interior 114 of the conduit body 112 without fear of the intersecting tube 170 collapsing.
  • the tool 180 to keep the intersecting tube 170 from collapsing may be sized to slip fit inside the interior 174 of the intersecting tube 170.
  • a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements.
  • a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features.
  • a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

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Abstract

L'invention concerne un conduit qui comprend un corps de conduit. Le corps de conduit a des première et seconde parties d'extrémité ouvertes opposées et un intérieur de conduit creux s'étendant entre celles-ci. L'intérieur de conduit est conçu pour recevoir un premier moignon de nerf par la première partie d'extrémité ouverte et un second moignon de nerf par la seconde partie d'extrémité ouverte pendant une procédure de réparation nerveuse sur un patient. Une structure de séparateur est positionnée à l'intérieur du conduit à l'intérieur du corps de conduit. La structure de séparateur est conçue pour fournir un espace de régénération prédéterminé entre les premier et second moignons de nerf insérés dans le conduit pendant la procédure de réparation nerveuse.
PCT/US2025/030605 2024-05-28 2025-05-22 Conduits pour une procédure de réparation nerveuse Pending WO2025250441A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463652239P 2024-05-28 2024-05-28
US63/652,239 2024-05-28

Publications (1)

Publication Number Publication Date
WO2025250441A1 true WO2025250441A1 (fr) 2025-12-04

Family

ID=97871120

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/030605 Pending WO2025250441A1 (fr) 2024-05-28 2025-05-22 Conduits pour une procédure de réparation nerveuse

Country Status (1)

Country Link
WO (1) WO2025250441A1 (fr)

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