Neurostimulation system with three-dimensional lead migration detection and automatic neurostimulation correction

• US 9,089,705 B2
• Filed: 12/05/2013
• Issued: 07/28/2015
• Est. Priority Date: 12/07/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Zhu, Changfang
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/098,380
• Publication Number:
  US 20140163639A1
• Time in Patent Office: 600 Days
• Field of Search: 607/46, 607/59, 607/60, 607/62, 607/117
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A neurostimulation system configured for providing therapy to a patient, comprises at least one implantable neurostimulation lead configured for being implanted adjacent target tissue of the patient, and an implantable neurostimulator configured for delivering electrical stimulation energy to the implantable neurostimulation lead(s) in accordance with a set of stimulation parameters capable, and monitoring circuitry configured for taking at least one measurement indicative of a three-dimensional migration of the neurostimulation lead(s) from a baseline position. The neurostimulation system further comprises at least one controller/processor configured for determining whether the three-dimensional migration of the neurostimulation lead(s) from the baseline position has occurred based on the measurement(s), and, based on the determined three-dimensional migration, generating a new set of stimulation parameters, and reprogramming the implantable neurostimulator with the new set of stimulation parameters.

Claims

1. A neurostimulation system configured for providing therapy to a patient, comprising:

at least one implantable neurostimulation lead configured for being implanted adjacent target tissue of the patient;

an implantable neurostimulator configured for delivering electrical stimulation energy to the at least one implantable neurostimulation lead in accordance with a current set of stimulation parameters;

monitoring circuitry configured for taking at least one measurement indicative of a three-dimensional migration of the at least one neurostimulation lead from a baseline position; and

at least one controller/processor configured for determining whether the three-dimensional migration of the at least one neurostimulation lead from the baseline position has occurred based on the at least one measurement, and, based on the determined three-dimensional migration, generating a new set of stimulation parameters, and reprogramming the implantable neurostimulator with the new set of stimulation parameters,

wherein the target tissue is a spinal cord, the at least one neurostimulation lead comprises at least two neurostimulation leads, and the at least one measurement is indicative of a rostro-caudal migration and a media-lateral migration between the at least two neurostimulation leads, and a dorsal-ventral migration of the at least two neurostimulation leads relative to the spinal cord.

2. The neurostimulation system of claim 1, wherein the current set of stimulation parameters is capable of creating a baseline volume of activation relative to the target tissue, and the new set of stimulation parameters is capable of mimicking the baseline volume of activation relative to the target tissue.

3. The neurostimulation system of claim 1, wherein the at least one neurostimulation lead carries a plurality of electrodes, and the monitoring circuitry is configured for taking one of the at least one measurement by conveying an electrical signal between the electrodes, and measuring an electrical parameter in response to the conveyance of the electrical signal.

4. The neurostimulation system of claim 3, wherein the measured electrical parameter is one of an impedance, a field potential, and an evoked potential.

5. The neurostimulation system of claim 1, wherein the at least one neurostimulation lead carries one of an optical transducer and an ultrasound transducer, and the monitoring circuitry is configured for taking one of the at least one measurement by conveying one of an optical signal or an ultrasound signal from the respective one of the optical transducer and ultrasound transducer to the target tissue, and measuring return signal in response to the conveyance of the optical signal or ultrasound signal.

6. The neurostimulation system of claim 1, wherein the at least one neurostimulation lead comprises at least two neurostimulation leads, one of the at least one measurement is indicative of a migration of the at least two neurostimulation leads relative to each other, and the at least one controller/processor is configured for determining whether the migration of the at least two neurostimulation leads relative to each other has occurred based on the one measurement.

7. The neurostimulation system of claim 6, wherein another one of the at least one measurement is indicative of a migration of the at least two neurostimulation leads relative to the target tissue, and the at least one controller/processor is configured for determining whether the migration of the at least two neurostimulation leads relative to the target tissue has occurred based on the other measurement.

8. The neurostimulation system of claim 1, further comprising memory configured for storing the baseline position of the at least one neurostimulation lead, and the at least one controller/processor is configured for determining a magnitude of the three-dimensional migration of the at least one neurostimulation lead from the baseline position by determining a current three-dimensional position of the at least one neurostimulation lead, comparing the current three-dimensional position of the at least one neurostimulation lead to the baseline position of the at least one neurostimulation lead to determine the magnitude.

9. The neurostimulation system of claim 8, wherein the memory is configured for storing at least one threshold value, and the at least one controller/processor is configured for comparing the determined magnitude of the three-dimensional migration to the at least one threshold value, and reprogramming the implantable neurostimulator with the new set of stimulation parameters based on the comparison.

10. The neurostimulation system of claim 9, wherein the at least one controller/processor is configured for automatically reprogramming the implantable neurostimulator with the new set of stimulation parameters when the determined magnitude of the three-dimensional migration exceeds any of the at least one threshold value.

11. The neurostimulation system of claim 8, further comprising an external control device configured tier receiving input from a user, for generating an alert signal when the determined magnitude of the three-dimensional migration exceeds the any threshold value, and for reprogramming the implantable neurostimulator with the new set of stimulation parameters in response to the user input.

