Patent US6466822B1 successfully refreshed from Google Patents.
US6466822B1
Expired / Lapsed
US
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Multimodal neurostimulator and process of using it
Assignee: Neuropace Inc
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Filing: 2000-04-05
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Granted: 2002-10-15
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Expires: 2020-04-05
Abstract
Abstract This is directed to an implantable multimodal neurostimulator having improved efficacy in treating epilepsy and other neurological disorders and to processes of using that neurostimulator. The neurostimulator itself generally has two modes of electrical stimulation: the first involves delivering a non-responsive electrical stimulation signal which is applied to the central nervous system to reduce the likelihood of a seizure or other undesirable neurological even from occurring, and a second mode that involves delivering electrical stimulation signal or signals when epileptiform waveforms are impending or extant. The responsive electrical stimulation signal or signals are intended to terminate epileptiform activity, e.g., to desynchronize abnormally synchronous brain electrical activity. Alternatively, the second mode may be used to deliver sensory stimulation, e.g., a scalp or sound stimulation, to the patient rather than deliver electrical stimulation to the patient. Finally, the implanted neurostimulator may be used by a physician to induce epileptiform activity and then verify the effectiveness of the parameters of the first and second neurostimulation signal or signals.
Inventors
- 👤 Benjamin D. Pless
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 16:11
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/18; A61N1/32; A61N1/36; A61N1/3605; A61N1/3606; A61N1/36064
Claims Analysis
Total Claims: 65
Claim 1
Independent Claim
63 words
A method for treating a disorder in a human brain, comprising the steps of: a.) providing at least one non-responsive electrical stimulation to said brain, b.) detecting at least one brain electrical activity of said brain, and c.) providing at least one responsive stimulation, which is not the non-responsive stimulation, which responsive stimulation is responsive to said at least one brain electrical activity.
Claim 2
Independent Claim
63 words
A method for treating a disorder in a human brain, comprising the steps of: a.) providing at least one non-responsive electrical stimulation to said brain, b.) detecting at least one brain electrical activity of said brain, and c.) providing at least one responsive stimulation, which is not the non-responsive stimulation, which responsive stimulation is responsive to said at least one brain electrical activity.
Claim 3
Dependent Claim
17 words
The method of claim 1 wherein said responsive stimulation is electrical stimulation applied to said human brain.
Claim 4
Dependent Claim
19 words
The method of claim 2 wherein blanking is performed when said non-responsive electrical stimulation is provided to said brain.
Claim 5
Dependent Claim
15 words
The method of claim 2 wherein said non-responsive electrical stimulation is paused during said detecting.
Claim 6
Dependent Claim
24 words
The method of claim 2 further comprising the step of modifying said at least one non-responsive electrical stimulation depending on the time of day.
Claim 7
Dependent Claim
19 words
The method of claim 2 wherein said at least one non-responsive electrical stimulation is applied to a first electrode.
Claim 8
Dependent Claim
32 words
The method of claim 2 further comprising the step of pausing said at least one non-responsive electrical stimulation during the step of providing said at least one responsive stimulation to said brain.
Claim 9
Dependent Claim
28 words
The method of claim 2 wherein said at least one non-responsive electrical stimulation continues during the step of providing said at least one responsive stimulation to said brain.
Claim 10
Dependent Claim
48 words
The method of claim 2 wherein said responsive electrical stimulation has responsive electrical stimulation signal parameters and further comprising the step of changing at least one of said responsive electrical stimulation signal parameters during the step of providing said at least one responsive electrical stimulation to said brain.
Claim 11
Dependent Claim
39 words
The method of claim 9 wherein said at least one responsive electrical stimulation signal parameter is selected from the group consisting of selected electrode, pulse width, pulse-to-pulse interval, pulse amplitude, number of bursts, and number of pulses in burst.
Claim 12
Dependent Claim
17 words
The method of claim 10 wherein at least one responsive electrical stimulation is at least one burst.
Claim 13
Dependent Claim
19 words
The method of claim 10 wherein said at least one responsive electrical stimulation signal parameter varies during said burst.
Claim 14
Dependent Claim
26 words
The method of claim 10 wherein said at least one responsive electrical stimulation signal parameter is pulse amplitude and the pulse amplitude varies during said burst.
