US20010039453A1
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Resorbable interbody spinal fusion devices
Assignee: DePuy Mitek LLC
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Filing: 2001-07-13
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Granted: —
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Expires: 2021-07-13
Abstract
Abstract A resorbable interbody fusion device for use in spinal fixation is disclosed. The device is composed of 25-100% bioresorbable or resorbable material. The interbody fusion device of the invention can be in any convenient form, such as a wedge, screw or cage. Preferably, the resorbable device of the invention is in the shape of a tapered wedge or cone, which further desirably incorporates structural features such as serrations or threads better to anchor the device in the adjoining vertebrae. The preferred device further comprises a plurality of peripheral voids and more desirably a central void space therein, which may desirably be filled with a grafting material for facilitating bony development and/or spinal fusion, such as an autologous grafting material. As the preferred material from which the resorbable interbody fusion device is manufactured is most likely to be a polymer that can produce acidic products upon hydrolytic degradation, the device preferably further includes a neutralization compound, or buffer, in sufficiently high concentration to decrease the rate of pH change as the device degrades, in order to prevent sterile abscess formation caused by the accumulation of unbuffered acidic products in the area of the implant.
Inventors
- 👤 Joseph Gresser
- 👤 Debra Trantolo
- 👤 Robert Langer
- 👤 Kai-Uwe Lewandrowski
- 👤 Alexander Klibanov
- 👤 Donald Wise
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:46
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/4455; A61F2/3094; A61F2/30965; A61F2/442; A61F2/28; A61F2002/2835; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30108; A61F2002/3011; A61F2002/30112; A61F2002/30133; A61F2002/30138; A61F2002/30153; A61F2002/30159; A61F2002/30179; A61F2002/30199; A61F2002/30205; A61F2002/30217; A61F2/30767; A61F2/30771; A61F2002/30772; A61F2002/30784; A61F2002/30785; A61F2002/30789; A61F2002/3085; A61F2002/30868; A61F2002/30904; A61F2/30942; A61F2002/30957; A61F2210/00; A61F2210/0004; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0015; A61F2230/0017; A61F2230/0019; A61F2230/0028; A61F2230/0058; A61F2230/0063; A61F2230/0067; Y; Y10; Y10S; Y10S623/00; Y10S623/924; Y10S623/926
Claims Analysis
Total Claims: 39
Claim 1
Independent Claim
17 words
1 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material.
Claim 2
Dependent Claim
17 words
1 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material.
Claim 3
Dependent Claim
20 words
2 . The resorbable interbody spinal fusion device of claim 1 , further comprising one or more void spaces therein.
Claim 4
Dependent Claim
32 words
3 . The resorbable interbody spinal fusion device of claim 2 , wherein one of said one or more void spaces contains a grafting material for facilitating bony development and/or spinal fusion.
Claim 5
Dependent Claim
21 words
4 . The resorbable interbody spinal fusion device of claim 3 , wherein said grafting material is an autologous grafting material.
Claim 6
Dependent Claim
24 words
5 . The resorbable interbody spinal fusion device of claim 1 , wherein said device is shaped substantially as a tapered wedge or cone.
Claim 7
Dependent Claim
22 words
6 . The resorbable interbody spinal fusion device of claim 1 , wherein said device is shaped substantially as a threaded screw.
Claim 8
Dependent Claim
25 words
7 . The resorbable interbody spinal fusion device of claim 1 , wherein said device is shaped substantially as a threaded rod of cruciform configuration.
Claim 9
Dependent Claim
22 words
8 . The resorbable interbody spinal fusion device of claim 5 , further comprising at least one serrated or threaded outer face.
Claim 10
Dependent Claim
31 words
9 . The resorbable interbody spinal fusion device of claim 1 , wherein said resorbable material is a polymer producing acidic products or low molecular weight resorbable fragments upon hydrolytic degradation.
Claim 11
Dependent Claim
41 words
10 . The resorbable interbody spinal fusion device of claim 9 , wherein said resorbable material further comprises a buffering or neutralizing agent in sufficiently high concentration to moderate the rate of change of pH of said resorbable material during resorption.
Claim 12
Dependent Claim
37 words
11 . The resorbable interbody spinal fusion device of claim 1 , wherein said resorbable material is, a polymer selected from the group consisting of polydioxanone, polyε-caprolactone), polyanhydride, polyester, copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate), and combinations thereof.
Claim 13
Dependent Claim
32 words
12 . The resorbable interbody spinal fusion device of claim 11 , wherein said bioerodible polymer comprises poly(lactide-co-glycolide) with a lactide to glycolide ratio in the range of 0:100% to 100:0% inclusive.
Claim 14
Dependent Claim
27 words
13 . The resorbable interbody spinal fusion device of claim 10 , wherein said buffering or neutralizing agent is a polymer comprising at least one basic group.
Claim 15
Dependent Claim
37 words
14 . The resorbable interbody spinal fusion device of claim 13 , wherein said polymer comprising at least one basic group is selected from the group consisting of polyamines, polyesters, vinyl polymers, and copolymers of acrylic acid.
