Device from naturally occuring biologically derived materials

• US 20040220574A1
• Filed: 01/12/2004
• Published: 11/04/2004
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Plouhar, Pamela Lynn, Malaviya, Prasanna, Pelo, Mark Joseph, Schwartz, Herbert Eugene, Whalen, Terrence David
• Granted Patent: US 8,337,537 B2
• Time in Patent Office: Days
• US Class Current: 606/73
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• 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: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• 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 2/3872 : Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/0864 : Fixation of tendon or ligament between anchor elements, e.g. by additional screws in the anchor, anchor crimped around tendon
• CPC Class Codes: A61F 2002/087 : Anchor integrated into tendons, e.g. bone blocks, integrated rings
• CPC Class Codes: A61F 2002/0888 : Anchor in or on a blind hole or on the bone surface without formation of a tunnel
• 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 2002/30032 : differing in absorbability or resorbability, i.e. in absorption or resorption time
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30199 : Three-dimensional shapes
• CPC Class Codes: A61F 2002/3021 : frustoconical
• CPC Class Codes: A61F 2002/30217 : hollow cones, e.g. tubular-like cones
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30233 : Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30281 : wedge-shaped
• CPC Class Codes: A61F 2002/30293 : Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30294 : Conical or frustoconical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30429 : made by inserting a hook into a cooperating slot
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30751 : for attaching cartilage scaffolds to underlying bone
• CPC Class Codes: A61F 2002/30764 : Cartilage harvest sites
• CPC Class Codes: A61F 2002/30766 : Scaffolds for cartilage ingrowth and regeneration
• 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 2002/30845 : with cutting edges
• 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 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30914 : Details of the mesh structure, e.g. disposition of the woven warp and weft wires
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/3096 : trimmed or cut to a customised size
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/30975 : made of two halves
• 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 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2230/0086 : Pyramidal, tetrahedral, or wedge-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 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2240/004 : Using a positive or negative model, e.g. moulds
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3645 : Connective tissue
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Orthopaedic devices are disclosed. The devices (16) include a part that is made of extracellular matrix material that has been hardened. One method of hardening the extracellular matrix is to comminute naturally occuring extracellular matrix and dry the comminuted material. The hardened extracellular matrix material can be machined to form a variety of orthopaedic devices.

Claims

1. An orthopedic device for attaching soft tissue such as cartilage, ligament and tendons to bone, the device having a head portion configured to engage soft tissue and a body portion configured to engage and attach to the bone, the head portion and body portion being monolithic and formed from naturally occurring extracellular matrix (ECM) cured to be rigid and hardened to facilitate attachment to the bone.

2. The device of claim 1 in which the body portion terminates with a pointed end distal from the head portion to facilitate penetration into the bone.

3. The device of claim 2 in which the body portion between the pointed end and the head portion is formed with radially outwardly extending barbs.

4. The device of claim 3 in which the barbs are inclined toward the head portion.

5. The device of claim 4 in which the body portion is provided with diametrically opposed flats extending therealong, the flats being generally parallel.

6. The device of claim 5 in which the device is formed by machining a mass of the cured matrix to define the head portion and body portion.

7. The device of claim 1 in which the cured ECM is cured by air drying.

8. The device of claim 1 in which the cured ECM is dried at room temperature.

9. The device of claim 1 in which the cured ECM is dried with pressure.

10. The device of claim 1 in which the cured ECM is dried with heat.

11. The device of claim 10 in which the cured ECM is dried with pressure.

12. The device of claim 1 in which the cured ECM has a hardness of at least 30 on the “

D”

scale.

13. The device of claim 1 in which the cured ECM has a hardness of at least 60 on the “

D”

scale.

14. The device of claim 1 in which the cured ECM has a hardness of at least 70 on the “

D”

scale.

15. The device of claim 1 in which the body portion is formed with an outer shell defining a central core space, and comprising a biological material to provide a framework for tissue regeneration disposed in the space.

16. The device of claim 15 in which the biological material is comminuted naturally occurring ECM.

17. The device of claim 16 in which the cured ECM is SIS and the. comnminuted ECM is SIS.

18. The device of claim 1 in which the head portion and body portion are formed about a central axis and concentrically and axially cannulated to receive a guide member.

