# US 2019/0167840 A1 · Hemostatic flowable

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- Number: US 2019/0167840 A1
- Document ID: US20190167840A1
- Status: Published application
- Kind: A1
- Application number: 16/324,637
- Filed: 2017-08-11
- Published: 2019-06-06
- Earliest claimed: 2016-08-12
- Assignees: Biom'up
- Applicants: Biom'up
- Inventors: William SPOTNITZ; Valérie CENTIS; Doris MOURA CAMPOS; Alexia DE GASPERIS
- Web page: https://patentgrep.com/patent/US20190167840A1

## CPC

- A61L 26/0052: {Mixtures of macromolecular compounds}
- A61L 26/0066: {Medicaments; Biocides}
- A61L 26/008: {Hydrogels or hydrocolloids}
- A61L 2300/232: Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
- A61L 2300/236: Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
- A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2400/04: Materials for stopping bleeding
- A61L 2400/06: Flowable or injectable implant compositions
- 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)

## Abstract

The invention relates to a kit to prepare an hemostatic flowable comprising: —A hemostatic powder having a composition comprising: ∘non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen; ∘at least one monosaccharide; and ∘at least one glycosaminoglycan; —A saline solution to be mixed with the hemostatic powder in order to form the hemostatic flowable. The invention also relates to a method for preparing an hemostatic flowable with such a kit, comprising the steps of: a. Providing the hemostatic powder in a container; b. Adding a quantity of the saline solution in the container enclosing the hemostatic powder, closing and shaking said container in order to promote hydration of the hemostatic powder to form the hemostatic flowable.

## Claims

### Claim 1

A kit to prepare an hemostatic flowable comprising:
a hemostatic powder having a composition comprising:
non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen;
at least one monosaccharide; and
at least one glycosaminoglycan;
a saline solution to be mixed with the hemostatic powder in order to form the hemostatic flowable.

### Claim 2 (depends on 1)

The kit of claim 1, wherein in the composition of the hemostatic powder:
the collagen is in an amount ranging from 80% to 90% by weight relative to the total weight of the composition of the hemostatic powder;
the at least one monosaccharide is in an amount ranging from 1% to 12.5% by weight relative to the total weight of the composition of the hemostatic powder; and
the at least one glycosaminoglycan is in an amount ranging from 2% to 25% by weight relative to the total weight of the composition of the hemostatic powder.

### Claim 3 (depends on 1)

The kit of claim 1, wherein in the composition of the hemostatic powder:
the collagen is in an amount ranging from 80% to 90% by weight relative to the total weight of the composition of the hemostatic powder;
the at least one monosaccharide is in an amount ranging from 2.5% to 7.5% by weight relative to the total weight of the composition of the hemostatic powder; and
the at least one glycosaminoglycan is in an amount ranging from 5% to 12.5% by weight relative to the total weight of the composition of the hemostatic powder.

### Claim 4 (depends on 1)

The kit of claim 1, wherein in the composition of the hemostatic powder:
the collagen is in an amount ranging from 84% to 88% by weight relative to the total weight of the composition of the hemostatic powder;
the at least one monosaccharide is in an amount ranging from 4% to 6% by weight relative to the total weight of the composition of the hemostatic powder; and
the at least one glycosaminoglycan is in an amount ranging from 8% to 10% by weight relative to the total weight of the composition of the hemostatic powder.

### Claim 5 (depends on 1)

The kit of claim 1, wherein in the composition of the hemostatic powder, the at least one monosaccharide is glucose and the at least one glycosaminoglycan is chondroitin sulfate.

### Claim 6 (depends on 1)

The kit of claim 1, wherein in the composition of the hemostatic powder, the at least one glycosaminoglycan is chosen among chondroitin sulfate, dermatan sulfate, hyaluronic acid and mixtures thereof.

### Claim 7 (depends on 1)

The kit of claim 1, wherein the composition of the hemostatic powder further comprises at least one coagulation factor in an amount lower than 0.1% by weight relative to the total weight of the composition of the hemostatic powder.

### Claim 8 (depends on 7)

The kit of claim 7, wherein the coagulation factor is thrombin.

