Systems and methods for detecting cerebrospinal-fluid pulsation using an implantable electrical stimulation device

• US 9,655,528 B2
• Filed: 07/14/2014
• Issued: 05/23/2017
• Est. Priority Date: 07/15/2013
• 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:
  US14/330,286
• Publication Number:
  US 20150018634A1
• Time in Patent Office: 1,044 Days
• Field of Search: 607 62, 607117, 600587, 600594
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/4058 for evaluating the central nervous system A61B5/4806, A61B5/4821 take precedence
• CPC Class Codes: A61B 5/6868 Brain
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

An electrical stimulation lead assembly includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length. Electrodes are disposed along the distal end portion of the lead body; terminals disposed along the proximal end portion of the lead body; and stimulation conductors couple the terminals to the electrodes. A cerebrospinal-fluid-pulsation detection assembly includes a sensor disposed along the distal end portion of the lead body. The sensor detects pulses of cerebrospinal fluid within a subarachnoid space of a patient and transforms the detected cerebrospinal-fluid pulses into sensor signals. A sensor processor receives the sensor signals from the sensor, processes the received sensor signals to cerebrospinal-fluid pulsation data (“CSF-pulsation data”), and estimates a patient blood-flow condition based on the CSF-pulsation data. A sensor control pathway couples the sensor to the sensor processor.

Claims

1. An electrical stimulation lead assembly, comprising:

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of electrodes disposed along the distal end portion of the at least one lead body;

a plurality of terminals disposed along the proximal end portion of the at least one lead body;

a plurality of stimulation conductors coupling the plurality of terminals to the plurality of electrodes; and

a cerebrospinal-fluid-pulsation detection assembly (“

CSF-pulsation detection assembly”

) comprising

at least one sensor disposed along the distal end portion of the at least one lead body, the at least one sensor configured and arranged for detecting pulses of cerebrospinal fluid within a subarachnoid space of a patient and transforming the detected pulses of cerebrospinal fluid into sensor signals,

a sensor processor for receiving the sensor signals from the at least one sensor, processing the received sensor signals to generate cerebrospinal-fluid pulsation data (“

CSF-pulsation data”

) comprising at least one of amplitude, duration, or rate of cerebrospinal-fluid pulses, and estimating at least one patient blood-flow condition based on the CSF-pulsation data, and

at least one sensor control pathway coupling the at least one sensor to the sensor processor.

2. The electrical stimulation lead assembly of claim 1, wherein the at least one sensor of the CSF-pulsation detection assembly comprises at least one of an electro-optical sensor, a photoelectric sensor, a pulse oximeter, a piezoelectric sensor, a pneumatic sensor, or a strain gauge.

3. The electrical stimulation lead assembly of claim 1, wherein the at least one sensor of the CSF-pulsation detection assembly comprises at least one of a light-emitting diode or a laser diode.

4. The electrical stimulation lead assembly of claim 1, wherein the at least one sensor control pathway of the CSF-pulsation detection assembly comprises an optical transport medium.

5. The electrical stimulation lead assembly of claim 1, wherein the at least one sensor is disposed proximal to all of the plurality of electrodes.

6. The electrical stimulation lead assembly of claim 1, wherein the at least one sensor is disposed distal to all of the plurality of electrodes.

7. The electrical stimulation lead assembly of claim 1, further comprising a paddle body disposed along the distal end portion of the at least one lead body, wherein the plurality of electrodes are disposed on the paddle body.

8. The electrical stimulation lead assembly of claim 7, wherein the at least one sensor is disposed on the paddle body.

9. The electrical stimulation lead assembly of claim 1, further comprising a display for displaying the estimated at least one patient blood-flow condition.

10. An electrical stimulating system comprising:

the electrical stimulation lead assembly of claim 1;

a control module coupleable to the electrical stimulation lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector comprising

a connector housing defining a port configured and arranged for receiving the proximal end portion of the at least one lead body of the electrical stimulation lead assembly, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to at least one of the plurality of terminals of the at least one lead body when the proximal end portion of the lead body is received by the port.

11. The electrical stimulation system of claim 10, wherein the sensor processor is disposed in the control module.

12. The electrical stimulation system of claim 10, wherein the sensor processor is disposed external to the patient during operation of the CSF-pulsation detection assembly of the electrical stimulation lead assembly.

13. A method of using an electrical stimulation lead assembly, the method comprising:

providing the electrical stimulation system of claim 10;

advancing the electrical stimulation lead assembly of the electrical stimulation system into a patient such that the distal end portion of the at least one lead body of the electrical stimulation lead assembly is in proximity to a target stimulation location along the patient'"'"'s dura mater;

stimulating patient tissue by generating electrical stimulation signals in the control module of the electrical stimulation system, propagating the generated electrical stimulation signals to the plurality of electrodes of the electrical stimulation lead assembly, and emitting the electrical stimulation signals from the plurality of electrodes;

detecting pulses of cerebrospinal fluid within the patient'"'"'s subarachnoid space using the CSF-pulsation detection assembly of the electrical stimulation lead assembly of the electrical stimulation system;

transforming the detected pulses of cerebrospinal-fluid into sensor signals; and

estimating at least one patient blood-flow condition based on the sensor signals.

14. The method of claim 13, wherein estimating the at least one patient blood-flow condition based on the sensor signals comprises estimating at least one of patient heart rate, patient arterial blood flow, or patient venous blood flow.

15. The method of claim 13, wherein estimating at least one patient blood-flow condition comprises

receiving, by the sensor processor of the CSF-pulsation detection assembly, the sensor signals from the at least one sensor of the CSF-pulsation detection assembly;

processing the received sensor signals to generate the CSF-pulsation data; and

estimating the at least one patient blood-flow condition based on the CSF-pulsation data.

16. The method of claim 15, further comprising adjusting the electrical stimulation signals generated in the control module based on the at least one estimated patient blood-flow condition.

17. A non-transitory computer-readable medium having processor-executable instructions for reading data from at least one sensor disposed along a distal end portion of an electrical stimulation lead assembly of an electrical stimulation system, the processor-executable instructions when installed onto a device enable the device to perform actions, comprising:

receiving a sensor signal from the at least one sensor;

processing the received sensor signal to generate cerebrospinal-fluid pulsation data (“

CSF-pulsation data”

) comprising at least one of amplitude, duration, or rate of cerebrospinal-fluid pulses; and

estimating at least one patient blood-flow condition based on the CSF-pulsation data.

18. The computer-readable medium of claim 17, further comprising adjusting electrical stimulation signals generated and emitted by the electrical stimulation system based on the at least one estimated at least one patient blood-flow condition.

19. A lead-based stimulator comprising:

at least one stimulator and at least one sensor disposed along an electrical stimulation lead insertable into a patient, the at least one stimulator configured and arranged for stimulating patient tissue, the at least one stimulator configured and arranged for detecting cerebrospinal-fluid-pulsation, the at least one stimulator and the at least one sensor each coupled to a control module; and

a processor in communication with the control module, the processor for executing processor-readable instructions that enable actions, including;

receiving a sensor signal from the at least one sensor,

processing the received sensor signal to generate cerebrospinal-fluid pulsation data (“

CSF-pulsation data”

) comprising at least one of amplitude, duration, or rate of cerebrospinal-fluid pulses, and

estimating at least one patient blood-flow condition based on the CSF-pulsation data.

20. The lead-based stimulator of claim 19, further comprising adjusting electrical stimulation signals generated and emitted by the stimulator based on the at least one estimated at least one patient blood-flow condition.