Patent Application
20220087891
Exemplary embodiments pertain to acute and chronic personalized pain relief.
Exemplary embodiments include a multi-modal personalized pain management system with a sensor subsystem within a single assembly, a skin stimulator subsystem within the single assembly, a drug delivery subsystem within the single assembly, a control subsystem within the single assembly, and a user interface subsystem. The single assembly may be configured to be attached or worn in a vicinity where pain relief is desired. The user interface subsystem includes software with instructions executed by a processor and configured to operate as part of the system or a separate computing device. The multi-modal personalized pain management system may include any of an oximeter, a pulse oximeter, a thermometer, an infrared radiation sensor, a colorimeter, a blood flow sensor, a pH sensor, a galvanic skin response sensor, an imbedded accelerometer, a biochemical sensor, an infrared radiation sensor, a colorimeter, a biochemical sensor, or a combination thereof.
The multi-modal personalized pain management system, according to exemplary embodiments, may further include the skin stimulator subsystem with an electrical stimulation portion, a thermal stimulation portion, a mechanical stimulation portion or any combination of an electrical portion, and a thermal portion, or a combination of an electrical portion and a mechanical portion, or a combination of a thermal portion and a mechanical portion, or a combination of an electrical portion, a thermal portion, and a mechanical portion. The electrical stimulation portion may induce a current flow to a tissue. The thermal stimulation portion may induce a temperature rise or fall in a tissue. The mechanical stimulation portion may apply a force to a tissue. Additionally, the control subsystem may be configured to cause a time-varying force.
Exemplary embodiments include the multi-modal personalized pain management system having any of a reciprocating electric motor, a rotating electric motor coupled to an eccentric weight, a piston driven by an external fluid such as air or water, a piezoelectric transducer, or any other means of applying a time-varying force. Additionally, the multi-modal personalized pain management system may include any of a drug dispensing mechanism, a drug dispensing control mechanism, a drug supply, a drug patch, a drug dispensing solid, a flat structure with a port and a channel, a trapped volume or any combination thereof. The drug delivery subsystem may be configured to dispense two or more types of drugs. The control subsystem may be configured to receive user inputs or sensed signals and to provide control over the skin stimulator subsystem or the drug delivery subsystem. The system may communicate over any of an Internet network, a radio frequency, near-field communication, optical communication, acoustic communication, or any other communication means capable of receiving sensed signals and transmitting control signals, or a combination thereof.
The multi-modal personalized pain management system, according to exemplary embodiments, also includes the user interface subsystem configured to provide information on functioning of the system and to provide information from a user on their preferences or perceptions as to the functioning of the system.
Also provided herein are exemplary methods for multi-modal personalized pain management, including receiving sensing input by a control subsystem in an assembly, receiving user input from a user interface by the control subsystem in the assembly, and generating a control signal by the control subsystem to control a skin stimulator subsystem in the assembly and a drug delivery subsystem in the assembly. Exemplary methods also include attaching the assembly in vicinity of where pain relief is desired and measuring by an infrared radiation sensor a combination of a temperature of skin and a temperature of a tissue beneath the skin. Various exemplary methods include measuring by a colorimeter any combination of skin color, tissue color beneath skin or color of a dye. A biochemical sensor may sense a substance exuded from skin, including any of water, sodium, potassium, oil, sebum, proteins including defensins, metabolic products including lactic acid, oxides of nitrogen, or a combination thereof.
In the description, for purposes of explanation and not limitation, specific details are set forth, such as particular embodiments, procedures, techniques, etc. to provide a thorough understanding of the present technology. However, it will be apparent to one skilled in the art that the present technology may be practiced in other embodiments that depart from these specific details.
The accompanying drawings, where like reference numerals refer to identical or functionally similar elements throughout the separate views, together with the detailed description below, are incorporated in and form part of the specification, and serve to further illustrate embodiments of concepts that include the claimed disclosure and explain various principles and advantages of those embodiments.
The methods and systems disclosed herein have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.
While the present technology is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail several specific embodiments with the understanding that the present disclosure is to be considered as an exemplification of the principles of the present technology and is not intended to limit the technology to the embodiments illustrated.
Chronic Pain has and continues to be a major challenge for the medical community. As a result, The US chronic Pain Relief Market is worth 21.97 billion and is expected to grow to $32.02 billion revenue by 2025, with a CAGR of 6.2%. Not only does chronic pain put a strain on the patient, but it also puts tremendous pressure on the physician. To figure out a way to get a patient's pain under control, in the least costly, the most targeted, and with the least addictive properties is a major challenge. However, most to all patients who suffer from chronic pain are treated with a multitude of medications, some of which are highly addictive and others that mask the entire body's pain receptors. These medications only work for a small percentage of patients, where the method of pain management does not target the point of pain, nor does it resolve the pain; as a result, roughly 20-30 percent of patients who were prescribed opioids misuse them, with 8-12 percent developing an addiction. There needs to be a more targeted way of controlling chronic pain.
