Fiber-hydrogel composite surgical meshes for tissue repair
AssigneeThe Johns Hopkins University
InventorsRussell Martin, Sashank Reddy, Justin Sacks, Xiaowei Li, Brian Honewee Cho, Hai-Quan Mao
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Abstract
The presently disclosed composition and methods are provided for a hydrogel or nanofiber-hydrogel composite integrated with a surgical scaffold or mesh. A surgical scaffold device comprised of laminar composite is disclosed for the purpose of reducing foreign body response, managing tissue-materials interface, and improving the integration of the surgical mesh with the surrounding tissue of a subject.
Claims21
1-53. (canceled)
A method for manufacturing a surgical scaffold device comprising a laminar scaffold complex, the method comprising the steps of:
- a. mixing a hydrogel material with the polymeric fibers in the presence of an effective amount of a crosslinking moiety to form the scaffold complex, wherein at least a portion of the polymeric fibers are cross-linked to the hydrogel material,
- b. providing the scaffold complex comprising polymeric fibers oriented to comprise a plurality of pores,
- c. configuring the scaffold complex in a geometry suitable for implantation in an organ or tissue selected from skin, fascia, pleura, dura, pericardium, paratenon, periosteum, perineurium, blood vessel wall, and lymphatic wall;
- and
- d. configuring the scaffold complex as a sheet having a first dimension and a second dimension independently at least five times as great in length as a third dimension;
- whereby a surgical scaffold device is manufactured,
- wherein the polymeric fibers comprise functional groups, wherein the surface density of the functional groups is from about 10 nmole/mg of fibers to about 160 nmole/mg of the fibers,
- wherein the polymeric fibers comprise a mean diameter of from about 100 nm to about 8000 nm and a mean length of less than about 500 micrometers.
A method for manufacturing a surgical device comprising a laminar scaffold complex and a surgical mesh material, the method comprising the steps of:
- a. mixing a hydrogel material with the polymeric fibers in the presence of an effective amount of a crosslinking moiety to form the scaffold complex, wherein at least a portion of the polymeric fibers are cross-linked to the hydrogel material,
- b. providing a scaffold complex comprising polymeric fibers oriented to comprise a plurality of pores,
- c. configuring the scaffold complex in a geometry suitable for implantation in an organ or tissue selected from skin, fascia, pleura, dura, pericardium, paratenon, periosteum, perineurium, blood vessel wall, and lymphatic wall;
- d. configuring the scaffold complex as a sheet having a first dimension and a second dimension independently at least five times as great in length as a third dimension;
- and
- e. covalently linking a surgical mesh material to the laminar scaffold complex wherein the surgical mesh material is disposed over all or portion of the laminar scaffold complex,
- whereby a surgical device is manufactured,
- wherein the polymeric fibers comprise functional groups, wherein the surface density of the functional groups is from about 10 nmole/mg of fibers to about 160 nmole/mg of the fibers, and wherein the polymeric fibers comprise a mean diameter of from about 100 nm to about 8000 nm and a mean length of less than about 500 micrometers.
A method for performing a surgical procedure, a cosmetic procedure or a reconstructive procedure for the reinforcement and/or regeneration of one or more tissues including skin, fascia, pleura, dura, pericardium, paratenon, periosteum, perineurium, blood vessel wall, lymphatic wall, comprising implanting an effective amount of a surgical scaffold device comprising a laminar scaffold complex into the tissue to thereby distend it, wherein the scaffold complex is configured as a sheet, wherein the scaffold complex comprises a hydrogel network with polymeric fibers, wherein the scaffold complex comprises a crosslinking moiety present in an amount effective to introduce bonding within the hydrogel material,
- wherein the polymeric fibers are uniformly dispersed throughout the hydrogel network, wherein the polymeric fibers are covalently linked to a hydrogel material, and wherein the polymeric fibers are oriented to produce a plurality of pores.
Dependencies are inferred from the claim text.