Methods for in situ formed nerve cap with rapid release

Patent metadata

Field	Value
Publication number	US-2021361292-A1
Application number	US-202117388327-A
Country	US
Kind code	A1
Filing date	Jul 29, 2021
Priority date	Jul 2, 2018
Publication date	Nov 25, 2021
Grant 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.

First claim

What is claimed is:

1 . A method of forming a nerve wrap, the method comprising:
identifying a nerve; positioning the nerve at least partially within a form; introducing media into the form to at least partially surround the nerve; filling the media at least part way around the nerve; and permitting the media to form a protective barrier at least part way around the nerve.

2 . The method of claim 1 , wherein permitting the media to form the protective barrier comprises transforming the media from a first state to a second state to form the protective barrier, and wherein the media is less flowable when in the second state than when in the first state.

3 . The method of claim 1 , further comprising rapid releasing the protective barrier from the form, wherein a hydrophilic characteristic of the media and a hydrophobic characteristic of the form is configured to facilitate rapid release of the protective barrier from the form.

4 . The method of claim 1 , wherein permitting the media to form the protective barrier comprises forming the protective barrier in situ.

5 . The method of claim 1 , wherein the form comprises a first end, a second end, and a cavity extending between the first end and the second end, and wherein the first end and the second end are configured to receive the nerve therethrough.

6 . The method of claim 1 , wherein the media comprises a transformable growth permissive hydrogel precursor.

7 . The method of claim 6 , wherein the transformable growth permissive hydrogel precursor is configured to polymerize in situ to form the protective barrier.

8 . A method of forming a nerve conduit, the method comprising:
identifying a first nerve end of a first nerve and a second nerve end of a second nerve to be coated; positioning the first and second nerve ends into a cavity at least partially defined by a first form; introducing a growth permissive media into the cavity to surround a gap between the first and second nerve ends; and introducing a growth inhibitory media; and permitting the growth inhibitory media to form a protective barrier around the first and second nerve ends.

9 . The method of claim 8 , further comprising rapid releasing the protective barrier from the first form, wherein a hydrophilic characteristic of at least one of the growth permissive media or the growth inhibitory media and a hydrophobic characteristic of the first form is configured to facilitate rapid release of the protective barrier from the first form.

10 . The method of claim 8 , wherein permitting the growth inhibitory media to form the protective barrier comprises transforming the growth inhibitory media from a first state to a second state to form the protective barrier, and wherein the growth inhibitory media is less flowable when in the second state than when in the first state.

11 . The method of claim 8 , further comprising positioning the growth inhibitory media and the first and second nerve ends into a second cavity of a second form, wherein introducing the growth inhibitory media comprises introducing the growth inhibitory media into the second cavity of the second form such that the growth inhibitory media is delivered around the growth permissive media.

12 . The method of claim 8 , wherein at least one of the first nerve or the second nerve is from an allograft.

13 . The method of claim 8 , wherein at least one of the first nerve or the second nerve is only partially transected, and wherein introducing the growth permissive media comprises placing the growth permissive media in a region of a transected nerve.

14 . The method of claim 8 , wherein the first form comprises a first end and a second end such that the cavity extends between the first end and the second end, wherein the first end is configured to receive the first nerve therethrough, and wherein the second end is configured to receive the second nerve therethrough.

15 . The method of claim 8 , further comprising permitting the growth permissive media to form a conductive bridge between the first and second nerve ends

16 . The method of claim 15 , wherein the growth permissive media comprises a transformable growth permissive hydrogel precursor.

17 . The method of claim 16 , wherein the transformable growth permissive hydrogel precursor is configured to polymerize in situ to form the conductive bridge between the first nerve end and the second nerve end.

18 . The method of claim 15 , wherein permitting the growth permissive media to form the conductive bridge the growth permissive media comprises transforming the growth permissive media from a first state to a second state, and wherein the growth permissive media is less flowable when in the second state than when in the first state.

Assignees

• Tulavi Therapeutics Inc
• Incept Llc

Inventors

• Bright Corinne
• Ren Yong
• Martin Ken
• Khosravi Farhad
• Sawhney Amarpreet S

Classifications

• A61B17/12181 Primary

  formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices · CPC title

• A61B17/3201

  Scissors (for biopsy A61B10/02) · CPC title

• A61L2430/32

  for nerve reconstruction · CPC title

• A61B17/1128 Primary

  of nerves · CPC title

• A61F2/02

  Prostheses implantable into the body · CPC title