US20020049498A1
Expired / Lapsed
US
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In situ bioprosthetic filler and methods, particularly for the in situ formation of vertebral disc bioprosthetics
Assignee: Artivion Inc
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Filing: 2001-10-24
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Granted: —
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Expires: 2021-10-24
Abstract
Abstract Bioprosthetic devices include an exterior biological tissue member which at least partly defines a cavity, and a proteinaceous biopolymer which fills the cavity, and intercalates and is chemically bound (fixed) to the tissue of the surrounding biological tissue member. In preferred forms, the bioprosthetic device is a bioprosthetic vertebral disc having a fibrillar outer annulus which surrounds and defines an interior cavity and is formed by removal of at least a substantial portion of the natural gelatinous core therefrom. The cavity defined by the fibrillar outer annulus may then be filled with a flowable proteinaceous biopolymer. Preferably, the proteinaceous biopolymer is a liquid mixture comprised of human or animal-derived protein material and a di- or polyaldehyde, which are allowed to react in situ to form a cross-linked biopolymer within the cavity. The liquid mixture may be formed in advance of being introduced into the cavity, or may be formed simultaneously during introduction into the cavity.
Inventors
- 👤 K. Yuksel
- 👤 Steven Walsh
- 👤 Kirby Black
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:45
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3691; A61L27/14; A61L27/18; A61L27/22; A61L27/227; A61L27/3604; A61L27/3641; A61L27/3645; A61L27/3654; A61L27/3658; A61L27/40; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/442; A61F2002/4445; A61F2002/445
Claims Analysis
Total Claims: 46
Claim 1
Independent Claim
45 words
1 . The combination comprised of an exterior biological tissue member which at least partly defines a cavity, and a polymeric material which fills the cavity, intercalates the surrounding biological tissue member, and is chemically bound to the tissue of the surrounding biological tissue member.
Claim 2
Dependent Claim
45 words
1 . The combination comprised of an exterior biological tissue member which at least partly defines a cavity, and a polymeric material which fills the cavity, intercalates the surrounding biological tissue member, and is chemically bound to the tissue of the surrounding biological tissue member.
Claim 3
Dependent Claim
16 words
2 . The combination of claim 1 , wherein the polymeric material is a proteinaceous biopolymer.
Claim 4
Dependent Claim
19 words
3 . The combination of claim 1 , wherein the polymeric material includes a fibrous or particulate filler material.
Claim 5
Dependent Claim
27 words
4 . The combination of claim 2 , wherein the biopolymer is the cross-linked reaction product of human or animal-derived protein material and a di- or polyaldehyde.
Claim 6
Dependent Claim
19 words
5 . The combination of claim 4 , wherein the protein is bovine or human serum albumin or hemoglobin.
Claim 7
Dependent Claim
13 words
6 . The combination of claim 5 , wherein the aldehyde is glutaraldehyde.
Claim 8
Dependent Claim
20 words
7 . The combination of any one of claims 1 - 6 , in the form of a vertebral disc.
Claim 9
Dependent Claim
31 words
8 . The combination of claim 7 , wherein the vertebral disc which remains intact and flexible after being subjected to 5 million cycles of a cyclic load of 0.85 MPa.
Claim 10
Dependent Claim
35 words
9 . The combination of claim 2 , wherein the proteinaceous biopolymer is the reaction product of at least two reactable components, and wherein one of the components includes a natural, synthetic or sequence-modified polypeptide.
Claim 11
Dependent Claim
39 words
10 . The combination of claim 1 , wherein the polymeric material is the reaction product of at least two reactable components, and wherein one of the components includes a synthetic polymeric component which contains a cross-linkable functional group.
Claim 12
Dependent Claim
23 words
11 . The combination of claim 10 , wherein the synthetic polymeric components includes polyethylene glycol polymer derivatized with electrophilic and/or nucleophilic groups.
Claim 13
Dependent Claim
26 words
12 . The combination of claim 11 , wherein the electrophilic and/or nucleophilic groups include at least one selected from amine, succinimidyl, anhydride and thiol groups.
Claim 14
Dependent Claim
51 words
13 . A bioprosthetic vertebral disc comprised of a fibrillar outer annulus which remains following removal of a gelatinous core from a biologically natural vertebral disc to thereby define an interior cavity, and a proteinaceous biopolymer which fills the cavity and intercalates the surrounding biological tissue of the fibrillar outer annulus.
Claim 15
Dependent Claim
51 words
13 . A bioprosthetic vertebral disc comprised of a fibrillar outer annulus which remains following removal of a gelatinous core from a biologically natural vertebral disc to thereby define an interior cavity, and a proteinaceous biopolymer which fills the cavity and intercalates the surrounding biological tissue of the fibrillar outer annulus.
Claim 16
Dependent Claim
20 words
14 . The bioprosthetic vertebral disc of claim 13 , that exhibits flexibility comparable to the biologically natural vertebral disc.
Claim 17
Dependent Claim
34 words
15 . The bioprosthetic vertebral disc of claim 14 , that exhibits flexibility comparable to the biologically natural vertebral disc after being subjected to 5 million cycles of a cyclic load of 0.85 MPa.
Claim 18
Dependent Claim
20 words
16 . The bioprosthetic vertebral disc of claim 14 , wherein the biopolymer includes a fibrous or particulate filler material.
Claim 19
Dependent Claim
29 words
17 . The bioprosthetic vertebral disc of claim 13 , wherein the biopolymer is the cross-linked reaction product of human or animal-derived protein material and a di- or polyaldehyde.
Claim 20
Dependent Claim
21 words
18 . The bioprosthetic vertebral disc of claim 17 , wherein the protein is bovine or human serum albumin or hemoglobin.
