Patent Application
20230364422
The inventions described below relate to devices and methods that provide treatment of movement disorders.
Deep brain stimulation (DBS) technology has shown promise for treatment of movement and effective disorders such as Parkinson's disease, epilepsy, essential tremor and dystonia. Typical protocols use multiple sensor probes and stimulation probes attached to wiring that is connected to an implantable pulse generator. The sensor probes are implanted in the brain, and the pulse generator is implanted under the skin of the chest or abdomen, and the two are connected by an insulated wire that runs below the skin, from the head, down the side of the neck, behind the ear, to the pulse generator. Thus, the current method entails surgical implantation of wires and components under the skin of the patient, in addition to the surgical implantation of probes and leads in the brain of the patient.
The devices and methods described below provide for improved treatment of movement disorders using sensor probes and stimulation probes operated by an external control system. The system includes a control system, a power source, and power coupling that can be placed on the scalp of a patient, an intracranial electrode, surface patch electrode which can be placed superficially on, or subcutaneously under, the scalp of a patient, a second, subcutaneous electrode configured for placement under the scalp of the patient, an implantable probe with an electrode array or other stimulation mechanism configured for implantation in the brain, and an electrical wire connecting the second electrode and the implant, operable as a conductor for delivery of power to the implant and delivery of sensor signals from the implant. The system includes a control system operable to deliver power to the implant through a circuit comprising the power coupling, the intracranial electrode, brain tissue of the patient to the probe (with no wired connection between the intracranial electrode and the probe), a wired connection to the subcutaneous electrode and through the subcutaneous scalp tissue to the patch electrode and hence to the power coupling. The system may be optionally operable to receive sensor signals from the implant, through the same circuit pathway, and provide bi-directional communications between the control system and the implantable probe through the inductive coupling. The system is operable to deliver therapeutic and/or diagnostic stimulation to the brain, and also to obtain diagnostic information from the brain.
The probes 3 of
To establish a power circuit from a power source to the probes, and/or communicate sensor data from the probes to a control system, in conjunction with the electrodes 8, the patch electrode 10 is disposed on the scalp, supracutaneously on the scalp, or subcutaneously under the scalp. The patch electrode is, preferably, located such that it is not in direct physical contact with the electrodes 8, and is spaced from the electrodes 8. The patch electrode 10 is connected to the secondary (remote) coupling component 11S of a coupling assembly 11, and the primary (base) coupling component 11P is connected to the power supply and control system 12. Preferably, the coupling assembly is an inductive coupling assembly, comprising a pair of coils. The secondary (remote) coupling component 11S may, like the patch electrode, also be installed on the scalp, supra-cutaneously, or subcutaneously under the scalp. The primary (base) coupling component 11P may be placed in proximity to the secondary coupling using a magnetic attachment or other releasable attachment means (secured to a headband, glued to the overlying skin) or non-releasable means (stitched to the scalp, nailed or screwed to the skull, or other means not considered “releasable attachment means and require tools for removal). An insulated conductor 13 extends from the secondary (remote) coupling component 11S, through a burr-hole and into the brain (including the dura and the cortex), and may be an insulated wire and include an electrode 14 at its distal end (a conductive wire, insulated or bare, will suffice). An additional conductor 15 connects the secondary (remote) coupling component 11S to the patch electrode 10. The control system is configured to provide power to the probes, for stimulation of brain tissue proximate the probes, and receive sensor data from the probe. The control system may operate as a DBS pulse generator, with or without further functionality. The control system 12 may be further programmed to analyze the sensor data and modify control signals to the probes to control the stimulation provided by the probes in response to the sensor data. The control system or console used to control the system and/or receive and store EEG data from the electrodes and provide bi-directional communications through the coupling, and provide stimulation pulses to the probed, may be implemented on a dedicated console such as the Kohden Neurofax EEG-1200 console (without all the wires), and EEG monitoring system, a DBS pulse generator such as a Vercise Genus™ implantable pulse generator, a general-purpose computer, or a mobile phone or tablet.
