US6726721B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Hydrogel-based prosthetic device for replaceing at least a part of the nucleus of a spinal disc
Assignee: Replication Medical Inc
•
Filing: 2001-05-10
•
Granted: 2004-04-27
•
Expires: 2021-05-10
Abstract
Abstract The present invention is a prosthetic for replacement of at least a part of the nucleus of a intravertebral disc. The prosthetic device is composed of at least two essentially parallel soft layers of an elastically deformable hydrogel and at least one rigid layer, the rigid layer having less compressibility than the soft layers, being adjacent to the soft layers, parallel to them, and firmly attached to them. In some embodiments, the soft layers have the same thickness and composition. Typically, the prosthesis has more than one rigid layer and these rigid layers have the same thickness and composition. The number of soft layers is usually one more than the number of rigid layers, with, e.g., at least three soft layers.
Inventors
- 👤 Vladimir A. Stoy
- 👤 Petr Stehlicek
- 👤 Zdena Kozlova
- 👤 Tomas Drunecky
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 10:32
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/14; A61L27/20; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/441; A61L27/16; A61L27/18; A61L27/40; A61L27/44; A61L27/50; A61L27/52; A61F2/442; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30075; A61F2002/4435; A61F2002/444; A61F2210/00; A61F2210/0061; A61L2430/00; A61L2430/38
Claims Analysis
Total Claims: 82
Claim 1
Independent Claim
85 words
A spinal disc implant for replacement of at least a part of the nucleus of a intravertebral disc, which comprises: an implant which is adapted to replace at least a part of the nucleus of an intravertebral disc and which is composed of at least two essentially parallel soft layers of an elastically deformable hydrogel and at least one rigid layer, said rigid layer having less compressibility than said soft layers, being adjacent to the soft layers, parallel to them, and firmly attached to them.
Claim 2
Dependent Claim
85 words
A spinal disc implant for replacement of at least a part of the nucleus of a intravertebral disc, which comprises: an implant which is adapted to replace at least a part of the nucleus of an intravertebral disc and which is composed of at least two essentially parallel soft layers of an elastically deformable hydrogel and at least one rigid layer, said rigid layer having less compressibility than said soft layers, being adjacent to the soft layers, parallel to them, and firmly attached to them.
Claim 3
Dependent Claim
16 words
The implant according to claim 1 wherein the soft layers have the same thickness and composition.
Claim 4
Dependent Claim
24 words
The implant according to claim 1 wherein there is more than one rigid layer and these rigid layers have the same thickness and composition.
Claim 5
Dependent Claim
25 words
The implant according to claim 1 wherein the number of soft layers is one more than the number of the at least one rigid layer.
Claim 6
Dependent Claim
14 words
The implant according to claim 1 wherein there are at least three soft layers.
Claim 7
Dependent Claim
41 words
The implant according to claim 1 wherein at least one of said at least one rigid layer is reinforced by a reinforcement component selected from the group consisting of textile fibers, a perforated polymer foil or a combination of the two.
Claim 8
Dependent Claim
40 words
The implant according to claim 6 wherein textile fibers are the reinforcing component and have a configuration selected from the group consisting of a knit net, a non-woven textile, or a woven lattice placed parallel to the firm layer surface.
Claim 9
Dependent Claim
27 words
The implant according to claim 1 wherein the elastically deformable hydrogel in a state of maximum swelling has a water content of more than 75% by weight.
Claim 10
Dependent Claim
27 words
The implant according to claim 1 wherein the elastically deformable hydrogel in a state of maximum swelling has a water content of more than 90% by weight.
Claim 11
Dependent Claim
32 words
The implant according to claim 1 wherein the hydrogel is selected from a group consisting of partially hydrolyzed polyacrylonitrile, partially aminolyzed polyacrylonitrile, crystallized polyvinylalcohol, hydrophilic polyurethane, and a hydrogel derived from agar.
Claim 12
Dependent Claim
33 words
The implant according to claim 1 wherein the at least one rigid layer contains a hydrogel of the same type as the hydrogel in the soft layers, but with a different water content.
Claim 13
Dependent Claim
34 words
The implant according to claim 1 wherein the layers are firmly attached by mutual cross-linking of the layers or by an adhesive selected from the group consisting of reactive adhesive and solvent based adhesive.
Claim 14
Dependent Claim
33 words
The implant according to claim 1 wherein the prosthetic has an initial volume, base contour and surface, and the volume of said prosthetic prior to implantation is lessened by at least partial dehydration.
