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US6409764B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Methods and articles for regenerating bone or peridontal tissue

Assignee: W.L. Gore and Associates Inc
•
Filing: 1998-12-03
•
Granted: 2002-06-25
•
Expires: 2018-12-03
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Abstract

Abstract There are numerous medical situations involving deficiencies of living bone or periodontal tissue and where increase of living bone or periodontal tissue mass is desired. Methods are described wherein a configured, shell-like device that is capable of being penetrated by living cells and tissues, is implanted into the body of a mammal in such a way as to establish a space, the space being at least partly, bounded by the device. The configuration of the device is such that the configuration of the established space is essentially the same as the configuration of living bone or periodontal tissue that is desired for treatment of the tissue deficiency. At least one protein from the Transforming Growth Factor-Beta Superfamily of proteins is placed within the established space for the purpose of stimulating the growth of living bone or periodontal tissue within the established space. A kit for the generation of living bone or periodontal tissue, comprised of the components mentioned above, is also disclosed.

Inventors

  • 👤 Charles F. White
  • 👤 Charles Flynn
  • 👤 Alonzo D. Cook
  • 👤 William R. Hardwick
  • 👤 Ulf M. E. Wikesjo
  • 👤 Robert C. Thomson

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:02
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/38; A61L27/3839; A61L27/3843; A61L27/3865; A61C; A61C8/00; A61C8/0003; A61C8/0004; A61C8/0006; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2/2803; A61F2/2846; A61L27/3847; A61L27/40; A61L27/44; A61L27/48; A61L27/50; A61L27/54; A61L27/56; A61F2/30; A61F2/46; A61F2/468; A61F2002/2817; A61F2002/2835; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30108; A61F2002/3011; A61F2002/30138; A61F2002/30153; A61F2002/30199; A61F2002/30224; A61F2002/30235; A61F2002/30237; A61F2/30767; A61F2/30771; A61F2002/30772; A61F2002/30784; A61F2002/30785; A61F2002/30787; A61F2002/3082; A61F2/30907; A61F2002/30909; A61F2002/30914; A61F2/3094; A61F2/30942; A61F2002/30948; A61F2002/30971; A61F2210/00; A61F2210/0004; A61F2230/00; A61F2230/0002; A61F2230/0017; A61F2230/0019; A61F2230/0063; A61F2230/0069; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2300/00; A61L2300/40; A61L2300/412; A61L2300/414; A61L2300/60; A61L2300/64; A61L2430/00; A61L2430/02; Y; Y10; Y10S; Y10S623/00; Y10S623/901

