Device and methods for delivery of stimulation to a body tissue
Inventors
Assignees
Publication Number
US-10688301-B2
Publication Date
2020-06-23
Expiration Date
2035-07-23
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Abstract
A system for delivering energy into a body tissue. A tissue puncturing device is adapted to puncture a tissue surface and generate micro-channels from the tissue surface into the body tissue. A stimulator is adapted to deliver energy to the body tissue over or adjacent to the micro-channels.
Core Innovation
The invention provides a system and method for delivering energy into a body tissue by first puncturing the tissue surface to generate micro-channels that extend from the surface into the underlying tissue. These micro-channels modify the tissue's electrical or optical properties such as resistance and capacitance, thereby facilitating deeper and more effective penetration of stimulation energy into the tissue.
The system comprises a tissue puncturing device that may use ultrasonic energy, laser light energy, heat energy, or electrical energy to create micro-channels, and a stimulator adapted to deliver types of stimulation energy including electrical stimulation, electrical nerve stimulation, or electromagnetic radiation through or adjacent to these micro-channels. A controller and processor monitor electrical or optical parameters of the tissue and control delivery of energy based on these parameters to optimize treatment.
The problem addressed is the limitation of existing transcutaneous electrical stimulation methods, where the skin's stratum corneum layer presents high resistance and capacitance that restrict penetration of electrical current to superficial nerves. Increasing the current often causes pain and irritation. Percutaneous methods require precise needle insertion and can cause pain and bleeding. The invention aims to overcome these issues by generating micro-channels that reduce tissue impedance, enabling deeper stimulation with reduced pain and improved efficacy.
Claims Coverage
The claims include one independent system claim and one independent method claim, each outlining main inventive features involving tissue puncturing and delivery of stimulation energy.
System comprising a tissue puncturing device and a stimulator operating separately
A system that includes a tissue puncturing device adapted to puncture the tissue surface at a selected site to generate open micro-channels from the tissue surface into the selected body tissue, and a stimulator comprising surface electrodes as the sole source of penetrating electrical energy positioned in contact with the tissue surface over at least one open micro-channel to deliver electrical energy when the puncturing device is not active.
Processor configured to monitor electrical or optical properties during stimulation
Inclusion of a processor connected to the stimulator that monitors one or more electrical or optical properties of the body tissue during the delivery of electrical energy through the micro-channels.
Tissue puncturing device with micro-needles and their configurations
The tissue puncturing device comprises at least one micro-needle or one or more matrices of micro-needles composed of conductive, semi-conductive, or ultrasonic conductive material. Some micro-needles may have electrically isolated shafts to allow current only from the tips. Micro-needles and electrodes can be contained in a single applicator arranged to allow electrodes to contact the body surface over micro-channels.
Micro-channel generation methods
The puncturing device generates micro-channels using one or more of ultrasonic energy, laser light energy, heat energy, and electrical energy.
Electrode types and patch with flap design
Surface electrodes include wet surface, glue based, hydrogel, cotton, or minimally invasive electrodes. At least one electrode can be incorporated into a patch having an aperture covered by a flap that can be opened to expose tissue for puncturing and stimulation.
Processor-controlled stimulator activation and remote control
The processor activates the stimulator when monitored parameters reach a predetermined adaptive or dynamic range. The system may include a remote control for operating the puncturing device and stimulator.
Ablation of tissue in micro-channels and maintenance of open micro-channels via electrical current
The tissue puncturing device is configured to ablate tissue in at least one micro-channel, and the stimulator applies electrical current to maintain the micro-channels open.
Simultaneous or sequential stimulation and housing configurations
The stimulator is adapted to stimulate two or more tissue areas simultaneously or sequentially. The puncturing device and stimulator may be contained in a single common housing.
Stimulation delivery via multiple electrodes and electrode pair energizing
The stimulator delivers electrical stimulation, current, or nerve stimulation via three or more electrodes, with the processor energizing different pairs of electrodes during stimulation. Electrodes may be arranged in a patch adapted to adhere to a body surface.
Method for delivering penetrating electrical energy via open micro-channels
A method involving applying a tissue puncturing device to form open micro-channels at a selected site, removing the device while leaving the micro-channels open, and placing at least one surface electrode on at least one micro-channel to deliver penetrating electrical energy exclusively through these micro-channels to the selected tissue.
The inventive features collectively define a system and method employing a tissue puncturing device to create micro-channels in body tissue, and a stimulator with surface electrodes positioned over these micro-channels to deliver penetrating electrical energy exclusively via the micro-channels. A processor monitors tissue properties to control stimulation, with features including micro-needle configurations, methods of micro-channel generation, specialized electrodes, and maintenance of open channels for effective stimulation.
Stated Advantages
Reduced current and/or voltage or light intensity required to achieve desired stimulation effect due to reduced tissue resistance and capacitance after forming micro-channels.
Reduced pain and irritation during stimulation by enabling penetration to deeper tissue layers.
Improved penetration of stimulation energy into deeper layers of the tissue.
Ability to monitor and adapt stimulation based on real-time electrical or optical tissue parameters.
Maintenance of micro-channels open during stimulation to prolong treatment efficacy and prevent sealing.
Documented Applications
Esthetic treatments such as facial skin treatments including cellulite reduction and skin elasticity improvement.
Pain relief treatments for back pain, carpal tunnel syndrome, shoulder pain, neuropathic pain, diabetic neuropathy, and chronic and intractable pain syndromes.
Peripheral nerve stimulation for conditions including movement disorders, muscle tone improvement, urinary and fecal incontinence, stroke rehabilitation, and restoration of motor functions after spinal cord or brain lesions.
Stimulation of vagus nerve and other nerves for treatment of neurological and psychiatric disorders including epilepsy, depression, Alzheimer's, anxiety, obesity, tinnitus, obsessive compulsive disorder, heart failure, and a range of other chronic diseases and conditions.
Treatment of cancer such as prostate cancer through nerve stimulation.
Control of the immune system and reduction of systemic inflammation via nerve stimulation, particularly vagus nerve stimulation.
Treatment of sleep disorders such as obstructive sleep apnea and snoring by stimulation of hypoglossal nerve to move tongue forward.
Stimulation for wound healing and sports medicine including muscle training, strength and stamina improvement, and muscle relaxation.
Hair growth stimulation by applying micro-channels and stimulation to the scalp.
Treatment of male impotence via stimulation of nerves controlling erection and enhancement of blood flow.
Treatment of neurological disorders affecting facial nerves such as Bell's Palsy.
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