Methods and devices for in situ formed nerve cap

Inventors

Bright, Corinne • Ren, Yong • Martin, Kenneth M. • Khosravi, Farhad • Sawhney, Amarpreet S.

Abstract

Disclosed are methods, devices and materials for the in situ formation of a nerve cap 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 provides a method of in situ formation of a nerve cap by identifying a severed end of a nerve and positioning the severed end into a cavity defined by a form. Media is introduced into the cavity to surround the severed end, and the media undergoes a transformation from a first, relatively flowable state to a second, relatively non flowable state within about 10 seconds to form a protective barrier surrounding the severed end.

The form is composed of a nondegradable material that can be removed from the surgical site after the media is transformed to the second, relatively non flowable state. The disclosure further relates to conforming nerve cap formation and related nerve wrap and junction constructs by placing the severed nerve end into a cavity defined by a form and introducing a flowable transformable media that becomes non-flowable to adhere to the nerve.

In embodiments, the transformable media includes a synthetic crosslinked hydrogel that transitions from flowable to non-flowable within seconds to form a protective barrier. The media can include optional anti-regeneration agents, and the disclosure includes dual-component constructs such as a growth-permissive hydrogel bridge together with a growth-inhibitory hydrogel jacket or capsule.

The disclosure further covers protective barrier persistence and mechanical strength, including target strength thresholds and in vivo persistence on the order of months. Form configurations can include nerve guides that maintain the severed end spaced apart from sidewalls of the form, and delivery can include needle/percutaneous delivery and open surgical delivery.

Claims Coverage

Independent claim clm-00001 is directed to an in situ method forming a nerve cap using a form-defined cavity, flowable-to-non-flowable transformable media, and removal of a nondegradable form after transformation. The independent claim contains three main inventive aspects.

Coverage centers on in situ formation of a protective nerve cap by transforming flowable media into a non-flowable protective barrier within about 10 seconds, using a cavity defined by a nondegradable form that is removable after transformation.

Stated Advantages

Documented Applications