Patent US6486232B1 successfully refreshed from Google Patents.
US6486232B1
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Bioerodible polymeric semi-interpenetrating network alloys for internal fixation devices and bone cements
Assignee: Cambridge Scientific Inc
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Filing: 2000-09-18
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Granted: 2002-11-26
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Expires: 2020-09-18
Abstract
Abstract A bioerodible polymeric material, and in particular a semi-interpenetrating network (“semi-IPN”) alloy, is disclosed. A beneficial end use of this material is in the form of internal fixation devices (IFDs) (such as bone supports, plates, and pins) and as cured bone cements for bone repair. A multi-part bioerodible cement system, which, upon mixing of the system parts, forms a cured bioerodible cement, includes, in one part, a first bioerodible polymer (e.g., PLGA) capable of producing acidic products upon hydrolytic degradation, and, in another part, a second bioerodible scaffolding polymer (e.g., PPF) which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for the cured cement. In another aspect, a bone cement system of the invention includes a bioerodible scaffolding polymer (such as PPF), which when polymerized provides a hardened bone cement, the cement system further including a gas generating agent in stabilized form for providing the cured bone cement with pores for facilitating inward cell migration.
Inventors
- 👤 Donald L. Wise
- 👤 Joseph D. Gresser
- 👤 Debra J. Trantolo
- 👤 Yung-Yueh Hsu
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-27 09:16
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/58; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/68; A61B17/84; A61B17/86; A61B17/866; A61L24/00; A61L24/001; A61L24/0042; A61L24/0047; A61L24/0073; A61L24/0094; A61L24/04; A61L24/043; A61L27/14; A61L27/26; A61L27/40; A61L27/44; A61L27/48; A61B17/80; A61B17/88; A61B17/8802; A61B17/8833; A61B2017/00004; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2002/2817; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/3006; A61F2002/30062; A61F2002/30667; A61F2002/30677; A61F2210/00; A61F2210/0004; A61F2250/00; A61F2250/0014; A61L2430/00; A61L2430/02
Claims Analysis
Total Claims: 51
Claim 1
Independent Claim
179 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric semi-IPN alloy, wherein a first said part comprises a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation and one of said parts, which may be the same as or different from said first part, comprises a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said second bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; wherein one of said parts comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components and said biologically active or therapeutic agent is in a said part comprising only said dry components.
Claim 2
Dependent Claim
179 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric semi-IPN alloy, wherein a first said part comprises a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation and one of said parts, which may be the same as or different from said first part, comprises a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said second bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; wherein one of said parts comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components and said biologically active or therapeutic agent is in a said part comprising only said dry components.
Claim 3
Dependent Claim
26 words
The bioerodible bone cement system of claim 1 , wherein said biologically active or therapeutic agent is in a protective coating of said first bioerodible polymer.
Claim 4
Dependent Claim
31 words
The bioerodible bone cement system of claim 1 , wherein said biologically active or therapeutic agent is in a protective coating of a bioerodible polymer other than said first bioerodible polymer.
Claim 5
Dependent Claim
34 words
The bioerodible bone cement system of claim 1 further comprising in one of said parts a buffering compound in sufficiently high concentration so as to buffer said acidic products within a desired pH range.
Claim 6
Dependent Claim
21 words
The bioerodible bone cement system of claim 1 further comprising in one of said parts an accelerator for said crosslinking agent.
Claim 7
Dependent Claim
21 words
The bioerodible bone cement system of claim 1 further comprising in one of said parts an inhibitor for said crosslinking agent.
Claim 8
Dependent Claim
18 words
The bioerodible bone cement system of claim 1 , wherein said second bioerodible polymer comprises polypropylene fumarate (PPF).
Claim 9
Dependent Claim
17 words
The bioerodible bone cement system of claim 7 , wherein said crosslinking agent is a vinyl monomer.
Claim 10
Dependent Claim
16 words
The bioerodible bone cement system of claim 8 , wherein said crosslinking agent is vinyl pyrrolidone.
Claim 11
Dependent Claim
17 words
The bioerodible bone cement system of claim 7 , wherein said crosslinking agent is methyl methacrylate (MMA).
Claim 12
Dependent Claim
43 words
The bioerodible bone cement system of claim 1 , wherein said biologically active or therapeutic agent is selected from the group consisting of bone repair proteins, bone morphogenic proteins, bone scrapings from host bone, demineralized bone, bone chips, antibiotics, cells, and mixtures thereof.
Claim 13
Dependent Claim
28 words
The bioerodible bone cement system of claim 1 , wherein said first bioerodible polymer which is not crosslinkable, is different from said second bioerodible polymer which is crosslinkable.
Claim 14
Dependent Claim
43 words
The bioerodible bone cement system of claim 1 , wherein said first bioerodible polymer is selected from the group consisting of poly(lactide-co-glycolide) (PLGA); polydioxanone; poly(ε-caprolactone); polyanhydrides; poly(ortho esters); copoly(ether-esters); polyamides; polylactones; polypropylene fumarates (H[—O—CH(CH 3 )—CH 2 —O—CO—CH═CH—CO—] n OH); and combinations thereof.
