Patent GB1277107A successfully refreshed from Google Patents.
US20050209602A1
Expired / Lapsed
US
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Multi-stage biomaterial injection system for spinal implants
Assignee: Disc Dynamics Inc
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Filing: 2004-11-09
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Granted: —
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Expires: 2024-11-09
Abstract
Abstract A method and apparatus for fluidly coupling a reservoir containing a flowable biomaterial to a mold. The flow of the flowable biomaterial into the mold is controlled in accordance with a first operating parameter. At least one injection condition is monitored. The flow of the flowable biomaterial is controlled in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level. The second operating parameter is maintained during at least a portion of the curing of the flowable biomaterial. In some embodiments, the second operating parameter may optionally include permitting a portion of the flowable biomaterial to be expelled from the mold.
Inventors
- 👤 Bruce Bowman
- 👤 Robert Kohler
- 👤 Erik Martz
- 👤 Daniel Melink
- 👤 Khin Myint
- 👤 Michael Ahrens
- 👤 Jean-Charles LeHuec
- 👤 John Sherman
- 👤 Scott Hook
- 👤 Dennis Johnson
- 👤 Qi-Bin Bao
- 👤 Robert Hudgins
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 04:09
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/88; A61B17/8802; A61B17/8805; A61B17/68; A61B17/70; A61B17/72; A61B17/8827; A61B17/8833; A61B17/8836; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/441; A61F2/46; A61F2/4601; A61F2/4603; A61F2/4611; A61B90/00; A61B90/06; A61B2090/064; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/3008; A61F2002/30316; A61F2002/30535; A61F2002/30581; A61F2002/30583; A61F2002/4625; A61F2002/4627; A61F2002/465; A61F2/4657; A61F2002/4663; A61F2002/467; A61F2002/4677; A61F2002/4688; A61F2002/4692; A61F2002/4693; A61F2002/4694; A61F2210/00; A61F2210/0004; A61F2210/0085; A61F2250/00; A61F2250/0058; A61F2250/0096; A61F2250/0098
Claims Analysis
Total Claims: 58
Claim 1
Independent Claim
120 words
1 . An apparatus adapted to deliver a flowable biomaterial to an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the intervertebral disc space; at least one sensor adapted to monitor at least one injection condition of the flowable biomaterial; a controller programmed to; monitor the at least one sensor; control the flow of the flowable biomaterial into the intervertebral disc space in accordance with a first operating parameter; controlling the flow of the flowable biomaterial in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level; and maintaining the second operating parameter during at least a portion of the curing of the flowable biomaterial.
Claim 2
Dependent Claim
120 words
1 . An apparatus adapted to deliver a flowable biomaterial to an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the intervertebral disc space; at least one sensor adapted to monitor at least one injection condition of the flowable biomaterial; a controller programmed to; monitor the at least one sensor; control the flow of the flowable biomaterial into the intervertebral disc space in accordance with a first operating parameter; controlling the flow of the flowable biomaterial in accordance with a second operating parameter in response to one or more of the injection conditions reaching a threshold level; and maintaining the second operating parameter during at least a portion of the curing of the flowable biomaterial.
Claim 3
Dependent Claim
25 words
2 . The apparatus of claim 1 comprising a mold located in the intervertebral disc space fluidly coupled to the reservoir containing the flowable biomaterial.
Claim 4
Dependent Claim
30 words
3 . The apparatus of claim 2 wherein the first operating parameter comprises delivering the flowable biomaterial to the mold so that the mold substantially fills the intervertebral disc space.
Claim 5
Dependent Claim
27 words
4 . The apparatus of claim 1 wherein the first operating parameter comprises delivering the flowable biomaterial at a pressure sufficient to distract the intervertebral disc space.
Claim 6
Dependent Claim
36 words
5 . The apparatus of claim 1 wherein the controller is programmed to waiting a predetermined period of time after the at least one injection condition reaches the threshold level before initiating the second operating parameter.