Claims Analysis

Total Claims: 68
Claim 1
Independent Claim 157 words
A method of generating living bone having desired configuration in a mammal, said method comprising: providing a tissue penetrable device comprising portions having a plurality of holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired form and retained substantially in said desired form; establishing a space with said tissue penetrable device in a mammal in such a way that a boundary is at least partially formed by said tissue penetrable device between said space and anatomical structures of said mammal surrounding said space, wherein said space has essentially the same conjuration as bone to be generated therein; placing at least one TGF-Beta protein in said space; allowing cells and blood vessels from said mammal to traverse said tissue penetrable device through said holes into said space; and generating bone in said space.
Claim 2
Independent Claim 157 words
A method of generating living bone having desired configuration in a mammal, said method comprising: providing a tissue penetrable device comprising portions having a plurality of holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired form and retained substantially in said desired form; establishing a space with said tissue penetrable device in a mammal in such a way that a boundary is at least partially formed by said tissue penetrable device between said space and anatomical structures of said mammal surrounding said space, wherein said space has essentially the same conjuration as bone to be generated therein; placing at least one TGF-Beta protein in said space; allowing cells and blood vessels from said mammal to traverse said tissue penetrable device through said holes into said space; and generating bone in said space.
Claim 3
Dependent Claim 18 words
The method of claim 1 wherein said holes have diameters from about 3 microns to about 3,000 microns.
Claim 4
Dependent Claim 18 words
The method of claim 1 wherein said holes have diameters from about 50 microns to about 1,000 microns.
Claim 5
Dependent Claim 18 words
The method of claim 1 wherein said holes have diameters from about 150 microns to about 500 microns.
Claim 6
Dependent Claim 14 words
The method of claim 1 wherein said tissue penetrable device comprises a non-degradable material.
Claim 7
Dependent Claim 57 words
The method of claim 1 wherein said tissue penetrable device comprises a non-degradable material selected from the group consisting of polytetrafluoroethylene, perfluorinated polymers such as fluorinated ethylene propylene, silicone elastomer, polyurethane, polyethylene, polyethylene teraphthalate, polysulfone, non-degradable polycarboxylate, non-degradable polycarbonate, non-degradable polyester, polypropylene, polyacrylic, poly(hydroxymethacrylate), polymethylmethacrylate, and polyamide such as polyesteramide, and copolymers, block copolymers, and blends thereof.
Claim 8
Dependent Claim 13 words
The method of claim 1 wherein said tissue penetrable device comprises expanded polytetrafluoroethylene.
Claim 9
Dependent Claim 14 words
The method of claim 1 wherein said tissue penetrable device comprises a degradable material.
Claim 10
Dependent Claim 51 words
The method of claim 1 wherein said tissue penetrable device comprises a degradable material selected from the group consisting of non-highly cross-linked collagen, non-highly cross-linked hyaluronic acid, hydrolyzable polyester such as polylactic acid and polyglycolic acid, polyorthoester, degradable polycarbonate, degradable polycarboxylate, degradable polycaprolactone, polyanhydride and copolymers, block copolymers and blends thereof.
Claim 11
Dependent Claim 16 words
The method of claim 1 wherein said tissue penetrable device comprises a copolymer of polyglycolide/trimethylene carbonate.
Claim 12
Dependent Claim 15 words
The method of claim 1 wherein said tissue penetrable device is provided with reinforcement means.
Claim 13
Dependent Claim 12 words
The method of claim 11 wherein said reinforcement means comprises polypropylene mesh.
Claim 14
Dependent Claim 13 words
The method of claim 1 further comprising placing living cells in said space.
Claim 15
Dependent Claim 13 words
The method of claim 13 wherein said living cells comprises undifferentiated stem cells.
Claim 16
Dependent Claim 11 words
The method of claim 13 wherein said cells comprise cryopreserved cells.
Claim 17
Dependent Claim 18 words
The method of claim 1 further comprising providing said at least one TGF-J protein in a carrier substance.
Claim 18
Dependent Claim 29 words
The method of claim 16 wherein said carrier substance is selected from the group consisting of collagen, hyaluronic acid, calcium carbonate, tri-calcium phosphate, hydroxyapatite ceramic, magnesium sulfate, and polyester.
Claim 19
Dependent Claim 11 words
The method of claim 16 wherein said carrier substance comprises collagen.
Claim 20
Dependent Claim 12 words
The method of claim 16 wherein said carrier substance comprises hyaluronic acid.
Claim 21
Dependent Claim 26 words
The method of claim 1 further providing a matrix material within said space, said matrix material directing the functional structure of said desired living tissue generated.
Claim 22
Dependent Claim 48 words
The method of claim 1 wherein said TGF-Beta protein is selected from the group of TGF-Beta proteins consisting of TGF-Beta1, TGF-Beta2, BMP-2, BMP-1, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-15, Vgr-2, GDF-3, GDF-5, GDF-9, GDF-6, GDF-7, GDF-8, GDF-10, GDF-11, GDF-12, BIP, and MP52.
