Spatial-temporal deep brain stimulation methods and systems

• US 8,024,049 B1
• Filed: 10/20/2004
• Issued: 09/20/2011
• Est. Priority Date: 10/20/2003
• Status: Active Grant

• Current Assignee: University of Central Florida (State University System of Florida)
• Original Assignee: University of Central Florida Research Foundation Inc. (State University System of Florida)
• Inventors: Razack, Nizam, Gilson, Richard D.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stewart; Jennifer
• Application Number:
  US10/969,420
• Time in Patent Office: 2,526 Days
• Field of Search: 607/62, 607/139, 607/45, 607/116
• US Class Current: 607/139
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

Methods, systems, and devices to reduce power demands substantially for current deep brain stimulation DBS using smart technology type applications. The invention uses miniaturized components that allow integration with the implanted probe(s) themselves, and includes a skull-sited housing having all the controls and battery power supply needed. This avoids implanting obtrusive card-deck size batteries in the chest area and the use of vulnerable wire leads under the skin from the chest area to connect with the implanted electrode(s) on the skull, improving comfort. The Generating of non-continuous pulses on demand of conditions such as the occurrence of a tremor occurs, without having to continuously run pulses at all times, substantially increasing life spans over current techniques. Shaped electrodes and their methods further reduce power demands and efficacy by directing electric fields to focus towards specific areas and regions of the brain rather than inefficient 360-degree emission.

Claims

1. A method for providing deep brain stimulation (DBS), consisting of the steps of:

providing an implantable pulse stimulator with battery supply and miniaturized controller within one single self-contained elongated probe for sensing and stimulating to eliminate spatially separated detection and stimulation electrodes, the providing step includes;

fabricating a single implantable lead line for implanting in the head of a patient below their skull;

attaching four electrodes to an exterior surface of the single implantable lead line for sensing and transmitting for both sensing and stimulating, wherein one of the four electrodes emits in an approximately 360 degree field about the implantable lead line, and the other electrodes emit in selected directional regions;

forming a single cylindrical disc housing, the single cylindrical disc housing containing components that fit into a space of approximately 60 millimeters in diameter by approximately 15 millimeters in height;

extending the single implantable lead line beneath a center portion of the single cylindrical disc housing;

enclosing the battery supply and the miniaturized controller as the components inside a compartment of the single cylindrical disc housing without implanting any batteries in a chest area of a user and avoiding use of any wires under skin from the chest area to connect to the stimulator, the compartment in the cylindrical disc housing contains a hole with the components arranged around the hole;

internally connecting the electrodes through the single implantable lead line to the controller located inside of the cylindrical disc housing; and

forming a top disc cover having perimeter side edges;

covering the compartment in the cylindrical disc housing with the top disc cover having the perimeter side edges;

producing a fully enclosed single self-contained deep brain simulation probe with both the cylindrical disc housing, the top disc cover and the single lead line so as to avoid the risk of implanting more than one single probe into different spatially separated areas of the brain;

imbedding only the single implantable lead line which extends beneath the one single self-contained probe below a single opening in the skull of the user into one single area of a brain as a self-contained bi-directional conduit for deep brain stimulation;

capping the skull with the single cylindrical disc housing and the top disc cover so that the single cylindrical disc housing with the top disc cover is positioned as a cap on top of the skull above the single opening in the skull;

covering the cylindrical disc housing and the top disc cover with the scalp so that the height of the cylindrical disc housing and the top disc cover protrudes so as to not cause a noticeable protrusion on the head of the user;

sensing an initiation of an unwanted electro-physiologically signaled event of an impulse burst in an area of the brain of the user caused by a condition using one of the electrodes, wherein the sensing of the initiation includes the steps of;

filtering sensed signals of the impulse burst from the one electrode to a noise amplitude filter;

counting impulses in the filtered signals with an impulse counter; and

triggering the single treatment pulse when a selected threshold of the counted impulse has been reached; and

selectively generating a single treatment pulse only from the one electrode to only the area of the brain of the user, the single pulse being selectively generated on demand of the sensed initiation of unwanted electro-physiologically signaled event of the impulse burst caused by the condition without user intervention, the sensing and stimulating of the electrodes being alternatively active.

2. The method of claim 1, wherein the step of generating includes generating a non-continuous spaced apart pulse upon occurrence of a follow-up sensed impulse burst.