The probe electrodes and electronics may be operable to detect native biological brain signals (electrical activity of the brain), and generate electronic signals corresponding to native biological brain signals and transmit those electronic signals to the control system through the electrode 8 and patch electrode 10 and power coupling 11. The control system 12 is operable to receive electronic signals corresponding to native biological brain signals from the probes and, optionally, to interpret those signals. The control system may also store this data, or transmit it elsewhere for storage and review. For example, the control system may be configured, with appropriate programming, to analyze the electronic signals corresponding to native biological brain signals and determine whether the native biological brain signals are within a predetermined band of native biological brain signals, or above or below a predetermined threshold for the native biological brain signals, or characteristic of movement disorders. The control system is may also be operable to generate and transmit control signals to the probes, to cause the probes to transmit stimulation pulses to structures within the brain to effect therapeutic changes in native biological brain signals. The native biological brain signals of interest correspond to motor deficiencies, which may include Parkinson's Disease, epilepsy, essential tremors and/or dystonia. The native biological brain signals may also be signals such as abnormal hyperactivity in Broadmann's area that correspond to mood disorders such as depression. Stimulation can also be applied to areas of the dorsolateral prefrontal and lateral orbitofrontal cortex for associative diseases involved in cognition or memory, to the limbic and paralimbic cortex, hippocampus and amygdala for the treatment of limbic ailments such as OCD or for treatment of pain management, stroke rehabilitation and cognition impairment. Monitoring and stimulation can be in different locations of the brain, using some of the probes 3 in a sensing mode and using some of the probes 3 in a stimulation mode, and/or using some of the probes in both modes.
The circuit established by the patch electrode 10, sensor/stimulation 21 electrodes and subcutaneous electrodes 8 is completed by the body tissue disposed between the various components.
In use, the components of the system are installed in and on the patient, as described above. The control system may be operated to cause the probes to apply stimulation to structures in the brain proximate the probes. The stimulation may be a voltage applied through one or more of the electrodes 21. This voltage may be applied in bipolar mode (with a voltage differential between the electrodes) or monopolar mode (with a voltage differential applied between the patch electrode and the electrodes 21). The stimulation may be light emitted by the LED 23. The control system may also be operated to cause the probes to sense electrical signal of the brain, particularly electrical signals associated with motor or mood disorders, and transmit those signals to the control system. The control system may be operated to generate and display images corresponding to the sensed electrical signal, forward those signals to other computers for storage and analysis, or analyze those signals and determine, based on those signals, whether to apply stimulation through the probe to affect the brain.
The probes are implanted within the brain and positioned in multiple regions of the brain subject to stimulation to affect symptoms of a disease such as Parkinson's disease, epilepsy, essential tremor and dystonia. The sensor components of the probes are operated to generate electronic signals corresponding to the sensed biological signals of the patient's brain. The electronic signals are transmitted to the control system through the circuit illustrated in the Figures. To provide stimulation to the brain through stimulation components of the probes, the control system may be programmed and configured to interpret whether the measured signal is within a predetermined band of signal readings, or above or below a predetermined threshold for the signal readings. The control system may then also be operable to generate and transmit control signals to the probes, to cause the probes to transmit stimulation pulses to structures within the brain if the signal readings are determined to be outside of a predetermined range to effect therapeutic changes in native biological brain signals. The control system may thus be programmed and operable to cause the probes to deliver a prescribed dosage of stimulation impulses to treat a variety of conditions and diseases such as Parkinson's disease, epilepsy, essential tremor and dystonia.
Sensor probes 3 inserted on or within the brain 2 detect and/or record signals linked to symptoms exhibited within the brain. The sensor probes detect EEG, ECoG, AP, LFP or other detectable bio-signals. The sensor probes transmit the electronic signal corresponding to the sensed bio-signal to the receiver of the control system. The control system processes the electronic signal and is operable to transmit control signals to the stimulation probes to cause the stimulation probes to apply stimulation in response to variations in the sensed signals. Depending on the placement, the sensor probes are operable to sense signals from the thalamus, STN, cortex or other associated structures of the brain, which are indicative of the conditions treated (signals indicative of reduced or increased unwanted motor activity in the patient, for example). Adjustment in the stimulation provided by the stimulation probes can also be made through operator input to the control system, in response to sensed signals from the sensor probes, for example in response to data provided by the control system through an output such as a display screen or audio speakers. Adjustment in the stimulation provided by the stimulation probes may also be made by the control system, without immediate operator input, if the control system is programmed to determine stimulation levels or patterns appropriate to apply or adjust in response to sensed signals from the sense probes. This real-time optimization would allow neurons the chance to rest and thus reduce overall deterioration over time.
For the purposes of the claims, we coin the term peri-cutaneous, to refer to supra-cutaneous and subcutaneous place (that is, “near” the skin), and clarify that subcutaneous refers to its normally understood meaning of placement under the skin, but superficial to the skull, and supra-cutaneous refers to its normally understood meaning of placement on the exterior surface of the skin (superficial to the skin) but not excluding the possibility of an intervening impedance matching substance, adhesive, cream or ointment or hair.
While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. The elements of the various embodiments may be incorporated into each of the other species to obtain the benefits of those elements in combination with such other species, and the various beneficial features may be employed in embodiments alone or in combination with each other. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.