19. The device of claim 1 in which the head portion and body portion are formed about a central longitudinal axis and a second body portion is provided to extend axially away from the head portion in a direction opposite to the first mentioned body portion.

20. The device of claim 19 in which the second body portion is threaded.

21. The device of claim 20 in which the second body portion is provided with diametrically opposed, longitudinally extending generally parallel flats in the portion threaded.

22. The device of claim 21 in which the first mentioned body portion is provided with outwardly extending barbs.

23. The device of claim 22 in which the barbs extend radially outwardly and axially toward the head portion.

24. The device of claim 23 in which the first mentioned body portion terminates with a pointed end distal from the head portion.

116. The device of claim 10 in which the at least one or more members comprises a lattice of interlocking first members extending generally radially toward the center of the knee and second members extending transversely to the first members, the first and second members defining a plurality of open spaces between the upper panel and the lower panel, and the device further comprises a biological material to promote regeneration of the meniscus disposed in the open spaces.

25. An orthopedic tack comprising a head portion and a first body portion formed from naturally occurring extracellular matrix cured to be hard and rigid.

26. The tack of claim 25 in which the extracellular matrix is SIS formed into a three-dimensional mass and cured by drying.

27. The tack of claim 26 in which the matrix is cured by air drying.

28. The tack of claim 27 in which the head portion and first body portion are formed by machining their shapes from the cured mass of SIS.

29. The tack of claim 25 in which the first body portion and head portion are formed about a central axis, and the first body portion terminates in a pointed end distal to the head portion.

30. The tack of claim 29 including a second body portion extending away from the head portion in an axial direction opposite to the first body portion.

31. The tack of claim 30 in which at least one of the body portions is provided with outwardly extending barbs.

32. The tack of claim 31 in which the barbs extend radially outwardly and axially toward the head portion.

33. The tack of claim 30 in which at least one of the body portions is threaded.

34. The tack of claim 31 in which the at least one body portion is formed with diametrically opposed, longitudinally extending generally parallel flats.

35. The tack of claim 33 in which the threaded body portion is formed with diametrically opposed, longitudinally extending generally parallel flats.

36. The tack of claim 25 in which the first body portion is formed to have a central bore, and comprising a biological material to provide a framework for regeneration of tissue disposed in the bore.

37. The tack of claim 25 in which the matrix is SIS and in which the first body portion is formed with a core space filled with comminuted SIS.

38. The tack of claim 37 in which the first body portion is further formed to have a distal end portion terminating with a pointed end, the distal end portion being provided with outwardly extending barbs.

39. A device for repairing a tear in a cartilaginous surface such as a meniscus, the device comprising strips of naturally occurring extracellular matrix laminated together to form a body portion to be placed down into the tear to extend along the tear, and one or more tacks coupled to the body portion to secure it in the tear, each of the one or more tacks being formed from naturally occurring extracellular matrix.

40. The device of claim 39 in which the body portion has an upper edge, a lower edge and opposite end edges, the one or more tacks comprising a tack coupled to each of the opposite end edges of the body portion.

41. The device of claim 40 in which each tack extends along the opposite end edge to which it is coupled.

42. The device of claim 41 in which the body portion is coupled to each tack along its length.

43. The device of claim 42 in which each tack is provided with barbs which extend radially outwardly and axially toward the upper edge.

44. The device of claim 39 comprising a member connecting the one or more tacks, the connecting member being formed from naturally occurring extracellular matrix.

45. The device of claim 44 in which the connecting member is detachable by a surgeon after the body portion and tacks are inserted into the tear.

46. The device of claim 39 in which the ECM is SIS that is cured to be hard and rigid.

47. The device of claim 46 in which the ECM is SIS is dried by air drying at room temperature.

48. The device of claim 46 in which the SIS has a hardness of at least 30 on the “

D”

scale.

49. The device of claim 48 in which the SIS has a hardness of at least 60 on the “

D”

scale.

50. The device of claim 49 in which the SIS has a hardness of at least 70 on the “

D”

scale.

51. The device of claim 39 in which the one or more tacks comprise a pair of tacks each having a pointed distal end and a proximal end and a connecting member coupled between the proximal ends of the tacks, the connecting member being coupled to the body portion.

