Systems and method for deep brain stimulation therapy

• US 9,999,772 B2
• Filed: 04/03/2014
• Issued: 06/19/2018
• 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:
  US14/244,596
• Publication Number:
  US 20150283379A1
• Time in Patent Office: 1,538 Days
• Field of Search: 607 45
• 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 Basalis 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;

infra-operatively acquiring at least one intra-operative image of the brain after obtaining an access opening through a skull of the patient;

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

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

coupling the lead to an implantable pulse generator (IPG) configured to deliver DBS pulses through the DBS electrodes to the NBM, the IPG to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s Disease (AD); and

wherein the surgical planning and advancing operations locate the DBS electrodes such that a Nucleus Accumbens (NAcc) and the NBM are both located within an energy trajectory of the DBS delivered by, and propagating from, the DBS electrodes.

2. The method of claim 1, wherein the target position is proximate to the NBM area such that a surface of the DBS electrodes is within 5.0 mm of the NBM.

3. The method of claim 1, wherein the advancing operation further comprises bilaterally advancing first and second leads to first and second target positions that are proximate to or within first and second NBM areas, respectively.

4. The method of claim 1, further comprising configuring the IPG to deliver a stimulation therapy that includes at least one of biphasic pulses having a pulse width of 50-150 usec and pulses having an amplitude of 1.0 to 10.0 mA.

5. The method of claim 1, further comprising delivering an NBM therapy utilizing a first combination of DBS electrodes to the NB M area, and delivering a Nucleus Accumbens (NAcc) therapy utilizing a second combination of DBS electrodes to a NAcc area, the first and second combination of DBS electrodes haying at least one different electrode.

6. The method of claim 1, further comprising the IPG configuring the DBS electrodes on the lead into first and second electrode sets, such that 1) at one point in time, the IPG setting the first electrode set in a STIM ON state in which the first electrode set deliver CGS pulses for a first period of time to the NB M area, while the second electrode set is in a STIM OFF state, and 2) at a second point in time, the IPG setting the second electrode set in a STIM ON state in which the second electrode set delivery DBS pulses for a second period of time to a Nucleus Accumbens (NAcc) area, while the first electrode set is in the STIM OFF state.

7. The method of claim 1, further comprising configuring the IPG to deliver a first DBS therapy directed toward the NBM and a second DBS therapy directed toward a Nucleus Accumbens (NAcc), the first and second DBS therapies being delivered intermittently.

8. The method of claim 1, further comprising maintaining parameters associated with the DBS pulses constant for an extended wait period of time while testing for a presence of acute or sub-acute side effects, following the wait period of time adjusting the parameters.

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

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;

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

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

an implantable pulse generator (IPG) coupled to the lead, the IPG configured to deliver DBS pulses through the DBS electrodes to the NBM, the implantable pulse generator configured to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s Disease (AD); and

wherein the surgical planning and advancing operations locate the DBS electrodes such that a Nucleus Accumbens (NAcc) and the NBM are both located within an energy trajectory of the DBS delivered by, and propagating from, the DBS electrodes.

11. The system of claim 10, wherein the target position is proximate to the NBM area such that a surface of the DBS electrodes is within 5.0 mm of the NBM.

12. The system of claim 10, further comprising first and second leads bilaterally advanced to first and second target positions that are proximate to or within first and second NBM areas, respectively.

13. The system of claim 10, wherein the IPG is further configured to deliver a secondary DBS therapy directed toward a Nucleus Accumbens (NAcc) for treating psychiatric symptoms.

14. The system of claim 10, wherein the IPG is further configured to deliver a stimulation therapy that includes at least one of biphasic pulses having a pulse width of 50-150 usec and pukes having an amplitude of 1.0 to 10.0 mA.

15. The system of claim 10, wherein the IPG is further configured to deliver an NBM therapy utilizing a first combination of DBS electrodes to the NPM area, and deliver a Nucleus Accumbens (NAcc) therapy utilizing a second combination of DBS electrodes to a NAcc area, the first and second combination of DBS electrodes having at least one different electrode.

16. The system of claim 10, wherein the DBS electrodes on the lead are configured into first and second electrode sets, wherein 1) at one point in time, the IPG sets the first electrode set in a STIM ON state in which the first electrode set deliver DBS pukes for a first period of time to the NBM area, while the second electrode set k in a STIM OFF state, and 2) at a second point in time, the IPG sets the second electrode set in a STIM ON state in which the second electrode set delivery DBS pulses for a second period of time to a Nucleus Accumbens (NAcc) area, while the first electrode set is in the STIM OFF state.

17. The system of claim 10, further comprising maintain parameters associated with the DBS pulses constant for an extended wait period of time while testing for a presence of acute or sub-acute side effects, following the wait period of time adjusting the parameters.

18. The system of claim 10, wherein a global measure of cognitive function is performed that includes tests for at least one of declarative memory, orientation, praxis, receptive language or expressive language.

19. 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 Balsas of Meynert (NBM) for therapy in the at least one pm-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;

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

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

coupling the lead to an implantable pulse generator (IPG) configured to deliver DBS pulses through the DBS electrodes to the NBM, the IPG to deliver DBS pulses for treating symptoms associated with Alzheimer'"'"'s Disease (AD); and

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

20. The method of claim 19, further comprising the IPG configuring the DBS electrodes on the lead into first and second electrode sets, such that 1) at one point in time, the IPG setting the first electrode set in a STIM ON state in which the first electrode set deliver DBS pulses for a first period of time to the NBM area, while the second electrode set is in a STIM OFF state, and 2) at a second point in time, the IPG setting the second electrode set in a STIM ON state in which the second electrode set delivery DBS pulses for a second period of time to a Nucleus Accumbens (NAcc) area, while the first electrode set is in the STIM OFF state.