The inventions described below relate to devices and methods that provide treatment for various diseases in the field of wireless deep brain stimulation.
Deep brain stimulation (DBS) technology has shown promise for treatment of movement and affective disorders such as Parkinson's disease, epilepsy, essential tremor and dystonia. Deep brain stimulation is accomplished by placing a neurostimulation lead connected to a pulse generator within the brain, near or contacting the brain structures that control motor functions, such as the subthalamic nucleus (STN). Typical treatment protocols use cylindrical probes with electrode assemblies disposed on the distal tip of the probes. The electrode assembles include circumferential electrodes or a number of electrodes arranged around the circumference of cylindrical probe, and provide omnidirectional or limited directional stimulation due to the cylindrical shape of the electrode of brain tissue proximate the tip of a probe. The electrodes on the tip of the probe may be placed in various locations within the brain, and may be operated to stimulate various parts of the brain. Because the circumferential electrodes or electrode arrays of the prior art provide omnidirectional or partial omnidirectional stimulation, they may stimulate structures in the brain to uncertain or undesired effect while stimulating desired structures to achieve a desired effect. For example, common side effects during lateral stimulation in STN-DBS include focal muscle contraction and dysarthria as a result of corticobulbar tract activation. There is a need for an electrode assembly that can stimulate desired areas but also simultaneously avoid stimulation of other non-targeted areas within the brain.
Additionally, cylindrical electrode assemblies are hard to place within the brain. The cylindrical electrode assemblies are prone to rotation or spinning and it can also be difficult to determine which parts of the electrode assemblies are live when placed within the brain. Also, the cylindrical electrodes can migrate back and forth within the brain once implanted instead of remaining securely positioned within the brain. Typically these devices require implantation of a battery pack and control pack within the patient's chest with subcutaneous wires threaded up through the neck to the top of the skull and ultimately to the implanted probes. The wires are a common source of irritation and infection. Also, some leads have multiple wires in the probes, making them bulky, stiff and prone to breakage. In addition, the probes are susceptible to limited battery life and electrical interference. The wireless DBS device described below eliminates wires and simplifies installation, reduces or entirely eliminates battery replacement and is operated and maintained easier than prior art DBS devices. Thus, there is a need for an electrode assembly that allows accurate electrode assembly placement within the brain. Also, there is a need for an electrode assembly that provides for better visualization, works easier under MRI, and is placed and oriented easier than previous electrode assemblies.
The devices and methods described below provide for improved deep brain stimulation treatment using an electrode assembly that allows for wireless stimulation of areas of the brain. The wireless DBS device is inserted within the brain while the DBS power transmitter assembly is disposed outside of the patient. The DBS power transmitter is operable outside of the patient's body to deliver power and control signals in order to provide power to the wireless DBS device inside the brain. The wireless DBS device has a housing that contains at least one electrode pair that protrudes from a surface of the housing. The wireless DBS device further includes stimulation electronics, optional sensing electronics, a microprocessor, a power converter and an antenna, all contained within the housing. The antenna is preferably disposed entirely within the housing while the electrode pair preferably protrudes from the housing. The DBS transmitter assembly may contain a power source or battery and an external power-transmitting antenna.
A method of performing deep brain stimulation in a patient's brain is also disclosed. The method is performed by inserting an implantable deep brain-stimulating device through the brain. The device is inserted into the patient brain so that the antenna is disposed entirely within the patient brain and does not extend beyond the brain of the patient. Then, a transceiver located outside of the patient is operated to induce a stimulus on the implantable deep brain-stimulating device to produce a brain stimulating current that stimulates the patient brain. Alternatively, the external transceiver can be used to set stimulation values in the device for parameters such as pulse time, frequency and power levels.
The transceiver assembly 7 is located external to the patient, providing the advantage that no surgery is required to replace the transceiver battery. Instead, the external transceiver can be recharged and it can be replaced like a hat, allowing the patient to swap a depleted or broken transceiver with a charged unit. In addition, the external transceiver does not need to be implanted within the patient and provides the additional benefit of no risk of infection or complications based on implantation of the transceiver.
In use, a surgeon will implant the DBS device within the brain of a patient so that the electrode pair contacts the patient brain, in a region subject to stimulation to affect symptoms of a disease such as Parkinson's disease.
The surgeon will implant the device with the antenna 13 disposed entirely within the brain. Preferably, the device will be provided in a form in which the antenna 13 is disposed entirely within the housing of the DBS device. The surgeon will implant the device, in either case, such that the antenna 13 remains entirely with brain tissue, and does to penetrate the dura or the skull of the patient. After the DBS device is implanted, surgeon, the patient, or a later care-giver, will operate the external DBS transmitter assembly, disposed proximate the external surface of the skull as necessary, to provide power to the DBS device and transmit control signals to the DBS device, as desired to affect symptoms of a disease subject to treatment by the DBS device. The patient may wear a transceiver that is configured in the form of a loop antenna that may be shaped as a piece of wearable headwear (a hat or headband). The transceiver is programmed and operated outside of the patient's body to cause the DBS device to deliver a prescribed dosage of electrical impulses to treat a variety of conditions and diseases. Alternatively, the external transceiver can be used to set stimulation values in the device for parameters such as pulse time, frequency and power levels. When stimulation is desired, the transceiver electronics generate and send a signal via the internal antenna through the microprocessor and to the stimulation electronics within the housing to produce a brain-stimulation to the patient brain.
Two or more DBS devices may be implanted in the same patient, and operated independently by the control system and transmitter electronic/transceiver electronic 16 by applying unique address numbers to each of the plurality of DBS devices, and operating the control system and transmitter electronics to broadcast unique address(es) of individual and broadcast control signals along with power signals, to cause an individual DBS device to generate stimulation pulses and deliver stimulation pulses to the brain through the electrode pair.
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.
This application claims priority to U.S. Provisional Application 63/018,224 filed Apr. 30, 2020.
Number | Date | Country | |
---|---|---|---|
63018224 | Apr 2020 | US |