52. The device of claim 51 in which the connecting member extends transverse to the body portion, the connecting member having a central portion coupled to the body portion.

53. An orthopedic device for attaching or repairing tissue, the device comprising two spaced apart barbs, each barb having a sharpened distal end and a proximal end, and a member connecting the proximal ends of the barbs, the barbs being formed from naturally occurring extracellular matrix.

54. The device of claim 53 in which the connecting member is formed of the naturally occurring extracellular matrix.

55. The device of claim 54 in which the matrix is SIS.

56. The device of claim 53 in which the connecting member and the barbs are formed from layers of naturally occurring extracellular matrix laminated together and cured to form a rigid and hardened sheet-like body, the barbs and the connecting member being cut from the body.

57. The device of claim 56 in which the barbs and connecting member are cut by laser machining a pattern on the sheet-like body.

58. The device of claim 57 in which the barbs have edges formed by fusing the layers together in the laser machining.

59. The device of claim 58 further having a plurality of laser-cut holes.

60. The device of claim 56 comprising a third barb cut from the sheet-like body and having a sharpened distal end and a proximal end formed from the sheet-like body, the connecting member being cut from the sheet-like body to connect to the proximal end of the third barb.

61. The device of claim 60 in which the three barbs lie in generally the same plane.

62. The device of claim 53 in which the barbs and the connecting member are machined from a single piece of extracellular matrix.

63. The device of claim 53 in which the barbs are machined from extracellular matrix cured to be hard and rigid and each barb has a proximal end portion configured to receive an end of the connecting member.

64. The device of claim 63 in which the connecting member is machined from extracellular matrix.

65. A device for anchoring a bone plug in an opening formed in a bone, the device comprising a mass of naturally occurring extracellular matrix formed into a rigid and hardened member configured to be wedged in the opening between the bone plug and the bone.

66. The device of claim 65 in which the member has a body portion formed with outwardly extending barbs to dig into the bone plug and bone.

67. The device of claim 66 in which the member is provided with a connecting portion to extend into the bone plug.

68. The device claim 65 in which the member is elongated to extend axially along side the bone plug, the member having a plurality of radially outwardly and longitudinally extending fins to dig into the bone plug and bone.

69. The device of claim 68 in which the elongated member is cannulated longitudinally to be sleeved over an elongated guide member such as a K- wire.

70. The device of claim 65 in which the matrix is SIS.

71. The device of claim 70 in which the SIS is cured by drying at room temperature to form the rigid and hardened member.

72. The device of claim 70 in which the SIS has a hardness of about 70 on the “

D”

scale.

73. The device of claim 65 in which the member is formed in the shape of a screw to be threaded into the opening between the bone plug and bone.

106. The device of claim 70 in which the SIS has a hardness of at least 70 on the “

D”

scale.

74. A method for anchoring a bone plug into an opening formed in a bone for receiving the plug, the method comprising the steps of:

providing a member formed into a rigid and hardened mass of naturally occurring extracellular matrix, and placing the member into the opening between the bone plug and the bone.

75. The method of claim 74 in which the member is provided with barbs that dig into the bone plug and bone.

76. The method of claim 74 in which the member is elongated to extend alongside the bone plug to be wedged between the bone plug and bone.

77. The method of claim 74 in which the member is elongated and threaded to provide a screw to be threaded between the bone plug and the bone.

78. The method of claim 74 in which the bone opening is formed with cylindrical wall and a bottom to receive a cylindrical bone plug, and the placing step comprising placing the member in the opening to engage the bone plug and the bone.

79. The method of claim 78 in the member is provided as a double- ended tack, one end of which extends into the bottom of the opening and the other end of which extends into a bottom surface of the bone plug.

80. The method of claim 79 in which the bottom surface of the bone plug is formed to have a split end, and the placing step further comprises forcing the bone plug split end over the other end of the tack to wedge the bone plug outwardly against the bone opening wall.

81. The method of claim 80 in which the split end of the bone plug is provided with a central pilot hole for receiving the other end of the tack.

82. The method of claim 74 in which the matrix is SIS.

83. The method of claim 82 in which the SIS is cured by drying at room temperature to form the rigid and hardened member.