Claim 15
Dependent Claim
48 words
The implant according to claim 13 wherein when said at least partially dehydrated prosthetic is in a flat state, and substantially disc-shaped, the base contour and surface are preserved, and the thickness of the layers is diminished in a ratio to the volumetric change caused by the dehydration.
Claim 16
Dependent Claim
27 words
The implant according to claim 1 wherein said prosthesis is plasticized by water, by a physiologically harmless plasticizer mixable with water, or a combination of such plasticizers.
Claim 17
Dependent Claim
21 words
The implant according to claim 15 wherein the softening point of the plasticized prosthetic is between −5° C. to 40° C.
Claim 18
Dependent Claim
104 words
A spinal disc implant which comprises an implant member dimensioned for positioning in a space between adjacent vertebrae, the implant member defining a longitudinal axis that is substantially coaxial with the adjacent vertebrae when implanted, and a length extending along the longitudinal axis, the implant member comprising at least two hydrogel layers, the layers oriented substantially coaxially to each other and in substantially coaxial relation to the adjacent vertebrae, whereby upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae.
Claim 19
Dependent Claim
104 words
A spinal disc implant which comprises an implant member dimensioned for positioning in a space between adjacent vertebrae, the implant member defining a longitudinal axis that is substantially coaxial with the adjacent vertebrae when implanted, and a length extending along the longitudinal axis, the implant member comprising at least two hydrogel layers, the layers oriented substantially coaxially to each other and in substantially coaxial relation to the adjacent vertebrae, whereby upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae.
Claim 20
Dependent Claim
34 words
A spinal disc implant according to claim 17 wherein the implant member comprises at least two hydrogel layers, a first of the hydrogel layers being less rigid than a second of the hydrogel layers.
Claim 21
Dependent Claim
29 words
A spinal disc implant according to claim 18 further comprising a reinforcing member which assists in limiting the increase in width of the implant member along the transverse axis.
Claim 22
Dependent Claim
20 words
A spinal disc implant according to claim 19 wherein the reinforcing member is located in the more rigid hydrogel layer.
Claim 23
Dependent Claim
29 words
A spinal disc implant according to claim 19 wherein the reinforcing member is selected from the group consisting of textile fibers, a perforated polymer foil and a combination thereof.
Claim 24
Dependent Claim
24 words
A spinal disc implant according to claim 21 wherein the textile fibers are in the form of a woven lattice, non-woven textile or web.
Claim 25
Dependent Claim
18 words
A spinal disc implant according to claim 18 wherein the at least two hydrogel layers are substantially parallel.
Claim 26
Dependent Claim
41 words
A spinal disc implant according to claim 18 further comprising a third layer which is more rigid than the first of the hydrogel layers and made of a material selected from the group consisting of non-hydrogel forming polymer, metal and graphite.
Claim 27
Dependent Claim
28 words
A spinal disc implant according to claim 24 wherein the polymer is selected from the group consisting of polyethyleneterephthalate, polyamide, polyurethane, polyurea, acrylic, methacrylic, polytetrafluoroethylene and combinations thereof.
Claim 28
Dependent Claim
25 words
A spinal disc implant according to claim 18 wherein the at least two layers are attached to each other by mutual crosslinking of the layers.
Claim 29
Dependent Claim
22 words
A spinal disc implant according to claim 18 wherein the at least two layers are attached to each other by an adhesive.
Claim 30
Dependent Claim
36 words
A spinal disc implant according to claim 18 wherein the implant member comprises at least three hydrogel layers, the first and third of the hydrogel layers being less rigid than the second of the hydrogel layers.
Claim 31
Dependent Claim
24 words
A spinal disc implant according to claim 28 wherein the first and third of the hydrogel layers have substantially the same thickness and composition.
Claim 32
Dependent Claim
21 words
A spinal disc implant according to claim 29 wherein the at least three hydrogel layers are substantially parallel to one another.
Claim 33
Dependent Claim
26 words
A spinal disc implant according to claim 28 wherein the second of the hydrogel layers is interposed between the first and third of the hydrogel layers.
Claim 34
Dependent Claim
29 words
A spinal disc implant according to claim 28 further comprising a reinforcing member which assists in limiting the increase in length of the implant member along the horizontal axis.
Claim 35
Dependent Claim
19 words
A spinal disc implant according to claim 32 wherein the reinforcing member is located in the second hydrogel layer.
Claim 36
Dependent Claim
47 words
A spinal disc implant according to claim 28 wherein the implant member includes a fourth hydrogel layer, the second and fourth hydrogel layers being more rigid than the first and third of the hydrogel layers, the second and fourth layers having substantially the same thickness and composition.