Claim 21
Dependent Claim
17 words
19 . The bioprosthetic vertebral disc of claim 17 or 18 , wherein the aldehyde is glutaraldehyde.
Claim 22
Dependent Claim
41 words
20 . A method for the in situ formation of a bioprosthetic device comprising filling a cavity defined at least partly by surrounding biological tissue material with a flowable polymeric material in situ within the cavity thereby forming the bioprosthetic device.
Claim 23
Dependent Claim
41 words
20 . A method for the in situ formation of a bioprosthetic device comprising filling a cavity defined at least partly by surrounding biological tissue material with a flowable polymeric material in situ within the cavity thereby forming the bioprosthetic device.
Claim 24
Dependent Claim
31 words
21 . The method of claim 20 , which comprises injecting a flowable proteinaceous biopolymer into the cavity, and allowing the proteinaceous biopolymer to at least partly solidify in situ therewithin.
Claim 25
Dependent Claim
38 words
22 . The method of claim 20 , said method comprises injecting at least two reactable biopolymeric components in situ within the cavity, and allowing the reactable biopolymeric components at least partly solidify by a cross-linkage reaction therebetween.
Claim 26
Dependent Claim
23 words
23 . The method of claim 21 , wherein said at least two reactable components are premixed before being injected into the cavity.
Claim 27
Dependent Claim
24 words
24 . The method of claim 21 , wherein said at least two reactable components are mixed simultaneously while being injected into the cavity.
Claim 28
Dependent Claim
52 words
25 . The method of claim 21 , wherein said at least two reactable components include a liquid mixture comprised of human or animal-derived protein material and a di- or polyaldehyde, and wherein the method comprises allowing the liquid mixture to form a cross-linked proteinaceous biopolymer material in situ within the cavity.
Claim 29
Dependent Claim
25 words
26 . The method of claim 25 , wherein said protein material and said di- or polyaldehyde are premixed before being introduced into the cavity.
Claim 30
Dependent Claim
26 words
27 . The method of claim 25 , wherein said protein material and said di- or polyaldehyde are mixed simultaneously while being introduced into the cavity.
Claim 31
Dependent Claim
21 words
28 . The method of claim 25 , which includes providing a fibrous or particulate filler material in the liquid mixture.
Claim 32
Dependent Claim
35 words
29 . The method of claim 21 , wherein the proteinaceous biopolymer is the reaction product of at least two reactable components, and wherein one of the components includes a natural, synthetic or sequence-modified polypeptide.
Claim 33
Dependent Claim
39 words
30 . The method of claim 20 , wherein the polymeric material is the reaction product of at least two reactable components, and wherein one of the components includes a synthetic polymeric component which contains a cross-linkable functional group.
Claim 34
Dependent Claim
27 words
31 . The method of claim 30 , wherein the at least one of the reactable components includes polyethylene glycol polymer derivatized with electrophilic and/or nucleophilic groups.
Claim 35
Dependent Claim
26 words
32 . The method of claim 31 , wherein the electrophilic and/or nucleophilic groups include at least one selected from amine, succinimidyl, anhydride and thiol groups.
Claim 36
Dependent Claim
75 words
33 . A method for the formation of a bioprosthetic vertebral disc comprising: (a) providing a vertebral disc having a fibrillar outer annulus which surrounds and defines an interior cavity formed by removal of at least a substantial portion of a gelatinous core therefrom; (b) filling the cavity defined by the fibrillar outer annulus with a flowable polymeric material, and (c) allowing the polymeric material to at least partly solidify in situ within the cavity.
Claim 37
Dependent Claim
75 words
33 . A method for the formation of a bioprosthetic vertebral disc comprising: (a) providing a vertebral disc having a fibrillar outer annulus which surrounds and defines an interior cavity formed by removal of at least a substantial portion of a gelatinous core therefrom; (b) filling the cavity defined by the fibrillar outer annulus with a flowable polymeric material, and (c) allowing the polymeric material to at least partly solidify in situ within the cavity.
Claim 38
Dependent Claim
16 words
34 . The method of claim 33 , wherein the polymeric material is a proteinaceous biopolymer.
Claim 39
Dependent Claim
36 words
35 . The method of claim 33 , said method comprises injecting at least two reactable biopolymeric components in situ within the cavity, and allowing the reactable biopolymeric components at least partly solidify by reaction therebetween.
Claim 40
Dependent Claim
23 words
36 . The method of claim 35 , wherein said at least two reactable components are premixed before being injected into the cavity.
Claim 41
Dependent Claim
24 words
37 . The method of claim 35 , wherein said at least two reactable components are mixed simultaneously while being injected into the cavity.
Claim 42
Dependent Claim
52 words
38 . The method of claim 35 , wherein said at least two reactable components include a liquid mixture comprised of human or animal-derived protein material and a di- or polyaldehyde, and wherein the method comprises allowing the liquid mixture to form a cross-linked proteinaceous biopolymer material in situ within the cavity.
Claim 43
Dependent Claim
25 words
39 . The method of claim 38 , wherein said protein material and said di- or polyaldehyde are premixed before being introduced into the cavity.
Claim 44
Dependent Claim
26 words
40 . The method of claim 38 , wherein said protein material and said di- or polyaldehyde are mixed simultaneously while being introduced into the cavity.
Claim 45
Dependent Claim
21 words
41 . The method of claim 38 , which includes providing a fibrous or particulate filler material in the liquid mixture.
Claim 46
Dependent Claim
43 words
42 . The method of claim 33 , wherein prior to step (a) there is practiced the step of (a1) removing a substantial portion of the gelatinous core of the vertebral disc to leave the fibrillar outer annulus which defines the interior cavity.
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