Claim 7
Dependent Claim
61 words
6 . The apparatus of claim 1 wherein the controller controls the delivery of the flowable biomaterial in accordance with a third operating parameter that maintains the flowable biomaterial at a predetermined pressure in the intervertebral disc space for a predetermined period of time after the at least one injection condition reaches the threshold level and before the second operating parameter.
Claim 8
Dependent Claim
27 words
7 . The apparatus of claim 1 wherein the second operating parameter permits a portion of the flowable biomaterial to be expelled from the intervertebral disc space.
Claim 9
Dependent Claim
21 words
8 . The apparatus of claim 1 wherein the second operating parameter delivers additional flowable biomaterial into the intervertebral disc space.
Claim 10
Dependent Claim
16 words
9 . The apparatus of claim 1 wherein the controller controls pretreatment of the flowable biomaterial.
Claim 11
Dependent Claim
28 words
10 . The apparatus of claim 1 comprising a source of ultraviolet light and/or heating directed at the flowable biomaterial prior to delivery to the intervertebral disc space.
Claim 12
Dependent Claim
23 words
11 . The apparatus of claim 1 comprising a mixing device located between the reservoir of flowable biomaterial and the intervertebral disc space.
Claim 13
Dependent Claim
16 words
12 . The apparatus of claim 1 wherein the flowable biomaterial comprises a plurality of components.
Claim 14
Dependent Claim
28 words
13 . The apparatus of claim 1 comprising a purging device adapted to direct a predetermined quantity of the flow of biomaterial away from the intervertebral disc space.
Claim 15
Dependent Claim
17 words
14 . The apparatus of claim 1 wherein the first operating parameter comprises a first operating pressure.
Claim 16
Dependent Claim
23 words
15 . The apparatus of claim 14 wherein the second operating parameter comprises a second operating pressure lower than the first operating pressure.
Claim 17
Dependent Claim
29 words
16 . The apparatus of claim 14 wherein the intervertebral disc space exerts pressure on the flowable biomaterial in the intervertebral disc space greater than the second operating pressure.
Claim 18
Dependent Claim
25 words
17 . The apparatus of claim 1 wherein the controller monitors the pressure of the flowable biomaterial between the reservoir and the intervertebral disc space.
Claim 19
Dependent Claim
22 words
18 . The apparatus of claim 1 wherein the controller monitors the pressure of the flowable biomaterial in the intervertebral disc space.
Claim 20
Dependent Claim
49 words
19 . The apparatus of claim 1 wherein the controller is programmed to monitor at least one injection condition comprises monitoring at least one of the pressure, the flow rate, elapsed time, or the total volume of the flowable biomaterial flowing between the reservoir and the intervertebral disc space.
Claim 21
Dependent Claim
25 words
20 . The apparatus of claim 1 wherein the first operating parameter comprises a first injection pressure of about 50 psi to about 270 psi.
Claim 22
Dependent Claim
25 words
21 . The apparatus of claim 1 wherein the second operating parameter comprises a second injection pressure of about 0 psi to about 150 psi.
Claim 23
Dependent Claim
23 words
22 . The apparatus of claim 1 wherein the threshold level of the injection condition is about 80 psi to about 150 psi.
Claim 24
Dependent Claim
30 words
23 . The apparatus of claim 1 wherein the controller is programmed to record data corresponding to at least one of the injection conditions during the flow of flowable biomaterial.
Claim 25
Dependent Claim
34 words
24 . The apparatus of claim 1 wherein the controller is programmed to upload to a computer data corresponding to at least one of the injection conditions recorded during the flow of flowable biomaterial.
Claim 26
Dependent Claim
35 words
25 . The apparatus of claim 1 wherein the controller is programmed to determine that the at least one injection condition comprises an out of specification condition and to indicate an out of specification condition.
Claim 27
Dependent Claim
40 words
26 . The apparatus of claim 1 wherein the controller is programmed to determine that the at least one injection condition comprises an out of specification condition and to alter the flow of flowable biomaterial to the intervertebral disc space.
