# US 11,896,732 B2 · Compacted hemostatic cellulosic aggregates

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- Number: US 11,896,732 B2
- Document ID: US11896732B2
- Status: Granted
- Kind: B2
- Application number: 17/559,372
- Filed: 2021-12-22
- Published: 2022-06-16
- Granted: 2024-02-13
- Earliest claimed: 2015-11-06
- Assignees: Cilag GmbH International
- Applicants: Cilag GmbH International
- Inventors: Yi-Lan Wang
- Web page: https://patentgrep.com/patent/US11896732B2

## CPC

- A61L 26/0023: {Polysaccharides}
- A61L 15/24: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof {(A61L15/225 takes precedence)}
- A61L 26/0061: {Use of materials characterised by their function or physical properties}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- D01D 5/426: {by cutting films}
- A61L 2400/04: Materials for stopping bleeding
- 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
- D01D: MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS

## Abstract

The present invention is directed to a hemostatic material comprising a compacted, hemostatic aggregates of cellulosic fibers. In some aspects, the hemostatic material further includes additives, such as carboxymethyl cellulose (CMC) or other polysaccharides, calcium salts, anti-infective agents, hemostasis promoting agents, gelatin, collagen, or combinations thereof. In another aspect, the present invention is directed to a method of making the hemostatic materials described above by compacting a cellulosic-based material into hemostatic aggregates. In another aspect, the present invention is directed to a method of treating a wound by applying hemostatic materials described above onto and/or into the wound of a patient.

## Claims

### Claim 1

A method of treating a wound comprising applying a plurality of hemostatic aggregates onto and/or into the wound of a patient, wherein the plurality hemostatic aggregates are made by a method of making comprising the steps of:
a) milling a cellulosic source material to form fibers;
b) humidifying the fibers to water content of between 11.0% and 20% by weight;
c) roller compacting the fibers to form hemostatic aggregates;
d) sieving the hemostatic aggregates;
e) dehumidifying the hemostatic aggregates to a moisture content of less than 5.5% determined by loss on drying; and
f) optionally dosing the resulting hemostatic aggregates into storage containers or into delivery devices.

### Claim 2 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the step a) is preceded by a step of slitting and cutting the cellulosic source material forming pieces acceptable for milling in step a).

### Claim 3 (depends on 2)

The method of treating of claim 2, wherein for the method of making, the step a) is a two-part process wherein the second part is performed in an air classifier or ball mill process.

### Claim 4 (depends on 2)

The method of treating of claim 2, wherein for the method of making the second part is repeated three times.

### Claim 5 (depends on 4)

The method of treating of claim 4, wherein for the method of making the fibers comprise intermediate fine fibers that have a size distribution of d50 less than about 100 microns and d90 of less than about 180 microns.

### Claim 6 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the fibers comprise intermediate fine fibers, and in step b) the intermediate fine fibers are humidified to water content of between 11.0% and 20% by weight.

### Claim 7 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the fibers comprise intermediate fine fibers, and said step c) is performed by compacting the intermediate fine fibers into a compacted material which is then subjected to pre-breaking, followed by a step of final milling.

### Claim 8 (depends on 7)

The method of treating of claim 7, wherein for the method of making, said compacting of the intermediate fine fibers is performed at a roller pressure of at least 125 bars.

### Claim 9 (depends on 7)

The method of treating of claim 7, wherein for the method of making, said compacting the intermediate fine fibers is performed at a roller force of at least 26.0 kN/cm.

### Claim 10 (depends on 1)

The method of treating of claim 1, wherein for the method of making, said step d) is performed to select a targeted hemostatic aggregates fraction having dimensions of 75-300 μm by screen sieving.

### Claim 11 (depends on 1)

The method of treating of claim 1, wherein for the method of making, said step d) is performed to select a targeted hemostatic aggregates fraction characterized by a size distribution such that d15 is greater than or equal to 80 microns, d50 is from 140 to 250 microns and d90 is less than or equal to 370 microns.

### Claim 12 (depends on 11)

The method of treating of claim 11, wherein for the method of making, said step e) is performed to produce hemostatic aggregates having moisture content of less than 2% determined by loss on drying.

### Claim 13 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the source material is oxidized regenerated cellulosic fabric, oxidized regenerated cellulose non-woven fabric, shredded oxidized regenerated cellulosic material or combinations thereof.

### Claim 14 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the source material further comprises an additive selected from the group consisting of carboxymethyl cellulose, calcium salt, gelatin, collagen and combinations thereof.

### Claim 15 (depends on 1)

The method of treating of claim 1, wherein the fibers comprise intermediate fine fibers, and wherein the method of making further comprises a step of admixing an additive prior to step a), or prior to step b) by admixing the additive to the intermediate fine fibers; or prior to step c) by admixing the additive to the humidified intermediate fine fibers; or prior to step e) by admixing the additive to hemostatic aggregates prior to drying or prior to step f) by admixing the additive to hemostatic aggregates prior to dosing.

### Claim 16 (depends on 1)

The method of treating of claim 1, wherein for the method of making, the source material further comprises an additive selected from the group consisting of an anti-infective agent, a hemostasis promoting agent and combinations thereof.