Claim 37
Dependent Claim
32 words
A spinal disc implant according to claim 18 wherein the implant member comprises at least three hydrogel layers, the second and third layers being more rigid than the first of said layers.
Claim 38
Dependent Claim
20 words
A spinal disc implant according to claim 35 wherein the first layer is interposed between the second and third layers.
Claim 39
Dependent Claim
19 words
A spinal disc implant according to claim 17 wherein the space between the adjacent vertebrae is the disc space.
Claim 40
Dependent Claim
35 words
A spinal disc implant according to claim 17 wherein the implant member includes at least four hydrogel layers, at least three of the hydrogel layers being less rigid than a fourth of the hydrogel layers.
Claim 41
Dependent Claim
37 words
A spinal disc implant according to claim 38 wherein the implant member includes at least five hydrogel layers, at least three of the hydrogel layers being less rigid than a fourth and fifth of the hydrogel layers.
Claim 42
Dependent Claim
46 words
A spinal disc implant according to claim 39 wherein the fourth and fifth of the hydrogel layers are respectively interposed between each of the at least three of the less rigid hydrogel layers to form an alternating arrangement of more rigid and less rigid hydrogel layers.
Claim 43
Dependent Claim
24 words
A spinal disc implant according to claim 40 wherein a reinforcing member is located in at least one of the more rigid hydrogel layers.
Claim 44
Dependent Claim
22 words
A spinal disc implant according to claim 41 wherein a reinforcing member is located within each of the more rigid hydrogel layers.
Claim 45
Dependent Claim
18 words
A spinal disc implant according to claim 39 wherein the at least five hydrogel layers are substantially parallel.
Claim 46
Dependent Claim
28 words
A spinal disc implant according to claim 17 wherein the implant member has a water content of more than about 75% by weight in a fully hydrated state.
Claim 47
Dependent Claim
34 words
A spinal disc implant according to claim 17 wherein the hydrogel includes a polymer selected from the group consisting of partially hydrolyzed polyacrylonitrile, partially aminolyzed polyacrylonitrile, crystallized polyvinylalcohol, hydrophilic polyurethane, agar and combinations thereof.
Claim 48
Dependent Claim
19 words
A spinal disc implant according to claim 17 wherein the implant member is encapsulated by a layer of hydrogel.
Claim 49
Dependent Claim
131 words
A spinal disc implant which comprises an implant member dimensioned for positioning in a space between adjacent vertebrae, the implant member defining a longitudinal axis which is substantially coaxial with the adjacent vertebrae when implanted and a length extending along the longitudinal axis, the implant member including at least two layers substantially coaxial with each other and the adjacent vertebrae, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae.
Claim 50
Dependent Claim
131 words
A spinal disc implant which comprises an implant member dimensioned for positioning in a space between adjacent vertebrae, the implant member defining a longitudinal axis which is substantially coaxial with the adjacent vertebrae when implanted and a length extending along the longitudinal axis, the implant member including at least two layers substantially coaxial with each other and the adjacent vertebrae, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae.
Claim 51
Dependent Claim
19 words
A spinal disc implant according to claim 47 wherein the space between the adjacent vertebrae is the disc space.
Claim 52
Dependent Claim
29 words
A spinal disc implant according to claim 47 further comprising a reinforcing member which assists in limiting the increase in length of the implant member along the horizontal axis.
Claim 53
Dependent Claim
19 words
A spinal disc implant according to claim 49 wherein the reinforcing member is located in the more rigid layer.
Claim 54
Dependent Claim
29 words
A spinal disc implant according to claim 49 wherein the reinforcing member is selected from the group consisting of textile fibers, a perforated polymer foil and a combination thereof.
Claim 55
Dependent Claim
24 words
A spinal disc implant according to claim 51 wherein the textile fibers are in the form of a woven lattice, non-woven textile or web.
Claim 56
Dependent Claim
17 words
A spinal disc implant according to claim 47 wherein the at least two layers are substantially parallel.
Claim 57
Dependent Claim
29 words
A spinal disc implant according to claim 47 wherein the second layer is made of a material selected from the group consisting of non-hydrogel forming polymer, metal and graphite.
Claim 58
Dependent Claim
28 words
A spinal disc implant according to claim 54 wherein the polymer is selected from the group consisting of polyethyleneterephthalate, polyamide, polyurethane, polyurea, acrylic, methacrylic, polytetrafluoroethylene and combinations thereof.
Claim 59
Dependent Claim
23 words
A spinal disc implant according to claim 47 wherein the two layers are attached to each other by mutual crosslinking of the layers.
Claim 60
Dependent Claim
20 words
A spinal disc implant according to claim 47 wherein the two layers are attached to each other by an adhesive.
