CA2280966A1 - Implantable collagen-containing putty material - Google Patents

Implantable collagen-containing putty material Download PDF

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Publication number
CA2280966A1
CA2280966A1 CA002280966A CA2280966A CA2280966A1 CA 2280966 A1 CA2280966 A1 CA 2280966A1 CA 002280966 A CA002280966 A CA 002280966A CA 2280966 A CA2280966 A CA 2280966A CA 2280966 A1 CA2280966 A1 CA 2280966A1
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CA
Canada
Prior art keywords
acid
collagen
composition
osteogenic
osteoinductive
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002280966A
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French (fr)
Other versions
CA2280966C (en
Inventor
James A. Benedict
Christopher J. Damien
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Zimmer Orthobiologics Inc
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Individual
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Publication of CA2280966A1 publication Critical patent/CA2280966A1/en
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Publication of CA2280966C publication Critical patent/CA2280966C/en
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/102—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof

Abstract

The present invention provides compositions for an implantable putty material for delivery of active compounds to a patient. More specifically, the present invention provides a material having a pH of between about 3 and 6 and possessing a putty like physical property, wherein the composition of the material includes collagen and water. The present invention also provides a method for using the implantable putty material.

Claims (77)

1. A putty material comprising collagen, a demineralized bone material and water, wherein the putty material has a pH of between about 3.0 to about 6.0, and wherein said collagen comprises from about 1% by weight to about 10% by weight, not including water, of said putty material.
2. The putty material of Claim 1, wherein the peak resistance force of the putty material having a trapozoidal shape measuring 53 mm (1) x 4 mm (h) x 4 mm (w) at one end and 2.5 mm (w) at another end is at least about 10 g.
3. The putty material of Claim 1, wherein the extensibility of the putty material having a trapozoidal shape measuring 53 mm (1) x 4 mm (h) x 4 mm (w) at one end and 2.5 mm (w) at another end is from about 2 mm to about 25 mm.
4. The putty material of Claim 1, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.
5. The putty material of Claim 1, wherein said collagen is bovine tendon Type I collagen.
6. The putty material of Claim 1, wherein the material is prepared by a process comprising addition of an acid to said collagen.
7. The putty material of Claim 6, wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.
8. The putty material of Claim 7, wherein said acid is ascorbic acid.
9. The putty material of Claim 1, wherein said putty material further comprises an active ingredient.
10. The putty material of Claim 9, wherein said active ingredient is selected from the group consisting of osteoinductive materials, growth factors, cartilage inducing factors, angiogenic factors, hormones, antibiotics, and antiviral compounds.
11. The putty material of Claim 10, wherein said active ingredient is an osteoinductive material.
12. The putty material of Claim 11, wherein the active ingredient is selected from the group consisting of bone growth protein, BMP 1-13, OP1, b-FGF, and TGF-beta.
13. The putty material of Claim 12, wherein said osteoinductive factor is bone growth protein.
14. Claim 14 has been cancelled.
15. An osteogenic composition comprising:
collagen;
an osteoinductive material; and an acid;

