Cartilage repair unit

• US 20010010023A1
• Filed: 03/08/2001
• Published: 07/26/2001
• Est. Priority Date: 06/04/1999
• Status: Active Grant

• Current Assignee: Daniel A. Grande, Robert E. Schwartz
• Original Assignee: Daniel A. Grande, Robert E. Schwartz
• Inventors: Grande, Daniel A., Schwartz, Robert E.
• Granted Patent: US 6,468,314 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• 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 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/38 for elbows or knees
• 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 2002/30011 differing in porosity
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30123 with two diametrically opposed lobes
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/3013 figure-"8"- or hourglass-shaped
• CPC Class Codes: A61F 2002/30143 : hexagonal
• CPC Class Codes: A61F 2002/30146 : octagonal
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30156 : triangular
• CPC Class Codes: A61F 2002/30159 : Concave polygonal shapes
• CPC Class Codes: A61F 2002/30171 : rosette- or star-shaped
• CPC Class Codes: A61F 2002/30291 : spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30299 : umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30306 : harpoon-shaped
• 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 2002/30354 : Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30405 : made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30477 : using sharp protrusions, e.g. spikes, for anchoring into connecting prosthetic part
• CPC Class Codes: A61F 2002/30484 : Mechanically expandable devices located on the first prosthetic part for locking into or onto the second prosthetic part
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/30495 : using a locking ring
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30751 : for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30761 : Support means for artificial cartilage, e.g. cartilage defect covering membranes
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• 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 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/001 : Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0097 : Harpoon-shaped
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0024 : made from both porous and non-porous parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof

Abstract

A bio-absorbable cartilage repair system is provided 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. The system is an assembly of a delivery unit and a porous insert. The delivery unit is formed of bio-absorbable material 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 cancellous bone. The delivery unit has a central body and a plurality of radially extending, flexible support arms projecting outwardly from the central body and configured and dimensioned to support the insert at least partially thereover. The insert is supported by the delivery unit, formed of bio-absorbable material, and establishes communication between the removed area and the adjacent healthy area for a 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 a delivery unit and a porous insert;

(A) said delivery unit being formed of bio-absorbable material 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 cancellous bone, said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert; and

(B) said insert being formed of bio-absorbable material and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.

2. The system of

claim 1

wherein said support arms have upper, lower, and outer surfaces and wherein said insert is disposed on the upper, lower and outer surfaces of said support arms.

3. The system of

claim 1

wherein said support arms have free ends circumferentially spaced from one another to define areas for receipt of a chondrogenic growth-supporting matrix.

4. The system of

claim 1

wherein said support arms have circumferentially spaced free ends adapted to engage and at least partially spatially stabilize said insert.

5. The system of

claim 1

wherein said support arms have free ends and wherein the free ends are horizontally barbed.

6. The system of

claim 1

wherein said support arm free ends are vertically barbed.

7. The system of

claim 1

wherein said insert has a top, a bottom and a sidewall connecting said top and bottom, said bottom allowing vascular invasion therethrough, and said top and sidewall allowing cellular migration.

8. The system of

claim 7

wherein said sidewall is polygonal in plan.

9. The system of

claim 1

wherein each of said delivery unit and said insert essentially consist of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.

10. The system of

claim 1

additionally including retainer means securing said insert to said delivery unit.

11. The system of

claim 10

wherein said retainer means is secured to a portion of said central body below said insert and bears upwardly against said insert.

12. The system of

claim 10

wherein said retainer means essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.

13. The system of

claim 1

comprising a porous film formed of bio-absorbable material securing said insert to said delivery unit.

14. The system of

claim 13

wherein said porous film has a central film portion disposed over said insert and a plurality of film fingers projecting outwardly from said central film portion, downwardly and inwardly, under said support arms.

15. The system of

claim 14

comprising retainer means secured to a lower part of said central body and bearing upwardly against said film fingers.

16. The system of

claim 13

wherein said porous film essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.

17. The system of

claim 1

wherein said central body comprises a plurality of outwardly extending flanges.

18. The system of

claim 1

wherein said insert is a flexible porous film formed of bio-absorbable material secured to said delivery unit.

19. The system of

claim 18

wherein said porous film has a central film portion disposed over said support arms and a plurality of film fingers projecting outwardly from said central film portion, downwardly and inwardly, under said support arms.

20. The system of

claim 19

additionally including retainer means secured to a lower part of said central body and bearing upwardly against said film fingers.

21. The system of

claim 18

wherein said porous film essentially consists of completely bio-absorbable material which is dimensionally stable in synovial joint fluid against expansion due to the absorption thereof.

22. The system of

claim 1

wherein said central body defines an aperture extending longitudinally therethrough.

