US20050149022A1
Expired / Lapsed
US
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Curable media for implantable medical device
Assignee: SDGI Holdings Inc
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Filing: 2005-02-11
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Granted: —
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Expires: 2025-02-11
Abstract
Abstract A subcutaneously formed in place orthopedic fixation device is provided, such as for fixation of the spine or other bone or bones. The device comprises an inflatable member, such as a tubular balloon. The balloon is positioned at a treatment site in the body while in a flexible, low crossing profile configuration. The balloon is thereafter inflated with a hardenable epoxy media comprising one or more epoxy compounds and one or more amine curing compounds that cures rapidly in place with low to moderate exotherm. Methods and delivery structures are also disclosed.
Inventors
- 👤 Samuel Shaolian
- 👤 George Teitelbaum
- 👤 Thanh Nguyen
- 👤 To Pham
- 👤 Richard Estes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:54
CPC Classifications
A; A61; A61L; A61L27/00; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/88; A61B17/8863; A61B17/16; A61B17/1662; A61B17/1671; A61B17/1697; A61B17/60; A61B17/68; A61B17/70; A61B17/7001; A61B17/7002; A61B17/7074; A61B17/7083; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/46; A61F2/4603; A61F2/4611; A61L27/28; A61L27/34; A61B17/17; A61B17/1739; A61B17/1757; A61B17/1796; A61B17/7004; A61B17/7008; A61B17/7011; A61B17/7013; A61B17/7049; A61B17/84; A61B17/86; A61B17/864; A61B2017/00535; A61B2017/00557
Claims Analysis
Total Claims: 43
Claim 1
Independent Claim
79 words
1 . A formed in place orthopedic device, comprising: an outer wall, defining a cavity therein; and a hardenable media within the cavity to form the orthopedic device, said hardenable media comprising a resin and hardener mixture that is substantially cured at a temperature below about 45° C. in about 90 minutes or less; wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place orthopedic device.
Claim 2
Dependent Claim
79 words
1 . A formed in place orthopedic device, comprising: an outer wall, defining a cavity therein; and a hardenable media within the cavity to form the orthopedic device, said hardenable media comprising a resin and hardener mixture that is substantially cured at a temperature below about 45° C. in about 90 minutes or less; wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place orthopedic device.
Claim 3
Dependent Claim
20 words
2 . The formed in place orthopedic device of claim 1 , wherein said hardenable media comprises an epoxy resin.
Claim 4
Dependent Claim
45 words
3 . The formed in place orthopedic device of claim 2 , wherein said epoxy resin comprises a total of about 65-75% by weight of one or more diepoxide resins and a total of about 25-35% by weight of one or more amine curing agents.
Claim 5
Dependent Claim
40 words
4 . The formed in place orthopedic device of claim 2 , wherein said epoxy resin comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
Claim 6
Dependent Claim
29 words
5 . The formed in place orthopedic device of claim 4 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F.
Claim 7
Dependent Claim
26 words
6 . The formed in place orthopedic device of claim 4 , wherein the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether.
Claim 8
Dependent Claim
31 words
7 . The formed in place orthopedic device of claim 4 , wherein the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
Claim 9
Dependent Claim
17 words
8 . The formed in place orthopedic device of claim 4 , wherein the cycloalkylamines are N-aminoalkylpiperazines.
Claim 10
Dependent Claim
42 words
9 . The formed in place orthopedic device of claim 4 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
Claim 11
Dependent Claim
34 words
10 . The formed in place orthopedic device of claim 1 , wherein said hardenable media cures to a hardened form having a static compression bending value (ASTM F1717) of at least 100 lbs.
Claim 12
Dependent Claim
5 words
11 .- 19 . (canceled)
Claim 13
Dependent Claim
5 words
11 .- 19 . (canceled)
Claim 14
Dependent Claim
111 words
20 . An orthopedic fixation device, comprising: an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen; a manifold at the proximal end of the tubular body comprising at least one port; an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body; a hardenable media for inflating said inflatable member, said hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; and a valve, provided at the proximal end of the inflatable member.
Claim 15
Dependent Claim
111 words
20 . An orthopedic fixation device, comprising: an elongate, flexible tubular body having a distal end and a proximal end, said body forming a central lumen; a manifold at the proximal end of the tubular body comprising at least one port; an inflatable member having a proximal end, a distal end, and an interior, removably attached to the distal end of the tubular body; a hardenable media for inflating said inflatable member, said hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; and a valve, provided at the proximal end of the inflatable member.
Claim 16
Dependent Claim
63 words
21 . The orthopedic fixation device of claim 20 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
Claim 17
Dependent Claim
40 words
22 . The orthopedic fixation device of claim 21 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
Claim 18
Dependent Claim
29 words
23 . The orthopedic fixation device of claim 20 , wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs (ASTM F1717).
Claim 19
Dependent Claim
22 words
24 . The orthopedic fixation device of claim 20 , wherein the media is substantially cured in about 90 minutes or less.
Claim 20
Dependent Claim
23 words
25 . The orthopedic fixation device of claim 20 , wherein the media cures at a temperature of about 45° C. or less.
Claim 21
Dependent Claim
81 words
26 . A method of forming an orthopedic device at a treatment site within the body of a patient, comprising the steps of: positioning an outer wall at the treatment site within the patient, the outer wall defining a chamber therein; and introducing a hardenable media into the chamber, wherein the hardenable media cures from a liquid form to a hardened form having a static compression bending value of at least 90 lbs (ASTM F1717) in about 90 minutes or less.
