Soft and calcified tissue implants

• US 20050101957A1
• Filed: 12/08/2004
• Published: 05/12/2005
• Est. Priority Date: 01/11/2000
• Status: Active Grant

• Current Assignee: RTI Surgical Incorporated
• Original Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Inventors: Seid, Chris, Gross, James M., Buskirk, Dayna, Wironen, John F., Scurti, Gina
• Granted Patent: US 7,513,910 B2
• Time in Patent Office: Days
• US Class Current: 623/16.110
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/8645 Headless screws, e.g. ligament interference screws
• 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 2/3094 Designing or manufacturing processes
• 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 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• 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 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30057 made from both cortical and cancellous adjacent parts
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30153 : rectangular
• CPC Class Codes: A61F 2002/30179 : X-shaped
• CPC Class Codes: A61F 2002/30224 : cylindrical
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30261 : parallelepipedal
• CPC Class Codes: A61F 2002/30266 : wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/3028 : polyhedral different from parallelepipedal and pyramidal
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30354 : Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• 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 2002/30387 : Dovetail connection
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30795 : Blind bores, e.g. of circular cross-section
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30962 : using stereolithography
• CPC Class Codes: A61F 2002/30975 : made of two halves
• CPC Class Codes: A61F 2002/4649 : Bone graft or bone dowel harvest sites
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : 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 2220/005 : using adhesives
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2/0082 : using chemical substances
• CPC Class Codes: A61L 24/0005 : Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 2430/34 : for soft tissue reconstruction
• CPC Class Codes: A61L 2430/40 : Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3641 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 : Connective tissue
• CPC Class Codes: A61L 27/365 : Bones
• CPC Class Codes: A61L 27/3658 : Intervertebral discs mechanical aspects and structures of intervertebral discs A61F2/442
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3687 : characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 : characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 31/005 : Ingredients of undetermined constitution or reaction products thereof

Abstract

Disclosed herein is processed dermis graft for use in orthopedic surgical procedures. Specifically exemplified herein is a processed dermis graft comprising one or more bone blocks having a groove cut into the surface thereof, wherein said groove is sufficient to accommodate a fixation screw. Also disclosed is a method of processing dermis that results in a dermis derived implant suitable to replace a tendon or ligament in a recipient in need thereof. Other compositions and applications of a dermis derived implant, and methods of manufacture and use, are disclosed.

Claims

1-63. -63. (canceled)

64. A dermis derived bone-ended graft useful in orthopedic surgery comprising at least one assembled bone block and an elongated section of processed dermis attached to said at least one bone block.

65. The graft of claim 64, wherein at least one of the at least one assembled bone block is comprised of cortical, cancellous, cortico-cancellous, or demineralized bone, obtained from human or xenograft sources.

66. The graft of claim 65, wherein at least one of the at least one assembled bone block is comprised of two segments.

67. The graft of claim 66, wherein said two segments are in the shape of disks.

68. A soft tissue implant for spanning two or more vertebrae, or for spanning a bone fracture site, comprising:

a. a middle section capable of flexion and having a first end and an opposing second end;

b. a top section attached to the first end of said middle section and comprising a first assembled bone block having at least one aperture for attaching to a first vertebrae or to a section of bone on a first side of a fracture, said first assembled bone block comprising two segments of cortical bone; and

c. a bottom section attached to the second end of said middle section and comprising a second assembled bone block having at least one aperture for attaching to a second vertebrae or to a section of bone on an opposing side of a fracture, said second assembled bone block comprising two segments of cortical bone.

69. The soft tissue implant of claim 68, wherein said middle section comprises dermis, fascia, pericardium, woven soft tissue, urinary bladder matrix, peritoneum, or demineralized bone.

70. The soft tissue implant of claim 68, wherein the first end and the second end of said middle section are calcified.

71. The soft tissue implant of claim 68, wherein said top section and said bottom section comprise allograft bone.

72. The soft tissue implant of claim 68, wherein said top section comprise xenograft bone.

73. An implant for use as a tension band between vertebrae in a patient in need thereof, comprising a longitudinal device having a top section, a bottom section, and a middle section, the middle section being flexible, wherein the top and the bottom sections each comprise an assembled bone block having a plurality of holes that facilitate attachment to a corresponding vertebrae.

74. The implant of claim 73, wherein said middle section is fabricated from a material selected from the group consisting of segmentally demineralized bone, fascia, pericardium, ligament, tendon, muscle, dura, xenograft demineralized bone, xenograft segmentally demineralized bone and a combination thereof.