12. The neurostimulation system of claim 11, wherein the at least one controller/processor is configured for instructing the implantable neurostimulator to deliver electrical stimulation energy to the at least one implantable neurostimulation lead in accordance with the new set of stimulation parameters prior to reprogramming the implantable neurostimulator with the new set of stimulation parameters, wherein the external control vice is configured to allow a user to prompt the at least one controller/processor to reprogram the implantable neurostimulator with the new set of stimulation parameters.

13. The neurostimulation system of claim 1, wherein the at least one neurostimulation lead carries a plurality of electrodes, wherein the at least one controller/processor is configured for reprogramming the implantable stimulator with the new set of stimulation parameters by defining a virtual multipole relative to the target tissue, and computing fractionalized amplitude values for electrodes carried by the at least one neurostimulation lead that emulate the virtual multipole, and wherein the new set of stimulation parameters includes the computed amplitude values.

14. The neurostimulation system of claim 1, wherein the at least one neurostimulation lead carries a plurality of electrodes, the monitoring circuitry is further configured for taking at least another measurement indicative of coupling efficiencies between the electrodes and the tissue, and the at least one controller/processor is configured for determining whether any of the electrodes has a degraded coupling efficiency based on the at least other measurement, and, if any of the electrodes is determined to have a degraded coupling efficiency, generating the new set of stimulation parameters, and reprogramming the implantable neurostimulator with the new set of stimulation parameters.

15. The neurostimulation system of claim 1, wherein the monitoring circuitry and the at least one controller/processor is contained in the implantable neurostimulator.

16. The neurostimulation system of claim 1, further comprising an external control device containing the at least one controller/processor.

17. A neurostimulation system configured for providing therapy to a patient, comprising:

at least two implantable neurostimulation leads configured for being implanted adjacent target tissue of the patient;

an implantable neurostimulator configured for delivering electrical stimulation energy to the at least one implantable neurostimulation lead in accordance with a current set of stimulation parameters, wherein the current set of stimulation parameters is capable of creating a baseline volume of activation relative to the target tissue;

monitoring circuitry configured for taking at least one measurement indicative of a three-dimensional migration of the at least one neurostimulation lead from a baseline position; and

at least one controller/processor configured for determining whether the three-dimensional migration of the at least one neurostimulation lead from the baseline position has occurred based on the at least one measurement, and, based on the determined three-dimensional migration, generating a new set of stimulation parameters capable of mimicking the baseline volume of activation relative to the target tissue, and reprogramming the implantable neurostimulator with the new set of stimulation parameters.

18. A neurostimulation system configured for providing therapy to a patient, comprising:

at least one implantable neurostimulation lead configured for being implanted adjacent target tissue of the patient;

an implantable neurostimulator configured for delivering electrical stimulation energy to the at least one implantable neurostimulation lead in accordance with a current set of stimulation parameters;

monitoring circuitry configured for taking at least one measurement indicative of a three-dimensional migration of the at least one neurostimulation lead from a baseline position;

at least one controller/processor configured for determining whether the three-dimensional migration of the at least one neurostimulation lead from the baseline position has occurred based on the at least one measurement, and, based on the determined three-dimensional migration, generating a new set of stimulation parameters, and reprogramming the implantable neurostimulator with the new set of stimulation parameters;

memory configured for storing the baseline position of the at least one neurostimulation lead, and the at least one controller/processor is configured for determining a magnitude of the three-dimensional migration of the at least one neurostimulation lead from the baseline position by determining a current three-dimensional position of the at least one neurostimulation lead, comparing the current three-dimensional position of the at least one neurostimulation lead to the baseline position of the at least one neurostimulation lead to determine the magnitude, wherein the memory is configured for storing at least one threshold value, and the at least one controller/processor is configured for comparing the determined magnitude of the three-dimensional migration to the at least one threshold value, wherein the at least one controller/processor is configured for automatically reprogramming the implantable neurostimulator with the new set of stimulation parameters when the determined magnitude of the three-dimensional migration exceeds any of the at least one threshold value.

19. The neurostimulation system of claim 18, wherein the at least one neurostimulation lead carries a plurality of electrodes, wherein the at least one controller/processor is configured for reprogramming the implantable stimulator with the new set of stimulation parameters by defining a virtual multipole relative to the target tissue, and computing fractionalized amplitude values for electrodes carried by the at least one neurostimulation lead that emulate the virtual multipole, and wherein the new set of stimulation parameters includes the computed amplitude values.

20. The neurostimulation system of claim 18, wherein the at least one neurostimulation lead carries a plurality of electrodes, the monitoring circuitry is further configured for taking at least another measurement indicative of coupling efficiencies between the electrodes and the tissue, and the at least one controller/processor is configured for determining whether any of the electrodes has a degraded coupling efficiency based on the at least other measurement, and, if any of the electrodes is determined to have a degraded coupling efficiency, generating the new set of stimulation parameters, and reprogramming the implantable neurostimulator with the new set of stimulation parameters.