IP Library › Granted Patent US 12,268,510
Granted Patent B2
US 12,268,510 · App. 16/792,098 · Granted Apr 8, 2025

Apparatus and method for treating neurological disorders

Inventors: Mattia Arlotti (Rimini, IT); Alberto Priori (Borgo Virgilio, IT); Lorenzo Rossi (Trento, IT)
Assignee: Newronika S.p.A.
A61B5/374A61B5/4076A61B5/4836A61N1/0534A61N1/3606A61N1/36067A61N1/36139A61N1/36178G16H20/30A61B5/4082A61B5/7257A61N1/36064A61N1/36071A61N1/36082
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Quick Facts
Patent No.
US 12,268,510
App. No.
16/792,098
Granted
Apr 8, 2025
Kind
B2
Abstract

The present invention concerns an apparatus for treating neurological disorders comprising (i) at least one electrode implantable in the brain of a patient and (ii) a processing and stimulation device connected to the at least one electrode, wherein the processing and stimulation device comprises (a) at least one stimulation module adapted to generate a stimulation signal to be sent to the at least one electrode, the stimulation signal being characterised by a plurality of parameters, (b) at least one acquisition module of a signal characteristic of cerebral activity coming from the brain of the patient adapted to determine its power in at least one frequency band, and (c) at least one control module of at least one parameter of the stimulation signal as a function of the power of the signal characteristic of cerebral activity acquired, based on a transfer function having a saturating trend, wherein the transfer function is such as to set the at least one parameter (Va, Vd, Vf) of the stimulation signal (Vstim) differently dependent on a plurality of power ranges, by keeping the at least one parameter within a predetermined stimulation range ([Vi_HighThreshold; Vi_LowThreshold]) with i=a,d,f.

Claims (127)

1. An apparatus for treating neurological disorders comprising:

an electrode implantable in a patient;

a processing and stimulation device connected to the electrode, wherein the processing and stimulation device comprises:

a stimulation module adapted to generate a stimulation signal (V stim ) to be sent to the electrode, the stimulation signal (V stim ) having a plurality of stimulation parameters including a stimulation amplitude, stimulation duration, and stimulation frequency (V a , V d , V f ),

an acquisition module configured to acquire neural activity signals from the patient and to calculate a power (P BF ) of a beta frequency band of the acquired neural activity signals, and

a control module configured to:

adjust a stimulation parameter (V a , V d , V f ) of the stimulation signal (V stim ) when the power (P BF ) of the beta frequency band meets or exceeds an upper power value threshold (P BF2 ), wherein the upper power value threshold (P BF2 ) is a power of the beta frequency band of the patient's neural activity signals measured in the absence of pharmacological therapy (P OFF );

adjust the stimulation parameter (V a , V d , V f ) of the stimulation signal (V stim ) when the power (P BF ) of the beta frequency band is at or below a lower power value threshold (P BF1 ), wherein the lower power value threshold (P BF1 ) is a power of the beta frequency band of the patient's neural activity signals measured in the presence of pharmacological therapy (P ON ); and

adjust the stimulation parameter (V a , V d , V f ) of the stimulation signal (V stim ) according to a piecewise transfer function based on the power (P BF ) of the beta frequency band, wherein the piecewise transfer function is:

V

a

,

d

,

f

(

P

B

⁢

F

)

=

{

V

i_HighThreshold

per

⁢

P

BF

≥

P

OFFOFF

U

i

(

P

BF

)

per

⁢

P

OFFOFF

>

P

BF

>

P

ONON

V

i_LowThreshold

per

⁢

P

BF

≤

P

ONON

where:

V i_HighThreshold is a maximum value of the stimulation parameter that provides a maximum clinical effect before side effects appear,

V i_LowThreshold is a minimum value of the stimulation parameter that provides a minimum clinical effect,

P OFFOFF is a power of the beta frequency band of the patient's neural activity signals measured in the absence of pharmacological therapy and in the absence of electrical stimulation,

P ONON is a power of the beta frequency band of the patient's neural activity signals measured in the presence of pharmacological therapy and in the presence of electrical stimulation, and

U i (P BF ) is a law of variability that correlates a value of the stimulation parameter with the power (P BF ) of the beta frequency band.

2. The apparatus of claim 1 , wherein when the power (P BF ) of the beta frequency band meets or exceeds the upper power value threshold (P BF2 ), a stimulation parameter of the stimulation signal (V stim ) is set to a maximum value (V i_HighThreshold ) of the stimulation parameter that provides a maximum clinical effect before side effects appear.

3. The apparatus of claim 1 , wherein when the power (P BF ) of the beta frequency band is at or below the lower power value threshold (P BF1 ), a stimulation parameter of the stimulation signal (V stim ) is set to a minimum value (V i_LowThreshold ) of the stimulation parameter that provides a minimum clinical effect.

4. The apparatus of claim 1 , wherein the upper power value threshold (P BF2 ) is a power of the beta frequency band of the patient's neural activity signals measured in the absence of pharmacological therapy and in the absence of electrical stimulation (P OFFOFF ).

5. The apparatus of claim 4 , wherein the lower power value threshold (P BF1 ) is a power of the beta frequency band of the patient's neural activity signals measured in the presence of pharmacological therapy and in the presence of electrical stimulation (P ONON ).

6. The apparatus of claim 5 , wherein when the power (P BF ) of the beta frequency band meets or exceeds P OFFOFF , a stimulation parameter of the stimulation signal is set to a maximum value (V i_HighThreshold ) of the stimulation parameter that provides a maximum clinical effect before side effects appear.

7. The apparatus of claim 6 , wherein when the power (P BF ) of the beta frequency band is at or below P ONON , a stimulation parameter of the stimulation signal is set to a minimum value (V i_LowThreshold ) of the stimulation parameter that provides a minimum clinical effect.

8. The apparatus of claim 1 , wherein the law of variability U i (P BF ) is:

U

i

(

P

B

⁢

F

)

=

(

V

i_HighThreshold

-

V

i_LowThreshold

P

O

⁢

F

⁢

F

⁢

O

⁢

F

⁢

F

-

P

O

⁢

N

⁢

O

⁢

N

)

⁢

(

P

B

⁢

F

-

P

O

⁢

N

⁢

O

⁢

N

)

+

V

i_LowThreshold

.

Assignments (2)
CHANGE OF NAME Recorded Oct 4, 2022
From: NEWRONIKA S.R.L.
To: NEWRONIKA S.P.A.
Reel/Frame 061878/0786 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 7, 2021
From: ARLOTTI, MATTIA; PRIORI, ALBERTO; ROSSI, LORENZO
To: NEWRONIKA S.R.L.
Reel/Frame 056779/0842 →
Priority Claims (1)
IT MI2015A000219 · Feb 16, 2015 · national
Continuity (2)
Continuation 15550284
Related Publication 20200254261A1 · Aug 13, 2020
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