Implantable meshes for controlling the movement of fluids

Inventors

Norchi, Terrence • Kates, Steven • Ellis-Behnke, Rutledge

Assignees

Vivex Biologics Group Inc

Abstract

Meshes for use to control the movement of bodily fluids, such as blood, are described herein. The mesh can be partially or completely biodegradable or non-biodegradable. In one embodiment, the mesh is formed from one or more self-assembling peptides. The peptides can be in the form of fibers, such as nanofibers. The peptides can be assembled prior to formation of the mesh or after the mesh has been formed but before it is applied. Alternatively, the mesh can be prepared from unassembled peptides, which assemble at the time of application. The peptides can assemble upon contact with bodily fluids (e.g., blood) or can be contacted with an ionic solution to initiate assembly.

Core Innovation

A wound dressing is formed from woven or non-woven fibers of self-assembling peptides. The self-assembling peptides comprise a sequence of amino acid residues conforming to one or more of Formulas I-IV, in which amino acid residues are categorized by physiological charge as Xaa neu (neutral), Xaa+ (positive), and Xaa− (negative). Integer parameters x and y each have a value of 1, 2, 3, or 4 independently, and n is an integer having a value of 1-5.

The peptides are self-assembling in a nanofiber form and are used to control bodily fluid movement via an implantable mesh or patch/wound dressing structure. Assembly timing can occur before, during, or after application, and peptide assembly is triggered by contact with bodily fluids or ionic solutions, including monovalent cations. The peptide-based dressing can include protective, backing or support layers, and the support can be biodegradable or non-biodegradable.

Active agents can be incorporated in the self-assembling peptide dressing, including therapeutic, prophylactic, and diagnostic agents, such as antimicrobial and hemostatic agents, growth factors, and anesthetics, as well as indicators. Formulation and manufacturing approaches include peptide formulation into nanofiber forms and production approaches including electrospinning. In vivo hemostasis is demonstrated in a rat liver biopsy model with rapid bleeding cessation, including under clinically significant anticoagulation with heparin.

Claims Coverage

The document provides one independent claim directed to a peptide-fiber wound dressing and several dependent claims that refine peptide sequences, assembly triggering, functional barrier effects, and optional backing/support and agent choices. The independent claim contains four inventive peptide-sequence formula alternatives (Formulas I-IV) parameterized by physiological charge categories and integer values.

Overall, the claim set is centered on a wound dressing made from woven or non-woven fibers of self-assembling peptides with sequences defined by charge-based Formulas I-IV and integer parameters. Dependent claims further emphasize a barrier structure mechanism for inhibiting bodily fluid movement, ionic concentration-dependent assembly using Li+, Na+, K+, or Cs+, and optional backing/support layer material selections including named polymer options.

Stated Advantages

Documented Applications