Patent US7077865B2 successfully refreshed from Google Patents.
US7077865B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of making an intervertebral disc prosthesis
Assignee: Disc Dynamics Inc
•
Filing: 2003-02-13
•
Granted: 2006-07-18
•
Expires: 2023-02-13
Abstract
Abstract A system for repairing an intervertebral disc by delivering and curing a biomaterial in situ within the disc. The system includes both a device, having an insertable balloon and related lumen, controls and adapters, as well as an in situ curable biomaterial (and related biomaterial delivery means). The system can allow the doctor to determine a suitable endpoint for biomaterial delivery, by controlling distraction and/or biomaterial delivery pressure, and in turn, to deliver a desired quantity of biomaterial to the balloon in order to achieve improved polymer cure and implant characteristics. Also provided is a related method for repairing an intervertebral disc by using such a system to deliver and cure the biomaterial in situ. The system can be used to implant a prosthetic total disc, or a prosthetic disc nucleus in a manner that leaves the surrounding disc tissue substantially intact.
Inventors
- 👤 Qi-Bin Bao
- 👤 Robert Garryl HUDGINS
- 👤 Jeffrey C. Felt
- 👤 Alexander Arsenyev
- 👤 Hansen A. Yuan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:08
CPC Classifications
C; C08; C08G; C08G18/00; C08G18/06; C08G18/28; C08G18/40; C08G18/48; C08G18/4854; A; A61; A61B; A61B17/00; A61B17/16; A61B17/17; A61B17/56; A61B17/58; A61B17/68; A61B17/70; A61B17/7097; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/30756; A61F2/44; A61F2/441; A61F2/442; A61F2/46; A61F2/4601; A61F2/4603; A61F2/4611; A61L; A61L27/00; A61L27/14; A61L27/18; A61L29/00; A61L29/04; A61L29/041; A61L29/06; C08G18/08; C08G18/10; C08G18/67; C08G18/69; A61B1/00; A61B1/00163; A61B1/00165; A61B17/00234; A61B2017/00535; A61F2/04; A61F2/06; A61F2/07; A61F2/28; A61F2/30767; A61F2/30988; A61F2/3099; A61F2/32; A61F2/38; A61F2/40; A61F2/4081; A61F2/42; A61F2/4202; A61F2/82; A61F2/94; A61F2/945; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30016; A61F2002/30024; A61F2002/3006; A61F2002/3008; A61F2002/30108; A61F2002/30199; A61F2002/30224; A61F2002/30235; A61F2002/30316; A61F2002/30535; A61F2002/30563; A61F2002/30576; A61F2002/30578; A61F2002/30581; A61F2002/30583; A61F2002/30601; A61F2/30771; A61F2002/30841; A61F2002/30929; A61F2/3094; A61F2/30942; A61F2002/30957; A61F2/4225; A61F2002/4233; A61F2002/444; A61F2002/4625; A61F2002/4627; A61F2002/4635; A61F2210/00; A61F2210/0085; A61F2230/00; A61F2230/0063; A61F2230/0069; A61F2250/00; A61F2250/0014; A61F2250/0019; A61F2250/0021; A61F2250/0058; A61F2250/0096; A61F2250/0098; A61L2430/00; A61L2430/38; B; B01; B01F; B01F2101/00; B01F2101/2305; Y; Y10; Y10S; Y10S606/00; Y10S606/907; Y10S606/91
Claims Analysis
Total Claims: 79
Claim 1
Independent Claim
110 words
A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of: providing a curable biomaterial; and performing the surgical steps of; (a) accessing and preparing the joint site for receipt of the biomaterial; (b) delivering a quantity of the curable biomaterial to the prepared joint site; (c) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and contouring the cured, retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (c) comprise an intervertebral disc replacement using minimally invasive surgical means.
Claim 2
Independent Claim
110 words
A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of: providing a curable biomaterial; and performing the surgical steps of; (a) accessing and preparing the joint site for receipt of the biomaterial; (b) delivering a quantity of the curable biomaterial to the prepared joint site; (c) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and contouring the cured, retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (c) comprise an intervertebral disc replacement using minimally invasive surgical means.
Claim 3
Dependent Claim
15 words
The method according to claim 1 wherein the minimally invasive surgical means are arthroscopic means.
Claim 4
Dependent Claim
25 words
The method according to claim 1 wherein the delivery step is performed under arthroscopic visualization using a cannula suitably dimensioned to deliver the curable biomaterial.
Claim 5
Dependent Claim
53 words
The method according to claim 1 comprising the further step of coating or modifying the surface of the contoured material with a permanent interface material in order to improve the biocompatability or coefficient of friction of the cured biomaterial, wherein the coating or modifying step is also performed using minimally invasive surgical means.
Claim 6
Dependent Claim
14 words
The method according to claim 1 wherein the biomaterial comprises a curable polyurethane polymer.
Claim 7
Dependent Claim
16 words
The method according to claim 1 wherein the delivery step is performed using an arthroscopic cannula.
