CONTAINMENT SYSTEM FOR DELIVERY OF BIOLOGICAL PRODUCTS AND METHOD OF SURGERY

• US 20090060975A1
• Filed: 08/26/2008
• Published: 03/05/2009
• Est. Priority Date: 08/27/2007
• Status: Active Grant

• Current Assignee: Arthrex Incorporated
• Original Assignee: Arthrex Incorporated
• Inventors: Teets, J. Maxwell, Schaneville, Tara L., Bare, Christopher
• Granted Patent: US 9,101,688 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 35/14 Blood; Artificial blood perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42
• CPC Class Codes: A61K 35/16 Blood plasma; Blood serum umbilical cord blood A61K35/51
• CPC Class Codes: A61K 35/19 Platelets; Megacaryocytes
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3616 Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/3654 Cartilage, e.g. meniscus
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

Methods and systems for delivering biological products such as bone marrow aspirate (BMA) to different surgical sites during surgery (for example, arthroscopic surgery). The biological product is encapsulated or contained within a containment system comprising a carrier such as collagen carrier. The containment system may be formed of water soluble polymers, either natural, synthetic or semisynthetic, provided into films that may be made or molded into various shapes and sizes, and that may be manipulated to confer specific properties (such as solubility or degradation rates according to a specific environment, for example) of such films. The water soluble films may be processed into capsules, packets or other containers.

Claims

1. A delivery system for delivery of biological products to an arthroscopic site, the delivery system comprising a containment system and a carrier for at least one biological product, the carrier being encapsulated or contained within the containment system.

2. The delivery system of claim 1, wherein the containment system is a capsule, a packet or a container.

3. The delivery system of claim 2, wherein the containment system is a capsule comprising a water soluble film.

4. The delivery system of claim 3, wherein the water soluble film is a starch or a polymer system.

5. The delivery system of claim 4, wherein the water soluble film is selected from the group consisting of polyvinyl alcohol, pectin, hydroxypropylmethyl cellulose, carboxymethyl cellulose, polysaccharide polymer, carrageenan, xanthan gum and alginate.

6. The delivery system of claim 1, wherein the containment system is a gelatin capsule.

7. The delivery system of claim 1, wherein the at least one biological product is selected from the group consisting of blood, blood components, platelet rich plasma, autologous conditioned plasma, and bone marrow aspirate.

8. The delivery system of claim 1, wherein the at least one biological product comprises bone marrow aspirate.

9. The delivery system of claim 1, wherein the at least one biological product consists essentially of bone marrow aspirate.

10. The delivery system of claim 1, wherein the carrier is a collagen matrix.

11. The delivery system of claim 10, wherein the carrier is a fibrillar collagen sponge.

16. The delivery system of claim 1, wherein the blood components are selected from the group consisting of blood, bone marrow aspirate, platelet-rich plasma, and autologous conditioned plasma.

12. A delivery system for delivery of blood components to an arthroscopic site, the delivery system comprising a capsule and a blood component carrier encapsulated or contained within the capsule.

13. The delivery system of claim 12, wherein the capsule comprises a water soluble film.

14. The delivery system of claim 13, wherein the water soluble film is a starch or a polymer system.

15. The delivery system of claim 14, wherein the water soluble film is selected from the group consisting of polyvinyl alcohol, pectin, hydroxypropylmethyl cellulose, carboxymethyl cellulose, polysaccharide polymer, carrageenan, xanthan gum and alginate.

17. A capsule for delivery of bone marrow aspirate, the capsule comprising a water soluble film, and a collagen sponge encapsulated or contained within the water soluble film and comprising bone marrow aspirate.

18. The capsule of claim 17, wherein the capsule is designed to retain its initial shape for about 10 minutes when immersed in water, saline solution or body fluid, at about 37°

C.

19. The capsule of claim 17, wherein the capsule is designed to retain its shape for about 75 minutes when immersed in water, saline solution or body fluid, at about 37°

C.

20. A graft for treatment of damaged tissue, the graft comprising a capsule encapsulating a collagen carrier and a biological component selected from the group consisting of blood, platelet-rich plasma, autologous conditioned plasma, and bone marrow aspirate.

21. The graft of claim 20, wherein the damaged tissue is part of shoulder, knee, hip, elbow, ankle, foot or hand.

22. The graft of claim 20, wherein the capsule further comprises growth factors, antiseptics, antibiotics or electrolytes.

23. The graft of claim 20, wherein the capsule is a gelatin capsule.

24. A method of delivering biological products to an arthroscopic site, comprising the steps of:

impregnating a carrier with a biological product to form an impregnated carrier;

encapsulating or containing the impregnated carrier within a containment system; and

delivering the containment system with the encapsulated or contained carrier to the arthroscopic site.

25. The method of claim 24, wherein the biological product is selected from the group consisting of blood, blood components, platelet rich plasma, autologous conditioned plasma, and bone marrow aspirate.

26. The method of claim 24, wherein the biological product is autologous conditioned plasma, and wherein the autologous conditioned plasma is obtained by subjecting blood to at least one centrifugation step to obtain the autologous conditioned plasma.

27. The method of claim 24, wherein the biological product comprises bone marrow aspirate.

28. The method of claim 24, wherein the arthroscopic site is a transosseous tunnel.

29. The method of claim 24, wherein the arthroscopic site is damaged cartilage.

30. The method of claim 24, wherein the containment system is a capsule, a packet or a container.

31. The method of claim 24, wherein the containment system is a capsule comprising a water soluble film.

32. A method of treating tissue in a mammal, comprising:

drawing autologous blood from the mammal;

subjecting the autologous blood to a centrifugation process to obtain an autologous conditioned plasma and a residual blood component;

separating the autologous conditioned plasma from the residual blood component;

hydrating a collagen support with the autologous conditioned plasma to obtain a hydrated collagen support;

encapsulating the hydrated collagen support into a gelatin capsule; and

delivering the gelatin capsule into the tissue, or to the tissue, to promote tissue growth.

33. The method of claim 32, further comprising the step of adding, to the hydrated collagen support, a component selected from the group consisting of growth factors, antiseptics, antibiotics and electrolytes.