IMPLANTABLE PATCH AND SURGICAL KIT FOR PREPARATION THEREOF

• US 20120282235A1
• Filed: 06/01/2010
• Published: 11/08/2012
• Est. Priority Date: 09/25/2009
• Status: Abandoned Application

• Current Assignee: Tornier Incorporated
• Original Assignee: Tornier Incorporated
• Inventors: Ohashi, Kevin L., Peterson, Dale R., Rushdy, Jamal
• Application Number:
  US13/498,284
• Publication Number:
  US 20120282235A1
• Time in Patent Office: Days
• US Class Current: 424/93.71
• CPC Class Codes: A61L 2300/30 Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3616 Blood, e.g. platelet-rich plasma
• 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 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Embodiments of the present invention include a surgical kit for preparation of a patch for implantation into a human body, characterized in that it comprises a package containing, on one hand, a synthetic substrate (1) and, on the other hand, means for treatment of the substrate with a solution (3) including at least one biologically active component (4, 5), adapted to integrate the biologically active component with the substrate. Embodiments of the invention include a patch for implantation into the human body, comprising a synthetic substrate (1), characterized in that at least one biologically active component (4, 5) is integrated with the substrate using the surgical kit.

Claims

1. A surgical kit (100;

200;

300;

400) for preparing a patch 10 for implantation into a human body, characterized in that it comprises a package (110;

210;

310;

410) containing, on one hand, a synthetic substrate (1) and, on the other hand, means for treatment (2, 6;

202;

302;

402) of the substrate with a solution (3) including at least one biologically active component (4, 5), adapted to combine the biologically active component with the substrate.

2. The surgical kit (100) according to claim 1, characterized in that the means for treatment comprise a receptacle (2), in particular a tube, adapted to receive the substrate (1) and to be filled with the solution (3).

3. The surgical kit (100) according to claim 2, characterized in that a lip is formed on the interior of the receptacle (2), the lip being adapted to receive and fixedly retain the substrate (1) in the receptacle (2).

4. The surgical kit (100) according to claim 2, characterized in that the means for treatment comprises a fixation mechanism (6), in particular a silicone ring, adapted to fixedly retain the substrate (1) in the receptacle (2).

5. The surgical kit (200) according to claim 1, characterized in that the means for treatment comprises a flexible pouch (202).

6. The surgical kit (300) according to claim 1, characterized in that the means for treatment comprises a pipette (302).

7. The surgical kit (400) according to claim 1, characterized in that the means for treatment comprises a syringe (402).

8. The surgical kit according to claim 1, characterized in that the synthetic substrate (1) is an absorbable polymer, in particular polyhydroxyalkanoate.

9. A patch (10) for implantation into a human body, comprising a synthetic substrate (1), characterized in that at least one biologically active component (4, 5) is integrated with the substrate using a surgical kit according to claim 1.

10. The patch according to claim 9, characterized in that each of the biologically active components (4,5) is one or more of the following:

platelet enriched plasma (4), platelet poor plasma, bone marrow aspirate, platelet cells, white blood cells, stem cells, growth factors, protein coagulators, fibrin, prothrombin, thrombin, and calcium ions.

11. A method for preparing a synthetic substrate for implantation, the method comprising:

opening a sterile bag containing the synthetic substrate and a receptacle;

inserting the synthetic substrate into the receptacle;

filling the receptacle at least partially with human blood; and

subjecting the receptacle to centrifugal forces to separate plasma rich platelets from the blood and to concentrate the plasma rich platelets at a level within the receptacle corresponding to a location of the synthetic substrate.

12. The method of claim 11, further comprising implanting the synthetic substrate to repair human soft tissue.

13. The method of claim 12, wherein the human blood and the human soft tissue are from a single patient.

14. The method of claim 11, further comprising positioning the synthetic substrate at a selected level within the receptacle.

15. The method of claim 14, wherein positioning the synthetic substrate comprises inserting an o-ring into the receptacle below the synthetic substrate.

16. The method of claim 14, wherein positioning the synthetic substrate comprises inserting an o-ring into the receptacle above the synthetic substrate.

17. The method of claim 14, wherein an inner surface of the receptacle comprises at least one protrusion or indentation configured to facilitate positioning of the synthetic substrate within the receptacle.

18. A surgical kit for preparing a synthetic substrate for implantation, the surgical kit comprising:

a sealed bag, wherein an inside of the sealed bag is sterile;

a container within the sealed bag; and

a synthetic substrate within the sealed bag, wherein the synthetic substrate is biocompatible,

wherein the container is configured to hold a solution containing one or more biologically active components for combining the one or more biologically active components with the synthetic substrate.

19. The surgical kit of claim 18, wherein the container is a container selected from the group consisting of:

a syringe, a pipette, and a flexible pouch.

20. The surgical kit of claim 18, wherein the synthetic substrate is positioned within the container within the sealed bag.

21. The surgical kit of claim 18, wherein the synthetic substrate is substantially circular, and wherein the container is a tube with a substantially circular inner diameter.

22. The surgical kit of claim 18, further comprising a protein coagulator.

23. The surgical kit of claim 22, wherein the protein coagulator is thrombin or calcium ion.

24. The surgical kit of claim 18, further comprising a growth factor.

25. The surgical kit of claim 18, wherein the synthetic substrate is an absorbable polymer.

26. The surgical kit of claim 25, wherein the absorbable polymer is polyhydroxyalkanoate.

27. The surgical kit of claim 18, further comprising a fixation mechanism, the fixation mechanism configured to hold the synthetic substrate at a desired position within the container.