The patent portfolio is assigned to our sister company, Innovations Holdings, L.L.C. It includes 11 issued patents and 3 pending patent applications, which can be divided into 6 patent families:
1. Multi-functional electrical stimulation systems and electronic components
2. Method and apparatus for configurable systems
3. Electrochemical treatment of tissues, especially tumors
4. Treatment of living tissues/Modulation of myosin phosphorylation using electromagnetic fields
5. Electronic delivery systems and methods with feedback
6. Method and apparatus for diagnosis and treatment
In most cases additional continuation applications or continuation-in-part (CIP) applications are possible, as indicated in each family description.
Patent Family 1: Multi-functional electrical stimulation systems and electronic components
The stimulator patent family includes two patents: US Patent No. 6,029,090 entitled “Multi-Functional Electrical Stimulation System” and US Patent No. 6,684,106 entitled “Method and Electronic Components for Multi-Functional Electrical Stimulation System”. A currently pending patent application that includes the stimulator subject matter is entitled “High Precision Multi-Output Pulse and/or Signal Generators”. The stimulator patent family encompasses at least two technology areas: medical technologies and semiconductors. Continuation/CIP application is possible.
The patents cover a multifunctional electrical stimulation system designed for variety of applications, with multiple adjustable, synchronous pulse/signal generators. The signal from the selected generator/s is fed to at least one output stage, where it is processed to produce a high or low voltage or current output of a desired polarity. The output stage is capable of yielding an electrical stimulation signal that is appropriate for its intended application.
The system can incorporate inputs from various sensors and a feedback mechanism for adjusting the output signal depending on one or more simultaneous sensor inputs. The sensors in the system can be physical, chemical, or biochemical/biosensors. The sensors can sense, e.g., current, voltage, magnetic field, impedance, temperature, pH, gas (O2, CO2, etc.), as well as various biochemical substances involved locally in, or resulting from the procedure at the site where the signal is administered, or at another site.
A flexible and customizable electrical stimulation system can support multiple application areas, including pain management, treatment of motor disorders, gastrointestinal modulation (e.g., for treatment of obesity), treatment of neuropsychiatric and neurodegenerative diseases, cardiac rhythm management, nerve regeneration, bone healing, wound healing, etc. For example, in the area of neurostimulation/neuromodulation, by measuring changes in a neurotransmitter, a closed-loop system can be provided that can continuously adjust the signal to achieve a desired result. Other applications for signals generated by the system are: electroporation, electrophoresis, application requiring mechanical or acoustic waves by applying signal to appropriate transducer, etc.
The pending patent application is a CIP of the US Patent No. 6,684,106 and adds the EH2000 series of pulse generators, digital electronic components which can be programmed or preset to deliver several simultaneous and synchronous timing parameters. Those electronic components can be used in multiple applications, in addition to electrical stimulation, including: programmable pulse generators, automatic test equipment, biomedical instrumentation, control systems, etc.
Patent Family 2: Method and apparatus for configurable systems
The configurable systems patent family includes 3 patents: US Patent No. 7,937,683; US Patent No. 8,365,122; and US Patent No. 8,595,672 - all titled “Method and Apparatus for Configurable Systems”. It encompasses following technology areas: semiconductors; medical technologies; instrumentation; and software. A continuation application of US Patent No. 8,595,672 has been filed.
The patented technology relates to methods and devices to define and control the design and/or function of a configurable chip module, instrument or system. The resulting products can be designed as a system on a chip (SoC) or as stand-alone, handheld, user-wearable, or implantable devices with functionality defined through a Graphical User Interface (GUI) or other methodology. This transformation process is transparent to the user, who operates the GUI only, and defines the measurement or action to be performed; which, in turn, results in an automatic combination of hardware and/or software elements available to create a specific configuration.
The system can include a user transparent configuration mechanism that automatically configures the connection elements of the configurable chip module system or device in response to receiving selections entered on a user interface, where the user interface allows a user to input commands to modify the structure of the chip module system or function of the device by desired function rather than by assembling individual components of such system or device.
Based on this technology, a Biosensor-Feedback PlatformTM for biomedical applications has been designed and implemented in a stand-alone device prototype. Patent No. 8,595,672 shows 23 graphical user interface screens for the device.