wherein the osteogenic composition comprises between about 0.05 mmol of said acid per 100 mg of said collagen to about 2.3 mmol of said acid per 100 mg of said collagen.
16. The osteogenic composition of Claim 15, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.
17. The osteogenic composition of Claim 16, wherein said collagen is bovine tendon Type I collagen.
18. The osteogenic composition of Claim 15, wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.
19. The osteogenic composition of Claim 18, wherein said acid is ascorbic acid.
20. The osteogenic composition of Claim 19, wherein the osteogenic composition comprises between about 0.1 mmol of said ascorbic acid per 100 mg of said collagen to about 1.5 mmol of said ascorbic acid per 100 mg of said collagen.
21. The osteogenic composition of Claim 15, wherein said osteoinductive material is selected from the group consisting of bone growth protein, BMP 1-13, and OP1.
22. The osteogenic composition of Claim 21, wherein said osteoinductive factor is bone growth protein.
23. The osteogenic composition of Claim 15, wherein the osteogenic composition is aseptic.
24. The osteogenic composition of Claim 23, wherein the osteogenic composition is produced by sterilization with ethylene oxide.
25. The osteogenic composition of Claim 23, wherein the osteogenic composition is produced by sterilization by an exposure to g-radiation.
26. The osteogenic composition of Claim 15, wherein the osteogenic composition is dry.
27. The osteogenic composition of Claim 15, wherein the osteogenic composition is a gel.
28. The osteogenic composition of Claim 15, further comprising water.
29. The osteogenic composition of Claim 15, further comprising a demineralized bone material.
30. A kit comprising the osteoinductive composition of Claim 15, a demineralized bone material and a container for mixing the osteoinductive composition and the demineralized bone material.
31. An osteogenic composition comprising:
bovine tendon Type I collagen;
ascorbic acid water;
bone growth protein; and a demineralized bone material, wherein said collagen comprises from about 1% by weight to about 10% by weight, not including water, of said osteogenic composition, and wherein said osteogenic composition has a pH of about 6.0 or less.
32. The osteogenic composition of Claim 31, wherein the osteogenic composition comprises from about 0.05 mmol of said ascorbic acid per 100 mg of said collagen to about 2.30 mmol of said ascorbic acid per 100 mg of said collagen.
33. The osteogenic composition of Claim 31, wherein the pH of the osteogenic composition is between about 3.0 to about 6Ø
34. The osteogenic composition of Claim 31, wherein the osteogenic composition comprises from about 1.0 % by weight to about 10.0 % by weight collagen.
35. The osteogenic composition of Claim 31, wherein the osteogenic composition comprises from about 0.1 % by weight to about 10.0 % by weight bone growth protein.
36. The osteogenic composition of Claim 31, wherein the osteogenic composition comprises from about 80.0 % by weight to about 98.9 % by weight demineralized bone material.
37. The osteogenic composition of Claim 31, wherein the peak resistance force of the composition having a trapozoidal shape measuring 53 mm (1) x 4 mm (h) x 4 mm (w) 35~

at one end and 2.5 mm (w) at another end is at least about g.
38. The osteogenic composition of Claim 31, wherein the extensibility of the composition having a trapozoidal shape measuring 53 mm (1) x 4 mm (h) x 4 mm (w) at one end and 2.5 mm (w) at another end is from about 2 mm to about 25 mm.
39. A composition produced from a process comprising the steps of:
admixing collagen, an acid, and water to form a gel; and adding a demineralized bone material to said gel to produce an osteogenic putty:
wherein the osteogenic putty has a pH of about 6.0 or less, and wherein said collagen comprises from about to by weight to about 10% by weight, not including water, of said composition.
40. The composition produced from the process of Claim 39, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.
41. The composition produced from the process of Claim 40, wherein said collagen is bovine tendon Type I
collagen.
42. The composition produced from the process of Claim 39, wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.
43. The composition produced from the process of Claim 42, wherein said acid is ascorbic acid.
44. The composition produced from the process of Claim 39, wherein said process further comprises the step of sterilizing said gel before the step of adding said demineralized bone material.
45. The composition produced from the process of Claim 44, wherein said step of sterilization comprises exposing said gel to g-radiation.
46. The composition produced from the process of Claim 39, wherein said process further comprises the step of lyophilizing said gel before the step of adding said demineralized bone material.
47. The composition produced from the process of Claim 46, wherein said process further comprises the step of sterilizing said lyophilized gel by contacting with ethylene oxide.
48. The composition produced from the process of Claim 39, wherein said step of adding said demineralized bone material further comprises adding water.

37~
49. The composition produced from the process of Claim 39, wherein said step of admixing further comprises admixing an osteoinductive material.
50. The composition produced from the process of Claim 49, wherein said osteoinductive material is selected from the group consisting of bone growth protein, BMP 1-13, and OP1.
51. The composition produced from the process of Claim 50, wherein said osteoinductive material is bone growth protein.
52. A method for preparing a putty material comprising the step of admixing collagen, an acid, an active ingredient, demineralized bone material and water to form a gel, wherein said collagen comprises from about 1%
by weight to about 10% by weight, not including water, of said composition, and wherein said putty material has a pH
of about 6.0 or less.
53. The method of Claim 52, further comprising the step of sterilizing said gel.
54. The method of Claim 53, wherein said step of sterilizing comprises exposing said gel to g-radiation.
55. The method of Claim 52, further comprising the step of sterilizing by contacting said lyophilized gel with ethylene oxide.
56. The method of Claim 52, further comprising the step of adding a demineralized bone material to the gel to 38~

