Methods for forming a nerve barrier
Inventors
Bright, Corinne • Ren, Yong • Martin, Ken • 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-12096941-B2
Publication Date
2024-09-24
Expiration Date
Abstract
Disclosed are methods, devices and materials for the in situ formation of an implant for treating a nerve. A treatment site on a nerve is positioned within a cavity defined by a form. A transformable media is introduced into the form cavity to surround the treatment site. 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 treatment site. The implant may be a growth inhibiting nerve cap to inhibit neuroma formation following planned or traumatic nerve injury, a growth permissive conduit for facilitating reconnection of a severed nerve, or an anchor for stabilizing a pain management electrode with respect to a nerve. Access to the nerve treatment site may be open surgical or percutaneous.
Core Innovation
The invention provides methods of forming a protective barrier by identifying a nerve, positioning the nerve at least partially within a form having a hydrophobic characteristic, and introducing a media with a hydrophilic characteristic to surround the nerve. The media is permitted to form a protective barrier at least part way around the nerve, and the media is a shorter-term degradable hydrogel configured to degrade over a term between about 1 hour and about 3 months.
The hydrophilic characteristic of the media and the hydrophobic characteristic of the form are configured to facilitate rapid removal of the form and leave the protective barrier from the form. In related configurations, the protective barrier is formed while the media transforms from a first state to a second state, with reduced flowability in the second state.
The invention also provides a method of forming a nerve wrap by identifying a first nerve end and a second nerve end, positioning the ends into a cavity defined by a first form, and introducing growth permissive media into the cavity to surround a gap between the nerve ends. Growth inhibitory media is introduced around the growth permissive media and the nerve ends and is permitted to form a protective barrier around the nerve ends, and the growth permissive media is removed after the growth inhibitory media is transformed from a first state to a second state.
Claims Coverage
The material includes two independent claims. The core inventive features center on a hydrophobic form with a hydrophilic, shorter-term degradable hydrogel for rapid form removal, and a growth permissive/growth inhibitory nerve wrap architecture with state-dependent reduced flowability.
Hydrophobic form with hydrophilic shorter-term degradable hydrogel barrier
Positioning an identified nerve at least partially within a form having a hydrophobic characteristic, introducing a hydrophilic media to surround the nerve, and permitting the media to form a protective barrier at least part way around the nerve, wherein the media is a shorter-term degradable hydrogel configured to degrade over a term between about 1 hour and about 3 months.
Rapid form removal via coordinated hydrophilic/hydrophobic characteristics
Coordinating the hydrophilic characteristic of the media with the hydrophobic characteristic of the form to facilitate rapid removal of the form and leave the protective barrier from the form.
Growth-permissive/growth-inhibitory nerve wrap with state-dependent flowability
Identifying first and second nerve ends to be coated, positioning the ends into a cavity defined by a first form, introducing growth permissive media into the cavity to surround a gap, introducing growth inhibitory media around the growth permissive media and the nerve ends to form a protective barrier, and removing the growth permissive media after the growth inhibitory media is transformed from a first state to a second state, wherein the growth inhibitory media is less flowable when in the second state than when in the first state.
Overall, the independent claims cover forming a protective barrier using a hydrophobic form and a hydrophilic, shorter-term degradable hydrogel with coordinated characteristics for rapid form removal, and forming a nerve wrap using growth permissive and growth inhibitory media in which the protective barrier forms via transformation to a less flowable second state.
Stated Advantages
Prevents neuroma formation and aberrant nerve regeneration by forming protective barriers around nerve structures.
Supports nerve regeneration when desired.
Provides reduced compression through low swelling characteristics.
Provides in vivo persistence (months) and mechanical strength such as compressive strength greater than 10 kPa.
Documented Applications
In situ formation of protective nerve caps and nerve wraps using open or percutaneous access.
Forming nerve conduits and dual-component constructs with a growth-permissive bridge encapsulated by a growth-inhibitory jacket.
Peripheral nerve stimulation (PNS) electrode anchoring using electrically conductive in situ hydrogels anchored around an electrode and the nerve.
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