TECHNICAL FIELD

The present disclosure relates generally to medical devices, and more particularly, to neuromodulation systems, devices, and methods.

BACKGROUND

Neural modulation has been proposed as a therapy for a number of conditions. Often, neural modulation and neural stimulation may be used interchangeably to describe excitatory stimulation that causes action potentials as well as inhibitory and other effects. Examples of neuromodulation include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES). SCS, by way of example and not limitation, has been used to treat chronic pain syndromes. Some neural targets may be complex structures with different types of nerve fibers within a complex three dimensional environment.

SUMMARY

This Summary includes examples that provide an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects of the disclosure will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present disclosure is defined by the appended claims and their legal equivalents.

An example (e.g. Example 1) of subject matter (e.g. a system) may be configured for use with a neuromodulation device connected to at least one neuromodulation lead. The neuromodulation device may be configured to deliver neuromodulation energy to spinal cord tissue in a patient using the at least one neuromodulation lead. The subject matter may include at least one sensor configured to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data, at least one processor configured to calibrate at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from the at least one sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the second neurophysiological response; and determine based on the first and second neurophysiological responses at least one of: physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline; or electrode-tissue coupling information indicative of a distance between the at least first electrode contact to the spinal cord tissue and a distance between the at least second electrode contact to the spinal cord tissue.

In Example 2, the subject matter of Example 1 may optionally be configured such that the at least one processor is further configured to program the neuromodulation device using at least one of the physiological midline information or the electrode-tissue coupling information.

In Example 3, the subject matter of any one or any combination of Examples 1-2 may optionally be configured such that the at least one processor is further configured to communicate the physiological midline information to a user interface to display a position of the at least one lead along with a representation of the physiological midline.

In Example 4, the subject matter of any one or any combination of Examples 1-3 may optionally be configured such that the at least one processor is further configured to communicate the physiological midline information and the electrode-tissue coupling information to a programming algorithm that is configured use the physiological midline information and the electrode-tissue coupling information to determine fractionalized energy contribution of active electrodes on the at least one lead to create a stimulation field for a three-dimensional environment. The determined fractionalized energy contribution may include a polarity for each of the active electrodes and a percentage of the energy contribution at the polarity for each of the active electrodes.

In Example 5, the subject matter of any one or any combination of Examples 1-4 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense electromyograms (EMGs) to provide bilateral sensing data.

In Example 6, the subject matter of any one or any combination of Examples 1-5 may optionally be configured such that the at least one sensor includes a plurality of EMG patches bilaterally positioned on the patient.

In Example 7, the subject matter of any one or any combination of Examples 1-6 may optionally be configured such that the at least one sensor includes: at least one sensor configured to bilaterally sense evoked compound action potentials (ECAPs) from the patient when the neural modulation energy is being delivered to provide bilateral sensing data; or at least one sensor configured to bilaterally sense electroencephalograms (EEGs) from the patient when the neural modulation energy is being delivered to provide bilateral sensing data.

In Example 8, the subject matter of any one or any combination of Examples 1-4 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense physiological signals indicative of changes in muscle tissue when the neural modulation energy is being delivered to provide bilateral sensing data.

In Example 9, the subject matter of any one or any combination of Examples 1-8 may optionally be configured such that the delivered neuromodulation energy includes monopolar neuromodulation energy.

In Example 10, the subject matter of any one or any combination of Examples 1-9 may optionally be configured such that the at least one processor is configured to calibrate a plurality of electrode contacts on the neuromodulation lead where the plurality of electrode contacts include the first and second electrode contacts. The at least one processor may be configured to determine physiological midline information and electrode-tissue coupling information for each of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses such that each of the plurality of electrode contacts is associated with at least one of the neurophysiological responses.