### Claim 9 (depends on 1)

The kit of claim 1, wherein the saline solution comprises distilled water and sodium chloride, wherein the sodium chloride is in an amount ranging from 0.5% to 1.5% by weight relative to the total weight of the saline solution, most preferably in an amount of 0.9% by weight relative to the total weight of the saline solution.

### Claim 10 (depends on 1)

The kit of claim 1, comprising between 1 g and 2 g of the hemostatic powder and 4 mL and 10 mL of saline solution.

### Claim 11 (depends on 1)

The kit of claim 1, wherein the mass of the saline solution is between 2 to 10 times of the mass of the hemostatic powder, and preferably between 4 to 5 times of the mass of the hemostatic powder.

### Claim 12 (depends on 1)

The kit of claim 1, wherein the hemostatic powder is enclosed in a dispenser having a container portion formed with bellows and a nozzle portion arranged on the container portion, wherein the nozzle portion has an opening for filing the container portion with the saline solution to be mixed with the hemostatic powder in order to form the hemostatic flowable.

### Claim 13 (depends on 12)

The kit of claim 12, wherein the container portion has a shape designed to promote hydration of the hemostatic powder with the saline solution in order to form the hemostatic flowable.

### Claim 14 (depends on 12)

The kit of claim 12, wherein the dispenser further comprises a cap designed to be removably coupled to the nozzle portion in order to close any opening to/from the container portion.

### Claim 15

A method for preparing an hemostatic flowable, comprising the steps of:
a. providing an hemostatic powder in a container, wherein said hemostatic powder has a composition comprising:
non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen;
at least one monosaccharide; and
at least one glycosaminoglycan;
b. adding a quantity of a saline solution in the container enclosing the hemostatic powder, closing and shaking said container in order to promote hydration of the hemostatic powder to form the hemostatic flowable.

### Claim 16 (depends on 15)

The method of claim 15, comprising a subsequent step c) wherein the container enclosing the hemostatic flowable is left to stand during a certain rest period.

### Claim 17 (depends on 15)

The method of claim 15, wherein in step b), the quantity of saline solution added in the container is between 50% and 100% of the quantity of the saline solution provided in a kit for forming an hemostatic flowable.

### Claim 18 (depends on 15)

The method of claim 15, wherein in step b), the quantity of saline solution added in the container is between 5 mL and 10 mL.

### Claim 19 (depends on 15)

The method of claim 15, wherein in step b), the quantity of saline solution added in the container is of 7 mL.

### Claim 20 (depends on 15)

The method of claim 15, wherein in step b), the container is shaken during between 10 seconds and 30 seconds.

### Claim 21 (depends on 15)

The method of claim 15, wherein in step b), the container is shaken during 20 seconds.

### Claim 22 (depends on 16)

The method of claim 16, wherein in step c), the rest period is at least of 30 seconds, preferably at least of 60 seconds, and even more preferably at least of 90 seconds.

### Claim 23 (depends on 16)

The method of claim 16, wherein in step c), the rest period is at least of 60 seconds.

### Claim 24 (depends on 16)

The method of claim 16, wherein in step c), the rest period is at least of 90 seconds.

### Claim 25 (depends on 16)

The method of claim 16, wherein in step c), the rest period is between 30 seconds and 120 seconds.

### Claim 26 (depends on 15)

The method of claim 15, wherein
in step a), a quantity of 1.65 mg of hemostatic powder is provided in the container;
in step b), the quantity of saline solution added in the container is of 7 mL and the container is shaken during 20 seconds.

### Claim 27

A kit to prepare an hemostatic flowable comprising:
a hemostatic powder having a composition comprising:
non-cross-linked collagen of the fibrillar type comprising a content of fibrous collagen and/or fibrillar collagen of at least 70% by weight relative to the total weight of the collagen;
at least one monosaccharide;
at least one glycosaminoglycan; and
at least one coagulation factor; and
a pure saline solution to be mixed with the hemostatic powder in order to form the hemostatic flowable.

### Claim 28 (depends on 2)

The kit of claim 2, wherein in the composition of the hemostatic powder, the at least one monosaccharide is glucose and the at least one glycosaminoglycan is chondroitin sulfate.

### Claim 29 (depends on 2)

The kit of claim 2, wherein the composition of the hemostatic powder further comprises at least one coagulation factor in an amount lower than 0.1% by weight relative to the total weight of the composition of the hemostatic powder.
