Patent Description:
The treatment of chronic migraine has been limited to a number of procedures, pharmacological procedures or neuro-stimulation procedures. With respect to the neuro- stimulation procedures, devices have been developed for implanting in association with electrode leads, such that the electrodes are disposed proximate to some particular neural structure in an individual. These implanted devices can have batteries associated there with for powering the electrodes or they can be externally activated.

Any methods disclosed hereinafter do not form part of the scope of the invention, and are mentioned for illustrative purposes only. This document discusses, among other things, systems and methods to treat chronic headaches. The use of a single pules generator to target more than one neural target around the head reduces surgical incisions and shortens the time to perform the implant procedure.

In one example, a neurostimulator system may include an implantable pulse generator with a processor, a driving system for driving electrodes, and a communication circuit,. At least one neurostimulation lead is provided having a plurality of electrodes disposed thereon and arranged in an array on the surface thereof, and one neurostimulator and lead having a plurality of branches, each branch radiating outward with each branch having at least one array of electrodes disposed on the external surface thereof.

This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the disclosure. 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 following detailed description should be read with reference to the drawings. These drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

<FIG> illustrates an implanted neurostimulation system <NUM> including an implanted system <NUM>, an external telemetry system and charging system <NUM>, and a remote controller <NUM>. The implanted system <NUM> may generally include an implanted pulse generator (IPG) <NUM>, and implanted stimulation lead system <NUM>. The IPG <NUM> may include a header <NUM> for connection with the stimulation leads <NUM>, and a hermetically insulated housing for electronics and non-chargeable or rechargeable battery (not shown), which electronics may include a processor, a driving circuit for driving stimulation leaves and a communication circuit for communicating external to the IPG <NUM>, a communication circuit comprising, without limitation, a near field conductive communication system. The stimulation lead(s) <NUM> may include a lead body with proximal connector and distal branches with nerve stimulation electrodes.

<FIG> illustrates a stimulation lead system <NUM> configured to be subcutaneously implanted. By way of example and not limitation, the stimulation lead system may include six distal lead branches <NUM> - <NUM>, which are shown schematically and not to scale. The proximal connectors <NUM> may include individual connectors that provide electrical connection between stimulation output channels of the IPG <NUM> embedded in the header <NUM> to the stimulation electrodes <NUM> on lead branch <NUM>. Each distal lead branch may, for example, include two to three stimulation electrodes. The system may include, by way example and not limitation, <NUM> to18 individual proximal connectors to provide electrical connection to the electrodes.

<FIG> illustrates, by way of example and not limitation, the implanted system <NUM> of the IPG <NUM> and implanted stimulation lead system <NUM> subcutaneously implanted in a patient. In the illustrated embodiment, the stimulation lead system <NUM> with its distal lead branches <NUM> - <NUM> and their stimulation electrodes are subcutaneously disposed on six groups of pre-determined location of nerve branches (left and right occipital nerves, left and right temporal nerves, and left and right supraorbital nerves). The IPG <NUM> may be implanted in a subcutaneous pocket generally in the area superficial to the splenius capitis muscle or semispinalis capitis muscle near the upper cervical region.

An alternative location for the IPG <NUM> with lead system <NUM>, as shown in <FIG>, may be a subcutaneous pocket superficial to the sternocleidomastoid muscle inferior to the mastoid process. In the illustrated embodiments, the lead generally ascends along a midline of the head, providing symmetrical distribution to neural targets on the left and right side of the head.

<FIG> illustrates an alternative subcutaneously implanted neurostimulation system <NUM> including an implanted system <NUM>, an external telemetry system <NUM> and charging system <NUM>, and remote controller <NUM> is shown schematically. The implanted system <NUM> may generally include an implanted pulse generator (IPG) <NUM>, and stimulation electrodes <NUM> embedded in the housing of IPG <NUM>. The IPG <NUM>, insulated hermetically, contains electronics and non-chargeable or rechargeable battery and four to six stimulation electrodes <NUM> embedded in the housing.

<FIG> illustrates, by way of example and not limitation, four subcutaneously implanted neurostimulation systems <NUM> implanted in a patient. One implanted system <NUM> may be placed with its stimulation electrodes disposed superficial to the left and right supraorbital nerves. One implanted system <NUM> may be placed with its stimulation electrode disposed superficial to the left and right occipital nerves. One implanted system <NUM> may be placed with its stimulation electrode disposed superficial to the left temporal nerves. One implanted system <NUM> may be placed with its stimulation electrode disposed superficial to the right temporal nerves.