Claim 15
Dependent Claim
18 words
The bioerodible bone cement system of claim 1 further comprising in one of said parts an osteoconductive composition.
Claim 16
Dependent Claim
18 words
The bioerodible bone cement system of claim 1 further comprising in one of said parts an osteoinductive composition.
Claim 17
Dependent Claim
15 words
The bioerodible bone cement system of claim 14 , wherein said osteoconductive composition comprises hydroxyapatite.
Claim 18
Dependent Claim
38 words
The bioerodible bone cement system of claim 15 , wherein said osteoinductive composition comprises a component selected from the group consisting of bone repair proteins, bone morphogenic proteins, bone scrapings from host bone, demineralized bone and bone chips.
Claim 19
Dependent Claim
17 words
The bioerodible bone cement system of claim 1 further comprising a gas generating agent in stabilized form.
Claim 20
Dependent Claim
23 words
The bioerodible bone cement system of claim 18 , wherein said gas generating agent is a combination of citric acid and sodium bicarbonate.
Claim 21
Dependent Claim
37 words
The bioerodible bone cement system of claim 19 , wherein said citric acid and said sodium bicarbonate are in separate parts of said system, one of which is said at least one part comprising only dry components.
Claim 22
Dependent Claim
29 words
The bioerodible bone cement system of claim 19 , wherein both said citric acid and said sodium bicarbonate are in said at least one part comprising only dry components.
Claim 23
Dependent Claim
18 words
The bioerodible bone cement system of claim 18 , wherein said gas generating agent is an organic isocyanate.
Claim 24
Dependent Claim
148 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric semi-IPN alloy, wherein a first said part comprises a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation and one of said parts, which may be the same as or different from said first part, comprises a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said second bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components, and said system comprises a gas generating agent in stabilized form.
Claim 25
Dependent Claim
148 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric semi-IPN alloy, wherein a first said part comprises a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation and one of said parts, which may be the same as or different from said first part, comprises a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said second bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components, and said system comprises a gas generating agent in stabilized form.
Claim 26
Dependent Claim
23 words
The bioerodible bone cement system of claim 23 , wherein said gas generating agent is a combination of citric acid and sodium bicarbonate.
Claim 27
Dependent Claim
37 words
The bioerodible bone cement system of claim 24 , wherein said citric acid and said sodium bicarbonate are in separate parts of said system, one of which is said at least one part comprising only dry components.
Claim 28
Dependent Claim
29 words
The bioerodible bone cement system of claim 24 , wherein both said citric acid and said sodium bicarbonate are in said at least one part comprising only dry components.
Claim 29
Dependent Claim
18 words
The bioerodible bone cement system of claim 23 , wherein said gas generating agent is an organic isocyanate.
Claim 30
Dependent Claim
113 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric semi-IPN alloy, said system comprising a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation, a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy, a crosslinking initiator and a crosslinking agent for said second bioerodible scaffolding polymer, wherein said system further comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer.
Claim 31
Dependent Claim
113 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric semi-IPN alloy, said system comprising a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation, a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy, a crosslinking initiator and a crosslinking agent for said second bioerodible scaffolding polymer, wherein said system further comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer.
Claim 32
Dependent Claim
101 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric semi-IPN alloy, said system comprising a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation, a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy, a crosslinking initiator and a crosslinking agent for said second bioerodible scaffolding polymer, wherein said system further comprises a gas generating agent in stabilized form.
Claim 33
Dependent Claim
101 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric semi-IPN alloy, said system comprising a first bioerodible polymer capable of producing acidic products upon hydrolytic degradation, a second bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said semi-IPN alloy, a crosslinking initiator and a crosslinking agent for said second bioerodible scaffolding polymer, wherein said system further comprises a gas generating agent in stabilized form.
Claim 34
Dependent Claim
22 words
The bioerodible bone cement system of claim 28 or claim 29 , wherein the components of said system are in separate parts.
Claim 35
Dependent Claim
22 words
The bioerodible bone cement system of claim 28 or claim 29 , wherein the components of said system are in one part.
Claim 36
Dependent Claim
147 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric bone cement, wherein one of said parts comprises a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said bone cement; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; wherein one of said parts comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components and said biologically active or therapeutic agent is in a said part comprising only said dry components.
Claim 37
Dependent Claim
147 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric bone cement, wherein one of said parts comprises a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said bone cement; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; wherein one of said parts comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components and said biologically active or therapeutic agent is in a said part comprising only said dry components.
Claim 38
Dependent Claim
116 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric bone cement, wherein one of said parts comprises a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said bone cement; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components, and said system comprises a gas generating agent in stabilized form.