produce an osteogenic putty, wherein said osteogenic putty has a pH of between about 3.0 to about 6Ø
57. The method of Claim 56, wherein said step of adding said demineralized bone material further comprises adding water.
58. The method of Claim 52, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.
59. The method of Claim 58, wherein said collagen is bovine tendon Type I collagen.
60. The method of Claim 52, wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.
61. The method of Claim 60, wherein said acid is ascorbic acid.
62. The method of Claim 52, wherein said step of admixing further comprises admixing an osteoinductive material.
63. The method of Claim 62, wherein said osteoinductive material is selected from the group consisting of bone growth protein, BMP 1-13, and OP1.
64. The method of Claim 63, wherein said osteoinductive material is bone growth protein.
65. A process for making a dry osteoinductive composition comprising the steps of:
admixing collagen, an acid, an osteoinductive material and water to form a gel having a pH of about 6.0 or less; and lyophilizing said gel, wherein said collagen comprises from about to by weight to about 10% by weight of said dry osteoinductive composition.
66. The process of Claim 65, wherein said acid comprises from about 0.05 mmol of said acid per 100 mg of said collagen to about 2.3 mmol of said acid per 100 mg of said collagen.
67. The process of Claim 65, wherein said acid is selected from the group consisting of ascorbic acid, acetic acid, acetyl salicylic acid, benzoic acid, citric acid, glutamic acid, glycolic acid, lactic acid, malic acid, salicylic acid, and hydrochloric acid.
68. The process of Claire 67, wherein said acid is ascorbic acid.
69. Claim 69 has been cancelled.
70. The process of Claim 65, wherein said collagen is selected from the group consisting of fibrillar collagen, atelopeptide collagen, telopeptide collagen and tropocollagen.
71. The process of Claim 70, wherein said collagen is bovine tendon Type I collagen.
72. The process of Claim 65, wherein said osteoinductive material comprises from about 0.1 % by weight to about 10.0 % by weight of said dry osteoinductive composition.
73. The process of Claim 65, wherein said osteoinductive material is selected from the group consisting of bone growth protein, BMP 1-13, and OP1.
74. The process of Claim 73, wherein said osteoinductive material is bone growth protein.
75. A method for administering an active compound to a patient comprising the steps of:
preparing a delivery vehicle by admixing collagen, demineralized bone material and an acid to form a composition having a pH of between about 3.0 and about 6.0;
incorporating an active compound into said delivery vehicle, wherein said collagen comprises from about 1% by weight to about 10% by weight, not including water, of said delivery vehicle; and implanting said delivery vehicle in a desired portion of the patient's body.
76. The method of Claim 75, wherein said step of implantation comprise a surgery.
77. The method of Claim 75, wherein said step of implantation comprises an injection.
CA2280966A 1997-02-13 1998-02-12 Implantable collagen-containing putty material Expired - Lifetime CA2280966C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US3707197P 1997-02-13 1997-02-13
US60/037,071 1997-02-13
PCT/US1998/002751 WO1998035653A1 (en) 1997-02-13 1998-02-12 Implantable collagen-containing putty material

Publications (2)

Publication Number Publication Date
CA2280966A1 true CA2280966A1 (en) 1998-08-20
CA2280966C CA2280966C (en) 2012-04-17

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CA2280966A Expired - Lifetime CA2280966C (en) 1997-02-13 1998-02-12 Implantable collagen-containing putty material

