Cartilage repair unit

• US 5,769,899 A
• Filed: 08/15/1996
• Issued: 06/23/1998
• Est. Priority Date: 08/12/1994
• Status: Expired due to Term

• Current Assignee: DePuy Orthopaedics Incorporated (Johnson & Johnson)
• Original Assignee: Matrix Technology (China) Co. Ltd.
• Inventors: Grande, Daniel Anthony Jr., Schwartz, Robert Elliott
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/698,468
• Time in Patent Office: 677 Days
• Field of Search: 623/11, 623/13, 623/16, 623/18, 606/77, 606/154, 606/230, 424/426, 424/428
• US Class Current: 606/77
• CPC Class Codes: A61B 17/846 Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface A61B17/72, A61B17/86 take precedence
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61F 2/30749 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: A61F 2/4618 of cartilage
• 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 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/3028 polyhedral different from parallelepipedal and pyramidal
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30367 with additional means for preventing said rotation
• CPC Class Codes: A61F 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30487 Circumferential cooperating grooves and beads on cooperating lateral surfaces of a mainly longitudinal connection
• CPC Class Codes: A61F 2002/305 Snap connection
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30733 : Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• CPC Class Codes: A61F 2002/30751 : for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30766 : Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30808 : parallel
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30881 : Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/4677 : using a guide wire
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2250/0014 : having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/227 : Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body

Abstract

A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on the surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of removed damaged or destroyed articular cartilage and the adjacent healthy cancellous bone. The system is at least one assembly of a bio-absorbable delivery unit, configured and dimensioned to be mounted in both the removed area and the adjacent healthy area, and a porous bio-absorbable insert supported by and in the delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix. The insert preferably includes a repair factor (e.g., a growth factor, an attachment factor, or both) releasably disposed in the insert to assist in establishing the chondrogenic growth-supporting matrix.

Claims

1. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of:

(A) a delivery unit consisting substantially of completely bio-absorbable material which is dimensionally stable against substantial expansion by absorption of synovial joint fluid and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone; and

(B) a porous insert supported by said delivery unit, consisting substantially of completely bio-absorbable material, and defining at least 95% voids by volume for establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.

2. The cartilage repair system of claim 1 wherein said insert includes a repair factor releasably disposed in said insert to assist in establishing said chondrogenic growth-supporting matrix.

3. The cartilage repair system of claim 2 wherein said repair factor is a growth factor.

4. The cartilage repair system of claim 3 wherein said growth factor is selected from the group consisting of fibroblast growth factor, transforming growth factor beta, insulin, insulin-like growth factor, platelet-derived growth factor and combinations thereof.

5. The cartilage repair system of claim 2 wherein said repair factor is an attachment factor.

6. The cartilage repair system of claim 5 wherein said attachment factor is selected from the group consisting of fibronectin, RGD polypeptide and combinations thereof. selected from the group consisting of hyaluronic acid, polyglycolic acid, collagen, polylactic acid, fibrin clot, periosteal cells, polydioxane, polyester, alginate and combinations thereof.

7. The cartilage repair system of claim 1 wherein said insert consists substantially of a bio-absorbable material.

8. The cartilage repair system of claim 1 wherein said delivery unit comprises a bio-absorbable material selected from the group consisting of hyaluronic acid, polyglycolic acid, polylactic acid, alginate and combinations thereof.

9. The cartilage repair system of claim 1 wherein said delivery unit defines channels therethrough to allow vascular invasion and cellular migration to an adjacent surface of said insert.

10. The cartilage repair system of claim 1 wherein said delivery unit is integrally molded.

11. The cartilage repair system of claim 1 including means precluding relative rotation of said delivery unit and said insert in said delivery unit.

12. The cartilage repair system of claim 1 wherein

said delivery unit defines channels therethrough to allow vascular invasion and cellular migration to an adjacent surface of said insert;

and

said assembly includes means precluding relative rotation of said delivery unit and said insert in said delivery unit.

13. The cartilage repair system of claim 12 including a plurality of assemblies, said delivery units of said assemblies being disposed within said healthy area of bone and said removed area, and said inserts of said assemblies establishing said chondrogenic growth-supporting matrix over a substantial portion of said removed area, said delivery units of said assemblies being polygonal in configuration and interfitting.

14. The cartilage repair system of claim 12 wherein said insert consists substantially of a bio-absorbable material selected from the group consisting of hyaluronic acid, polyglycolic acid, collagen, polylactic acid, fibrin clot, periosteal cells, polydioxane, polyester, alginate and combinations thereof;

and said delivery unit comprises a bio-absorbable material selected from the group consisting of hyaluronic acid, polyglycolic acid, polylactic acid, alginate and combinations thereof.

15. The cartilage repair system of claim 1 wherein said delivery unit is configured as a polygon and dimensioned to be mounted in an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone.

16. The cartilage repair system of claim 12 wherein said insert includes a repair factor releasably disposed in said insert to assist in establishing said chondrogenic growth-supporting matrix, said repair factor being selected from the group consisting of a growth factor, an attachment factor and combinations thereof.

17. The cartilage repair system of claim 1 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

18. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of:

(A) a delivery unit consisting substantially of completely bio-absorbable material which is dimensionally stable against substantial expansion by absorption of synovial joint fluid and configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone; and

(B) a porous insert supported by said delivery unit, consisting substantially of completely bio-absorbable material, and defining at least 95% voids by volume for establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

said system including a plurality of assemblies, said delivery units of said assemblies being disposed within said bone and said removed area, and said inserts of said assemblies establishing said chondrogenic growth-supporting matrix over a substantial portion of said removed area.