Claim 23
Dependent Claim 15 words
The method of claim 1 wherein said TGF-Beta protein is recombinant human Bone Morphogenetic Protein-2.
Claim 24
Independent Claim 160 words
A method of generating living periodontal tissue having desired configuration in a mammal, said method comprising: providing a tissue penetrable device comprising portions having a plurality of holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired form and retained substantially in said desired form; establishing a space with said tissue penetrable device in a mammal in such a way that a boundary is at least partially formed by said tissue penetrable device between said space and anatomical structures of said mammal surrounding said space, wherein said space has essentially the same configuration as periodontal tissue to be generated therein; placing at least one TGF-Beta protein in said space; allowing cells and blood vessels from said mammal to traverse said tissue penetrable device through said holes into said space; and generating periodontal tissue in said space.
Claim 25
Independent Claim 160 words
A method of generating living periodontal tissue having desired configuration in a mammal, said method comprising: providing a tissue penetrable device comprising portions having a plurality of holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired form and retained substantially in said desired form; establishing a space with said tissue penetrable device in a mammal in such a way that a boundary is at least partially formed by said tissue penetrable device between said space and anatomical structures of said mammal surrounding said space, wherein said space has essentially the same configuration as periodontal tissue to be generated therein; placing at least one TGF-Beta protein in said space; allowing cells and blood vessels from said mammal to traverse said tissue penetrable device through said holes into said space; and generating periodontal tissue in said space.
Claim 26
Dependent Claim 18 words
The method of claim 23 wherein said holes have diameters from about 3 microns to about 3,000 microns.
Claim 27
Dependent Claim 18 words
The method of claim 23 wherein said holes have diameters from about 50 microns to about 1,000 microns.
Claim 28
Dependent Claim 18 words
The method of claim 23 wherein said holes have diameters from about 150 microns to about 500 microns.
Claim 29
Dependent Claim 14 words
The method of claim 23 wherein said tissue penetrable device comprises a non-degradable material.
Claim 30
Dependent Claim 58 words
The method of claim 23 wherein said tissue penetrable device comprises a non-degradable material selected from the group consisting of polytetrafluoroethylene, perfluorinated polymers such as fluorinated ethylene propylene, silicone, silicone rubber, polyurethane, polyethylene, polyethylene teraphthalate, polysulfone, non-degradable polycarboxylate, non-degradable polycarbonate, non-degradable polyester, polypropylene, polyacrylic, poly(hydroxymethacrylate), polymethylmethacrylate, and polyamide such as polyesteramide, and copolymers, block copolymers, and blends thereof.
Claim 31
Dependent Claim 13 words
The method of claim 23 wherein said tissue penetrable device comprises expanded polytetrafluoroethylene.
Claim 32
Dependent Claim 14 words
The method of claim 23 wherein said tissue penetrable device comprises a degradable material.
Claim 33
Dependent Claim 51 words
The method of claim 23 wherein said tissue penetrable device comprises a degradable material selected from the group consisting of non-highly cross-linked collagen, non-highly cross-linked hyaluronic acid, hydrolyzable polyesters such as polylactic acid and polyglycolic acid, polyorthoester, degradable polycarbonate, degradable polycarboxylate, degradable polycaprolactone, polyanhydride, and copolymers block copolymers, and blends thereof.
Claim 34
Dependent Claim 16 words
The method of claim 23 wherein said tissue penetrable device comprises a copolymer of polyglycolide/trimethylene carbonate.
Claim 35
Dependent Claim 15 words
The method of claim 23 wherein said tissue penetrable device is provided with reinforcement means.
Claim 36
Dependent Claim 12 words
The method of claim 33 wherein said reinforcement means comprises polypropylene mesh.
Claim 37
Dependent Claim 13 words
The method of claim 23 further comprising placing living cells in said space.
Claim 38
Dependent Claim 13 words
The method of claim 35 wherein said living cells are undifferentiated stem cells.
Claim 39
Dependent Claim 11 words
The method of claim 35 wherein said cells are cryopreserved cells.
Claim 40
Dependent Claim 18 words
The method of claim 23 further comprising providing said at least one TGF-J protein in a carrier substance.
Claim 41
Dependent Claim 29 words
The method of claim 38 wherein said carrier substance is selected from the group consisting of collagen, hyaluronic acid, calcium carbonate, tri-calcium phosphate, hydroxyapatite ceramic, magnesium sulfate, and polyester.
Claim 42
Dependent Claim 11 words
The method of claim 38 wherein said carrier substance is degradable.
Claim 43
Dependent Claim 11 words
The method of claim 38 wherein said carrier substance comprises collagen.
Claim 44
Dependent Claim 12 words
The method of claim 38 wherein said carrier substance comprises hyaluronic acid.
Claim 45
Dependent Claim 26 words