Claim 28
Dependent Claim
42 words
27 . The apparatus of claim 1 wherein the controller is programmed to determine that the at least one injection condition comprises an out of specification condition and to withdraw at least a portion of the biomaterial from the invertebral disc space.
Claim 29
Dependent Claim
37 words
28 . The apparatus of claim 1 comprising a switch to manually switch the flow of flowable biomaterial to the second operating parameter in response to one or more of the injection conditions reaching a threshold level.
Claim 30
Dependent Claim
39 words
29 . The apparatus of claim 1 wherein a controller automatically controls the delivery of the flowable biomaterial in accordance with the second operating parameter in response to one or more of the injection conditions reaching a threshold level.
Claim 31
Dependent Claim
20 words
30 . The apparatus of claim 1 wherein the controller adjusts the threshold level as a function of mold size.
Claim 32
Dependent Claim
20 words
31 . The apparatus of claim 1 wherein the controller adjusts the threshold level as a function of patient parameters.
Claim 33
Dependent Claim
17 words
32 . The apparatus of claim 1 wherein the first operating parameter comprises a plurality of variable.
Claim 34
Dependent Claim
17 words
33 . The apparatus of claim 1 wherein the second operating parameter comprises a plurality of variables.
Claim 35
Dependent Claim
71 words
34 . The apparatus of claim 1 comprising: an evaluation mold adapted to be positioned in the intervertebral disc space prior to the delivery of the biomaterial; a liquid adapted to be delivered to the evaluation mold so that the mold substantially fills the intervertebral disc space; wherein the controller is programmed to remove the liquid from the evaluation mold and measure the amount of liquid present in the evaluation mold.
Claim 36
Dependent Claim
21 words
35 . The apparatus of claim 34 wherein one or both of the liquid and the evaluation mold have radiopaque properties.
Claim 37
Dependent Claim
50 words
36 . The apparatus of claim 34 wherein the controller is programmed to estimate the volume of biomaterial required to fill the intervertebral disc space and to comparing the amount of liquid present in the evaluation mold with an estimated volume of the intervertebral disc space measured using imaging techniques.
Claim 38
Dependent Claim
75 words
37 . The apparatus of claim 1 comprising an evaluation mold located in the intervertebral disc space, wherein the controller is programmed to deliver a liquid under pressure to the evaluation mold sufficient to distract the intervertebral disc space, to hold the volume of liquid in the evaluation mold constant for a period of time, and to add additional liquid to the evaluation mold when the pressure in the mold drops to a predetermined level.
Claim 39
Dependent Claim
20 words
38 . The apparatus of claim 37 wherein the controller is programmed to repeat the steps a plurality of cycles.
Claim 40
Dependent Claim
72 words
39 . The apparatus of claim 1 comprising an evaluation mold located in the intervertebral disc space wherein the controller is programmed to continuously deliver a liquid to the evaluation mold at a constant pressure, to measure the rate at which the liquid is delivered to the evaluation mold, and to estimate the compliance of the intervertebral disc space as a function of the changing rate at which the liquid is delivered.
Claim 41
Dependent Claim
27 words
40 . The apparatus of claim 1 comprising: a guide wire positioned in the mold; and an image of the intervertebral disc space containing the guide wire.
Claim 42
Dependent Claim
15 words
41 . The apparatus of claim 40 wherein the guide wire comprises an imaging target.
Claim 43
Dependent Claim
26 words
42 . The apparatus of claim 2 comprising: a radiopaque sheath over the mold; and an image of the intervertebral disc space containing the radiopaque sheath.
Claim 44
Dependent Claim
29 words
43 . The apparatus of claim 42 wherein the radiopaque sheath comprises at least one bend adapted to direct the mold to selected regions of the intervertebral disc space.
Claim 45
Dependent Claim
22 words
44 . The apparatus of claim 2 comprising at least one bend in a delivery tube connecting the reservoir to the mold.