Topical Analgesic-Based Pain Management:
Chronic pain is caused by a multitude of elements, such as an initial injury, back sprains, pulled muscles, etc. Therefore, the resulting pain is usually located in one specific part of the body, e.g. neck, back, etc. So, it's not inconceivable to try and treat pain where the pain originated, rather than masking pain over the whole body. There has been an increasing shift in the medical community on developing new and innovative ways of drug administration, that are customized to the individual patient. The use of Transdermal and Topical Compounded Custom Medication is one of the innovative avenues that primary care physicians take to treat chronic pain. For instance, Ketamine has shown tremendous promise to treat neuropathic pain as well as chronic pain of all types. Lidocaine and Gabapentin have shown great promise in treating general inflammation as well as neuropathic pain. And Baclofen a (NSAID) reduces substances in the body that cause pain and inflammation. Additionally, with companies such as Icy Hot, Bengay, Tiger Balm and others creating their own custom formulations of topicals to treat chronic pain, there are now many options for patients to customize their pain management regime. Since primary care physicians can now combine these medications to treat individualized ailments, there has been an increase in prescribing compounded medications. And with a 47% success rate and close to 0% chance of addiction, it is evident why primary care physicians are moving towards a more individualistic way of treating chronic pain.
Electrical Stimulus-Based Pain Management:
Another innovative way of treating chronic pain is through the use of a TENS (transcutaneous electrical nerve stimulation) devices, which is one of the most commonly used forms of electroanalgesia. These devices use low voltage, electric current to relieve pain and to target specific areas of pain. These devices can be used on any point on the body where there is pain and will send electric stimulus to the point of pain to contract and relieve the muscle. Other devices of this nature have been used such as heating pads, IcyHot's Smart Relief unit, and cooling units to target and treat chronic pain. The TENS device is also programmable, meaning you can code the system to have different modes depending on where its located. For instance, the back has thicker skin and have deeper muscles. Therefore, you could program a specific back algorithm to a TENS unit to target the muscles in the back. Same applies to the neck, hands, shoulders, etc. The theory is if you stimulate nerves, either through electric, thermal, or mechanical stimulus, you close a “gate” mechanism that can help eliminate the feeling of pain. While there is some discrepancy with the effectiveness of TENS units, patients generally have a 70-80 percent success rate in treating chronic pain after a few months or longer.
Cannabis-Based Pain Management:
Cannabis has been used medically for many purposes that span from treating epilepsy to stimulating a cancer patient's appetite. And only recently have people started applying the inflammation reducing properties of cannabis for treating chronic pain. However, since cannabis is not regulated by the FDA, there are large discrepancies over valid and invalid concentrations of CBD. But since pain is a purely subjective feeling, and over 100 million U.S. adults are plagued with chronic pain, this prompts patients to visit their doctors more and to test different modes of pain reduction. This is evident as CBD's starting revenue in 2018 was $350 million and product sales have grown in the United States to $590 million. It is predicted that the CBD market will grow to $117 billion dollars in 2025 with at a rate of 132%. As of 2018, hemp derived CBD is legalized in all 50 states and is already having a large impact on the way that people treat their pain. CBD may offer many options to patients who have had no success with their current medication regime. According to Eur J Pain, author of “Transdermal cannabidiol reduces inflammation and pain-related behaviors in a rat model of arthritis,” concluded that topical applications of CBD have been shown in some cases to inhibit neuropathic and inflammatory pain, which are extremely hard to treat. Of course, more research needs to go into to determine the efficacy of CBD, but there is no question that it is the next movement of supplemental medication.
Conclusion: A New Multi-Modal Pain Management System.
Since no medical profession contains the holy grail to treating chronic pain, different modalities will work in some cases and others will not. Therefore, having a device that combines different subsystems of treating chronic pain and incorporating them into one singular system would pose a great compliment to treating chronic pain.
Modii is a multi-modal pain management system that combines the therapeutic effects of transdermal medication and varying forms of external stimulation that include but are not limited to, electrical, thermal, mechanical and ultrasonic. The system uses machine learning to adjust skin stimulation based on qualitative measures (specific drug, user comfort, skin sensitivity, body placement). The system contains various imbedded sensors including but not limited to oximeters, colorimeters, pulse oximeters, optical sensors, hydration sensors, GRS sensors, accelerometers and PH sensors, and temperature sensors to monitor, analyze and promote skin health. Using sensors and circuitry to monitor changes (capacitive touch or resistive touch) in a particular state, the system can accommodate one or more drug releasing patches that can be placed in any custom arrangement. The properties of the patches can be interrogated to determine drug type, concentration, location, or depletion. The system could be controlled by a smart phone application which is used to operate all aspects of the system's stimulators, controllers, sensors and monitors. Using machine learning, the application will collect and analyze the patient's biometric data and eventually will make regimen recommendations based on positive experiences.