In Example 11, the subject matter of any one or any combination of Examples 1-9 may optionally be configured such that the at least one processor is configured to calibrate less than all of a plurality of electrode contacts on the neuromodulation lead by determining physiological midline information and electrode-tissue coupling information for a first subset of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses, each of the first subset of the plurality of electrode contacts being associated with at least one of the plurality of neurophysiological responses, and each of a second subset of the plurality of electrode contacts being not associated with at least one of the neurophysiological responses. The at least one processor may be configured to estimate at least one of the physiological midline information or the electrode-tissue coupling information for the second subset of the plurality of electrode contacts based on the determined physiological midline information and the electrode-tissue coupling information for the first subset of the plurality of electrode contacts.

In Example 12, the subject matter of any one or any combination of Examples 1-11 may optionally be configured such that the at least one processor is configured to calibrate the at least a first electrode contact and the second electrode contact on the least one neuromodulation lead by instructing the neuromodulation device to deliver neuromodulation energy using at least a first neuromodulation parameter set and a second neuromodulation parameter set; a neuromodulation parameter has a first value in the first neuromodulation parameter set and a second value in the second neuromodulation parameters set; and the at least on processor is configured to determine physiological midline information and electrode-tissue coupling information for the at least the first and second neuromodulation parameter sets.

In Example 13, the subject matter of Example 12 may optionally be configured such that the at least one neuromodulation parameter includes pulse width such that the first and second neuromodulation parameter sets have different pulse widths.

In Example 14, the subject matter of Example 12 may optionally be configured such that the at least one processor is configured to interpolate at least one of the physiological midline information or the electrode-tissue coupling information for a neuromodulation parameter value based on at least the first value and the second value.

An example (e.g. Example 15) of subject matter (e.g. a method, a means for performing acts, or a machine-readable medium including instructions that, when performed by the machine, cause the machine to perform acts), may calibrate at least a first electrode contact and a second electrode contact on at least one neuromodulation lead, including: instruct a neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from at least one sensor first sensed data corresponding to the first neurophysiological response and second sensed data corresponding to the sensed neurophysiological response; determine first neurophysiological response data based on the received first sensed data and determine second neurophysiological response data based on the received second sensed data; and determine based on the first and second neurophysiological response data physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline.

An example (e.g. Example 16) of subject matter (e.g. a method, a means for performing acts, or a machine-readable medium including instructions that, when performed by the machine, cause the machine to perform acts), may be performed using a neuromodulation device connected to at least one neuromodulation lead and configured to deliver neuromodulation energy to spinal cord tissue in a patient using the at least one neuromodulation lead, at least one processor, and at least one sensor configured to bilaterally sense neurophysiological signals from a patient to provide bilateral sensing data. The subject matter may include calibrating at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including using the at least one processor to: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from the at least one sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the sensed neurophysiological response; determine first neurophysiological response data based on the received first bilateral sensed data and determine second neurophysiological response data based on the received second bilateral sensed data; and determine based on the first and second neurophysiological response data both: physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline; and electrode-tissue coupling information indicative of a distance between the at least first electrode contact to the spinal cord tissue and a distance between the at least second electrode contact to the spinal cord tissue.

In Example 17, the subject matter of Example 16 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense electromyograms (EMGs).

In Example 18, the subject matter of Example 17 may optionally be configured such that the at least one sensor includes a plurality of EMG patches bilaterally positioned on the patient.

In Example 19, the subject matter of any one or any combination of Examples 16-18 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense evoked compound action potentials (ECAPs).

In Example 20, the subject matter of Example 19 may optionally be configured such that the at least one sensor includes an electrode contact on the neurostimulation lead other than an electrode contact being used to concurrently deliver neural modulation energy.

In Example 21, the subject matter of any one or any combination of Examples 16-20 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense electroencephalograms (EEGs).

In Example 22, the subject matter of Example 16 may optionally be configured such that the at least one sensor includes at least one sensor configured to bilaterally sense physiological signals indicative of changes in muscle tissue when the neural modulation energy is being delivered to provide bilateral sensing data.

In Example 23, the subject matter of any one or any combination of Examples 16-22 may optionally be configured such that the at least one processor is used to program the neuromodulator device using the physiological midline information and the electrode-tissue coupling information.