Claim 61
Dependent Claim
36 words
A spinal disc implant according to claim 47 wherein the implant member includes at least three layers, a first and a second of the layers being a hydrogel less rigid than a third of the layers.
Claim 62
Dependent Claim
24 words
A spinal disc implant according to claim 58 wherein the first and second of the hydrogel layers have substantially the same thickness and composition.
Claim 63
Dependent Claim
17 words
A spinal disc implant according to claim 58 wherein the layers are substantially parallel to one another.
Claim 64
Dependent Claim
25 words
A spinal disc implant according to claim 58 wherein the third of the layers is interposed between the first and second of the hydrogel layers.
Claim 65
Dependent Claim
29 words
A spinal disc implant according to claim 58 further comprising a reinforcing member which assists in limiting the increase in length of the implant member along the horizontal axis.
Claim 66
Dependent Claim
20 words
A spinal disc implant according to claim 62 wherein the reinforcing member is located in the more rigid third layer.
Claim 67
Dependent Claim
25 words
A spinal disc implant according to claim 63 wherein the implant member includes at least two more rigid layers respectively interposed between the hydrogel layers.
Claim 68
Dependent Claim
41 words
A spinal disc implant according to claim 58 wherein the implant member contains at least two layers which are more rigid than the first and second of the hydrogel layers, the more rigid layers having substantially the same thickness and composition.
Claim 69
Dependent Claim
18 words
A spinal disc implant according to claim 47 wherein the implant member includes at least three hydrogel layers.
Claim 70
Dependent Claim
19 words
A spinal disc implant according to claim 47 wherein the implant member is encapsulated by a layer of hydrogel.
Claim 71
Dependent Claim
57 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a horizontal axis which is transverse to the longitudinal axis, the implant member comprising a hydrogel and an interiorly disposed reinforcing member which assists in limiting expansion of the implant along the horizontal axis.
Claim 72
Dependent Claim
57 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a horizontal axis which is transverse to the longitudinal axis, the implant member comprising a hydrogel and an interiorly disposed reinforcing member which assists in limiting expansion of the implant along the horizontal axis.
Claim 73
Dependent Claim
32 words
A spinal disc implant according to claim 68 wherein the implant member comprises at least two hydrogel layers, a first of the layers being less rigid than a second of the layers.
Claim 74
Dependent Claim
29 words
A spinal disc implant according to claim 68 wherein the reinforcing member is selected from the group consisting of textile fibers, a perforated polymer foil and a combination thereof.
Claim 75
Dependent Claim
24 words
A spinal disc implant according to claim 70 wherein the textile fibers are in the form of a woven lattice, non-woven textile or web.
Claim 76
Dependent Claim
32 words
A spinal disc implant according to claim 68 wherein the implant member has a capacity to swell to length along the longitudinal axis which is greater than the space between adjacent vertebrae.
Claim 77
Dependent Claim
81 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member comprising a hydrogel, whereby upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the implant member being encapsulated by a layer of hydrogel.
Claim 78
Dependent Claim
81 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member comprising a hydrogel, whereby upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the implant member being encapsulated by a layer of hydrogel.
Claim 79
Dependent Claim
149 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member comprising at least three layers, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers and a third of the layers being a hydrogel layer which is less rigid that the second of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the second layer being made of a material selected from the group consisting of non-hydrogel forming polymer, metal and graphite.
Claim 80
Dependent Claim
149 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member comprising at least three layers, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers and a third of the layers being a hydrogel layer which is less rigid that the second of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the second layer being made of a material selected from the group consisting of non-hydrogel forming polymer, metal and graphite.
Claim 81
Dependent Claim
119 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member including at least two layers, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the implant member being encapsulated by a layer of hydrogel.
Claim 82
Dependent Claim
119 words
A spinal disc implant which comprises an implant member dimensioned for positioning between adjacent vertebrae, the implant member defining a longitudinal axis and a length extending along the longitudinal axis, the implant member including at least two layers, a first of the layers being a hydrogel layer which is less rigid than a second of the layers, the second of the layers being substantially planar and more rigid than the first of the layers, whereby, upon at least partial hydration of the implant member, the implant member has a capacity to swell to a length along the longitudinal axis which is greater than the space between the adjacent vertebrae, the implant member being encapsulated by a layer of hydrogel.
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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) | 2007-04-27 | 2007-10-27 | 2008-04-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2011-04-27 | 2011-10-27 | 2012-04-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2015-04-27 | 2015-10-27 | 2016-04-27 | $7700.00 | Window Closed / Lapsed |