3. The method of claim 1, wherein the condition includes:

a tremor.

4. The method of claim 1, wherein the providing step includes:

providing a processor based controller for executing

a set of monitoring instructions for sensing initiation of an unwanted electro-physiologically signaled event, and

a set of triggering instructions for activating the stimulator to generate the single treatment pulse, the monitoring and sensing being alternately activated.

5. Thu method of claim 1, wherein the sensing step includes

sensing modes in the electrodes between approximately 20 to approximately 60 milli-volts, and

triggering the electrodes between approximately 2 to approximately 4 volts, wherein

the electrodes switch back and forth between sensing and triggering modes without overloading circuit components, and thus maximizing power usage during operation.

6. The method of claim 1, wherein the filtering step includes

filtering out false alarms and allowing for a selected threshold value with an impulse firing threshold circuit.

7. The method of claim 6, wherein the threshold value includes approximately 5 impulses within approximately 50 milli-seconds.

8. The method of claim 1, wherein the enclosing the battery step includes

wirelessly recharging the battery supply by an external electric field.

9. The method of claim 1, wherein the sensed impulse burst includes a tremor of approximately 5 to approximately 7 tremor cycles per second.

10. The method of claim 1, wherein the sensed impulse burst includes a tremor of approximately 3 to approximately 5 tremor cycles per second.

11. A method for providing deep brain stimulation (DBS), consisting of the steps of:

providing a single lead line having a plurality of electrodes, wherein each of the electrodes alternate from being a detection electrode and a stimulation electrode, the single lead line having a diameter;

providing a single cylindrical disc housing, having components that fit within a space of approximately 60 millimeters in diameter by approximately 15 millimeters in height;

housing a battery supply and a controller for controlling the detection electrode and stimulation electrode inside a compartment in the single cylindrical disc housing, the compartment in the cylindrical housing contains a hole with the components arranged around the hole;

within one single self-contained elongated probe for sensing and stimulating to eliminate spatially separated detection and stimulation electrodes, the providing step includes;

fabricating a single implantable lead line for implanting in the head of a patient below their skull;

covering the cylindrical disc housing with the top disc cover having perimeter side edges that cover the compartment in the cylindrical disc housing;

attaching the single lead line through a center of a bottom of the cylindrical disc housing;

imbedding only the single lead line below a single opening in the skull;

capping the skull with the single cylindrical disc housing and the top disc cover so that the single cylindrical disc housing with the top disc cover is positioned as a cap mounted on top of the skull above the single opening in the skull;

covering the cylindrical disc housing and the top disc cover with the scalp so that the height of the cylindrical disc housing and the top disc cover protrudes so as to not cause a noticeable protrusion on the head of the user;

sensing an initiation of an unwanted electro-physiologically signaled event of an impulse burst in the user caused by a condition in an area of the brain using one of the plurality of the electrodes on the lead line; and

selectively generating a single treatment pulse from the one electrode to the area of the brain of the user on demand of the sensed initiation of unwanted electro-physiologically signaled event of the impulse burst caused by the condition.

12. The method of claim 11, wherein the sensing step includes

filtering sensed signals from electrode sensors to a noise amplitude filter,

counting impulses in the filtered signals with an impulse counter, and

triggering the single treatment pulse when a selected threshold of the counted impulses has been reached.

13. The method of claim 12, wherein the sensing step includes

sensing modes in the electrodes between approximately 20 to approximately 60 milli-volts, and

triggering the electrodes between approximately 2 to approximately 4 volts, wherein

the electrodes switch back and forth between sensing and triggering modes without overloading circuit components, and thus maximizing power usage during operation.

14. The method of claim 11, wherein the filtering step includes

filtering out false alarms and allowing for a selected threshold value with an impulse firing threshold circuit.

15. The method of claim 14, wherein the threshold value includes approximately 5 impulses within approximately 50 milli-seconds.

16. The method of claim 14, wherein the housing the battery supply step includes

wirelessly recharging the battery supply wireless by an external electric field.

17. The method of claim 11, wherein the sensed impulse burst includes a tremor of approximately 5 to approximately 7 tremor cycles per second.

18. The method of claim 11, wherein the sensed impulse burst includes a tremor of approximately 3 to approximately 5 tremor cycles per second.