FIRST TIME RIGHT PLACEMENT OF A DBS LEAD

• US 20100036468A1
• Filed: 11/16/2007
• Published: 02/11/2010
• Est. Priority Date: 12/13/2006
• Status: Active Grant

• Current Assignee: Medtronic Bakken Research Center B.V. (Medtronic Plc)
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Martens, Hubert Cecile Francois, Decre, Michael Marcel Jose
• Granted Patent: US 9,180,299 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

The disclosure is directed to a deep brain stimulation (DBS) lead having a distal end for providing therapeutic electrical stimulation to tissue in a stimulation target area of a patient'"'"'s brain, comprising an array of one or more stimulation elements and sensing elements located at the distal end of the lead; each of the one or more stimulation elements is capable of providing electrical stimulation to the brain tissue in the target area; and each of the one or more sensing elements is capable of detecting electrical signals produced by nerve cells within the brain; wherein after the first implantation of the lead into the brain along a trajectory that is pre-determined by non-surgical procedures, the array of stimulation and sensing elements is capable of facilitating the location of the target area and the determination for each of the stimulation elements of the required stimulation parameters needed to provide the therapeutic stimulation to the brain tissue in the stimulation target area, without requiring any additional implantations of the lead after the first implantation. A stimulation system including the DBS lead and a pulse generator is disclosed. Also disclosed is a method of providing therapeutic DBS to brain tissue using the lead.

Claims

1. A stimulation lead having a distal end for providing therapeutic electrical stimulation to tissue in a target area, comprising:

an array of one or more stimulation elements with one or more sensing elements located at the distal end of the lead;

each of the one or more stimulation elements being capable of providing electrical stimulation to the tissue in the target area; and

each of the one or more sensing elements being capable of detecting electrical signals;

wherein after the first implantation of the lead along a trajectory that is pre-determined by non-surgical procedures, the array of stimulation and sensing elements facilitate locating the target area and determining, for each of the stimulation elements, the required stimulation parameters needed for therapeutic tissue stimulation without requiring additional implantations of the lead.

2. The stimulation lead of claim 1 wherein the stimulation elements are metal electrodes.

3. The stimulation lead of claim 1 wherein the sensing elements are metal micro-electrodes or capacitative sensing elements.

4. The stimulation lead of claim 1 wherein the one or more stimulation elements and the one or more sensing elements are distributed in an array circumferentially on the surface of the lead.

5. The stimulation lead of claim 1 wherein the sensing elements are each individually capable of detecting one or more of electrical signals, action potentials, field potentials, biochemical signals and neurotransmitters.

6. The stimulation lead of claim 1 wherein the area of a single sensing element is smaller than the area of a single stimulation element.

7. The stimulation lead of claim 1 wherein a plurality of sensing elements are electrically combined to detect a single electrical signal.

8. The stimulation lead of claim 1 wherein the number of sensing elements is larger than the number of stimulation elements.

9. The stimulation lead of claim 1 wherein the stimulation parameters are selected from one or more of stimulation amplitude, polarity, duration repetition frequency, waveform, and relative phase within the stimulation duty cycle.

10. The stimulation lead of claim 1 wherein the lead has a controller for receiving signals from the one or more sensing elements, for determining the location of the target area and for determining which of the stimulation elements is located at least near the target area and that should provide the therapeutic stimulation.

11. The stimulation lead of claim 10 wherein the controller is capable of determining for each of the selected stimulation elements the required stimulation parameters needed for the therapeutic stimulation.

12. The stimulation lead of claim 10 wherein the controller is capable of using the signals received from one or more specific sensing elements to control relative stimulation amplitudes and/or timings of one or more specific stimulating elements.

13. A stimulation system for providing after implantation therapeutic electrical stimulation to tissue, comprising:

a pulse generator for generating and transmitting electrical pulses required for the stimulation; and

a stimulation lead, the simulation lead having an array of one or more stimulation elements and one or more sensing elements located at a distal end thereof, with each of the one or more stimulation elements being capable of providing electrical stimulation to tissue in a target area, and each of the one or more sensing elements being capable of detecting electrical signals,

wherein after the first implantation of the lead along a trajectory, the array of stimulation and sensing elements facilitate locating the target area, associating and/or selecting stimulation elements at least near the target area, as well as determining, for each selected stimulation element, the required stimulation parameters needed to provide therapeutic tissue stimulation without requiring additional implantations of the lead after the first implantation.

14. A method of providing therapeutic electrical stimulation to tissue in a target area, comprising the steps of:

determining by non-surgical imaging procedures an approximate target area for stimulation and a trajectory for implantation of a stimulation lead relative to the approximate target area;

implanting, along the trajectory, the stimulation lead, wherein the simulation lead has an array of one or more stimulation elements and one or more sensing elements located at a distal end thereof, with each of the one or more stimulation elements being capable of providing electrical stimulation to tissue, and each of the one or more sensing elements being capable of detecting electrical signals so that after a first implantation of the lead along a trajectory that is pre-determined by non-surgical procedures, the array of stimulation and sensing elements facilitate locating the target area, associating and/or selecting stimulation elements at least near the target area, as well as determining, for each selected stimulation element, the required stimulation parameters needed for the therapeutic stimulation without requiring additional implantations of the lead after the first implantation;

detecting by the one or more sensing elements of the electrical signals produced by nerve cells within the brain;

determining from detected electrical signals a three dimensional spatial location and boundary for a stimulation target area within the approximate target area;

determining one or more stimulation elements to provide stimulation to the stimulation target area and the stimulation parameters for each stimulation element to be used during stimulation; and

stimulating tissue in the stimulation target area using the specific stimulation parameters.

15. The method of claim 14 wherein the detecting by the one or more sensing elements of the electrical signals, further comprises the steps of:

reading out electrical signal characteristics; and

determining specific sensing elements that detect the electrical signal characteristics corresponding to the stimulation target area.

16. The method of claim 14 further comprising, prior to the step of stimulating tissue, the steps of:

testing the stimulation target area by delivering a test electrical stimulation via selected one or more stimulation elements and repeating steps of the method as needed until confirmation of a functionally efficient stimulation target area is obtained.

17. The method of claim 14 wherein the stimulation parameters are selected from one or more of stimulation amplitude, polarity, duration repetition frequency, waveform, and relative phase within the stimulation duty cycle.