Systems and method for deep brain stimulation therapy

• US 10,806,929 B2
• Filed: 05/16/2018
• Issued: 10/20/2020
• Est. Priority Date: 04/03/2014
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Venkatesan, Lalit
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/981,687
• Publication Number:
  US 20180256896A1
• Time in Patent Office: 888 Days
• Field of Search: None
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/364 Correlation of different images or relation of image positions in respect to the body
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

A system and method for performing deep brain stimulation (DBS) therapy are provided. The method and system include pre-operatively acquiring at least one pre-operative image of the brain with at least one imaging sub-system and determining a location of a Nucleus Basalls of Meynert (NBM) for therapy in the at least one pre-operative image, and intra-operatively acquiring at least one intra-operative image of the brain after obtaining an access opening through the skull. The method and system further provide performing surgical planning based on the pre-operative image in the intra-operative image, advancing a lead having DBS electrodes on the lead to a target position proximate to or within the NBM area, and coupling the lead to an implantable pulse generator (IPG) configured to deliver DBS pulses through the DBS electrodes to the NBM. Further, the IPG is configured to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s disease.

Claims

1. A method for performing deep brain stimulation (DBS) therapy, the method comprising:

pre-operatively acquiring at least one pre-operative image of a brain of a patient with at least one imaging sub-system;

determining a location of a Nucleus Basalis of Meynert (NBM) for therapy in the at least one pre-operative image;

intra-operatively acquiring at least one intra-operative image of the brain after obtaining an access opening through a skull of the patient and after positioning a fiducial on or within the brain through the access opening;

performing surgical planning based on the at least one pre-operative image and the at least one intra-operative image;

advancing a first lead having a first plurality of deep brain stimulation (DBS) electrodes to a first target position proximate to or within a first NBM area;

advancing a second lead having a second plurality of DBS electrodes to a second target position proximate to or within a second NBM area;

coupling the first and second leads to an implantable pulse generator (IPG) configured to deliver DBS pulses through the respective pluralities of DBS electrodes to the first and second NBM areas, the IPG to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s Disease (AD); and

delivering an NBM therapy utilizing a first subset of the first plurality of DBS electrodes to stimulate the first NBM area and delivering a Nucleus Accumbens (NAcc) therapy utilizing a second subset of the first plurality of DBS electrodes to stimulate an NAcc area proximate to the first NBM area, the first and second subsets of the first plurality of DBS electrodes having at least one different electrode.

2. The method of claim 1, wherein the first NBM area and the NAcc area are each stimulated by respective DBS pulses having different amplitudes.

3. The method of claim 2, wherein the surgical planning and advancing operations are performed responsive to identifying a registered position of the fiducial on one or more of the at least one pre-operative image and the at least one intra-operative image.

4. The method of claim 3, wherein the first and second target positions are proximate to the first and second NBM areas respectively such that a surface of the first plurality of DBS electrodes is within 5.0 mm of the first NBM area and a surface of the second plurality of DBS electrodes is within 5.0 mm of the second NBM area.

5. The method of claim 1, wherein the NBM therapy and the NAcc therapy are delivered intermittently.

6. The method of claim 5, further comprising delivering the NBM therapy to the first NBM area when the first subset of the first plurality of DBS electrodes are configured to be in a STIM ON state while the second subset of the first plurality of the DBS electrodes are in a STIM OFF state.

7. The method of claim 5, further comprising delivering the NAcc therapy to the NAcc area when the first subset of the first plurality of DBS electrodes are configured to be in a STIM OFF state while the second subset of the first plurality of the DBS electrodes are in a STIM ON state.

8. The method of claim 1, further comprising performing a global measure of cognitive function that includes testing the patient for at least one of declarative memory, orientation, praxis, receptive language or expressive language.

9. The method of claim 1, wherein the surgical planning and advancing operations include the step of advancing the first lead to the first target position such that the first plurality of DBS electrodes are operative to be stimulated by DBS pulses having a particular amplitude for generating an energy trajectory propagating from the first plurality of DBS electrodes that covers the first NBM area and the NAcc area proximate thereto.

10. A system for performing deep brain stimulation (DBS) therapy, the system comprising:

a surgical planning (SP) work station having an input configured to receive at least one pre-operative image of a brain of a patient with at least one imaging sub-system;

the SP work station configured to permit a user to determine a location of a Nucleus Basalis of Meynert (NBM) for therapy in the at least one pre-operative image;

the SP work station having an input configured to receive at least one intra-operative image of the brain after obtaining an access opening through a skull of the patient and after positioning a fiducial on or within the brain through the access opening;

the SP work station configured to perform surgical planning based on the at least one pre-operative image and the at least one intra-operative image;

a first lead having a first plurality of deep brain stimulation (DBS) electrodes, the first lead configured to be advanced to a first target position proximate to or within a first NBM area;

a second lead having a second plurality of DBS electrodes, the second lead configured to be advanced to a second target position proximate to or within a second NBM area;

an implantable pulse generator (IPG) coupled to the first and second leads, the IPG configured to deliver DBS pulses through the respective pluralities of DBS electrodes to the first and second NBM areas, the IPG configured to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s Disease (AD); and

the IPG further configured to deliver an NBM therapy utilizing a first subset of the first plurality of DBS electrodes to stimulate the first NBM area and to deliver a Nucleus Accumbens (NAcc) therapy utilizing a second subset of the first plurality of DBS electrodes to stimulate an NAcc area proximate to the first NBM area, the first and second subsets of the first plurality of DBS electrodes having at least one different electrode.

11. The system of claim 10, wherein the IPG is further configured to stimulate the first NBM area and the NAcc area by respective DBS pulses having different amplitudes.

12. The system of claim 10, wherein the SP work station is configured to perform the surgical planning and advancing operations responsive to identifying a registered position of the fiducial on one or more of the at least one pre-operative image and the at least one intra-operative image.

13. The system of claim 10, wherein the IPG is configured to deliver the NBM therapy and the NAcc therapy intermittently.

14. The system of claim 13, wherein the IPG is configured to deliver the NBM therapy to the first NBM area when the first subset of the first plurality of DBS electrodes are configured by the IPG to be in a STIM ON state while the second subset of the first plurality of the DBS electrodes are in a STIM OFF state.

15. The system of claim 13, wherein the IPG is configured to deliver the NAcc therapy to the NAcc area when the first subset of the first plurality of DBS electrodes are configured by the IPG to be in a STIM OFF state while the second subset of the first plurality of the DBS electrodes are in a STIM ON state.

16. The system of claim 10, wherein the IPG includes pulse generating circuitry configured to deliver DBS pulses having a particular amplitude for generating an energy trajectory propagating from the first plurality of DBS electrodes that covers at least a portion of both the first NBM area and the NAcc area proximate thereto.