Claim 16
Dependent Claim
30 words
15 . The resorbable interbody spinal fusion device of claim 10 , wherein said buffering-or neutralizing agent is a compound that, on exposure to water, hydrolyzes to form a base.
Claim 17
Dependent Claim
31 words
16 . The resorbable interbody spinal fusion device of claim 10 , wherein said buffering or neutralizing agent is selected from the group consisting of carbonates, phosphates, acetates, succinates and citrates.
Claim 18
Dependent Claim
19 words
17 . The resorbable interbody spinal fusion device of claim 1 wherein said resorbable material further comprises reinforcing fibers.
Claim 19
Dependent Claim
22 words
18 . The resorbable interbody spinal fusion device of claim 17 , wherein said reinforcing fibers are made of said resorbable material.
Claim 20
Dependent Claim
20 words
19 . The resorbable interbody spinal fusion device of claim 10 , wherein said resorbable material further comprises reinforcing fibers.
Claim 21
Dependent Claim
24 words
20 . The resorbable interbody spinal fusion device of claim 19 , wherein said reinforcing fibers are made of said buffering or neutralizing agent.
Claim 22
Dependent Claim
62 words
21 . A method of making a resorbable interbody spinal fusion device, comprising the steps of: providing a mold for said resorbable interbody spinal fusion device; orienting reinforcing fibers under tension in said mold; introducing a resorbable material into said mold; molding said resorbable material under pressure; and releasing tension on said reinforcing fibers prior to removing said device from said mold.
Claim 23
Dependent Claim
62 words
21 . A method of making a resorbable interbody spinal fusion device, comprising the steps of: providing a mold for said resorbable interbody spinal fusion device; orienting reinforcing fibers under tension in said mold; introducing a resorbable material into said mold; molding said resorbable material under pressure; and releasing tension on said reinforcing fibers prior to removing said device from said mold.
Claim 24
Dependent Claim
23 words
22 . The method of claim 21 wherein said resorbable reinforcing fibers are made of the same material as said resorbable interbody material.
Claim 25
Dependent Claim
17 words
23 . The method of claim 21 wherein said resorbable reinforcing fibers do not contain a buffer.
Claim 26
Dependent Claim
54 words
24 . The resorbable interbody spinal fusion device of claim 10 wherein said buffering or neutralizing agent is selected from the group consisting of compounds wherein the pKa of the conjugate acids of said compounds is greater than the pKa of acids produced by hydrolysis of the polymer(s) from which said device is prepared.
Claim 27
Dependent Claim
23 words
25 . The resorbable interbody spinal fusion, device of claim 1 , wherein said device is fabricated from at least two resorbable polymers.
Claim 28
Dependent Claim
22 words
26 . The resorbable interbody spinal fusion device of claim 25 , wherein one of said resorbable polymers is poly (propylene fumarate).
Claim 29
Dependent Claim
41 words
27 . The resorbable interbody spinal fusion device of claim 25 , wherein one of said resorbable polymers has been cross-linked in the presence of a crosslinking agent and an initiator, whereby said crosslinked resorbable polymer forms a reinforcing interpenetrating network.
Claim 30
Dependent Claim
19 words
28 . The resorbable interbody spinal fusion device of claim 25 , wherein said crosslinking agent is vinyl pyrrolidone.
Claim 31
Dependent Claim
18 words
29 . The resorbable interbody spinal fusion device of claim 25 , wherein said initiator is benzoyl peroxide.
Claim 32
Dependent Claim
33 words
30 . The resorbable interbody spinal fusion device of claim 1 , wherein said device is fabricated from a polymer wherein molecular chains of said polymer have been aligned to be essentially parallel.
Claim 33
Dependent Claim
37 words
31 . The resorbable interbody spinal fusion device of claim 30 , wherein said device has been cut such that the aligned polymer molecular chains are at approximately a 450 angle to a surface of said device.
Claim 34
Dependent Claim
48 words
32 . A resorbable interbody spinal fusion device, wherein said device is substantially manufactured from a resorbable material poly(d,l-lactide-co-glycolide), said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite, and wherein said device further comprises one or more void spaces therein.
Claim 35
Dependent Claim
48 words
32 . A resorbable interbody spinal fusion device, wherein said device is substantially manufactured from a resorbable material poly(d,l-lactide-co-glycolide), said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite, and wherein said device further comprises one or more void spaces therein.
Claim 36
Dependent Claim
46 words
33 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material, said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite, and wherein said device further comprises one or more void spaces therein.
Claim 37
Dependent Claim
46 words
33 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material, said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite, and wherein said device further comprises one or more void spaces therein.
Claim 38
Dependent Claim
34 words
34 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material, said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite.
Claim 39
Dependent Claim
34 words
34 . A resorbable interbody spinal fusion device for spinal fixation, said device comprising 25-100% resorbable material, said device further comprising a buffering or neutralizing agent wherein said buffering or neutralizing agent is hydroxyapatite.
References Cited (Backward Citations)
No citation records indexed.
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