Claim 15
Dependent Claim
20 words
The method of claim 10 wherein at least two of said responsive electrical stimulation signal parameters vary during said burst.
Claim 16
Dependent Claim
26 words
The method of claim 10 wherein said at least one responsive electrical stimulation signal parameter is pulse-to-pulse interval and said pulse-to-pulse interval varies during said burst.
Claim 17
Dependent Claim
20 words
The method of claim 15 wherein said pulse-to-pulse interval is varied based on measured intervals of said brain electrical activity.
Claim 18
Dependent Claim
19 words
The method of claim 2 wherein said at least one responsive electrical stimulation is applied to said first electrode.
Claim 19
Dependent Claim
19 words
The method of claim 2 wherein said at least one responsive electrical stimulation is applied to a second electrode.
Claim 20
Dependent Claim
17 words
The method of claim 18 wherein multiple responsive electrical stimulations are independently applied to multiple second electrodes.
Claim 21
Dependent Claim
25 words
The method of claim 19 wherein said multiple responsive electrical stimulations are responsive to multiple electrical brain activities detected at different parts of the brain.
Claim 22
Dependent Claim
22 words
The method of claim 20 wherein said multiple electrical brain activities are independently and selectably measured at different parts of the brain.
Claim 23
Dependent Claim
18 words
The method of claim 21 wherein said different parts of the brain include the hippocampus and cortical regions.
Claim 24
Dependent Claim
15 words
The method of claim 18 wherein each said second electrical stimulations have different signal parameters.
Claim 25
Dependent Claim
37 words
The method of claim 2 further comprising the further steps of terminating the application of at least one of the non-responsive electrical stimulation and the responsive electrical stimulation and re-measuring said at least one brain electrical activity.
Claim 26
Dependent Claim
21 words
The method of claim 24 further comprising the step of again providing said at least one responsive stimulation to said brain.
Claim 27
Dependent Claim
18 words
The method of claim 24 further comprising the step of providing said non-responsive electrical stimulation to said brain.
Claim 28
Dependent Claim
46 words
The method of claim 24 wherein said non-responsive electrical stimulation and the responsive electrical stimulation have signal parameters and further comprising the step of changing at least one of said signal parameters in response to the step of re-detecting said at least one brain electrical activity.
Claim 29
Dependent Claim
28 words
The method of claim 1 wherein said detecting is accomplished during a period when neither said non-responsive stimulation nor said responsive electrical stimulation is provided to said brain.
Claim 30
Dependent Claim
18 words
The method of claim 1 wherein said at least one responsive stimulation comprises sensory input to the patient.
Claim 31
Dependent Claim
27 words
The method of claim 29 wherein said sensory input is selected from vibration, other electrical signals not to brain tissue, scalp twitch, light flashes, and sound pulses.
Claim 32
Dependent Claim
32 words
The method of claim 1 wherein the step of detecting said at least one brain electrical activity of said brain comprises detecting said electrical activity simultaneously at different sites in said brain.
Claim 33
Dependent Claim
32 words
The method of claim 31 wherein the step of simultaneously measuring said at least one brain electrical activity of said brain comprises measuring said electrical activity at the hippocampus in said brain.
Claim 34
Dependent Claim
32 words
The method of claim 31 wherein the step of simultaneously measuring said at least one brain electrical activity of said brain comprises measuring said electrical activity at the cortex in said brain.
Claim 35
Dependent Claim
13 words
The method of claim 1 wherein said first electrical activity is measured cortically.
Claim 36
Dependent Claim
18 words
The method of claim 1 wherein said first electrical activity is measured at a depth within the brain.
Claim 37
Dependent Claim
15 words
The method of claim 1 wherein said first electrical activity is measured on the scalp.
Claim 38
Dependent Claim
17 words
The method of claim 1 further comprising the step of initiating epileptiform electrical activity under physician control.
Claim 39
Independent Claim
52 words
A method for determining the efficacy of stimulation signal parameters for terminating epileptiform events using an implanted neurostimulator, comprising the steps of: a.) initiating epileptiform electrical activity in a human brain, b.) observing said epileptiform electrical activity, and c.) providing a stimulation having stimulation signal parameters for terminating said epileptiform electrical activity.
