Method and device for reconstruction of articular cartilage

• US 5,904,717 A
• Filed: 01/09/1995
• Issued: 05/18/1999
• Est. Priority Date: 01/28/1986
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: THM Biomedical, Inc. (DSM-Firmenich AG)
• Inventors: Coutts, Richard D., Brekke, John H.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/370,161
• Time in Patent Office: 1,590 Days
• Field of Search: 623/11, 623/12, 623/16, 623/17, 623/18, 623/66, 424/422, 424/424, 424/426, 606/60, 606/72, 606/73, 606/76, 606/77
• US Class Current: 424/423
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3601 for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4649 Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0082 parallelepipedal
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biodegradable device for facilitating healing of structural voids in bone, cartilage as well as soft tissue is disclosed in the most preferred form including a porous macrostructure made from a biodegradable polymer and a chemotactic ground substance in the form of an RGD attachment moiety of fibronectin formed as a porous microstructure. For repair of articular cartilage, harvested precursor cells are secured to the biodegradable carrier which is shaped for press fitting into the articular cartilage lesion. In the most preferred form, the chemotactic ground substance enhances the attractiveness of the biodegradable device for cellular attachment at the site of repair and also facilitates the attachment of free, precursor cells such as chondrocytes and bone marrow to the biodegradable device. In the most preferred form, biological modifiers such as transforming growth factor B and basic fibroblastic growth factor is incorporated in the biodegradable device to mediate cellular activity and regulate cellular functions.

Claims

1. Method for promoting the repair of a lesion extending through articular cartilege into bone comprising the steps of:

providing a biodegradable carrier carrying a chemotactic ground substance, with the biodegradable carrier being formed by a structure having surfaces, with the chemotactic ground substance being carried by the surfaces and separate from the structure, wherein the providing step comprises the step of providing the biodegradable carrier including at least one biological modifier incorporated in the biodegradable carrier selected from the group of;

modifiers being joined to the surfaces of the structure, modifiers being joined to the chemotactic ground substance, modifiers being located between the structure and the chemotactic ground substance, and modifiers being carried within the chemotactic ground substance;

harvesting precursor cells for the production of connective tissue;

securing the precursor cells to the biodegradable carrier;

shaping the biodegradable carrier and the precursor cells secured thereto to the shape of the lesion, with the shaped biodegradable carrier and the precursor cells secured thereto having a peripheral surface; and

implanting the biodegradable carrier and the precursor cells secured thereto into the lesion with the peripheral surface of the biodegradable carrier and the precursor cells abutting with the lesion.

2. The method of claim 1 wherein the step of harvesting precursor calls comprises the step of harvesting periosteum from a source including blastic cells.

3. The method of claim 2 wherein the step of harvesting precursor cells comprises the step of harvesting periosteum from the proximal tibia.

4. The method of claim 1 wherein the harvesting step comprises the step of harvesting precursor cells in the form of tissue;

and wherein the securing step comprises the step of suturing the precursor cells to the biodegradable carrier.

5. The method of claim 1 wherein the providing step comprises the step of providing a biodegradable carrier formed from a porous, biodegradable polymer.

6. The method of claim 5 wherein the providing step comprises the step of providing a biodegradable carrier carrying a chemotactic ground substance in turn carrying an RGD attachment moiety of fibronectin.

7. The method of claim 6 wherein the providing step comprises the step of providing a biodegradable polymer arranged as a gross structure with interconnecting voids, generally with each void communicating with all the others and with substantially the entire exterior of the gross structure, with the chemotactic ground substance formed into a microstructure located in the voids and carried by and separate from the biodegradable polymer forming the gross structure.

8. The method of claim 7 wherein the providing step comprises the step of providing a biodegradable polymer preformed into the gross structure prior to the introduction of the chemotactic ground substance.

