# US 12,214,106 B2 · Compositions comprising silk fibroin particles and uses thereof

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- Number: US 12,214,106 B2
- Document ID: US12214106B2
- Status: Granted
- Kind: B2
- Application number: 18/179,777
- Filed: 2023-03-07
- Published: 2023-11-09
- Granted: 2025-02-04
- Earliest claimed: 2016-10-31
- Assignees: Sofregen Medical, Inc.
- Applicants: Sofregen Medical, Inc.
- Inventors: Anh Hoang-Lindsay; Christopher P. Gulka; Jodie E. M. Giordano; Joseph E. Brown; Thomas L. Carroll
- Web page: https://patentgrep.com/patent/US12214106B2

## CPC

- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/26: Mixtures of macromolecular compounds
- A61L 27/502: {Plasticizers}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- C08K 5/0016: {Plasticisers}
- C08K 5/053: Polyhydroxylic alcohols
- C08L 5/08: Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
- C08L 89/00: Compositions of proteins; Compositions of derivatives thereof
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/34: for soft tissue reconstruction
- 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)
- C08K: Use of inorganic or non-macromolecular organic substances as compounding ingredients (paints, inks, varnishes, dyes, polishes, adhesives C09)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

Various aspects described herein relate to compositions comprising silk fibroin particles and methods of using the same, as well as devices and methods of delivering such compositions. The compositions described herein are suitable for injection into a site of defect in a soft tissue to provide bulking and/or augmentation effect to the soft tissue.

## Claims

### Claim 1

An injectable composition comprising:
crosslinked hyaluronic acid; and
silk fibroin particles having an average particle size of about 50 um to about 1000 um, wherein:
the crosslinked hyaluronic acid has a crosslink density of about 4 mol % to about 30 mol %,
the crosslinked hyaluronic acid has a concentration in the injectable composition of greater than or equal to about 1% (w/v) and less than or equal to about 10% (w/v),
the silk fibroin particles are hydrated, and
the silk fibroin particles have an average hydrated density of about 0.4 g/mL particles to about 1 g/mL particles.

### Claim 2 (depends on 1)

The injectable composition of claim 1, wherein the crosslinked hyaluronic acid and the silk fibroin particles are present in a volume ratio of between about 80:20 to about 40:60, the average particle size of the silk fibroin particles is between about 200 um to about 600 um, and the average extrusion force of the composition through a 18-21 gauge needle is about 40 N or lower.

### Claim 3 (depends on 1)

The injectable composition of claim 1, wherein the crosslinked hyaluronic acid and the silk fibroin particles are present in a volume ratio of between about 70:30 to about 30:70, the average particle size of the silk fibroin particles is less than about 200 um, and the average extrusion force of the composition through a 21-30 gauge needle is about 40 N or lower.

### Claim 4 (depends on 1)

The injectable composition of claim 1, wherein the silk fibroin particles are porous.

### Claim 5 (depends on 4)

The injectable composition of claim 4, wherein the porous silk fibroin particles have a porous structure characterized by interconnected pores having an average pore size of about 20 um to about 100 um.

### Claim 6 (depends on 4)

The injectable composition of claim 4, wherein the porous silk fibroin particles have an average porosity of at least about 90%.

### Claim 7 (depends on 1)

The injectable composition of claim 1, wherein the hyaluronic acid, prior to crosslinking, has a weight average molecular weight of about 200 kDa to about 1 MDa.

### Claim 8 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition is pre-loaded in a syringe.