Claim 39
Dependent Claim
116 words
A multi-part bioerodible bone cement system comprising two or more separate parts which, upon mixing of the system parts, forms a bioerodible polymeric bone cement, wherein one of said parts comprises a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said bone cement; wherein one of said parts comprises crosslinking initiator and one of said parts comprises a crosslinking agent for said bioerodible scaffolding polymer, wherein said crosslinking agent and said crosslinking initiator are in separate parts; and wherein, further, at least one of said parts comprises only dry components, at least one of said parts comprises liquid components, and said system comprises a gas generating agent in stabilized form.
Claim 40
Dependent Claim
100 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric bone cement, said system comprising a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, a crosslinking initiator and a crosslinking agent for said bioerodible scaffolding polymer, wherein said system further comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer.
Claim 41
Dependent Claim
100 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric bone cement, said system comprising a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, a crosslinking initiator and a crosslinking agent for said bioerodible scaffolding polymer, wherein said system further comprises a therapeutically effective amount of a biologically active or therapeutic agent in a protective coating of a bioerodible polymer.
Claim 42
Dependent Claim
88 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric bone cement, said system comprising a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, a crosslinking initiator and a crosslinking agent for said bioerodible scaffolding polymer, wherein said system further comprises a gas generating agent in stabilized form.
Claim 43
Dependent Claim
88 words
A bioerodible bone cement system, the shelf-stability of which is maintained at a temperature which is below the freezing points of the components of the system and which, upon raising of the temperature of the system, forms a bioerodible polymeric bone cement, said system comprising a bioerodible scaffolding polymer which upon crosslinking provides a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, a crosslinking initiator and a crosslinking agent for said bioerodible scaffolding polymer, wherein said system further comprises a gas generating agent in stabilized form.
Claim 44
Dependent Claim
22 words
The bioerodible bone cement system of claim 34 or claim 35 , wherein the components of said system are in separate parts.
Claim 45
Dependent Claim
22 words
The bioerodible bone cement system of claim 34 or claim 35 , wherein the components of said system are in one part.
Claim 46
Independent Claim
86 words
A method of making a foaming, bioerodible, polymeric bone cement, said cement comprising a crosslinked bioerodible scaffolding polymer, said crosslinked polymer providing a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, said method comprising the steps of: providing a bioerodible scaffolding polymer; combining said polymer with a crosslinking agent for said polymer to initiate formation of a cured cement material; prior to cure of said cement material, introducing a gas, as a foaming agent, into said uncured cement; and permitting said cement to cure.
Claim 47
Independent Claim
86 words
A method of making a foaming, bioerodible, polymeric bone cement, said cement comprising a crosslinked bioerodible scaffolding polymer, said crosslinked polymer providing a biopolymeric scaffolding or internal reinforcement for said polymeric bone cement, said method comprising the steps of: providing a bioerodible scaffolding polymer; combining said polymer with a crosslinking agent for said polymer to initiate formation of a cured cement material; prior to cure of said cement material, introducing a gas, as a foaming agent, into said uncured cement; and permitting said cement to cure.
Claim 48
Independent Claim
119 words
A method of making a foaming, bioerodible, polymeric semi-IPN alloy bone cement, said cement comprising a bioerodible polymer capable of producing acidic products upon hydrolytic degradation and a crosslinked bioerodible scaffolding polymer, said crosslinked polymer providing a biopolymeric scaffolding or internal reinforcement for said polymeric semi-IPN alloy bone cement, said method comprising the steps of: providing a mixture comprising a bioerodible polymer capable of producing acidic products upon hydrolytic degradation and a bioerodible scaffolding polymer; combining said mixture with a crosslinking agent for said bioerodible scaffolding polymer to initiate formation of a cured cement material; prior to cure of said cement material, introducing a gas, as a foaming agent, into said uncured cement; and permitting said cement to cure.
Claim 49
Independent Claim
119 words
A method of making a foaming, bioerodible, polymeric semi-IPN alloy bone cement, said cement comprising a bioerodible polymer capable of producing acidic products upon hydrolytic degradation and a crosslinked bioerodible scaffolding polymer, said crosslinked polymer providing a biopolymeric scaffolding or internal reinforcement for said polymeric semi-IPN alloy bone cement, said method comprising the steps of: providing a mixture comprising a bioerodible polymer capable of producing acidic products upon hydrolytic degradation and a bioerodible scaffolding polymer; combining said mixture with a crosslinking agent for said bioerodible scaffolding polymer to initiate formation of a cured cement material; prior to cure of said cement material, introducing a gas, as a foaming agent, into said uncured cement; and permitting said cement to cure.
Claim 50
Dependent Claim
25 words
The method of claim 38 or claim 39 , wherein said gas is introduced into said uncured cement by vigorous stirring of said uncured cement.
Claim 51
Dependent Claim
27 words
The method of claim 38 or claim 39 , wherein said gas is introduced into said uncured cement by bubbling of said gas through said uncured cement.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2005-11-25 | 2006-05-27 | 2006-11-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-11-25 | 2010-05-27 | 2010-11-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-11-25 | 2014-05-27 | 2014-11-26 | $7700.00 | Window Closed / Lapsed |