Use of a biological material containing three-dimensional scaffolds of hyaluronic acid derivatives for the preperation of implants in arthroscopy and kit for instruments for implanting said biological material by arthroscopy

• US 20040044416A1
• Filed: 06/27/2003
• Published: 03/04/2004
• Est. Priority Date: 12/28/2000
• Status: Active Grant

• Current Assignee: Anika Therapeutics Incorporated
• Original Assignee: Fidia Advanced Biopolymers S.R.L. (Anika Therapeutics Incorporated)
• Inventors: Callegaro, Lanfranco, Di Fede, Sergio, Marcacci, Maurilio
• Granted Patent: US 7,722,616 B2
• Time in Patent Office: Days
• US Class Current: 623/23.76
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

Use of a biological material containing cells supported on three-dimensional scaffolds containing at least one hyaluronic acid derivative for the preparation of grafts suitable for application by arthroscopy, and a kit of surgical instruments for implanting said biological material by arthroscopy.

Claims

1. Use of a biological material containing cells supported on three-dimensional scaffolds, said scaffolds comprising at least one hyaluronic acid derivative for the preparation of autologous and/or allogenic grafts suitable for implantation by arthroscopic techniques.

2. The use according to claim 1, wherein said autologous and/or allogenic cells are chosen from the group consisting of chondrocytes, osteocytes, mesenchymal and stem cells.

3. The use according to anyone of claims 1-2, wherein said three-dimensional scaffolds further comprise natural, semisynthetic or synthetic polymers.

4. The use according to claim 3, wherein said natural polymers are chosen from the group consisting of collagen, coprecipitates of collagen and glycosaminoglycans, cellulose, polysaccharides in the form of gels such as chitin, chitosan, pectin or pectic acid, agar, agarose, xanthane, gellan, alginic acid or alginates, polymannan or polyglycans, starch and natural gums.

5. The use according to claim 3, wherein said semisynthetic polymers are chosen from the group consisting of collagen crosslinked with agents such as aldehydes or precursors thereof, dicarboxylic acids or their halides, diamines, derivatives of cellulose, hyaluronic acid, chitin or chitosan, gellan, xanthane, pectin or pectic acid, polyglycans, polymannan, agar, agarose, natural gum or glycosaminoglycans.

6. The use according to claim 3, wherein said synthetic polymers are chosen from the group consisting of polylactic acid, polyglycolic acid, copolymers or derivatives thereof, polydioxanes, polyphosphazenes, polysulphonic resins, polyurethanes and PTFE.

7. The use according to anyone of claims 1-6 wherein said hyaluronic acid derivatives are selected form the group consisting of:

i) esters of hyaluronic acid wherein part or all of the carboxy functions are esterified with alcohols of the aliphatic, aromatic, arylaliphatic, cycloaliphatic or heterocyclic series;

ii) crosslinked esters of hyaluronic acid wherein part or all of the carboxy functions are esterifed with the alcoholic functions of the same polysaccharide chain or other chains;

iii) crosslinked esters of hyaluronic acid wherein part or all of the carboxy functions are esterified with polyalcohols of the aliphatic, aromatic, arylaliphatic, cycloaliphatic, heterocyclic series, generating crosslinking by means of spacer chains;

iv) wherein said hyaluronic acid derivative is chosen from the hemiesters of succinic acid or heavy metal salts of the hemiesters of succinic acid with hyaluronic acid or partial or total esters of hyaluronic acid;

v) O-sulphated or N-sulphated derivatives of hyaluronic acid,

vi) a quaternary ammonium salt of hyaluronic acid or the derivatives thereof chosen from the group consisting of O-sulphated or N-sulphated derivatives of hyaluronic acid or hemiesters of succinic acid with hyaluronic acid possibly partially salified with heavy metals;

vii) O-sulphated or N-sulphated hyaluronic acid and the derivatives thereof covalently bound to polyurethane;

8. The use according to anyone of claims 1-7 wherein said three-dimensional scaffolds consist of at least one hyaluronic acid derivative.

