Implantable system with inputs

• US 8,825,153 B2
• Filed: 08/21/2012
• Issued: 09/02/2014
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kokones, Scott, Carlton, Keith, Greszler, Alan
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US13/590,633
• Publication Number:
  US 20120316616A1
• Time in Patent Office: 742 Days
• Field of Search: 607/45, 607/2, 607/46, 607/48, 607/62
• US Class Current: 607/2
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/224 Measuring muscular strength
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/37 Intracranial electroencephalography [IC-EEG], e.g. electrocorticography [ECoG]
• CPC Class Codes: A61B 5/384 Recording apparatus or displays specially adapted therefor
• CPC Class Codes: A61B 5/386 Accessories or supplementary instruments therefor
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

A stimulation system can have a first sensor to generate a first reading and a second sensor to generate a second reading. An analysis module of a programmer such as a patient programmer, which programs a stimulation signal to be delivered to a patient, conducts an evaluation of the patient based on the first and second readings. Evaluations may include determinations such as range of motion determinations, posture determinations, physical task-specific brain activity determinations, cognitive task-specific brain activity determinations, and brain activity-specific movement determinations.

Claims

1. A stimulation system comprising:

a stimulation lead configured to perform a neuro-stimulation of an anatomical region of a patient;

a first sensor to generate a first reading;

a second sensor to generate a second reading; and

at least one computer processor configured to;

compare the first reading to the second reading;

conduct an evaluation of the patient based on the comparison; and

based on the evaluation, modify a stimulation parameter according to which to perform the neuro-stimulation;

wherein at least one of;

the evaluation includes a determination, based on the comparison, of a posture of the patient, the first sensor is located at a burr hole cap, and the second sensor is located on an implantable pulse generator that triggers stimulation pulses of the stimulation lead; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers and (b) the first sensor is disposed on the burr hole cap and the second sensor is disposed on the implantable pulse generator.

2. A stimulation system of claim 1, comprising:

a stimulation lead configured to perform a neuro-stimulation of an anatomical region of a patient;

a first sensor to generate a first reading;

a second sensor to generate a second reading; and

at least one computer processor configured to;

compare the first reading to the second reading;

conduct an evaluation of the patient based on the comparison; and

based on the evaluation, modify a stimulation parameter according to which to perform the neuro-stimulation;

wherein;

the stimulation system is configured to select at least one of a progress input question and a task instruction for presentation to the patient based on the evaluation; and

at least one of;

the evaluation includes a determination, based on the comparison, of a range of motion of which the patient is capable;

the evaluation includes a determination, based on the comparison, of a posture of the patient, the first sensor is located at a burr hole cap, and the second sensor is located on an implantable pulse generator that triggers stimulation pulses of the stimulation lead; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers and (b) the first sensor is disposed on the burr hole cap and the second sensor is disposed on the implantable pulse generator.

3. The stimulation system of claim 1, wherein:

the first and second readings are simultaneously generated;

the evaluation includes the determination, based on the comparison, of a migration of the stimulation lead from the treatment site within the patient;

the first and second sensors are accelerometers; and

the first sensor is on the stimulation lead.

4. The stimulation system of claim 3, wherein the stimulation system includes at least one of the implantable pulse generator and an external pulse generator in communication with the stimulation lead.

5. A stimulation system of claim 1, comprising:

a stimulation lead configured to perform a neuro-stimulation of an anatomical region of a patient;

a first sensor to generate a first reading;

a second sensor to generate a second reading; and

at least one computer processor configured to;

compare the first reading to the second reading;

conduct an evaluation of the patient based on the comparison; and

based on the evaluation, modify a stimulation parameter according to which to perform the neuro-stimulation;

wherein;

the evaluation is conducted by a processor disposed within at least one of a patient programmer remote control configured for receiving user-input of stimulation parameter changes, a clinician programmer device configured for receiving user-input of stimulation parameter changes, an implantable pulse generator configured to trigger stimulation pulses of the stimulation lead, and an external pulse generator configured to trigger stimulation pulses of the stimulation lead; and

at least one of;

the evaluation includes a determination, based on the comparison, of a range of motion of which the patient is capable;

the evaluation includes a determination, based on the comparison, of a posture of the patient, the first sensor is located at a burr hole cap, and the second sensor is located on the implantable pulse generator; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers and (b) the first sensor is disposed on the burr hole cap and the second sensor is disposed on the implantable pulse generator.

6. The stimulation system of claim 5, wherein:

the evaluation includes the determination, based on the comparison, of the range of motion of which the patient is capable; and

at least one of the first and second sensors is coupled to the patient programmer remote control.

7. The stimulation system of claim 1, wherein at least one of the first and second sensors is an accelerometer.

8. The stimulation system of claim 1, wherein the at least one processor is configured to store data relating to the evaluation to a memory of the stimulation system.

9. The stimulation system of claim 1, wherein the comparison is performed to obtain a relative measurement of simultaneous motion, the evaluation being based on the relative measurement.

