Devices for in situ formed nerve caps and/or nerve wraps
Inventors
Bright, Corinne • Ren, Yong • Martin, Kenneth M. • Khosravi, Farhad • Sawhney, Amarpreet S.
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Assignees
Incept LLC • Tulavi Therapeutics Inc
Member
Tulavi TherapeuticsTulavi Therapeutics is a medical device company specializing in solutions for peripheral nerve surgery. The company focuses on developing absorbable hydrogel-based technologies to optimize nerve recovery, reduce the risk of neuroma formation, and improve patient outcomes. Its platform leverages in situ forming, sutureless biomaterials suitable for a variety of nerve injuries, addressing critical gaps in current surgical care. Tulavi is committed to innovation, clinical evidence, and accessibility for both adult and pediatric populations.
Tulavi Therapeutics is a medical device company specializing in solutions for peripheral nerve surgery. The company focuses on developing absorbable hydrogel-based technologies to optimize nerve recovery, reduce the risk of neuroma formation, and improve patient outcomes. Its platform leverages in situ forming, sutureless biomaterials suitable for a variety of nerve injuries, addressing critical gaps in current surgical care. Tulavi is committed to innovation, clinical evidence, and accessibility for both adult and pediatric populations.
Publication Number
US-11944717-B2
Publication Date
2024-04-02
Expiration Date
Abstract
Disclosed are methods, devices and materials for the in situ formation of a nerve cap and/or a nerve wrap to inhibit neuroma formation following planned or traumatic nerve injury. The method includes the steps of identifying a severed end of a nerve, and positioning the severed end into a cavity defined by a form. A transformable media is introduced into the form cavity to surround the severed end. The media is permitted to undergo a transformation from a first, relatively flowable state to a second, relatively non flowable state to form a protective barrier surrounding the severed end. The media may be a hydrogel, and the transformation may produce a synthetic crosslinked hydrogel protective barrier. The media may include at least one anti-regeneration agent to inhibit nerve regrowth.
Core Innovation
The invention relates to in situ formation of a nerve cap and/or a nerve wrap around a nerve to nerve junction in order to inhibit neuroma formation after nerve transection, trauma, or planned injury. A removable form confines a transformable flowable precursor that converts to a non-flowable, synthetic crosslinked hydrogel barrier around a nerve end and/or at a nerve-to-nerve junction.
The formed barrier is configured as a physical block against aberrant nerve regrowth and is designed with performance criteria including maintaining in vivo mechanical strength and persistence. The description emphasizes low swelling, small pore size/charge properties to prevent cellular infiltration, and durability metrics such as compressive strength and multi-month persistence.
The disclosed systems include geometries using a concave cavity with a top opening and side access features for positioning nerve ends away from a bottom interior surface, with internal spacing elements such as one or more posts. The in situ wrap can further incorporate anti-regeneration agents, including P2XR/P2X7 antagonists such as Brilliant Blue FCF (BBG/Brilliant Blue FCF) and Brilliant Blue G (BBG), and can be implemented with growth-permissive bridges combined with growth-inhibitory jackets to guide regeneration while inhibiting neuromas.
Claims Coverage
The document provides two independent claim sets, each focused on a form/device for creating an in situ wrap around a nerve to nerve junction, with core inventive elements for internal geometry, nerve-end spacing, stabilization, and a hydrogel kit composition with defined transformation and performance constraints. The independent claims contain four main inventive features across the two forms: concave cavity with top opening, side access nerve guides, elevated positioning to space nerve ends away from a bottom interior surface, and internal posts or stabilizing transverse support features.
Concave form cavity with top opening for wrap access
A form comprising a concave wall at least partially defining a cavity and a top opening for accessing the cavity, wherein the top opening has a first cross-sectional area less than a second cross-sectional area of the cavity.
Side access nerve guides positioning nerve ends away from the bottom interior surface
A first nerve guide comprising a first surface at least partially defining a first side access through the concave wall for positioning a first nerve end in the cavity, the first surface being on a first end of the form at a first elevated position relative to a bottom interior surface of the concave wall so that the first nerve end is spaced away from the bottom interior surface when positioned and at least partially within the cavity; and a second nerve guide comprising a second surface at least partially defining a second side access through the concave wall for positioning a second nerve end in the cavity, the second surface being on a second end of the form at a second elevated position relative to the bottom interior surface so that the second nerve end is spaced away from the bottom interior surface when positioned and at least partially within the cavity.
Internal posts to space the nerve end from the bottom interior surface
One or more posts positioned within the cavity, each configured to position a nerve end away from the bottom interior surface of the concave wall.
Stabilizing transverse support surface extending along or parallel to a tangent
At least one stabilizing feature configured to stabilize the form, the at least one stabilizing feature comprising a transverse support surface extending along or parallel to a tangent to the concave wall.
Across the independent claims, the inventive contribution is a removable form having a concave cavity with a top opening, paired side-access nerve guides that place respective nerve ends in elevated positions spaced away from a bottom interior surface, and either internal posts or transverse stabilizing support along or parallel to a tangent. The dependent claim coverage described in the provided family summary indicates additional limitations related to kit-based in situ forming hydrogel transformation and defined performance metrics.
Stated Advantages
Inhibits neuroma formation after nerve transection, trauma, or planned injury by physically blocking aberrant nerve regrowth.
Maintains in vivo mechanical strength and persistence through multi-month performance criteria and prevents cellular infiltration via small pore size/charge properties.
Minimizes swelling as reflected by swelling limits.
Documented Applications
In situ formation of a nerve wrap/cap to inhibit neuroma formation after nerve transection, trauma, or planned injury.
Use in guided regeneration using growth-permissive bridges plus growth-inhibitory jackets around nerve-to-nerve junctions.
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