Cartilage repair and regeneration device and method

• US 20030033022A1
• Filed: 07/15/2002
• Published: 02/13/2003
• 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: Plouhar, Pamela Lynn, Malaviya, Prasanna, Schwartz, Herbert Eugene
• Granted Patent: US 8,012,205 B2
• Time in Patent Office: Days
• US Class Current: 623/23.57
• 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 or resorptive
• 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: 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 2002/2817 : 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 27/3604 : 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 27/3633 : 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 27/3852 : 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: 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

A method for the repair of a cartilagenous tissue defect, a cartilage repair device and a method of making a cartilage repair device are disclosed. In the method for the repair of a cartilagenous tissue defect, a device comprising a scaffold, for example an extracellular matrix material, is implanted into the defect, and a biological lubricant is administered to the defect. The device comprises a scaffold, for example a naturally occurring extracellular matrix material, and a biological lubricant.

Claims

1. A method for the repair of a cartilagenous tissue defect comprising the steps of

implanting a scaffold into the defect, and

administering a biological lubricant to the defect.

2. The method of claim 1 wherein the implanting step and administering step take place during a single surgical procedure.

3. The method of claim 2 further comprising an additional postoperative administration of the biological lubricant to the defect.

4. The method of claim 1 wherein the biological lubricant comprises a GAG.

5. The method of claim 1 wherein the biological lubricant is selected from the group consisting of hyaluronic acid;

a salt of hyaluronic acid;

sodium hyaluronate;

a glucosaminoglycan;

dermatan sulfate;

heparan sulfate;

chondroiton sulfate;

keratan sulfate;

synovial fluid;

a component of synovial fluid;

vitronectin; and

rooster comb hyaluronate.

6. The method of claim 1 further comprising the step of

closing an incision site created to implant the scaffold,

wherein the administering step is subsequent to the closing step, and the biological lubricant is administered to the defect via injection in the area of the defect.

7. The method of claim 1 wherein the defect is in the knee and the biological lubricant is administered by injection into the knee joint cavity.

8. The method of claim 1 wherein the biological lubricant is administered to the defect by saturating the device with a biological lubricant solution prior to implantation.

9. The method of claim 1 wherein the device is provided pre-saturated with biological lubricant and in a lyophilized form, and further comprising the step of

rehydrating the device prior to implantation.

10. The method of claim 1 further comprising the step of

providing a series of additional biological lubricant injections to the area of the defect subsequent to the implanting and administering steps.

11. The method of claim 10 wherein the defect is in the knee joint and the injections are into the knee joint cavity.

12. The method of claim 10 wherein the series of additional biological lubricant injections comprises a first additional biological lubricant injection two weeks subsequent to implantation and a second additional biological lubricant injection four weeks subsequent to implantation.

13. The method of claim 1 wherein the defect is in a meniscus and implanting step comprises

performing a partial menisectomy to create a space,

placing the device into the space, and

fixing the device to surrounding meniscal tissue.

14. The method of claim 1 wherein the defect is in articular cartilage and the implanting step comprises creating a space in the articular cartilage, placing the device into the space, and fixing the device to surrounding native tissue.

15. The method of claim 1 wherein the scaffold comprises an extracellular matrix.

16. The method of claim 15 wherein the extracellular matrix comprises naturally occurring tissue derived from a source selected from the group consisting of:

vertebrate small intestine submucosa;

vertebrate liver basement membrane;

vertebrate bladder submucosa;

vertebrate stomach submucosa;

vertebrate alimentary tissue;

vertebrate respiratory tissue; and

vertebrate genital tissue.

17. The method of claim 15 wherein the naturally occurring extracellular matrix comprises tissue derived from at least one of the following sources:

bovine tissue;

ovine tissue; and

porcine tissue.

18. The method of claim 1 wherein the device further comprises a material selected from the group consisting of:

a bioactive agent;

a biologically derived substance;

cells;

a biocompatible polymer; and

a biocompatible inorganic material.

19. A method for the repair of a cartilagenous tissue defect comprising the steps of

implanting a device comprising an extracellular matrix into the defect, and

administering a GAG to the defect.

20. The method of claim 19 wherein the extracellular matrix comprises naturally occurring tissue derived from a source selected from the group consisting of:

vertebrate small intestine submucosa;

vertebrate liver basement membrane;

vertebrate bladder submucosa;

vertebrate stomach submucosa;

vertebrate alimentary tissue;

vertebrate respiratory tissue; and

vertebrate genital tissue.

21. The method of claim 19 wherein the naturally occurring extracellular matrix comprises tissue derived from a source selected from the group consisting of:

bovine tissue;

ovine tissue; and

porcine tissue.

22. The method of claim 19 wherein the implanting step and administering step take place during a single surgical procedure.

23. The method of claim 22 further comprising an additional postoperative administration of a biological lubricant to the defect.

24. The method of claim 23 wherein the biological lubricant of the additional post-operative administration comprises the GAG.

25. The method of claim 24 wherein the GAG comprises HA.

26. The method of claim 25 wherein the HA has a molecular weight ranging from about 300,000 kDa to about 6,000,000 kDa.

27. The method of claim 26 wherein the HA has a molecular weight ranging from about 2,400,000 and 3,600,00 kDa.

28. The method of claim 19 further comprising the step of closing an incision site created to implant the device, and wherein the administering step is subsequent to the closing step, and the GAG is administered to the defect via injection in the area of the defect.