Claim 40
Independent Claim
52 words
A method for determining the efficacy of stimulation signal parameters for terminating epileptiform events using an implanted neurostimulator, comprising the steps of: a.) initiating epileptiform electrical activity in a human brain, b.) observing said epileptiform electrical activity, and c.) providing a stimulation having stimulation signal parameters for terminating said epileptiform electrical activity.
Claim 41
Dependent Claim
46 words
The method of claim 38 further comprising the additional steps of changing at least one of said stimulation signal parameters, re-initiating said epileptiform electrical activity, re-observing said epileptiform electrical activity, and providing a stimulation having said changed stimulation signal parameters for terminating said epileptiform electrical activity.
Claim 42
Dependent Claim
37 words
The method of claim 39 wherein said at least one stimulation signal parameter is selected from the group consisting of selected electrode, pulse width, pulse-to-pulse interval, pulse amplitude, number of bursts, and number of pulses in burst.
Claim 43
Dependent Claim
13 words
The method of claim 38 wherein said stimulation is a responsive electrical stimulation.
Claim 44
Dependent Claim
22 words
The method of claim 38 wherein said determining the efficacy of stimulation signal parameters also verifies the function of an implanted neurostimulator.
Claim 45
Independent Claim
104 words
A method of determining the efficacy of stimulation parameters in an implanted neurostimulator comprising the steps of: a.) providing to a human brain undergoing non-responsive stimulation, said non-responsive stimulation having selected stimulation parameters, an epileptiform initiating stimulation, having epileptiform initiating stimulation parameters, b.) observing electrical activity in said human brain for epileptiform activity, c.) if epileptiform activity is neither existent nor imminent in step b.), varying at least one of said epileptiform initiating stimulation parameters and repeating steps a.), b.) and c.) until epileptiform activity is imminent or existent; and d.) varying said selected non-responsive stimulation parameters and repeat steps a.), b.) and c.).
Claim 46
Independent Claim
104 words
A method of determining the efficacy of stimulation parameters in an implanted neurostimulator comprising the steps of: a.) providing to a human brain undergoing non-responsive stimulation, said non-responsive stimulation having selected stimulation parameters, an epileptiform initiating stimulation, having epileptiform initiating stimulation parameters, b.) observing electrical activity in said human brain for epileptiform activity, c.) if epileptiform activity is neither existent nor imminent in step b.), varying at least one of said epileptiform initiating stimulation parameters and repeating steps a.), b.) and c.) until epileptiform activity is imminent or existent; and d.) varying said selected non-responsive stimulation parameters and repeat steps a.), b.) and c.).
Claim 47
Dependent Claim
17 words
The method of claim 43 further including the steps of providing non-responsive stimulation to said human brain.
Claim 48
Dependent Claim
27 words
The method of claim 43 wherein said epileptiform initiating stimulation parameters are selected from the group consisting of pulse amplitude, burst duration, pulse duration, and pulse-to-pulse interval.
Claim 49
Dependent Claim
153 words
The method of claim 43 further comprising the prior steps of establishing a pre-stimulus threshold by the steps of: a1.) providing to said human brain an epileptiform initiating stimulation, having minimum epileptiform initiating stimulation parameters b1.) observing electrical activity in said human brain for epileptiform activity, c1.) if epileptiform activity is neither existent nor imminent in step b1.), increment at least one of said minimum epileptiform initiating stimulation parameters and repeat steps a1.), b1.), and c1.) until epileptiform activity is imminent or existent, d1.) providing to said human brain a non-responsive stimulation, said non-responsive stimulation having selected non-responsive stimulation parameters, e1.) observing electrical activity in said human brain for epileptiform activity, and f1.) if epileptiform activity is existent or imminent in step e1.), vary said non-responsive stimulation parameters until said epileptiform activity can no longer be initiated by application of said minimum epileptiform initiating stimulation parameters to thereby determine threshold non-responsive stimulation parameters.
Claim 50
Dependent Claim
120 words
An implantable neurostimulator assembly for modifying an electrical activity in a human brain, comprising in combination: a.) at least a first brain electrical activity sensor for sensing electrical activity in said brain, b.) at least a first non-responsive electrode, c.) at least a first non-responsive electrical signal source connectable to said at least said first non-responsive electrical neurostimulator electrode, d.) at least a second responsive electrode, e.) at least a second responsive electrical signal source connectable to said at least second responsive electrode, said responsive second electrical signal source initiating a responsive stimulation to said at least a second responsive electrode which is responsive to said brain electrical activity sensed by said at least a first brain electrical activity sensor.