In Example 24, the subject matter of any one or any combination of Examples 16-23 may optionally be configured such that at least one processor is used to communicate the physiological midline information to a user interface to display a position of the at least one lead along with a representation of the physiological midline.

In Example 25, the subject matter of any one or any combination of Examples 16-24 may optionally be configured such that the at least one processor is used to communicate the physiological midline information and the electrode-tissue coupling information to a programming algorithm that is configured use the physiological midline information and the electrode-tissue coupling information to determine fractionalized energy contribution of active electrodes on the at least one lead to create a stimulation field for a three-dimensional environment. The determined fractionalized energy contribution may include a polarity for each of the active electrodes and a percentage of the energy contribution at the polarity for each of the active electrodes.

In Example 26, the subject matter of any one or any combination of Examples 16-25 may optionally be configured such that calibrating at least the first electrode contact and the second electrode contact on the least one neuromodulation lead includes calibrating a plurality of electrode contacts on the neuromodulation lead. The at least one processor may be used to determine physiological midline information and electrode-tissue coupling information for each of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses such that each of the plurality of electrode contacts is associated with at least one of the neurophysiological responses.

In Example 27, the subject matter of any one or any combination of Examples 16-25 may optionally be configured such that calibrating at least the first electrode contact and the second electrode contact on the at least one neuromodulation lead may include calibrating less than all of a plurality of contacts on the at least one neuromodulation lead. The at least one processor may be used to determine physiological midline information and electrode-tissue coupling information for a first subset of the plurality of electrode contacts by instructing the neuromodulation device to step through a routine to deliver neuromodulation energy to cause a plurality of neurophysiological responses. Each of the first subset of the plurality of electrode contacts may be associated with at least one of the plurality of neurophysiological responses, and each of a second subset of the plurality of electrode contacts being not associated with at least one of the neurophysiological responses. The at least one processor may be used to estimate at least one of the physiological midline information or the electrode-tissue coupling information for the second subset of the plurality of electrode contacts based on the determined physiological midline information and the electrode-tissue coupling information for the first subset of the plurality of electrode contacts.

Example 28, the subject matter of any one or any combination of Examples 16-27 may optionally be configured such that calibrating the at least a first electrode contact and the second electrode contact on the least one neuromodulation lead includes instructing the neuromodulation device to deliver neuromodulation energy using at least a first neuromodulation parameter set and a second neuromodulation parameter set; a neuromodulation parameter has a first value in the first neuromodulation parameter set and a second value in the second neuromodulation parameters set; and using the at least one processor to determine physiological midline information and electrode-tissue coupling information for the at least the first and second neuromodulation parameter sets.

In Example 29, the subject matter of Example 28 may optionally be configured such that the at least one processor is used to interpolate at least one of the physiological midline information or the electrode-tissue coupling information for a neuromodulation parameter value based on at least the first value and the second value.

An example (e.g. Example 30) of subject matter (e.g. a system) may be configured for use with a neuromodulation device connected to at least one neuromodulation lead where the neuromodulation device is configured to deliver neuromodulation energy to spinal cord tissue in a patient using the at least one neuromodulation lead. The system may include at least one sensor configured to sense neurophysiological signals from the patient to provide sensing data; and at least one processor configured to calibrate at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and using at least the second electrode contact of the lead to cause a second neurophysiological response; receive from the at least one sensor first sensed data corresponding to the first neurophysiological response and second sensed data corresponding to the second neurophysiological response; and determine based on the first and second neurophysiological responses physiological midline information indicative of a medial-lateral position of the at least first electrode contact to the physiological midline and the at least second electrode contact to the physiological midline.

In Example 31, the subject matter of Example 30 may optionally be configured such that the at least one sensor may be configured to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data. By way of example and not limitation, the at least one sensor may include at least one sensor laterally positioned on the left side the midline and at least one sensor laterally positioned on the right side of the midline to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data.