84. The device of claim 83 in which the SIS has a hardness of about 70 on the “

D”

scale.

85. A device for attaching a soft tissue to a bone that has been prepared with an opening to receive the device, the device being formed from a hardened mass of naturally occurring extracellular matrix to form an elongated body to be received in the opening, the body having a channel therein for receiving a portion of the soft tissue, the body being configured to collapse inwardly to grip and hold the soft tissue portion in the channel when the body is inserted into the opening.

86. The device of claim 85 in which the body is elongated and formed generally about an axis, the body having a threaded outer surface to accomplish threading the device into the bone opening.

87. The device of claim 86 in which the body is formed such that the channel is a central bore extending through at least a portion of the body, the body having an axially extending slot opening between the channel and the outer surface to accommodate the inward collapse of the device as the device is threaded into the bone opening.

88. The device of claim 85 in which the matrix is SIS.

89. The device of claim 88 in which the mass of SIS is dried to be hardened and then machined to have external threads for threadedly engaging the bone opening.

90. The device of claim 89 in which the device is provided with an axial slot to accommodate the inward collapse of the device as it is threaded into the bone opening.

91. The device of claim 85 in which the body is elongated and formed generally about an axis, the body having an outer surface providing radially outwardly extending engagers to engage into bone.

92. The device of claim 91 in which the engagers are formed to have axially and radially inclined surfaces that force the device to collapse inwardly.

93. A tack for driving into a bone, the tack having a proximal head end portion, a distal pointed end portion, and an intermediate body portion, the tack being formed from a hardened mass of naturally occurring extracellular matrix.

94. The tack of claim 93 in which the intermediate body portion is formed with barbs extending radially outwardly and axially toward the head end portions.

95. The tack of claim 94 in which the barbs are each formed in part by forming flats on the intermediate body portion.

96. The device of claim 93 in which the matrix is SIS.

97. The device of claim 96 in which the SIS is comminuted.

98. The device of claim 97 in which the SIS is cured by air drying.

99. The device of claim 97 in which the SIS is dried at room temperature.

100. The device of claim 97 in which the SIS is dried with pressure.

101. The device of claim 97 in which the SIS is dried with heat.

102. The device of claim 101 in which the SIS is dried with pressure.

103. The device of claim 97 in which the SIS has a hardness of at least 30 on the “

D”

scale.

104. The device of claim 103 in which the SIS has a hardness of at least 50 on the “

D”

scale.

105. The device of claim 104 in which the SIS has a hardness of at least 60 on the “

D”

scale.

107. The device of claim 96 in which the SIS has a hardness of at least 30 on the “

D”

scale.

108. The device of claim 96 in which the SIS has a hardness of at least 60 on the “

D”

scale.

109. The device of claim 96 in which the SIS has a hardness of at least 70 on the “

D”

scale.

110. A device for regenerating a meniscus or a portion thereof, the device comprising a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally occurring extracellular matrix, and a support structure disposed between the upper panel and lower panel, the support structure comprising one or more members of rigid and hardened naturally occurring extracellular matrix.

111. The device of claim 110 in which the one or more members comprise a plurality of generally wedge shaped members, each member having an upper edge supporting the upper panel and a lower edge supported on the lower panel.

112. The device of claim 110 in which the one or more members comprise a plurality of wafer-like members, each member having a generally wedge shape corresponding to a meniscus section taken from a natural meniscus in a plane extending radially outwardly and axially along the tibial axis, the plurality of members being disposed in a side-by-side relation about the circumference of the meniscus being generated between the upper and lower panels, each member having an upper edge supporting the upper panel and a lower edge resting on the lower panel.

113. The device of claim 112 in which the plurality of wafer-like members are connected together to allow some individual movement of each member.

114. The device of claim 112 in which each of the members is provided with an opening therethrough, and the device further comprises a connecting member extending through the openings in the members.

115. The device of claim 110 in which the extracellular matrix is rigid and hardened SIS.

117. An orthopedic device comprising a mass of naturally occurring extracellular matrix having a hardness greater than 30 HRD on the Rockwell D Scale.

118. The orthopedic device of claim 117 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 60 HRD on the Rockwell D scale.