Claim 51
Dependent Claim
120 words
An implantable neurostimulator assembly for modifying an electrical activity in a human brain, comprising in combination: a.) at least a first brain electrical activity sensor for sensing electrical activity in said brain, b.) at least a first non-responsive electrode, c.) at least a first non-responsive electrical signal source connectable to said at least said first non-responsive electrical neurostimulator electrode, d.) at least a second responsive electrode, e.) at least a second responsive electrical signal source connectable to said at least second responsive electrode, said responsive second electrical signal source initiating a responsive stimulation to said at least a second responsive electrode which is responsive to said brain electrical activity sensed by said at least a first brain electrical activity sensor.
Claim 52
Dependent Claim
29 words
The implantable neurostimulator of claim 47 wherein said first non-responsive electrical signal source is configured to pause said non-responsive electrical signal when said second responsive electrical signal is initiated.
Claim 53
Dependent Claim
30 words
The implantable neurostimulator of claim 47 wherein said first non-responsive electrical signal source is configured to continue said first non-responsive electrical signal when said second responsive electrical signal is initiated.
Claim 54
Dependent Claim
16 words
The implantable neurostimulator of claim 47 wherein said first brain electrical activity sensor comprises multiple sensors.
Claim 55
Dependent Claim
34 words
The implantable neurostimulator of claim 47 wherein said multiple brain electrical activity sensors comprises sensors for measuring said at least one brain electrical activity of said brain simultaneously at different sites in said brain.
Claim 56
Dependent Claim
24 words
The implantable neurostimulator of claim 51 wherein said sensors are configured to measure said brain activity at least at the hippocampus in said brain.
Claim 57
Dependent Claim
24 words
The implantable neurostimulator of claim 51 wherein said sensors are configured to measure said brain activity at least at the cortex in said brain.
Claim 58
Dependent Claim
17 words
The implantable neurostimulator of claim 51 wherein said sensors are configured to measure said brain activity cortically.
Claim 59
Dependent Claim
22 words
The implantable neurostimulator of claim 51 wherein said sensors are configured to measure said brain activity at a depth within the brain.
Claim 60
Dependent Claim
19 words
The implantable neurostimulator of claim 51 wherein said sensors are configured to measure said brain activity on the scalp.
Claim 61
Dependent Claim
26 words
The implantable neurostimulator of claim 47 wherein said first non-responsive electrical signal source and said second responsive signal source comprise a single electrical signal source circuit.
Claim 62
Independent Claim
71 words
A method for treating a disorder in a human brain having non-responsive stimulation, comprising the steps of a.) detecting at least one brain electrical activity of said brain, b.) providing at least one responsive stimulation having selected stimulation parameters, which responsive stimulation is responsive to said at least one brain electrical activity, and varying said at least one stimulation parameter of said responsive stimulation upon detection of said brain electrical activity.
Claim 63
Independent Claim
71 words
A method for treating a disorder in a human brain having non-responsive stimulation, comprising the steps of a.) detecting at least one brain electrical activity of said brain, b.) providing at least one responsive stimulation having selected stimulation parameters, which responsive stimulation is responsive to said at least one brain electrical activity, and varying said at least one stimulation parameter of said responsive stimulation upon detection of said brain electrical activity.
Claim 64
Independent Claim
43 words
A method for treating a disorder in a human brain, comprising the steps of: a.) providing at least one non-responsive electrical stimulation to said brain, and b.) modifying said at least one non-responsive electrical stimulation as a function of the time of day.
Claim 65
Independent Claim
43 words
A method for treating a disorder in a human brain, comprising the steps of: a.) providing at least one non-responsive electrical stimulation to said brain, and b.) modifying said at least one non-responsive electrical stimulation as a function of the time of day.
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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) | 2005-10-14 | 2006-04-15 | 2006-10-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-10-14 | 2010-04-15 | 2010-10-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-10-14 | 2014-04-15 | 2014-10-15 | $7700.00 | Window Closed / Lapsed |