# US 10,869,907 B2 · Implantable meshes for controlling the movement of fluids

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- Number: US 10,869,907 B2
- Document ID: US10869907B2
- Status: Granted
- Kind: B2
- Application number: 16/394,990
- Filed: 2019-04-25
- Published: 2019-08-15
- Granted: 2020-12-22
- Earliest claimed: 2013-08-22
- Assignees: Arch Biosurgery, Inc.
- Applicants: Arch Biosurgery, Inc.
- Inventors: Terrence Norchi; Steven Kates; Rutledge Ellis-Behnke
- Web page: https://patentgrep.com/patent/US10869907B2

## CPC

- A61K 38/10: Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 9/70: Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 38/02: Peptides of undefined number of amino acids; Derivatives thereof
- A61L 15/32: Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin {(A61L15/225 takes precedence)}
- A61L 26/0028: {Polypeptides; Proteins; Degradation products thereof}
- A61L 26/0047: {Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042}
- A61L 27/22: Polypeptides or derivatives thereof {, e.g. degradation products}
- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 31/043: {Proteins; Polypeptides; Degradation products thereof}
- A61L 31/047: {Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046}
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 1

A wound dressing formed from woven or non-woven fibers of self-assembling peptides,
wherein the self-assembling peptides comprise a sequence of amino acid residues conforming to one or more of Formulas I-IV:
((Xaaneu−Xaa+)x(Xaaneu−Xaa−)y)n (I);
((Xaaneu−Xaa−)x(Xaaneu−Xaa+)y)n (II);
((Xaa+−Xaaneu)x(Xaa−−Xaaneu)y)n (III);
((Xaa−−Xaaneu)x(Xaa+−Xaaneu)y)n (IV);
wherein Xaaneu represents an amino acid residue having a neutral charge under physiological conditions; Xaa+ represents an amino acid residue having a positive charge under physiological conditions; Xaa− represents an amino acid residue having a negative charge under physiological conditions; x and y are integers having a value of 1, 2, 3, or 4, independently; and n is an integer having a value of 1-5.

### Claim 2 (depends on 1)

The wound dressing of claim 1, wherein all of the self-assembling peptides have the same size and amino acid sequence.

### Claim 3 (depends on 1)

The wound dressing of claim 1 further comprising a non-peptide material.

### Claim 4 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing is partially or completely biodegradable.

### Claim 5 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing further comprises one or more therapeutic, prophylactic, or diagnostic agents.

### Claim 6 (depends on 5)

The wound dressing of claim 5, wherein the one or more therapeutic, prophylactic, or diagnostic agents are selected from the group consisting of hemostatic agents, anti-infectives, growth factors, cells, anesthetics, vasoconstrictors, and a combination thereof.

### Claim 7 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing forms a barrier structure that inhibits or prevents passage of bodily fluid through the structure upon contact with a bodily fluid at an exposed wound site of a subject.

### Claim 8 (depends on 1)

The wound dressing of claim 1 further comprising a pH-adjusting agent.

### Claim 9 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing is prepared by a method selected from the group consisting of microfluidics, injection molding, stamping, templating onto a surface having a desired shape, electrospinning, freezing of a powder, freezing of a solution, coating of a solid substrate, and combinations thereof.

### Claim 10 (depends on 9)

The wound dressing of claim 9, wherein the wound dressing is prepared by electrospinning a stock solution of the self-assembling peptides comprising a concentration of less than 5 mM Li+, Na+, K+ or Cs+ ions.

### Claim 11 (depends on 1)

A method for inhibiting or preventing the movement of bodily fluids in a subject, the method comprising applying the wound dressing of claim 1 to a wound on or within the subject,
wherein the self-assembling peptides assemble to form a barrier structure that inhibits or prevents the movement of bodily fluids through the dressing.

### Claim 12 (depends on 11)

The method of claim 11, wherein the bodily fluid is blood.

### Claim 13 (depends on 11)

The method of claim 11, wherein the subject suffers from a primary, secondary, or acquired bleeding/coagulation/clotting disorder.

### Claim 14 (depends on 11)

The method of claim 11, wherein the self-assembling peptides are assembled immediately prior to, during or after application of the mesh wound dressing.

### Claim 15 (depends on 14)

The method of claim 14, wherein assembly is induced by contacting the wound dressing with a solution having a concentration of greater than 5 mM Li+, Na+, K+ or Cs+ ions.

### Claim 16 (depends on 14)

The method of claim 14, wherein assembly is induced by contacting the dressing with one or more bodily fluids present at the wound.

### Claim 17 (depends on 11)

The method of claim 11, wherein the wound is a site of traumatic injury or surgery of an organ selected from the brain, liver, stomach, intestine, skin, lung, and heart.

### Claim 18 (depends on 11)

The method of claim 11, wherein the wound is on or within a diseased or damaged tissue.

### Claim 19 (depends on 11)

The method of claim 11, wherein the wound is a burn or other wound to the skin, an ulcer, or a canker sore.

### Claim 20 (depends on 11)

The method of claim 11, wherein the wound dressing biodegrades over a period of 1 day to 8 weeks following application.

### Claim 21 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing is multilayered.

### Claim 22 (depends on 21)

The wound dressing of claim 21, wherein the different layers comprise self-assembling peptides having distinct sequences or sizes.

### Claim 23 (depends on 21)

The wound dressing of claim 21, wherein the wound dressing comprises a protective, backing or support layer.

### Claim 24 (depends on 23)

The wound dressing of claim 23, wherein the protective, backing or support layer comprises an adhesive bandage, an adhesive strip, a non-adhesive, a film, a micro-porous substrate, or a sponge.

### Claim 25 (depends on 23)

The wound dressing of claim 23, wherein the protective, backing or support layer comprises poly(L-lactic acid co-ε-caprolactone) (PLCL), poly(DL-lactic acid) (PDLA), poly(lactic-co-glycolicacid) (PLGA), poly(ethylene oxide) (PEO), poly(vinyl alcohol) (PVA), poly (methyl methacrylate) (PMMA), poly(ethylene-co-vinyl acetate) (PEVA), polystyrene, polyurethane, poly(L-lactic acid) (PLLA), polylactic acid (PLA), or mixtures thereof.

### Claim 26 (depends on 1)

The wound dressing of claim 1, wherein the wound dressing is solid, semi-solid, or a gel.