Meniscus regeneration device

• US 8,092,529 B2
• Filed: 07/15/2002
• Issued: 01/10/2012
• Est. Priority Date: 07/16/2001
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: Malaviya, Prasanna, Schwartz, Herbert Eugene, Whalen, Terrence David, Pelo, Mark Joseph, Jenks, Philip Joseph, Plouhar, Pamela Lynn, Lower, Jerry Lee
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/195,794
• Publication Number:
  US 20030036797A1
• Time in Patent Office: 3,466 Days
• Field of Search: 623/23.52, 623/23.63, 623/23.72, 623/14.12, 623/13.17
• US Class Current: 623/14.12
• 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 2017/00526 Methods of manufacturing
• 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 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• 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 2002/2817 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 27/3629 : Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/3633 : Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3654 : Cartilage, e.g. meniscus
• 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 27/3691 : 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 27/3852 : Cartilage, e.g. meniscus
• 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: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Methods and devices are provided for regenerating a meniscus. The devices comprise a layer of toughened naturally occurring extracellular matrix. The devices may, optionally, further comprise a biologic material to provide a framework for meniscus regeneration. The methods comprise the steps of removing a portion of a meniscus to provide a space, and inserting a device comprising a layer of toughened naturally occurring extracellular matrix into the space.

Claims

1. A device for insertion into a space in a knee meniscus from which space a meniscus portion has been removed, the device comprising:

a shell defining an interior space, said shell comprising an extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane that has been dehydrated by dehydrothermal cross-linking, wherein at least a portion of the dehydrothermal cross-linked extracellular matrix has a density of at least 0.9 gm/cm³.

2. The device of claim 1 wherein a biological material is contained within the interior space of said shell.

20. The device of claim 1 wherein the shell is formed as a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion.

21. The device of claim 20 wherein the upper and lower panels have outer edges joined together by dehydrothermal cross-linking, said joined edges having a density of at least 0.9 gm/cm³.

22. The device of claim 21 wherein a biological material is contained within the interior space.

23. The device of claim 22 wherein the biological material comprises fibrin, blood clot, platelet rich plasma, comminuted extracellular matrix or combinations thereof.

24. The device of claim 22 wherein the biological material comprises material selected from the group consisting of comminuted small intestine submucosa, small intestine submucosa pieces, small intestine submucosa foam, an small intestine submucosa roll, woven small intestine submucosa, non-woven small intestine submucosa mat, braided small intestine submucosa, small intestine submucosa solution, small intestine submucosa dispersion, small intestine submucosa slurry, small intestine submucosa gel, small intestine submucosa paste, and small intestine submucosa that has not been toughened.

3. An implantable device for regenerating at least a portion of a meniscus of a knee, the device comprising:

a dehydrated cover sheet and

a mass of extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, the dehydrated cover sheet extending over and beyond the mass of extracellular matrix, wherein at least a portion of the dehydrated cover sheet has a density of at least 0.9 gm/cm³.

4. The implantable device of claim 3 wherein the extracellular matrix comprises small intestine submucosa.

5. The implantable device of claim 4 wherein the small intestine submucosa comprises at least one material selected from the group consisting of:

comminuted small intestine submucosa, small intestine submucosa pieces, small intestine submucosa foam, an small intestine submucosa roll, woven small intestine submucosa, non-woven small intestine submucosa mat, braided small intestine submucosa, small intestine submucosa solution, small intestine submucosa dispersion, small intestine submucosa slurry, small intestine submucosa gel, small intestine submucosa paste, and small intestine submucosa that has not been toughened.

6. The implantable device of claim 3 wherein the cover sheet comprises at least one of the following:

a biocompatible polymer and extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.

7. The implantable device of claim 3 further comprising at least one of the following:

a bioactive agent, a biologically-derived agent, cells, a biological lubricant, a biocompatible polymer, and a biocompatible inorganic material.

8. The implantable device of claim 3 further comprising at least one biologically compatible material associated with the mass of extracellular matrix, said biologically compatible material selected from the group consisting of:

a bioactive agent, a biologically-derived agent, cells, a biological lubricant, a biocompatible polymer, and a biocompatible inorganic material.

9. The implantable device of claim 3 wherein the cover sheet comprises a wedge-shaped body having an upper panel and a lower panel angularly separated to define an apex portion and a base portion.

10. The implantable device of claim 9 wherein the mass of extracellular matrix is positioned between the upper panel and lower panel.

11. The implantable device of claim 3 wherein the cover sheet has a toughness sufficient to at least temporarily withstand the forces of articulation at the knee without degrading.

12. The implantable device of claim 3 wherein the cover sheet is treated to increase its density.

13. The implantable device of claim 3 wherein the cover sheet has a density greater than the density of the mass of extracellular matrix.

25. The implantable device of claim 3 wherein the cover sheet comprises a biocompatible polymer and extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane.

14. An implantable device for regenerating at least a portion of a meniscus of a knee, the device comprising at least two adjacent dehydrated materials having different densities, wherein each of the materials comprises extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane, wherein at least a portion of one of the dehydrated materials is treated to increase its density to a density of at least 0.9 gm/cm³.

15. The implantable device of claim 14 wherein the extracellular matrix comprises small intestine submucosa.

16. The implantable device of claim 14 wherein one of the materials comprises a mass of biological material and the other material comprises a cover.

17. The implantable device of claim 14 wherein at least a portion of the other dehydrated materials has a density greater than 0.5 gm/cm³ when dehydrated.

18. An implantable device for repairing or regenerating at least a portion of the tissue of a vertebrate, the device comprising a sheet of extracellular matrix selected from the group consisting of small intestine submucosa, stomach submucosa, bladder submucosa, alimentary submucosa, respiratory submucosa, genital submucosa, and liver basement membrane dehydrated to have a density of at least 0.9 gm/cm3, wherein the extracellular matrix has been dehydrated by dehydrothermal cross-linking.

19. The device of claim 18 wherein the dehydrothermal cross-linking comprises applying mechanical pressure to the extracellular matrix while using vacuum to remove water.