<FIG> illustrates an implanted stimulation lead system <NUM> including one lead body with three electrode sets or groups <NUM> - <NUM>, which is shown schematically and not to scale. The proximal connectors <NUM> may include of <NUM> to <NUM> individual connectors that provide electrical connection between stimulation output channels of the IPG <NUM> embedded in the header <NUM> to the stimulation electrodes <NUM> as a part of electrode group <NUM>, as illustrated at one of the electrode group and represent similar configuration for other electrode groups. Generally, each distal lead branch may include an electrode set, where the electrode set may include two to three stimulation electrodes. Each of the stimulation electrodes can function as either a cathode or anode and the IPG and be programmed to configure the electrodes as anodes, cathodes or nonfunctional electrodes, depending upon the application.

<FIG> illustrates, by way of example and not limitation, the implanted system <NUM> of the IPG <NUM> and implanted stimulation lead system <NUM> subcutaneously implanted in a patient. The stimulation lead system <NUM> may have two leads, each with at least one electrode set or group and illustrated with three electrode sets or groups <NUM> - <NUM>. The stimulation electrodes of each of the six electrode sets are disposed on six neural targets (e.g. nerve branches such as left and right occipital nerves, left and right temporal nerves, and left and right supraorbital nerves). The IPG <NUM> may be implanted in a subcutaneous pocket generally in the area superficial to the splenius capitis muscle or semispinalis capitis muscle near the upper cervical region.

An alternative location for the IPG <NUM> with lead system <NUM>, as shown in <FIG>, may be a subcutaneous pocket superficial to the sternocleidomastoid muscle inferior to the mastoid process.

With reference to the systems and devices depicted in <FIG>, an implanting surgeon may place the electrode sets (e.g. the distal leads <NUM> - <NUM> of the stimulation leads system <NUM>) near pre-determined nerve targets (e.g., left and right supraorbital, left and right temporal, and left and right occipital nerves) through subcutaneous tunneling after making one or multiple incisions. The implanting surgeon may then make a subcutaneous pocket either superficial to the sternocleidomastoid muscle or in a more medial location that is superficial to the semispinalis capitis muscle. The surgeon may then connect the stimulation lead <NUM> to the IPG <NUM> and place them in the subcutaneous pocket.

As indicated above, left-side nerve targets may include one or more of the following nerve targets: left supraorbital nerve, left temporal nerve, and left occipital nerve. Similarly, right-side nerve targets may include one or more of the following nerve targets: right supraorbital nerve, right temporal nerve, and right occipital nerve. One or more of these nerves may be targeted to provide a therapy to treat a headache such as a migraine headache. Other therapies may be delivered, and neuromodulation may be delivered to these or other neural target(s) as may be indicated to treat various conditions. A non-exclusive example of other neural target(s) includes combinations of one or more of a greater occipital nerve (GON), a supraorbital nerve (SON), and a sphenopalatine ganglion (SPG). Modulation of one or more of these neural targets may be useful to treat cluster headaches. Another non-exclusive example includes combinations of one or more of a supraorbital nerve (SON) and a facial nerve. Modulation of one or more of these neural targets may be useful to treat facial pain. The lead(s) are designed to extend from the implantable pulse generator to enable electrode sets to be positioned at these neural target(s).

With reference to an alternative system and devices depicted in <FIG>, the implanting surgeon may place the electrode sets (e.g. groups <NUM> - <NUM> of the stimulation leads system <NUM>) near pre-determined nerve targets (e.g., supraorbital, temporal, and occipital nerves) with two lead systems to cover both the left and right side of these nerves.

The patient with the implanted system <NUM> or a physician can adjust stimulation output parameters using the remote controller <NUM> through an external telemetry system <NUM>. The patient can recharge the implanted system with a rechargeable battery using the external charging system <NUM>.

The IPG <NUM> may contain hardware and firmware that deliver independent output to each stimulation electrode. The stimulation output parameters consist of amplitude, polarity, frequency, pulse width and duty cycle.

The remote controller <NUM> may be configured (e.g. via software, to provide a graphic user interface used to make adjustments of stimulation output parameters. The remote controller <NUM> also contains a stimulation algorithm from user input or through machine learning. The stimulation algorithm may include time dependent of individual setting (amplitude, polarity, frequency, pulse width and duty cycle) for each stimulation electrode.

With reference to the systems and devices depicted in <FIG>, the implanting surgeon may place implanted system <NUM> through an incision directly over pre-determined nerve targets (e.g., left and right supraorbital, left and right temporal, and left and right occipital nerves). The surgeon may fix the implanted system <NUM> on nearby fascia with the suture rings on the two ends of the IPG <NUM>.