23. The system of

claim 22

wherein said insert defines an aperture extending longitudinally therethrough.

24. The system of

claim 22

additionally including retainer means secured to a lower part of said central body and bearing upwardly against said insert, said retainer body defining an aperture extending longitudinally therethrough coaxial with said central body aperture.

25. The system of

claim 22

additionally including a porous film consisting substantially of completely bio-absorbable material securing said insert to said delivery unit, said porous film defining an aperture extending, longitudinally therethrough coaxial with said central body aperture.

26. The system of

claim 22

wherein said insert is a flexible porous film consisting substantially of completely bio-absorbable material secured to said delivery unit, said porous film defining an aperture extending longitudinally therethrough coaxial with said central body aperture.

27. The system of

claim 1

wherein at least a portion of said delivery unit central body disposed below said insert defines flexible legs, said system additionally including means for moving said legs from a horizontally retracted orientation enabling removal of said assembly to a horizontally expanded orientation fixing said assembly in place.

28. The system of

claim 27

wherein said flexible legs are resilient, and said moving means is retractable to enable movement of said legs from said expanded orientation to said retracted orientation.

29. The system of

claim 1

wherein said insert includes cartilage or cartilage-progenitor cells to facilitate establishing said communication.

30. The system of

claim 1

wherein said delivery unit is provided by two separately formed components, one of said components being 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 the other component providing the central body and plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert.

31. The system of

claim 30

wherein said delivery unit includes retainer means for bearing on a portion of said insert intermediate said two components to lock said insert portion in place.

32. The system of

claim 30

wherein said delivery unit is assembled with said insert prior to use.

33. The system of

claim 30

wherein said one component defines a longitudinal aperture therethrough, and said central body of said other component is configured and dimensioned to at least partially pass through said aperture.

34. The system of

claim 30

wherein at least one of said components includes means for retaining said components together after assembly.

40. The system of

claim 7

wherein said sidewall is circular in plan.

42. The system of

claim 1

wherein a top layer of said insert contains a chondrogenic growth-supporting matrix and a lower portion of said insert contains an osteogenic growth-supporting matrix, the insert configured and dimensioned to be disposed with said chondrogenic growth-supporting matrix adjacent a healthy area of articular cartilage and said osteogenic growth-supporting matrix adjacent a healthy area of subchondral cancellous bone, thereby establishing chondrogenic and osteogenic growth-supporting matrices in removed areas of damaged or destroyed articular cartilage and subchondral bone, respectively.

35. 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 consisting essentially of two delivery units and a single flexible porous insert;

(A) each of said delivery units being formed of bio-absorbable material 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 cancellous bone, each said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert; and

(B) said insert being formed of flexible bio-absorbable material and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix;

said delivery units being configured and dimensioned to enable them to be disposed facing each other and connected only by said insert for insertion into a patient and then unfolded to enable them to be separately mounted side-by-side.

36. The system of

claim 35

wherein said insert defines a pair of insert portions, each said insert portion extending over the top of a respective one of said delivery units, and a connecting portion of reduced width foldably connecting said insert portions together.

37. 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 a delivery unit and a porous insert;

(A) said delivery unit being formed of bio-absorbable material 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 cancellous bone, said delivery unit having a central body and a plurality of inwardly compressible flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert; and

(B) said insert being formed of bio-absorbable material and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix.

38. The system of

claim 37

comprising at least two of said delivery units, each said delivery unit being mounted side-by-side such that at least one support arm of one of said delivery units inwardly compresses at least one support arm of the other of said delivery units.

39. The system of

claim 38

wherein said at least one support arm of said one delivery unit would overlap said at least one support arm of said other delivery unit if at least one of the support arms was not inwardly compressed.

41. The system of

claim 38

wherein said insert and said support arms are deflectable.

43. 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 delivery unit and a porous insert;

(A) said delivery unit being formed of bio-absorbable material 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 cancellous bone, said delivery unit having a central body and a plurality of radially extending, flexible support arms projecting outwardly from said central body and configured and dimensioned to support said insert;

(B) said insert being formed of bio-absorbable material and establishing communication between the removed area and the adjacent healthy area for a chondrogenic growth-supporting matrix; and

said delivery unit including a head portion and a stem portion, said head and stem portions being pivotally joined together.

44. The system of

claim 43

wherein one of said portions defines a ball and the other of said portions defines a socket.

45. The system of

claim 44

wherein said delivery unit includes a head portion and a stem portion, said stem portion defining a ball at a distal end, and said head portion defining a socket at a proximal end, said ball being pivotally maintained in said socket such that said head portion is pivotable relative to said stem portion.