The method of claim 23 further providing a matrix material within said space, said matrix material directing the functional structure of said desired living tissue generated.
Claim 46
Dependent Claim 48 words
The method of claim 23 wherein said TGF-Beta protein is selected from the group of TGF-Beta proteins consisting of TGF-Beta1, TGF-Beta2, BMP-2 BMP-1, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-15, Vgr-2, GDF-3, GDF-5, GDF-9, GDF-6, GDF-7, GDF-8, GDF-10, GDF-11, GDF-12, BIP, and MP52.
Claim 47
Dependent Claim 15 words
The method of claim 23 wherein said TGF-Beta protein is recombinant human Bone Morphogenetic Protein-2.
Claim 48
Dependent Claim 75 words
A kit for generating living bone or periodontal tissue having desired configuration in a mammal, said kit comprising: a tissue penetrable device comprising portions having a plurality holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired shape and retained substantially in said desired shape; and at least one TGF-Beta protein.
Claim 49
Dependent Claim 75 words
A kit for generating living bone or periodontal tissue having desired configuration in a mammal, said kit comprising: a tissue penetrable device comprising portions having a plurality holes therethrough, wherein said holes permit cells and vascular structures to grow through said tissue penetrable device, said tissue penetrable device having mechanical properties that allow the device to be configured into a desired shape and retained substantially in said desired shape; and at least one TGF-Beta protein.
Claim 50
Dependent Claim 18 words
The kit of claim 46 wherein said holes have diameters from about 3 microns to about 3,000 microns.
Claim 51
Dependent Claim 18 words
The kit of claim 46 wherein said holes have diameters from about 50 microns to about 1,000 microns.
Claim 52
Dependent Claim 18 words
The kit of claim 46 wherein said holes have diameters from about 150 microns to about 500 microns.
Claim 53
Dependent Claim 16 words
The kit of claim 46 wherein said tissue penetrable device in comprised of a non-degradable material.
Claim 54
Dependent Claim 55 words
The kit of claim 46 wherein said tissue penetrable device comprises a non-degradable material selected from the group consisting of polytetrafluoroethylene, perfluorinated polymers such as fluorinated ethylene propylene, silicone, silicone rubber, polyurethane, polyethylene, polyethylene teraphthalate, polysulfone, non-degradable polycarboxylate, non-degradable polycarbonate, non-degradable polyester, polypropylene, polyacrylic, poly(hydroxymethacrylate), polymethylmethacrylate, and polyamide, and copolymers, block copolymers, and blends thereof.
Claim 55
Dependent Claim 13 words
The kit of claim 46 wherein said tissue penetrable device comprises expanded polytetrafluoroethylene.
Claim 56
Dependent Claim 14 words
The kit of claim 46 wherein said tissue penetrable device comprises a degradable material.
Claim 57
Dependent Claim 51 words
The kit of claim 46 wherein said tissue penetrable device comprises a degradable material selected from the group consisting of non-highly cross-linked collagen, non-highly cross-linked hyaluronic acid, hydrolyzable polyesters such as polylactic acid and polyglycolic acid, polyorthoesters, degradable polycarbonates, degradable polycarboxylates, degradable polycaprolactones, polyanhydrides and copolymers, block copolymers, and blends thereof.
Claim 58
Dependent Claim 16 words
The kit of claim 46 wherein said tissue penetrable device comprises a copolymer of polyglycolide/trimethylene carbonate.
Claim 59
Dependent Claim 15 words
The kit of claim 46 wherein said tissue penetrable device is provided with reinforcement means.
Claim 60
Dependent Claim 12 words
The kit of claim 46 wherein said reinforcement means comprises polypropylene mesh.
Claim 61
Dependent Claim 9 words
The kit of claim 46 further comprising cryopreserved cells.
Claim 62
Dependent Claim 16 words
The kit of claim 46 further comprising at least one TGF-Beta protein in a carrier substance.
Claim 63
Dependent Claim 30 words
The kit of claim 59 wherein wherein said carrier substance is selected from the group consisting of collagen, hyaluronic acid, calcium carbonate, tri-calcium phosphate, hydroxyapatite ceramic, magnesium sulfate, and polyester.
Claim 64
Dependent Claim 11 words
The kit of claim 59 wherein said carrier substance comprises collagen.
Claim 65
Dependent Claim 12 words
The kit of claim 59 wherein said carrier substance comprises hyaluronic acid.
Claim 66
Dependent Claim 23 words
The kit of claim 46 further providing a matrix material, said matrix material directing the functional structure of said desired living tissue generated.
Claim 67
Dependent Claim 48 words
The kit of claim 46 wherein said TGF-Beta protein is selected from the group of TGF-J proteins consisting of TGF-Beta1, TGF-Beta2, BMP-2 BMP-1, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-15, Vgr-2, GDF-3, GDF-5, GDF-9, GDF-6, GDF-7, GDF-8, GDF-10, GDF-11, GDF-12, BIP, and MP52.
Claim 68
Dependent Claim 15 words
The kit of claim 46 wherein said TGF-Beta protein is recombinant human Bone Morphogenic Protein-2.

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Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2005-06-24 2005-12-24 2006-06-25 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2009-06-24 2009-12-24 2010-06-25 $3760.00 Window Closed / Lapsed
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