10. The stimulation system of claim 1, wherein:

the evaluation includes at least one of the posture determination and the lead migration determination;

the first sensor is disposed on the burr hole cap; and

the second sensor is disposed on the implantable pulse generator.

11. A stimulation system comprising:

a stimulation lead configured to perform a neuro-stimulation of an anatomical region of a patient;

a burr hole cap for the stimulation lead;

a first accelerometer, on the stimulation lead, to generate a first reading;

a second accelerometer to generate a second reading simultaneously with the generation of the first reading; and

at least one computer processor configured to;

compare the first reading to the second reading;

determine, based on the comparison, a migration of the stimulation lead from a treatment site within the patient; and

based on the determination, modify a stimulation parameter according to which to perform the neuro-stimulation.

12. A method of operating a stimulation system comprising:

transmitting a first reading from a first sensor to an analysis module of the stimulation system;

transmitting a second reading from a second sensor to the analysis module;

comparing, by a computer processor, the first reading to the second reading;

conducting, by the processor, an evaluation of a patient based on the comparison; and

based on the evaluation, modifying, by the processor, a stimulation parameter according to which to perform a neuro-stimulation of an anatomical region of the patient using a stimulation lead;

wherein at least one of;

the evaluation includes a determination, based on the comparison, of a posture of the patient, the first sensor is located at a burr hole cap, and the second sensor is located on an implantable pulse generator that triggers stimulation pulses of the stimulation lead; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers and (b) the first sensor is disposed on the burr hole cap and the second sensor is disposed on the implantable pulse generator.

13. The method of claim 12, wherein at least one of the first and second sensors is an accelerometer.

14. The method of claim 12, wherein the comparison is performed to obtain a relative measurement of simultaneous motion, the evaluation being based on the relative measurement.

15. A method of operating a stimulation system, the method comprising:

transmitting a first reading from a first sensor to an analysis module of the stimulation system;

transmitting a second reading from a second sensor to the analysis module;

comparing, by a computer processor, the first reading to the second reading;

conducting, by the processor, an evaluation of a patient based on the comparison; and

based on the evaluation;

selecting at least one of a progress input question and a task instruction for presentation to the patient; and

modifying, by the processor, a stimulation parameter according to which to perform a neuro-stimulation of an anatomical region of the patient using a stimulation lead;

wherein at least one of;

the evaluation includes a determination, based on the comparison, of a range of motion of which the patient is capable;

the evaluation includes a determination, based on the comparison, of a posture of the patient, the first sensor is located at a burr hole cap, and the second sensor is located on an implantable pulse generator that triggers stimulation pulses of the stimulation lead; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers and (b) the first sensor is disposed on the burr hole cap and the second sensor is disposed on the implantable pulse generator.

16. A method of operating a deep brain stimulation system, the method comprising:

transmitting a first reading from a first sensor to an analysis module of the stimulation system;

transmitting a second reading from a second sensor, included one of on and in an implantable pulse generator, to the analysis module;

comparing, by a computer processor, the first reading to the second reading;

conducting, by the processor, an evaluation of a patient based on the comparison;

based on the evaluation, modifying, by the processor, a stimulation parameter according to which to perform a neuro-stimulation of an anatomical region of the patient using a stimulation lead;

generating a pulse trigger signal by the implantable pulse generator;

transmitting the pulse trigger signal to the stimulation lead via a stimulation extension; and

performing the neuro-stimulation at the treatment site by the stimulation lead based on the pulse trigger;

wherein at least one of;

the evaluation includes a determination, based on the comparison, of a range of motion of which the patient is capable;

the evaluation includes a determination, based on the comparison, of a posture of the patient and the first sensor is located at a burr hole cap; and

the first and second readings are simultaneously generated, the evaluation includes a determination, based on the comparison, of a migration of the stimulation lead from a treatment site within the patient, and at least one of;

(a) the first and second sensors are accelerometers, and (b) the first sensor is disposed on the burr hole cap.

17. The method of claim 16, further including selecting at least one of a progress input question and a task instruction for presentation to the patient based on the evaluation.

18. The method of claim 16, wherein at least one the first and second sensors is an accelerometer.

19. The method of claim 16, wherein the processor is disposed within at least one of a patient programmer remote control configured for receiving user-input of stimulation parameter changes, a clinician programmer device configured for receiving user-input of stimulation parameter changes, the implantable pulse generator and an external pulse generator.

20. A stimulation system comprising:

a stimulation lead configured to perform a neuro-stimulation of an anatomical region of a patient;

a first sensor to generate a first reading, the first sensor being disposed one of on and in a patient programmer remote control that is configured for obtaining user input of stimulation parameter modifications and for controlling the stimulation lead in accordance with the user input stimulation parameter modifications;

a second sensor to generate a second reading, the second sensor being disposed one of on and in an implantable pulse generator that triggers stimulation pulses of the stimulation lead; and

at least one computer processor configured to;

compare the first reading to the second reading;

determine, based on the comparison, a range of motion of which the patient is capable; and

based on the determination, modify a stimulation parameter according to which to perform the neuro-stimulation.