Methods for forming a nerve barrier

Patent metadata

Field	Value
Publication number	US-12096941-B2
Application number	US-202117388327-A
Country	US
Kind code	B2
Filing date	Jul 29, 2021
Priority date	Jul 2, 2018
Publication date	Sep 24, 2024
Grant date	Sep 24, 2024

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 protective barrier, the method comprising:
identifying a nerve;
positioning the nerve at least partially within a form, the form comprising a hydrophobic characteristic;
introducing a media into the form to surround the nerve, the media comprising a hydrophilic characteristic; 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,
wherein the shorter-term degradable hydrogel is configured to degrade over a term between about 1 hour and about 3 months, and
wherein the hydrophilic characteristic of the media and the hydrophobic characteristic of the form are configured to facilitate a rapid of the form and leave the protective barrier from the form.

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

3. 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.

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

5. The method of claim 4 , wherein the transformable growth permissive hydrogel precursor is configured to polymerize in situ to form the protective barrier.

6. A method of forming a nerve wrap, 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 defined by a first form;
introducing a growth permissive media into the cavity to surround a gap between the first and second nerve ends;
introducing a growth inhibitory media around the growth permissive media and the first and second nerve ends;
permitting the growth inhibitory media to form a protective barrier around the first and second nerve ends; 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.

7. The method of claim 6 , 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.

8. The method of claim 6 , 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.

9. The method of claim 6 , wherein at least one of the first nerve or the second nerve is from an allograft.

10. The method of claim 6 , 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.

11. The method of claim 6 , 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.

12. The method of claim 6 , further comprising permitting the growth permissive media to form a conductive bridge between the first and second nerve ends.

13. The method of claim 12 , wherein the growth permissive media comprises a transformable growth permissive hydrogel precursor.

14. The method of claim 13 , 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.

15. The method of claim 12 , wherein permitting the growth permissive media to form the conductive bridge 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.

16. The method of claim 15 , wherein the media comprises a first polymer having the first reactive group and a second polymer having the second reactive group.

17. The method of claim 1 , wherein the media comprising a first reactive group and a second reactive group, wherein permitting the media to form the protective barrier comprises permitting the first reactive group to crosslink to the second reactive group to transform the media from a first state to a second state, and wherein the media is less flowable when in the second state than when in the first state.

18. The method of claim 1 , wherein the media provides a compressive strength greater than 10 kPa.

19. The method of claim 6 , wherein the growth inhibitory media provides a compressive strength greater than 10 kPa.

20. The method of claim 1 , wherein the media is less flowable when in a second state than when in a first state, wherein the hydrophobic characteristic of the form is removable after the hydrophilic characteristic of the media is transformed from the first state to the second state.

21. The method of claim 1 , wherein the hydrophilic characteristic of the media further comprises at least one of:
a biodegradable or bioerodable polymer susceptible to hydrolysis, enzymatic, or oxidative degradation;
a multi-arm PEG-NHS ester;
or
a PEG-ester, preferably wherein a polyethylene glycol comprises a blend of two multi-arm polyethylene glycols, wherein the multi-arm polyethylene glycol comprises at least a 4-arm polyethylene glycol.

Assignees

• Tulavi Therapeutics Inc
• Incept Llc

Inventors

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

Classifications

• A61F2/0059

  Cosmetic or alloplastic implants (A61F2/10 - A61F2/16, A61F2/28 take precedence) · CPC title

• A61F2/02

  Prostheses implantable into the body · CPC title

• A61L27/52

  Hydrogels or hydrocolloids · CPC title

• A61F2/08

  Muscles; Tendons; Ligaments · CPC title

• A61L2430/32

  for nerve reconstruction · CPC title