9. The method of claim 8 wherein the biodgeradable polymer comprises a homogeneous polymer.

10. The method of claim 9 wherein the providing step comprises the step of providing a biodegradable polymer selected from the group of D,L-polylactic acid, L-polylactic acid, glycolic acid or co-polymers thereof.

13. The method of claim 1 wherein the providing step comprises the step of providing a biodegradable carrier carrying a chemotactic ground substance in turn carrying an RGD attachment moiety of fibronectin.

14. The method of claim 13 wherein the harvesting step comprises the step of harvesting free, precursor cells having receptors on the surfaces of the cells;

and wherein the securing step comprises the step of permitting the receptors of the free, precursor cells to be engaged to the biodegradable carrier.

15. The method of claim 1 wherein the biological modifier providing step comprises the step of providing a biodegradable carrier including at least one biological modifier selected from the group of transforming growth factor B and basic fibroblastic growth factor incorporated therein.

16. The method of claim 1 wherein the harvesting step comprises the step of harvesting free, precursor cells having receptors on the surfaces of the cells;

and wherein the securing step comprises the step of permitting the receptors of the free, precursor cells to be engaged to the biodegradabe carrier.

17. The method of claim 8 wherein the biodegradable polymer comprises a co-polymer of at least two alphahydroxy acids.

18. The method of claim 1 wherein the step of implanting the biodegradable carrier and the precursor cells secured thereto comprises the step of press fitting the biodegradable carrier and the precursor cells secured thereto into the lesion.

19. The method of claim 18 further comprising the step of drilling into the bone to create the lesion into which the shaped biodegradable carrier and the free, precursor cells attached thereto are press fit.

20. The method of claim 5 wherein the providing step comprises the step of providing a biodegradable polymer arranged as a gross structure with interconnecting voids, generally with each void communicating with all the others and with substantially the entire exterior of the gross structure, with the chemotactic ground substance formed into a microstructure located in the voids and carried by and separate from the biodegradable polymer forming the gross structure.

21. The method of claim 20 wherein the providing step comprises the step of providing a biodegradable polymer preformed into the gross structure prior to the introduction of the chemotactic ground substance.

22. The method of claim 21 wherein the biodegradable polymer comprises a homogeneous polymer.

23. The method of claim 22 wherein the providing step comprises the step of providing a biodegradable polymer selected from the group of D,L-polylactic acid, L-polylactic acid, glycolic acid or co-polymers thereof.

24. The method of claim 21 wherein the biodegradable polymer comprises a co-polymer of at least two alphahydroxy acids.

25. The method of claim 15 wherein the providing step comprises the step of providing a biodegradable carrier formed from a porous, biodegradable polymer.

11. Method for promoting the repair of a lesion extending through articular cartilage into bone comprising the steps of:

providing a biodegradable carrier formed from a porous, biodegradable polymer having surfaces and carrying a chemotactic ground substance in turn carrying an RGD attachment moiety of fibronectin, with the chemotactic ground substance being carried by the surfaces and separate from the structure, wherein the providing step comprises the step of providing the biodegradable carrier including at least one biological modifier incorporated in the biodegradable carrier selected from the group of;

modifiers being joined to the surfaces of the structure, modifiers being joined to the chemotactic ground substance, modifiers being located between the structure and the chemotactic ground substance, and modifiers being carried within the chemotactic ground substance;

harvesting precursor cells for the production of connective tissue;

securing the precursor cells to the biodegradable carrier;

shaping the biodegradable carrier and the precursor cells secured thereto to the shape of the lesion, with the shaped biodegradable carrier and the precursor cells secured thereto having a peripheral surface; and

press fitting the biodegradable carrier and the precursor cells secured thereto into the lesion with the peripheral surface of the biodegradable carrier and the precursor cells abutting with the lesion.

12. The method of claim 11 wherein the biological modifier providing step comprises the step of providing a biodegradable carrier including at least one biological modifier selected from the group of transforming growth factor B and basic fibroblastic growth factor incorporated therein.