19. The cartilage repair system of claim 18 wherein said delivery units of said assemblies are polygonal in configuration and interfitting.

20. The cartilage repair system of claim 18 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

21. A cartilage repair system adapted to be mounted on a joint surface of a bone to establish a chondrogenic growth-supporting matrix, comprising a delivery unit consisting substantially of completely bio-absorbable material which is dimensionally stable against substantial expansion by absorption of synovial joint fluid and configured and dimensioned to be mounted on and within the bone, said unit including a support frame and means for mounting said unit on and within the bone, and a porous insert consisting substantially of completely bio-absorbable material, defining at least 95% voids by volume, and supported by said support frame to provide a chondrogenic growth-supporting matrix.

22. The cartilage repair system of claim 21 wherein said insert includes a repair factor releasably disposed in said insert to assist in providing said chondrogenic growth-supporting matrix.

23. The cartilage repair system of claim 21 wherein said support frame is constructed to allow vascular invasion and cellular migration to said insert.

24. The cartilage repair system of claim 23 wherein said support frame has an open top and a bottom defining a plurality of channels therethrough to allow vascular invasion and cellular migration to the bottom of said insert.

25. The cartilage repair system of claim 24 wherein said insert has sides, and said support frame has side walls defining windows through which said insert extends to allow cellular migration to the sides of said insert by an adjacent healthy area of articular cartilage.

26. The cartilage repair system of claim 21 wherein said unit and said insert define an assembly, and said system consists of a plurality of said assemblies in contiguous and abutting relationship.

27. The cartilage repair system of claim 21 wherein said unit is more rigid than said insert.

28. The cartilage repair system of claim 21 additionally including means precluding relative rotation of said unit and said insert.

29. The cartilage repair system of claim 21 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

30. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone, said system comprising an assembly of:

(A) a bio-absorbable delivery unit configured and dimensioned to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and cancellous bone; and

(B) a porous, bio-absorbable insert supported by said delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

said delivery unit having an open top, a bottom and a sidewall connecting said top and bottom, said bottom defining a plurality of channels therethrough to allow vascular invasion and cellular migration through the bottom of said insert, and said sidewall defining windows to which said insert extends to allow cellular migration to the sides of said insert by an adjacent healthy area of articular cartilage.

31. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of:

(A) a delivery unit consisting substantially of completely bio-absorbable material to be mounted in both an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said delivery unit including means for retaining itself in the adjacent healthy area without either an expansion of the dimensions thereof or a relative rotation thereof; and

(B) a porous insert supported by said delivery unit, consisting substantially of completely bio-absorbable material, and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.

32. The cartilage repair system of claim 31 wherein said delivery unit defines channels therethrough to allow vascular invasion and cellular migration to an adjacent surface of said insert;

and

said assembly includes means precluding relative rotation of said delivery unit and said insert in said delivery unit.

33. The cartilage repair system of claim 31 wherein said delivery unit comprises a platform to receive and support said insert and a plug to mount said platform relative to the adjacent healthy area, said plug including said retaining means.

34. The cartilage repair system of claim 32 wherein said insert includes a repair factor releasably disposed in said insert to assist in establishing said chondrogenic growth-supporting matrix, said repair factor being selected from the group consisting of a growth factor, an attachment factor and combinations thereof.

35. The cartilage repair system of claim 31 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

36. A cartilage repair system adapted to be mounted on a joint surface of a bone to establish a chondrogenic growth-supporting matrix, comprising a delivery unit consisting substantially of completely bio-absorbable material and configured and dimensioned to be mounted on and within the bone, said delivery unit including a support frame and means for mounting said delivery unit on and within the bone, said delivery unit including means for retaining itself in the bone without either an expansion of the dimensions thereof or a relative rotation thereof, and a porous insert consisting substantially of completely bio-absorbable material and supported by said support frame to provide a chondrogenic growth-supporting matrix.

37. The cartilage repair system of claim 36 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

38. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of:

(A) a bio-absorbable delivery unit configured, as a polygon and dimensioned to be mounted in an area, of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said delivery unit including means for retaining itself in the adjacent healthy area without either an expansion of the dimensions thereof or a relative rotation thereof; and

(B) a porous, bio-absorbable insert supported by said delivery unit and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.

39. The cartilage repair system of claim 38 wherein said delivery unit comprises a platform to receive and support said insert and a plug to mount said platform relative to the adjacent healthy area, said plug including said retaining means.

40. The cartilage repair system of claim 38 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.

41. A bio-absorbable cartilage repair system for regenerating damaged or destroyed articular cartilage on a joint surface of a bone by establishing a chondrogenic growth-supporting matrix between an area of damaged or destroyed articular cartilage that has been removed and an adjacent healthy area of articular cartilage and subchondral cancellous bone, said system comprising an assembly of:

(A) a porous, bio-absorbable insert defining at least 95% voids by volume for establishing communication between a removed area and an adjacent healthy area for a chondrogenic growth-supporting matrix; and

(B) a bio-absorbable delivery unit configured and dimensioned to be mounted in the removed area and the adjacent healthy area, said delivery unit including means for positioning said insert in the removed area and surrounded by the adjacent healthy area.

42. The cartilage repair system of claim 41 wherein said insert includes cells selected from the group consisting of isolated periosteal cells, mesenchymal stem cells, chondrocytes and combinations thereof.