Claim 22
Dependent Claim
81 words
26 . A method of forming an orthopedic device at a treatment site within the body of a patient, comprising the steps of: positioning an outer wall at the treatment site within the patient, the outer wall defining a chamber therein; and introducing a hardenable media into the chamber, wherein the hardenable media cures from a liquid form to a hardened form having a static compression bending value of at least 90 lbs (ASTM F1717) in about 90 minutes or less.
Claim 23
Dependent Claim
27 words
27 . A method of forming an orthopedic device as in claim 26 , wherein the positioning step comprises positioning the outer wall between two bone anchors.
Claim 24
Dependent Claim
36 words
28 . The method of claim 26 , wherein said hardenable media comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
Claim 25
Dependent Claim
61 words
29 . The method of claim 28 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
Claim 26
Dependent Claim
38 words
30 . The method of claim 28 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
Claim 27
Dependent Claim
19 words
31 . The method of claim 26 , wherein the hardenable media cures at temperature below about 45° C.
Claim 28
Dependent Claim
28 words
32 . The method of claim 26 , wherein the hardenable media has a static compression bending value (ASTM F1717) of at least 150 lbs within 12 hours.
Claim 29
Dependent Claim
83 words
33 . A method of stabilizing an orthopedic fracture, comprising: inserting at least two anchors having portals into a bone; delivering an orthopedic device comprising an inflatable balloon to the bone; and inflating said balloon with a hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; wherein said orthopedic device extends through said portals, such that said inflating fixes said anchors in relation to one another.
Claim 30
Dependent Claim
83 words
33 . A method of stabilizing an orthopedic fracture, comprising: inserting at least two anchors having portals into a bone; delivering an orthopedic device comprising an inflatable balloon to the bone; and inflating said balloon with a hardenable media comprising about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines; wherein said orthopedic device extends through said portals, such that said inflating fixes said anchors in relation to one another.
Claim 31
Dependent Claim
61 words
34 . The method of claim 33 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
Claim 32
Dependent Claim
38 words
35 . The method of claim 33 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
Claim 33
Dependent Claim
27 words
36 . The method of claim 33 , wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).
Claim 34
Dependent Claim
20 words
37 . The method of claim 33 , wherein the media is substantially cured in about 90 minutes or less.
Claim 35
Dependent Claim
21 words
38 . The method of claim 33 , wherein the media cures at a temperature of about 45° C. or less.
Claim 36
Dependent Claim
72 words
39 . A method of stabilizing an orthopedic fracture, comprising: inserting at least two anchors having portals into a bone; delivering an orthopedic device comprising an inflatable balloon through the portals; and inflating said balloon with a liquid curable material; wherein the inflating step fixes said anchors in relation to one another and the curable material is substantially cured at a temperature below about 45° C. in about 90 minutes or less.
Claim 37
Dependent Claim
72 words
39 . A method of stabilizing an orthopedic fracture, comprising: inserting at least two anchors having portals into a bone; delivering an orthopedic device comprising an inflatable balloon through the portals; and inflating said balloon with a liquid curable material; wherein the inflating step fixes said anchors in relation to one another and the curable material is substantially cured at a temperature below about 45° C. in about 90 minutes or less.
Claim 38
Dependent Claim
36 words
40 . The method of claim 39 , wherein said curable material comprises about 45-52% by weight aromatic diepoxide resin, about 19-23% by weight aliphatic diepoxide resin, about 20-29% by weight dialkylamines and about 4-9% cycloalkylamines.
Claim 39
Dependent Claim
61 words
41 . The method of claim 40 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A or diglycidyl ether of Bisphenol F; the aliphatic diepoxide resin comprises one or more alkane diols of glycidyl ether; the cycloalkylamines are N-aminoalkylpiperazines; and the dialkylamines are according to the formula H2N—R—NH2, wherein R is a branched or unbranched C2-C10 alkyl group.
Claim 40
Dependent Claim
38 words
42 . The method of claim 40 , wherein the aromatic diepoxide resin comprises diglycidyl ether of Bisphenol A, the aliphatic diepoxide resin comprises butane diol of glycidyl ether, the dialkylamine comprises 1,3-diaminopropane, and the cycloalkylamine comprises N-aminoethylpiperazine.
Claim 41
Dependent Claim
27 words
43 . The method of claim 39 , wherein said hardenable media, when cured, has a static compression bending value of at least 100 lbs. (ASTM F1717).
Claim 42
Dependent Claim
88 words
44 . A formed in place medical device, comprising: an outer wall, defining a cavity therein; and a hardenable media within the cavity to form the medical device, said hardenable media comprising a resin and hardener mixture that cures at a temperature below about 45° C. wherein said cured media has a static compression bending value (ASTM F1717) of at least 150 lbs; wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place medical device.
Claim 43
Dependent Claim
88 words
44 . A formed in place medical device, comprising: an outer wall, defining a cavity therein; and a hardenable media within the cavity to form the medical device, said hardenable media comprising a resin and hardener mixture that cures at a temperature below about 45° C. wherein said cured media has a static compression bending value (ASTM F1717) of at least 150 lbs; wherein the hardenable media is hardened while the device is positioned within the body of a patient to create the formed in place medical device.
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