Claim 46
Dependent Claim
23 words
45 . The apparatus of claim 2 comprising at least guide wire located in a delivery tube connecting the reservoir to the mold.
Claim 47
Dependent Claim
59 words
46 . The apparatus of claim 1 wherein the intervertebral disc space includes an annulus with an inlet connected to a cavity formed therein, the apparatus comprising: a delivery tube fluidly coupling the reservoir to the cavity in the annulus; and a flange located on a distal end of the delivery tube biased against the inlet to the cavity.
Claim 48
Dependent Claim
74 words
47 . The apparatus of claim 1 wherein the intervertebral disc space includes an annulus with an inlet connected to a cavity formed therein, the apparatus comprising: a delivery tube fluidly coupling the reservoir to the cavity in the annulus; and a distal end of the delivery tube having an expandable portion positioned adjacent the inlet to the annulus, the expandable portion being adapted to expand in response to the delivery of flowable biomaterial.
Claim 49
Dependent Claim
44 words
48 . A apparatus of claim 1 wherein the intervertebral disc space includes an annulus with an inlet connected to a cavity formed therein, the apparatus comprising a delivery tube fluidly coupling the reservoir containing the flowable biomaterial to the cavity in the annulus.
Claim 50
Dependent Claim
98 words
49 . An apparatus adapted to deliver a flowable biomaterial to an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the intervertebral disc space; at least one sensor adapted to monitor at least one injection condition of the flowable biomaterial; a controller programmed to; monitor the at least one sensor; control the flow of the flowable biomaterial into the intervertebral disc space in accordance with a first operating parameter; determine that the at least one injection condition comprises an out of specification condition; and generating a signal of the out of specification condition.
Claim 51
Dependent Claim
98 words
49 . An apparatus adapted to deliver a flowable biomaterial to an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the intervertebral disc space; at least one sensor adapted to monitor at least one injection condition of the flowable biomaterial; a controller programmed to; monitor the at least one sensor; control the flow of the flowable biomaterial into the intervertebral disc space in accordance with a first operating parameter; determine that the at least one injection condition comprises an out of specification condition; and generating a signal of the out of specification condition.
Claim 52
Dependent Claim
25 words
50 . The apparatus of claim 49 comprising a mold located in the intervertebral disc space fluidly coupled to the reservoir containing the flowable biomaterial.
Claim 53
Dependent Claim
31 words
51 . The apparatus of claim 49 wherein the controller is programmed to automatically altering the flow of flowable biomaterial to the mold in response to the out of specification condition.
Claim 54
Dependent Claim
22 words
52 . The apparatus of claim 49 comprising a manual switch adapted to alter the flow of flowable biomaterial to the mold.
Claim 55
Dependent Claim
29 words
53 . The apparatus of claim 49 wherein the controller opens a purge device located between the reservoir and the mold in response to the out of specification condition.
Claim 56
Dependent Claim
98 words
54 . An apparatus adapted to deliver a flowable biomaterial to a mold located in an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the mold; an actuator providing a flow of the flowable biomaterial into the mold in accordance with a first operating parameter; at least one sensor monitoring at least one operating parameter of the flowable biomaterial; a display adapted to indicate that the at least one injection condition has reached a threshold level; and a switch that controls the flow the flowable biomaterial in accordance with a second operating parameter.
Claim 57
Dependent Claim
98 words
54 . An apparatus adapted to deliver a flowable biomaterial to a mold located in an intervertebral disc space, comprising: a reservoir containing the flowable biomaterial fluidly coupled to the mold; an actuator providing a flow of the flowable biomaterial into the mold in accordance with a first operating parameter; at least one sensor monitoring at least one operating parameter of the flowable biomaterial; a display adapted to indicate that the at least one injection condition has reached a threshold level; and a switch that controls the flow the flowable biomaterial in accordance with a second operating parameter.
Claim 58
Dependent Claim
19 words
55 . The apparatus of claim 54 wherein the switch is adapted for manual operation by the surgical staff.
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