Patent US20030195628A1 successfully refreshed from Google Patents.
US20030195628A1
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US
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Method of making an intervertebral disc prosthesis
Assignee: Disc Dynamics Inc
•
Filing: 2003-02-13
•
Granted: —
•
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 Hudgins
- 👤 Jeffrey Felt
- 👤 Alexander Arsenyev
- 👤 Hansen Yuan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 16:09
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: 61
Claim 1
Independent Claim
110 words
1 . A method for repairing or resurfacing the site of an injured 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
Dependent Claim
110 words
1 . A method for repairing or resurfacing the site of an injured 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
17 words
2 . The method according to claim 1 wherein the minimally invasive surgical means are arthroscopic means.
Claim 4
Dependent Claim
27 words
3 . 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
55 words
4 . 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
16 words
5 . The method according to claim 1 wherein the biomaterial comprises a curable polyurethane polymer.
Claim 7
Dependent Claim
18 words
6 . The method according to claim 1 wherein the delivery step is performed using an arthroscopic cannula.
Claim 8
Dependent Claim
20 words
7 . The method according to claim 1 wherein the intervertebral disc comprises a mold for retaining the curable biomaterial.
Claim 9
Dependent Claim
162 words
8 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus; and applying mechanical distraction in combination with the pressurized injection of flowable biomaterial to distract the intervertebral disc space.
Claim 10
Dependent Claim
162 words
8 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus; and applying mechanical distraction in combination with the pressurized injection of flowable biomaterial to distract the intervertebral disc space.
Claim 11
Dependent Claim
14 words
9 . The method of claim 8 wherein the biomaterial comprises a polyurethane system.
Claim 12
Dependent Claim
23 words
10 . The method of claim 8 wherein the balloon is inflated fills less than the entire volume of the intervertebral disc space.
Claim 13
Dependent Claim
19 words
11 . The method of claim 8 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 14
Dependent Claim
29 words
12 . The method of claim 8 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
30 words
13 . The method of claim 8 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
18 words
14 . The method of claim 8 wherein the biomaterial located in the annular shell is in-situ curable.
Claim 17
Dependent Claim
20 words
15 . The method of claim 8 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 18
Dependent Claim
36 words
16 . 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
20 words
17 . The method of claim 8 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 20
Dependent Claim
20 words
18 . The method of claim 8 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 21
Dependent Claim
151 words
19 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; deflating the balloon as biomaterial is delivered; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 22
Dependent Claim
151 words
19 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon using minimally invasive techniques to provide a distraction pressure to the intervertebral disc space; deflating the balloon as biomaterial is delivered; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 23
Dependent Claim
14 words
20 . The method of claim 19 wherein the biomaterial comprises a polyurethane system.
Claim 24
Dependent Claim
23 words
21 . The method of claim 19 wherein the balloon is inflated fills less than the entire volume of the intervertebral disc space.
Claim 25
Dependent Claim
19 words
22 . The method of claim 19 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 26
Dependent Claim
29 words
23 . 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
30 words
24 . 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
18 words
25 . The method of claim 22 wherein the biomaterial located in the annular shell is in-situ curable.
Claim 29
Dependent Claim
31 words
26 . 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
20 words
27 . The method of claim 19 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 31
Dependent Claim
36 words
28 . 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
20 words
29 . The method of claim 19 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 33
Dependent Claim
20 words
30 . The method of claim 19 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 34
Dependent Claim
169 words
31 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 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
Dependent Claim
169 words
31 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 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
46 words
32 . 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
14 words
33 . The method of claim 31 wherein the biomaterial comprises a polyurethane system.
Claim 38
Dependent Claim
23 words
34 . The method of claim 31 wherein the balloon is inflated fills less than the entire volume of the intervertebral disc space.
Claim 39
Dependent Claim
19 words
35 . The method of claim 31 comprising locating biomaterial in the intervertebral disc space outside of the balloon.
Claim 40
Dependent Claim
29 words
36 . 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
30 words
37 . 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
18 words
38 . The method of claim 31 wherein the biomaterial located in the annular shell is in-situ curable.
Claim 43
Dependent Claim
33 words
39 . The method of claim 31 comprising applying herein mechanical distraction is applied in combination with the pressurized injection of flowable biomaterial to apply a distraction force to the intervertebral disc space.
Claim 44
Dependent Claim
20 words
40 . The method of claim 31 comprising purging a portion of the biomaterial prior to delivery to the balloon.
Claim 45
Dependent Claim
36 words
41 . 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
20 words
42 . The method of claim 31 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 47
Dependent Claim
20 words
43 . The method of claim 31 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 48
Dependent Claim
146 words
44 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 49
Dependent Claim
146 words
44 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 50
Dependent Claim
41 words
45 . 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
20 words
46 . The method of claim 44 wherein the delivery of biomaterial is done at a substantially constant flow rate.
Claim 52
Dependent Claim
20 words
47 . The method of claim 44 wherein the delivery of biomaterial is done at a substantially continuous flow rate.
Claim 53
Dependent Claim
156 words
48 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 54
Dependent Claim
156 words
48 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into 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 to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 55
Dependent Claim
22 words
49 . The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by delivery pressure of the biomaterial.
Claim 56
Dependent Claim
21 words
50 . The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by volume of biomaterial delivered.
Claim 57
Dependent Claim
22 words
51 . The method of claim 48 wherein the endpoint for delivery of biomaterial is determined by distraction of the intervertebral disc.
Claim 58
Dependent Claim
140 words
52 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon at a substantially constant flow rate using minimally invasive techniques; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 59
Dependent Claim
140 words
52 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon at a substantially constant flow rate using minimally invasive techniques; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 60
Dependent Claim
140 words
53 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon at a substantially continuous flow rate using minimally invasive techniques; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
Claim 61
Dependent Claim
140 words
53 . 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 plurality of components adapted to be mixed at the time of use to provide a flowable biomaterial and initiate its cure; mixing the biomaterial components; delivering the flowable biomaterial into the balloon at a substantially continuous flow rate using minimally invasive techniques; and allowing the delivered biomaterial to cure to permit the cannula to be removed and to provide a permanent replacement for the nucleus.
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