29. The method of claim 28 wherein the defect is in the knee and the injection is into the knee joint cavity.

30. The method of claim 19 wherein the biological lubricant is administered to the defect by saturating the device with a biological lubricant solution prior to implantation.

31. The method of claim 19 wherein the device is provided pre-saturated with biological lubricant and in a lyophilized form, and further comprising the step of re-hydrating the device prior to implantation.

32. The method of claim 19 further comprising the step of

providing a series of post-operative biological lubricant injections to the area of the defect subsequent to the surgery.

33. The method of claim 32 wherein the series of post-operative biological lubricant injections comprises a first post-operative lubricant injection two weeks subsequent to the surgical procedure and a second post-operative biological lubricant injection four weeks subsequent to the surgical procedure.

34. The method of claim 19 wherein the defect is in a meniscus and implanting step comprises

performing a partial menisectomy to create a space,

placing the device into the space, and

fixing the device to surrounding meniscal tissue.

35. The method of claim 19 wherein the defect is in articular cartilage and the implanting step comprises removing the defect from the articular cartilage to create a space, placing the device into the space, and fixing the device to surrounding native tissue.

45. The cartilage repair device of claim 35 wherein the extracellular matrix comprises a plug configured to be positioned in an opening formed in damaged cartilage.

46. The cartilage repair device of claim 45 wherein the plug is secured to an anchor.

47. The cartilage repair device of claim 45 further comprising an anchor configured to secure the plug in the opening.

36. A cartilage repair device comprising naturally occurring extracellular matrix and a biological lubricant applied to the naturally occurring extracellular matrix.

37. The cartilage repair device of claim 36 wherein the biological lubricant comprises a solution.

38. The cartilage repair device of claim 37 wherein the biological lubricant solution comprises a GAG.

39. The cartilage repair device of claim 38 wherein the biological lubricant solution comprises HA.

40. The cartilage repair device of claim 36 wherein the naturally occurring extracellular matrix and biological lubricant are co-lyophilized.

41. The cartilage repair device of claim 36 wherein the biological lubricant portion is crosslinked onto the naturally occurring extracellular matrix portion.

42. The cartilage repair device of claim 36 further comprising an additional material selected from the group consisting of:

a bioactive agent;

a biologically derived substance; and

cells.

43. The cartilage repair device of claim 36 wherein the naturally occurring extracellular matrix comprises tissue derived from a source selected from the group consisting of:

vertebrate small intestine submucosa;

vertebrate liver basement membrane;

vertebrate bladder submucosa;

vertebrate stomach submucosa;

vertebrate alimentary tissue;

vertebrate respiratory tissue; and

vertebrate genital tissue.

44. The cartilage repair device of claim 36 wherein the naturally occurring extracellular matrix comprises tissue derived from a source selected from the group consisting of:

bovine tissue;

ovine tissue; and

porcine tissue.

48. A method of making a cartilage repair device comprising:

providing a naturally occurring extracellular matrix;

providing a biological lubricant in liquid form; and

wetting the naturally occurring extracellular matrix with the liquid biological lubricant to form a wet implant.

49. The method of claim 48 further comprising packaging the wet implant and terminally sterilizing the packaged wet implant.

50. The method of claim 48 further comprising drying the wet implant, packaging the dry implant and terminally sterilizing the packaged dry implant.

51. The method of claim 48 wherein providing a naturally occurring extracellular matrix comprises providing tissue derived from a source selected from the group consisting of:

vertebrate small intestine submucosa;

vertebrate liver basement membrane;

vertebrate bladder submucosa;

vertebrate stomach submucosa;

vertebrate alimentary tissue;

vertebrate respiratory tissue; and

vertebrate genital tissue.

52. The method of claim 51 wherein the naturally occurring extracellular matrix comprises tissue derived from a source selected from the group consisting of:

bovine tissue;

ovine tissue; and

porcine tissue.

53. The method of claim 48 further comprising incorporating a material into the device, the material selected from the group consisting of:

a bioactive agent;

a biologically derived substance; and

cells.

54. A method for the repair of a cartilagenous tissue defect comprising the steps of

implanting a device comprising bioremodelable collagenous tissue matrix into the defect, and

administering a biological lubricant to the defect.

55. The method of claim 54 wherein the biological lubricant is fluidized.

56. The method of claim 54 wherein the biological lubricant comprises GAG.

57. The method of claim 54 wherein the biological lubricant includes a component selected from the group consisting of:

hyaluronic acid;

a salt of hyaluronic acid;

sodium hyaluronate;

a glycosaminoglycan;

dermatan sulfate;

heparan sulfate;

chondroiton sulfate;

keratan sulfate;

synovial fluid;

a component of synovial fluid;

vitronectin; and

rooster comb hyaluronate.

58. The method of claim 54 wherein the biological lubricant has a viscosity substantially the same as that of a compound selected from the group consisting of hyaluronic acid, salts of hyaluronic acid, and synovial fluid.

59. A method for the repair of a cartilagenous tissue defect comprising the steps of

implanting a device comprising bioremodelable collagenous tissue matrix into the defect, and

administering a biological lubricant to the defect, the biological lubricant selected from the group consisting of hyaluronic acid and sodium hyaluronate.

60. The method of claim 59 wherein the bioremodelable collageneous tissue matrix comprises a naturally occurring matrix.