9. The use according to claim 8, wherein said scaffolds are in the form of a non woven fabric.

10. The use according to claim 8 wherein said scaffolds are in meshes form.

11. The use according to claim 8, wherein said scaffolds are in the form of unperforated membranes.

12. The use according to claim 8, wherein said scaffolds are in the form of perforated membranes.

13. The use according to claim 8, wherein said scaffolds are in the form of sponges.

14. The use according to anyone of claims 1-13, in association with pharmaceutically or biologically active ingredients.

15. Use of a biological material according to anyone of claims 1-3, wherein said biological material has previously been cryopreserved in order to pr serve th characteristics of cell viability ready for grafts to be performed at a future tim.

16. A kit of surgical instruments for implanting by arthroscopic surgery:

α

) the biological material whose use is claimed in anyone of claims 1-15 or

β

) a biological material containing cells grown on three-dimensional-bio-engineered scaffolds free from hyaluronic acid derivatives

said kit comprising;

a) a sterilisation tray;

b) a cannula (5) with relative sterile valves used as a guide in arthroscopy giving access to the instruments listed hereafter;

c) a mapper-sampler (1) constituted by a hollow tube, used to circumscribe the lesion creating a circular imprint and at the same time to take a piece of cartilage tissue in the same circular shape and of the same dimensions as the imprint;

d) a guide wire (3) that is fixed by means of a drill to the centre of the lesion to guarantee stability to the cutter-abrasor (4) while it is in action;

e) a cutter-abrasor (4) to create within the margins of the imprint made by the mapper-sampler (1) the site in which the biological material (a) or the biological material (p) will subsequently be implanted;

f) a hollow plunger (2) that is introduced inside the mapper (1) to push;

the biological material, the biological material (α

) or the biological material (β

) into the previously prepared lesion.

17. The kit according to claim 16 wherein the mapper-sampler (1) is hollow so that the plunger can be inserted into it, it has a concave tip that adheres to the circular surface of the joint and has a control system by which the pressure exercised by the advancing plunger can be interrupted.

18. The kit according to claim 16, wherein the plunger (2) is a hollow cylinder large enough to hold a guide wire and that it has a concave tip like the mapper.

19. The kit according to claim 16, the blades of the cutter (4) are concave so that they produce convex surfaces.

20. The kit according to claim anyone of claims 16-19, wherein the cells of said biological material (p) are autologous and/or allogenic and are chosen from the group consisting of chondrocytes, osteocytes, mesenchymal and stem cells.

21. The kit according to anyone of claims 16-19 wherein the three-dimensional scaffold of the biological material (β

) contain natural, semisynthetic or synthetic polymers.

22. The kit according to claim 21 wherein said natural polymers are chosen from the group consisting of collagen, coprecipitates of collagen and glycosaminoglycans, cellulose, polysaccharides in the form of gels such as chitin, chitosan, pectin or pectic acid, agar, agarose, xanthane, gellan, alginic acid or alginates, polymannans or polyglycans, starch or natural gums.

23. The kit according to claim 21 wherein said semisynthetic polymers are chosen from the group consisting of collagen crosslinked with agents such as aldehydes or precursors thereof, dicarboxylic acids or their halides, diamines, derivatives of cellulose, hyaluronic acid, chitin or chitosan, gellan, xanthane, pectin or pectic acid, polyglycans, polymannan, agar, agarose, natural gum and glycosaminoglycans.

24. The kit according to claim 21 wherein said synthetic polymers are chosen from the group consisting of polylactic acid, polyglycolic acid, copolymers or derivatives thereof, polydioxanes, polyphosphazenes, polysulphonic resins, polyurethane and PTFE.

25. The kit according to anyone of claims 16-24 wherein said biological material (p) further comprises pharmaceutically or biologically active ingredients.

26. The kit according to claim 25, wherein said pharmaceutically or biologically active ingredients are chosen from the group consisting of anti-inflammatory agents, antibiotics, growth factors, antimicotics and antiviral agents.

27. The kit according to anyone of claims 16-26 wherein said biological material (β

) has been cryopreserved in order to maintain its characteristics of cell viability in view of future grafts to be performed by arthroscopy.