Claim 8
Dependent Claim
18 words
The method according to claim 1 wherein the intervertebral disc comprises a mold for retaining the curable biomaterial.
Claim 9
Independent Claim
140 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; purging a portion of the flowable biomaterial prior to delivery to the intervertebral disc space; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 10
Independent Claim
140 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; purging a portion of the flowable biomaterial prior to delivery to the intervertebral disc space; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 11
Dependent Claim
12 words
The method of claim 8 wherein the biomaterial comprises a polyurethane system.
Claim 12
Dependent Claim
21 words
The method of claim 8 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.
Claim 13
Dependent Claim
17 words
The method of claim 8 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 14
Dependent Claim
27 words
The method of claim 11 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.
Claim 15
Dependent Claim
28 words
The method of claim 11 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.
Claim 16
Dependent Claim
16 words
The method of claim 11 wherein the biomaterial located outside of the balloon is in-situ curable.
Claim 17
Dependent Claim
18 words
The method of claim 8 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 18
Dependent Claim
34 words
The method of claim 8 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.
Claim 19
Dependent Claim
18 words
The method of claim 8 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 20
Dependent Claim
18 words
The method of claim 8 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 21
Independent Claim
137 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; withdrawing air from the balloon located in the intervertebral disc space; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 22
Independent Claim
137 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; withdrawing air from the balloon located in the intervertebral disc space; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 23
Dependent Claim
12 words
The method of claim 19 wherein the biomaterial comprises a polyurethane system.
Claim 24
Dependent Claim
21 words
The method of claim 19 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.
Claim 25
Dependent Claim
17 words
The method of claim 19 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 26
Dependent Claim
27 words
The method of claim 22 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.
Claim 27
Dependent Claim
28 words
The method of claim 22 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.
Claim 28
Dependent Claim
16 words
The method of claim 22 wherein the biomaterial located in the annular shell is in-situ curable.
Claim 29
Dependent Claim
29 words
The method of claim 19 comprising applying herein mechanical distraction in combination with the pressurized injection of flowable biomaterial to apply a distraction force to the intervertebral disc space.
Claim 30
Dependent Claim
18 words
The method of claim 19 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 31
Dependent Claim
34 words
The method of claim 19 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.
Claim 32
Dependent Claim
18 words
The method of claim 19 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 33
Dependent Claim
18 words
The method of claim 19 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 34
Independent Claim
151 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus, wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions with a more rigid outer region and a more flexible inner region.
Claim 35
Independent Claim
151 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus, wherein the cured biomaterial provides a heterogeneous implant having a plurality of regions with a more rigid outer region and a more flexible inner region.
Claim 36
Dependent Claim
44 words
The method of claim 31 wherein the injection of pressurized biomaterial is sufficient to distract the intervertebral disc space from constricted dimensions of on the order of 3 mm to 4 mm to dimensions of on the order of 8 mm to 12 mm.
Claim 37
Dependent Claim
12 words
The method of claim 31 wherein the biomaterial comprises a polyurethane system.
Claim 38
Dependent Claim
21 words
The method of claim 31 wherein the balloon when inflated fills less than the entire volume of the intervertebral disc space.
Claim 39
Dependent Claim
17 words
The method of claim 31 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 40
Dependent Claim
27 words
The method of claim 35 wherein the biomaterial located in the intervertebral disc space outside of the balloon is different from the biomaterial located in the balloon.
Claim 41
Dependent Claim
28 words
The method of claim 35 wherein the biomaterial located in the balloon is more flexible than the biomaterial located in the intervertebral disc space outside of the balloon.
Claim 42
Dependent Claim
16 words
The method of claim 31 wherein the biomaterial located in the annular shell is in-situ curable.
Claim 43
Dependent Claim
28 words
The method of claim 31 comprising applying mechanical distraction in combination with the pressurized injection of flowable biomaterial to apply a distraction force to the intervertebral disc space.
Claim 44
Dependent Claim
18 words
The method of claim 31 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 45
Dependent Claim
34 words
The method of claim 31 comprising purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.
Claim 46
Dependent Claim
18 words
The method of claim 31 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 47
Dependent Claim
18 words
The method of claim 31 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 48
Independent Claim
128 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; purging a portion of the biomaterial prior to delivery to the balloon; delivering the flowable biomaterial into the balloon using minimally invasive techniques; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 49
Independent Claim
128 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; purging a portion of the biomaterial prior to delivery to the balloon; delivering the flowable biomaterial into the balloon using minimally invasive techniques; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 50
Dependent Claim
39 words
The method of claim 44 wherein the step of purging comprises purging a volume of biomaterial equal to about 1 to about 4 times a volume of a mixing element prior to delivery of the biomaterial to the balloon.