The patient with the implanted system <NUM> or a physician can adjust stimulation output parameters using the remote controller <NUM> through an external telemetry system, and the patient may recharge the implanted system with a rechargeable battery using the external charging system. Both the eternal telemetry system and external charging system are illustrated by an external device identified using reference number <NUM>.

The IPG <NUM> may contain hardware and firmware that deliver independent output to each stimulation electrode. The stimulation output parameters may include amplitude, clarity, frequency, pulse width and duty cycle.

The remote controller <NUM> may contain software that provides a graphic user interface for making adjustments of stimulation output parameters. The remote controller <NUM> may contain a stimulation algorithm from user input or through machine learning. The stimulation algorithm may include time dependent of individual setting (amplitude, frequency, clarity, pulse width and duty cycle) for each stimulation electrode.

<FIG> depicts embodiments that incorporate the above concepts into a single body device with no header. The lead(s) may be permanently attached to the pulse generator, and the pulse generator and lead(s) together may form a unibody construction where lead body (bodies) is (are) integrally formed with the pulse generator. For example, a lead body may be integrally formed with a housing of the pulse generator.

A circuit or circuitry may be implemented as part of a microprocessor circuit, which may be a dedicated processor such as a digital signal processor, application specific integrated circuit (ASIC), microprocessor, or other type of processor for processing information including physical activity information. The microprocessor circuit may be a general purpose processor that may receive and execute a set of instructions of performing the functions, methods, or techniques described herein. The circuit or circuitry may be implemented as one or more other circuits or sub-circuits that may, alone or in combination, perform the functions, methods or techniques described herein. In an example, hardware of the circuit set may be immutably designed to carry out a specific operation (e.g., hardwired). In an example, the hardware of the circuit set may include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including a computer readable medium physically modified to encode instructions of the specific operation. Instructions may enable embedded hardware (e.g., the execution units or a loading mechanism) to create members of the circuit set in hardware via variable connections to carry out portions of the specific operation when in operation. Accordingly, the computer readable medium is communicatively coupled to the other components of the circuit set member when the device is operating. In an example, any of the physical components may be used in more than one member of more than one circuit set. For example, under operation, execution units may be used in a first circuit of a first circuit set at one point in time and reused by a second circuit in the first circuit set, or by a third circuit in a second circuit set at a different time.

The terms "tangible" and "non-transitory," as used herein, are intended to describe a machine-readable storage medium such as a computer-readable storage medium (or "memory") excluding propagating electromagnetic signals, but are not intended to otherwise limit the type of physical computer-readable storage device that is encompassed by the phrase computer-readable medium or memory. By way of example and not limitation, a machine may include a modulation device or a programming device such as a remote control or clinician programmer.

The term "machine readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) configured to store instructions, and includes any medium that is capable of storing, encoding, or carrying instructions for execution by the machine and that cause the machine to perform any one or more of the techniques of the present disclosure, or that is capable of storing, encoding or carrying data structures used by or associated with such instructions. Nonlimiting machine readable medium examples may include solid-state memories, and optical and magnetic media. In an example, a machine readable medium include: nonvolatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

Some examples may include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform methods as described in the above examples. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.

Various embodiments are illustrated in the figures above. One or more features from one or more of these embodiments may be combined to form other embodiments.

Claim 1:
A neurostimulator system (<NUM>; <NUM>), comprising:
one implantable pulse generator (<NUM>; <NUM>) comprising:
a processor;
a driving system for driving electrodes;
a communication circuit; and
an implantable device housing configured to contain the processor, the driving system and the communication circuit, and further configured to be subcutaneously implanted;
at least one implantable lead (<NUM>) is configured to extend from the subcutaneously-implanted one implantable pulse generator (<NUM>) to at least two neural targets, the at least two neural targets including at least one neural target on a left side of a head and at least one neural target on a right side of the head, the at least one implantable lead (<NUM>) including at least two electrode sets (<NUM>-<NUM>), each of the at least two electrode sets (<NUM>-<NUM>) including at least two electrodes, the at least one implantable lead (<NUM>) with the at least two electrode sets (<NUM>-<NUM>) being configured to:
be used to subcutaneously place the at least two electrode sets near the at least two neural targets, respectively; and
electrically connect the one implantable pulse generator to each of the at least two electrodes sets to enable the driving system to drive the at least two electrode sets to stimulate the at least two neural targets including the at least one neural target on the left side of the head and the at least one neural target on the right side of the head,
characterised in that
the one implantable pulse generator is configured to deliver independent stimulation output parameters to stimulation electrodes included in the at least two electrode sets, wherein each of the stimulation electrodes on the at least one lead is capable of functioning as either a cathode or anode and is configurable by the implantable pulse generator to be an anode, a cathode or non-functional.