Patent Family 3: Electrochemical treatment of tissues, especially tumors
The patent family for electrochemical treatment of tissues includes 3 patents: US Patent No. 6,021,347 entitled “Electrochemical Treatment of Malignant Tumors”; and US Patent No. 6,708,066 and US Patent No. 7,526,334 both titled “Electrochemical Treatment of Tissues, Especially Tumors”. Continuation/CIP application is possible.
The issued patents describe electrochemical techniques and devices to treat in situ a tissue, and specifically a malignant tumor, in order to destroy it with a minimal damage to the healthy tissues. The devices use at least one working electrode and one counter electrode placed in the vicinity of the tissue being treated and a control unit which regulates the applied voltage. The resulting electrochemical reactions yield various reaction products, at least one of which is a cytotoxic agent destructive of the particular tissues desired to be eliminated. The feedback mechanism optimizes the yield of those reaction products which act as cytotoxic agents. By an appropriate choice of signal parameters, the process can result in apoptosis (programmed cell death) rather than in tissue necrosis.
For a combined electrochemical and chemotherapy approach, hollow electrodes with multiple ports connected to a chemotherapy source can be used for in situ delivery of drugs or medication. Similar electrodes with internal fiber optics coupled to a light source can be used for photochemically activated drugs. Several other approaches, utilizing properties of the material of the electrodes to create cytotoxic agents, are also claimed.
Patent Family 4: Treatment of living tissues/Modulation of myosin phosphorylation using electromagnetic fields
The EMF patent family includes 2 patents: US Patent No. 7,160,241, entitled “Treatment of Living Tissues Using Electromagnetic Fields” and US Patent No. 7,517,311, entitled “Modulation of Myosin Phosphorylation Using Electromagnetic Fields,” which relate to apparatuses and methods for diagnosing and/or treating tissues/cells using electromagnetic fields, and for determining therapeutically useful electromagnetic fields, and harmful electromagnetic fields.
Patent Family 5: Electronic delivery systems and methods with feedback
US Patent Application No. 12/098,257, entitled “Electronic Delivery Systems and Methods with Feedback” and published as U.S. Patent Pub. No. US 2011/0230857 has been abandoned and included in co-pending US Patent Application No. 13/475,833 in Patent Family 6, now US Patent No. 9,199,076. It is possible to extract the subject matter and file a continuation or CIP application.
In accordance with some embodiments of the present invention, delivery systems and methods for delivering a substance in a medium is provided. The delivery system may include a delivery component, an electronic controller, one or more sensors, and a feedback mechanism. The delivery component has at least one reservoir that contains a substance (e.g., a liquid, a drug, etc.). The electronic controller is connected to the delivery component and controls the release of the substance from the at least one reservoir into the medium. The sensors monitor one or more parameters in the medium and provide a signal to the feedback mechanism. The feedback mechanism, in response to the signal, sends an electrical signal that directs the controller to release the substance from the reservoir into the medium, thereby maintaining a desire level of a monitored parameter (e.g., pH, pO2, temperature, pressure, ions, volume, impedance, dosage, biomarkers, etc.).
In an individualized delivery system, such as for drug delivery, feedback can monitor sensitive parameters such as level, dosage, and timing for highly effective delivery, which may be especially attractive for long-term treatment, for example for persistent pain associated with chronic headache, disease-associated neuropathies (diabetic, post-herpetic, etc.), peripheral ischemia, back pain, or for controlled chemotherapy.
Patent Family 6: Method and apparatus for diagnosis and treatment
US Patent No. 9,199,076 entitled “Method and Apparatus for Diagnosis and Treatment” is a combination of the original US Patent Application No. 12/485,855 (Pub. No.: US 2011/0224502 A1) and the Patent Family 5 patent application No. 12/098,257 (see above). A continuation application of US Patent No. 9,199,076 has been filed. The subject matter in the original, non-combined, application can be extracted and filed as a continuation or CIP application.
The invention relates to measurement, diagnostic, and treatment equipment and analysis methods which allow not only for performing multiple measurements and diagnoses simultaneously but also for long term monitoring of the disease, and for treatment in response to such monitoring, as well as for monitoring of treatment efficacy, which can have importance both for personalized medicine and for drug discovery.
Development of applications using versatile, flexible electrical systems has significant potential, not only in the treatment areas discussed above, but in emerging fields such as personalized medicine - in which treatment is tailored based on sensing and feedback regarding any number of biological parameters, which are specific to the individual's immediate condition and to the disease being treated or the wellness characteristic desired.