119. The orthopedic device of claim 117 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 70 HRD on the Rockwell D scale.

121. The orthopedic device of claim 117 wherein the mass of naturally occurring extracellular matrix has a density greater than 0.7 g/cc.

122. The orthopedic device of claim 117 wherein the device is a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring ECM that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring ECM having a density less than 0.7 g/cc;

a mat including a nonwoven naturally occurring ECM;

braided naturally occurring ECM;

an ECM foam;

an ECM laminate;

an ECM woven;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven material; and

a mat including a nonwoven naturally occurring biologically absorbable polymer.

123. The orthopedic device of claim 117 wherein the device comprises a configuration selected from the group consisting of:

an orthopedic tack comprising a monolithic head portion and a body portion;

an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone;

an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs;

an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs;

an anchor for anchoring a bone plug in an opening formed in bone, the naturally occurring extracellular matrix being configured to be wedged between the bone plug and the bone;

an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression;

an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a hardness greater than 30 HRD on the Rockwell D Scale and the inner portion has a hardness less than 70 HRD on the Rockwell D Scale; and

a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally occurring extracellular matrix.

124. The orthopedic device of claim 123 wherein the device comprises a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring extracellular matrix that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring extracellular matrix having a density less than 0.7 g/cc;

a mat of nonwoven naturally occurring extracellular matrix;

an ECM foam;

an ECM laminate;

an ECM woven;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven; and

a mat of nonwoven naturally occurring biologically absorbable polymer.

125. The orthopedic device of claim 124 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 60 HRD on the Rockwell D Scale.

120. The orthopedic device of 117-wherein the mass of naturally occurring extracellular matrix has a density greater than 0.5 g/cc.

126. The orthopedic device of 125 wherein the mass of naturally occurring extracellular matrix has a hardness of at least 70 HRD on the Rockwell D scale.

127. A composite orthopedic device comprising two connected portions, each portion comprising naturally occurring extracellular matrix material, each portion having a hardness and a density, wherein one portion is configured for anchoring the device to native tissue and has a hardness of no less than 50 HRD on the Rockwell D Scale and a density greater than 0.5 g/cc, and the other portion has a different configuration, a different hardness and a different density.

128. The composite orthopedic device of claim 127 wherein at least one of the portions has a density of no less than 0.7 g/cc.

129. The composite device of claim 127 wherein at least one of the portions further comprises a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a mat including nonwoven naturally occurring extracellular matrix;

an ECM foam;

an ECM laminate;

an ECM woven;

a toughened ECM material;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven; and

a mat including nonwoven naturally occurring biologically absorbable polymer.

130. The composite device of claim 127 wherein the device comprises a configuration selected from the group consisting of:

an orthopedic tack comprising a monolithic head portion and a body portion;

an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone;

an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs;

an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs;

an anchor for anchoring a bone plug in an opening formed in bone, at least part of the device being configured to be wedged between the bone plug and the bone;

an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression;

a meniscal repair device comprising a pair of barbs and a sheet of naturally occurring extracellular matrix material extending between the barbs;

an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a density greater than the inner portion; and

a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally occurring extracellular matrix.

131. An orthopedic device comprising bioremodelable collagenous tissue matrix having a hardness greater than 30 HRD on the Rockwell D Scale.

132. The orthopedic device of claim 131 wherein the bioremodelable collagenous tissue matrix has a hardness of at least 60 HRD on the Rockwell D scale.

133. The orthopedic device of claim 131 wherein the bioremodelable collagenous tissue matrix has a hardness of at least 70 HRD on the Rockwell D scale.

134. The orthopedic device of claim 131 wherein the bioremodelable collagenous tissue matrix has a density greater than 0.5 g/cc.

135. The orthopedic device of claim 131 wherein the bioremodelable collagenous tissue matrix has a density greater than 0.7 g/cc.

136. The orthopedic device of claim 131 wherein the device comprises a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring bioremodelable collagenous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring bioremodelable collagenous tissue matrix having a density less than 0.7 g/cc;

a mat including a non-woven naturally occurring bioremodelable collagenous tissue matrix;

braided naturally occurring bioremodelable collagenous tissue matrix;

a foam comprising bioremodelable collagenous tissue matrix;

a laminate comprising bioremodelable collagenous tissue matrix;

a woven material comprising bioremodelable collagenous tissue matrix;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven material; and

a mat including a non-woven biologically absorbable polymer.