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EP (1) EP1019027A4 (en)
JP (1) JP5105216B2 (en)
AU (1) AU6654598A (en)
CA (1) CA2280966C (en)
WO (1) WO1998035653A1 (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6569172B2 (en) 1996-08-30 2003-05-27 Verigen Transplantation Service International (Vtsi) Method, instruments, and kit for autologous transplantation
US5989269A (en) 1996-08-30 1999-11-23 Vts Holdings L.L.C. Method, instruments and kit for autologous transplantation
EP0896825B1 (en) 1997-08-14 2002-07-17 Sulzer Innotec Ag Composition and device for in vivo cartilage repair comprising nanocapsules with osteoinductive and/or chondroinductive factors
US6511958B1 (en) 1997-08-14 2003-01-28 Sulzer Biologics, Inc. Compositions for regeneration and repair of cartilage lesions
US20040081704A1 (en) 1998-02-13 2004-04-29 Centerpulse Biologics Inc. Implantable putty material
EP1104313A2 (en) 1998-08-14 2001-06-06 Verigen Transplantation Service International (VTSI) AG Methods, instruments and materials for chondrocyte cell transplantation
AU3556400A (en) 1999-03-17 2000-10-04 Novartis Ag Pharmaceutical compositions
US6576249B1 (en) * 2000-11-13 2003-06-10 El Gendler Bone putty and method
US20020114795A1 (en) 2000-12-22 2002-08-22 Thorne Kevin J. Composition and process for bone growth and repair
US7132110B2 (en) * 2001-08-30 2006-11-07 Isotis Orthobiologics, Inc. Tissue repair compositions and methods for their manufacture and use
US6974862B2 (en) 2003-06-20 2005-12-13 Kensey Nash Corporation High density fibrous polymers suitable for implant
US20050020506A1 (en) * 2003-07-25 2005-01-27 Drapeau Susan J. Crosslinked compositions comprising collagen and demineralized bone matrix, methods of making and methods of use
US20050186240A1 (en) 2004-02-23 2005-08-25 Ringeisen Timothy A. Gel suitable for implantation and delivery system
DE102005045671A1 (en) * 2005-09-15 2007-03-29 Ossacur Ag Use of a collagen of xenogenic origin
US7824703B2 (en) * 2006-02-01 2010-11-02 Warsaw Orthopedics, Inc. Medical implants with reservoir(s), and materials preparable from same
US7892577B2 (en) * 2006-02-27 2011-02-22 Globus Medical, Inc. Bone graft materials derived from mineralized gelatin
US20070248575A1 (en) * 2006-04-19 2007-10-25 Jerome Connor Bone graft composition
US7718616B2 (en) 2006-12-21 2010-05-18 Zimmer Orthobiologics, Inc. Bone growth particles and osteoinductive composition thereof
EP2222348B1 (en) * 2007-12-21 2013-07-03 RTI Biologics, Inc. Osteoinductive putties and methods of making and using such putties
US8840913B2 (en) 2008-03-27 2014-09-23 Warsaw Orthopedic, Inc. Malleable multi-component implants and materials therefor
JP2013542837A (en) * 2010-11-15 2013-11-28 ジンマー オーソバイオロジクス，インコーポレイティド Bone void filler
KR101361810B1 (en) 2011-12-22 2014-02-12 전북대학교산학협력단 DBP Gels for Tissue Engineering Application
KR102348476B1 (en) * 2021-03-02 2022-01-06 한국전통문화대학교산학협력단 Natural adhesive and method of improving its adhesive strength

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3471598A (en) * 1966-02-14 1969-10-07 Fmc Corp Method of producing absorbent mats
US3443261A (en) * 1967-09-01 1969-05-13 Fmc Corp Prosthetic structures from microcrystalline collagen
US3949073A (en) * 1974-11-18 1976-04-06 The Board Of Trustees Of Leland Stanford Junior University Process for augmenting connective mammalian tissue with in situ polymerizable native collagen solution
US4066083A (en) * 1976-06-03 1978-01-03 Pentapharm A.G. Sterile surgical collagen product
CH645271A5 (en) * 1979-10-08 1984-09-28 Pentapharm Ag METHOD FOR PRODUCING A COLLAGEN PRODUCT FOR MEDICAL AND COSMETIC PURPOSES.
EP0030583B1 (en) * 1979-12-18 1984-06-13 Oscobal Ag Bone replacement material and process for producing a bone replacement material
US4394370A (en) * 1981-09-21 1983-07-19 Jefferies Steven R Bone graft material for osseous defects and method of making same
US4440750A (en) * 1982-02-12 1984-04-03 Collagen Corporation Osteogenic composition and method
CA1259914A (en) * 1984-07-06 1989-09-26 Donald G. Wallace Methods of bone repair using collagen
US4969912A (en) * 1988-02-18 1990-11-13 Kelman Charles D Human collagen processing and autoimplant use
US5475052A (en) * 1988-11-21 1995-12-12 Collagen Corporation Collagen-synthetic polymer matrices prepared using a multiple step reaction
US5707962A (en) * 1994-09-28 1998-01-13 Gensci Regeneration Sciences Inc. Compositions with enhanced osteogenic potential, method for making the same and therapeutic uses thereof

Also Published As

Publication number Publication date
EP1019027A4 (en) 2004-05-12
AU6654598A (en) 1998-09-08
WO1998035653A1 (en) 1998-08-20
JP2001521414A (en) 2001-11-06
EP1019027A1 (en) 2000-07-19
CA2280966C (en) 2012-04-17
JP5105216B2 (en) 2012-12-26

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