Claim 51
Dependent Claim
18 words
The method of claim 44 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 52
Dependent Claim
18 words
The method of claim 44 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 53
Independent Claim
151 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; delivering the flowable biomaterial into the balloon located in the intervertebral disc space while applying a vacuum to the balloon using minimally invasive techniques; terminating the flow of biomaterial in response to an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 54
Independent Claim
151 words
A method for repairing a damaged or diseased intervertebral disc, the method comprising the steps of: using minimally invasive techniques to remove damaged or diseased nucleus from the disc; providing a mold apparatus comprising a balloon adapted to contain a biomaterial and a delivery cannula adapted to flowably connect a biomaterial source to the balloon; positioning the balloon in the intervertebral disc space using minimally invasive techniques; providing a biomaterial source comprising a flowable biomaterial; mixing the flowable biomaterial; delivering the flowable biomaterial into the balloon located in the intervertebral disc space while applying a vacuum to the balloon using minimally invasive techniques; terminating the flow of biomaterial in response to an endpoint monitor adapted to provide an indication of an endpoint for biomaterial delivery; and allowing the delivered biomaterial to cure a sufficient amount to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 55
Dependent Claim
20 words
The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by delivery pressure of the biomaterial.
Claim 56
Dependent Claim
19 words
The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by volume of biomaterial delivered.
Claim 57
Dependent Claim
23 words
The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by the amount of distraction of the intervertebral disc.
Claim 58
Independent Claim
124 words
A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of: providing a curable biomaterial; and performing the surgical steps of; (a) accessing and preparing the joint site for receipt of the biomaterial; (b) purging a portion of the biomaterial prior to delivery into the prepared joint site; (c) delivering a quantity of the curable biomaterial to the prepared joint site; (d) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and contouring the retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (d) comprise an intervertebral disc replacement using minimally invasive surgical means.
Claim 59
Independent Claim
124 words
A method for repairing or resurfacing the site of an injured or diseased articulating joint, the method comprising the steps of: providing a curable biomaterial; and performing the surgical steps of; (a) accessing and preparing the joint site for receipt of the biomaterial; (b) purging a portion of the biomaterial prior to delivery into the prepared joint site; (c) delivering a quantity of the curable biomaterial to the prepared joint site; (d) curing the delivered biomaterial in such a manner that the cured biomaterial is permanently retained in apposition to the prepared site; and contouring the retained biomaterial to achieve a desired conformation approximating that of the natural joint, wherein steps (a) through (d) comprise an intervertebral disc replacement using minimally invasive surgical means.
Claim 60
Dependent Claim
14 words
The method according to claim 52 wherein the biomaterial comprises a curable polyurethane polymer.
Claim 61
Dependent Claim
16 words
The method according to claim 52 wherein the delivery step is performed using an arthroscopic cannula.
Claim 62
Dependent Claim
19 words
The method according to claim 52 wherein the intervertebral disc site comprises a mold for retaining the curable biomaterial.
Claim 63
Dependent Claim
25 words
The method according to claim 19 wherein air is withdrawn from the balloon at the same time the flowable biomaterial is delivered into the balloon.
Claim 64
Dependent Claim
19 words
The method according to claim 7 comprising providing a mold with elastic properties and non-elastic properties at different regions.
Claim 65
Dependent Claim
27 words
The method according to claim 7 wherein at least one lateral wall of the mold comprises a compliance value higher than a delivery pressure of the biomaterial.
Claim 66
Dependent Claim
28 words
The method according to claim 7 wherein the mold provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.
Claim 67
Dependent Claim
19 words
The method according to claim 7 comprising incorporating a reinforcing material in at least a portion of the mold.
Claim 68
Dependent Claim
19 words
The method according to claim 8 comprising providing a mold with elastic properties and non-elastic properties at different regions.
Claim 69
Dependent Claim
27 words
The method according to claim 8 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.
Claim 70
Dependent Claim
28 words
The method according to claim 8 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.
Claim 71
Dependent Claim
19 words
The method according to claim 8 comprising incorporating a reinforcing material in at least a portion of the balloon.
Claim 72
Dependent Claim
19 words
The method according to claim 19 comprising providing a mold with elastic properties and non-elastic properties at different regions.
Claim 73
Dependent Claim
27 words
The method according to claim 19 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.
Claim 74
Dependent Claim
28 words
The method according to claim 19 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.
Claim 75
Dependent Claim
19 words
The method according to claim 19 comprising incorporating a reinforcing material in at least a portion of the balloon.
Claim 76
Dependent Claim
19 words
The method according to claim 44 comprising providing a mold with elastic properties and non-elastic properties at different regions.
Claim 77
Dependent Claim
27 words
The method according to claim 44 wherein at least one lateral wall of the balloon comprises a compliance value higher than a delivery pressure of the biomaterial.
Claim 78
Dependent Claim
28 words
The method according to claim 44 wherein the balloon provides a distraction force in essentially a vertical direction without exerting a high expansion force on a surrounding annulus.
Claim 79
Dependent Claim
19 words
The method according to claim 44 comprising incorporating a reinforcing material in at least a portion of the balloon.
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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) | 2009-07-17 | 2010-01-16 | 2010-07-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2013-07-17 | 2014-01-16 | 2014-07-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2017-07-17 | 2018-01-16 | 2018-07-18 | $7700.00 | Window Closed / Lapsed |