137. The orthopedic device of claim 131 wherein the device comprises a configuration selected from the group consisting of:

an orthopedic tack comprising a monolithic head portion and a body portion;

an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone;

an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of -the barbs;

an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs;

an anchor for anchoring a bone plug in an opening formed in bone, the bioremodelable collagenous tissue matrix being configured to be wedged between the bone plug and the bone;

an anchor comprising a body having a channel therein, the body being configured to collapse inwardly under compression;

an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a hardness greater than 50 HRD on the Rockwell D Scale and the inner portion has a hardness less than 70 HRD on the Rockwell D Scale; and

a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion, the panels being formed of a naturally occurring bioremodelable collagenous tissue matrix.

138. The orthopedic device of claim 137 wherein the device comprises a composite with a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a naturally occurring bioremodelable collagenous tissue matrix that has a hardness less than 70 HRD on the Rockwell D Scale;

a naturally occurring bioremodelable collagenous tissue matrix having a density less than 0.7 g/cc;

a mat of nonwoven naturally occurring bioremodelable collagenous tissue matrix;

a foam comprising bioremodelable collagenous tissue matrix;

a laminate comprising bioremodelable collagenous tissue matrix;

a woven material comprising bioremodelable collagenous tissue matrix;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven; and

a mat of non-woven biologically absorbable polymer.

139. The orthopedic device of claim 138 wherein the bioremodelable collagenous tissue matrix has a hardness of at least 50 HRD on the Rockwell D Scale.

140. The orthopedic device of claim 137 wherein the bioremodelable collagenous tissue matrix has a hardness of at least 70 HRD on the Rockwell D scale.

141. A composite orthopedic device comprising two connected portions, each portion comprising naturally occurring bioremodelable collagenous tissue matrix, each portion having a hardness and a density, wherein one portion has a hardness of no less than 50 HRD on the Rockwell D Scale and a density greater than 0.5 g/cc, and the other portion has a different hardness and a different density.

142. The composite orthopedic device of claim 141 wherein at least one of the portions has a density of no less than 0.7 g/cc.

143. The composite device of claim 141 wherein at least one of the portions comprises a material selected from the group consisting of:

a bioactive agent;

a biologically derived agent;

a biological lubricant;

a biocompatible polymer;

a biocompatible inorganic material;

cells;

chondrocytes;

osteocytes;

synoviocytes;

a mat including non-woven naturally occurring bioremodelable collagenous tissue matrix;

a foam comprising bioremodelable collagenous tissue matrix;

a laminate comprising bioremodelable collagenous tissue matrix;

a woven material comprising bioremodelable collagenous tissue matrix;

a toughened bioremodelable collagenous tissue matrix material;

a biologically absorbable polymer laminate;

a biologically absorbable polymer foam;

a biologically absorbable polymer woven; and

a mat including non-woven biologically absorbable polymer.

144. The composite device of claim 141 wherein the device comprises a configuration selected from the group consisting of:

an orthopedic tack comprising a monolithic head portion and a body portion;

an anchor for attaching soft tissue to bone, the device having a portion configured to engage soft tissue and an integral portion configured to engage bone;

an anchor comprising at least two spaced apart barbs, each barb having a sharpened distal end and a proximal end, the device further comprising a member connecting the proximal ends of the barbs;

an anchor comprising at least two spaced apart barbs and an integral member connecting the two barbs;

an anchor for anchoring a bone plug in an opening formed in bone, at least part of the device being configured to be wedged between the bone plug and the bone;

an anchor comprising a body having a, channel therein, the body being configured to collapse inwardly under compression;

a meniscal repair device comprising a pair of barbs and a sheet of naturally occurring extracellular matrix material extending between the barbs;

an outer shell portion and an inner portion surrounded by the shell, wherein the outer shell portion has a density greater than the inner portion; and

a wedge-shaped body having an upper panel and a lower panel. angularly separated to define an apex portion and a base portion, the panels being formed of a naturally occurring bioremodelable collagenous tissue matrix.