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

• US 9,713,720 B2
• Filed: 07/22/2015
• Issued: 07/25/2017
• 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): CAREY, MICHAEL JAMES
• Application Number:
  US14/805,979
• Publication Number:
  US 20150321009A1
• Time in Patent Office: 734 Days
• Field of Search: 607 46, 607 59, 607 60, 607 62, 607117
• 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, comprising:

an implantable device connected to at least two implantable neurostimulation leads, the implantable device including a neurostimulator configured to deliver, using a first set of stimulation parameters, electrical energy through the neurostimulation leads to spinal cord tissue; and

an external device configured to communicate with the implantable device, wherein the neurostimulation system includes;

monitoring circuitry configured to monitor migration between the leads and monitor migration of at least one of the leads with respect to the spinal cord tissue; and

at least one controller/processor configured to communicate with the monitoring circuitry, to use the monitored migration between the leads, the monitored migration of at least one of the leads with respect to the spinal cord tissue, and at least one threshold value to determine when lead migration is significant, and to generate, when lead migration is determined to be significant, a second set of stimulation parameters using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue,

wherein the neurostimulator is configured to use the first set of stimulation parameters to stimulate a virtual multipole defining a volume of activation relative to the spinal cord tissue, and to use the second set of stimulation parameters, which was generated using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue, to stimulate the virtual multipole wherein the second set of stimulation parameters include fractionalized amplitude values that emulate the virtual multipole.

2. The neurostimulation system of claim 1, wherein each lead has electrodes, and the monitoring circuitry is configured to deliver an electrical signal between the electrodes, measure an electrical parameter in response to delivering the electrical signal, and use the measured electrical parameter to monitor migration between leads.

3. The neurostimulation system of claim 2, wherein the measured electrical parameter includes impedance.

4. The neurostimulation system of claim 2, wherein the measured electrical parameter includes a field potential.

5. The neurostimulation system of claim 2, wherein the monitoring circuitry is configured to generate an electric field and monitor for a deviation in voltage caused by action potentials in the target tissue induced by the electric field.

6. The neurostimulation system of claim 1, wherein at least one of the leads has an optical transducer and the monitoring circuitry is configured to send an optical signal from the optical transducer to the target tissue, measure a return signal from the target tissue and use the return signal to monitor the migration with respect to the target tissue.

7. The neurostimulation system of claim 1, wherein at least one of the leads has an ultrasound transducer and the monitoring circuitry is configured to send an ultrasound signal from the ultrasound transducer to the target tissue, measure a return signal from the target tissue, and use the return signal to monitor the migration with respect to the target tissue.

8. The neurostimulation system of claim 1, wherein the at least one controller/processor is configured to automatically reprogram the neurostimulator with the second set of stimulation parameters when lead migration is determined to be significant.

9. The neurostimulation system of claim 1, further comprising an external control device configured to generate an alert signal when the lead migration is determined to be significant, and to reprogram the neurostimulator with the second set of stimulation parameters in response to a user input.

10. The neurostimulation system of claim 1, wherein the monitoring circuitry is configured to sense coupling efficiency with the target tissue and use the sensed coupling efficiency to monitor the migration with respect to the target tissue.

11. The neurostimulation system of claim 1, wherein the leads are configured to be implanted in an epidural space to deliver electrical energy to the spinal cord tissue.

12. The neurostimulation system of claim 11, wherein the monitoring circuitry is configured to monitor migration between the leads to monitor rostro-caudal migration along the spinal cord.

13. The neurostimulation system of claim 11, wherein the monitoring circuitry is configured to monitor migration between the leads to monitor medio-lateral migration transverse to the spinal cord.

14. The neurostimulation system of claim 11, wherein the monitoring circuitry is configured to monitor migration of at least one of the leads with respect to the target tissue to monitor dorsal-ventral migration relative to the spinal cord.

15. The neurostimulation system of claim 1, wherein the external device includes both the monitoring circuitry and the at least one controller/processor.

16. The neurostimulation system of claim 1, wherein the implantable device includes both the monitoring circuitry and the at least one controller/processor.

17. The neurostimulation system of claim 1, wherein the implantable device includes the monitoring circuitry and the external device includes the at least one controller/processor.

18. A method, comprising:

delivering, using a first set of stimulation parameters, electrical energy through neurostimulation leads to stimulate a virtual multipole defining a volume of activation relative to spinal cord tissue;

monitoring migration between the neurostimulation leads;

monitoring migration of at least one of the leads with respect to the spinal cord tissue;

using at least one controller/processor to use the monitored migration between the leads, the monitored migration of at least one of the leads with respect to the spinal cord tissue, and at least one threshold value to determine when lead migration is significant, and generate, when lead migration is determined to be significant, a second set of stimulation parameters using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue; and

delivering, using the second set of stimulation parameters which was generated using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue, electrical energy through neurostimulation leads to stimulate the virtual multipole defining the volume of activation relative to the spinal cord tissue, wherein the second set of stimulation parameters include fractionalized amplitude values that emulate the virtual multipole.

19. The method of claim 18, further comprising:

automatically reprogramming a neurostimulator to stimulate the virtual multipole defining the volume of activation with the second set of stimulation parameters when lead migration is determined to be significant;

or

generating an alert signal using an external control device when the lead migration is determined to be significant; and

reprogramming a neurostimulator to stimulate the virtual multipole defining the volume of activation with the second set of stimulation parameters in response to a user input.

20. A non-transitory machine-readable medium including instructions, which when operated on by a machine, cause the machine to perform a method including:

deliver, using a first set of stimulation parameters, electrical energy through neurostimulation leads to stimulate a virtual multipole defining a volume of activation relative to spinal cord tissue;

monitor migration between the neurostimulation leads;

monitor migration of at least one of the leads with respect to the spinal cord tissue;

use the monitored migration between the leads;

the monitored migration of at least one of the leads with respect to the spinal cord tissue, and at least one threshold value to determine when lead migration is significant, and generate, when lead migration is determined to be significant, a second set of stimulation parameters using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue; and

deliver, using the second set of stimulation parameters which was generated using the monitored migration between the leads and the monitored migration of at least one of the leads with respect to the spinal cord tissue, electrical energy through neurostimulation leads to stimulate the virtual multipole defining the volume of activation relative to the spinal cord tissue, wherein the second set of stimulation parameters include fractionalized amplitude values that emulate the virtual multipole.