IP Library Granted Patent US 11,052,172
Granted Patent B2
US 11,052,172 · App. 16/324,637 · Granted Jul 6, 2021

Hemostatic flowable

Inventors: William Spotnitz (Gainesville, FL); Valérie Centis (Lyons, FR); Doris Moura Campos (Bourgoin Jallieu, FR); Alexia De Gasperis (Saint Genis Laval, FR)
Assignee: BIOM'UP FRANCE SAS
A61L26/0052A61L26/008A61L26/0066A61L2300/232A61L2300/236A61L2300/252A61L2300/418A61L2400/04A61L2400/06
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Quick Facts
Patent No.
US 11,052,172
App. No.
16/324,637
Granted
Jul 6, 2021
Kind
B2
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 (60)

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 component which makes the hemostatic flowable, wherein said component consists of a saline solution to be mixed with the hemostatic powder.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. A method for preparing an hemostatic flowable using the kit of claim 1 , comprising the steps of:

a. providing the hemostatic powder of the kit in a container;

b. adding a quantity of the saline solution to the container and closing and shaking said container to promote hydration of the hemostatic powder to form the hemostatic flowable.

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

17. 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 the kit for forming an hemostatic flowable.

18. 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.

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

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

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

22. 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.

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

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

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

26. 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.

27. 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.

28. 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.

29. A kit to prepare an hemostatic flowable comprising:

a hemostatic powder having a composition comprising:

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 component which makes the hemostatic flowable, wherein said component consists of a saline solution to be mixed with the hemostatic powder,

wherein the hemostatic flowable has a viscosity of 20 Pa·s to 10000 Pa·s when the hemostatic powder is mixed with the saline solution.

30. 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 component which makes the hemostatic flowable, wherein said component consists of a saline solution to be mixed with the hemostatic powder,

wherein the hemostatic flowable has a viscosity of 20 Pa·s to 10000 Pa·s when the hemostatic powder is mixed with the saline solution.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 25, 2023
From: BIOM'UP FRANCE SAS
To: DILON TECHNOLOGIES INC.
Reel/Frame 063779/0436 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 12, 2021
From: BIOM'UP
To: BIOM'UP FRANCE SAS
Reel/Frame 055292/0061 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 11, 2019
From: SPOTNITZ, WILLIAM; CENTIS, VALÉRIE; MOURA CAMPOS, DORIS; DE GASPERIS, ALEXIA
To: BIOM'UP
Reel/Frame 048858/0753 →
Priority Claims (1)
EP 16184119 · Aug 12, 2016 · regional
Continuity (1)
Related Publication 20190167840A1 · Jun 6, 2019