The skin thermal stimulator is a non-pharmaceutical, complementary pain management feature that can emit thermal heat with a maximum temperature of 43° C. Additionally, the thermal stimulator can also drop to a maximum temperature of −2° C. Depending on the injury the patient will want to use either cold or thermal stimulation to either increase or decrease the skins permeability rate, control the depletion of certain drugs, or for comfort. Thermal emission is used to dilate the blood vessels of inflamed muscles to promote blood flow and help sore and tightened muscles relax. Cold emission is used to reduce inflammation by decreasing blood flow.
The skin mechanical/ultrasound stimulator is a non-pharmaceutical, complementary pain management feature that can emit high-frequency sound or vibrational waves. For the ultrasound stimulator, 80 dBA is used for a cumulative exposure of 24 h over a 24 h period; an offset of 3 dBA is to be added to this value when halving the cumulative exposure time over a 24 h period (e.g. 83 dBA for 12 h over a 24 h period); 140 dB un-weighted BC (peak) sound pressure level for impulsive or impact acoustic energy (noise). For the vibrational stimulator, the max vibration is 2.5 m/s2 for a cumulative time of 8 h during a 24 h period. Both mechanical and ultrasonic vibration has shown tremendous effectiveness in relieving sore muscles, increasing muscle range of motion, increasing blood blow and improving muscle strength.
Adjustable Stimulation Controller
The device has an adjustable stimulation controller, operated by a smartphone application, which can be calibrated to the individual needs of the patient. The external stimulation controller can also be adjusted to either increase or decrease the skins permeability rate, in conjunction with the adjusting the speed at which the drug is delivered. For instance, if certain medications take longer to absorbed into the skin; the patient has the ability to increase the thermal stimulation to both aid in muscle relaxation and skin absorption. The device's stimulation controller is powered by machine learning, that is able to learn, adapt and adjust stimulation based on different qualitative measures (specific drug, user comfortability, skin sensitivity, body placement). For example, the back muscles are protected by thick skin and would need a more intense stimulation level for the patient to achieve a therapeutic effect. Therefore, through individual patient use and feedback, the devices AI will determine which stimulation/stimulation level achieves the most pain relief, per the individual. The stimulation controller also has a limit to how much stimulation can be applied to the skin. The stimulation will not go over FDA's ISO 60601 limits for maximum allowable voltage, current, temperature, vibration, and cold.
Skin Sensors
The system will contain a multitude of Skin Sensors to monitor, analyze and promote continuous skin health. The system will contain a Pulse Oximeter to measure oxygen saturation levels. Oximeters can determine small changes in how oxygen is being carried throughout the extremities of the body. The systems contain an embedded oximeter to determine how well the heart is pumping oxygen throughout the body, especially in the area where the system is placed.
The system will contain an infrared temperature sensor to determine the base temperature of the patient's skin and make sure that there are no dramatic spikes that cause skin irritation or damage.
The system will contain a colorimeter, which is a light sensitive device, used to determine how much of the medication has been depleted. Each medical patch will contain a dye, that when interacts with an external stimulus, changes color as it's absorbed into the skin. The colorimeter will track the color change in the patch and report the percentage depleted overall. Additionally, the colorimeter will also determine how well blood is flowing through the body, by measuring the transmittance and absorption of light that is passed through the affected area.
The system will contain optical sensors for the detection and placement of medical patches. The device will support a custom mosaicking the medical patches, almost like a patch quilt, so the patient can easily assemble a custom array of medical patches. These optical sensors will be placed along the bottom of the device and will be able to determine the type of medication, the dosage, the percentage depleted and the location. The system will contain hydration and a PH sensor for individuals wanting to monitor the hydration status of their skin, in real time. The sensor will monitor the patient hydration vitals, particularly in elderly patient, and will update them on whether or not they are in need of hydration. The device will use a PH sensor to determine that the skin has a balanced PH. The PH sensor will be able to measure the about of alkalinity and acidity on the skin. The system will contain an Accelerometer to determine where on the patient body, the system has been placed and the relative motion of the location. The system is able to be placed on any part of the body.
Skin Drug Monitor
By using hydrogel adhesives, the system can attach to any desired body part. Similarly, the medical patches can be placed on any part on the adhesive side of the system. Each patch will contain a custom barcode that can be read and recorded through a smartphone camera. Once the barcode is read and the app records the patch information, the patient has complete freedom to place the patch anywhere on the device.
The system's gel matrix contains a resistive touch circuit and will be able to record the exact location of the patch. Patient customizability will arise from the ease of attaching and detaching different patches onto the device, in a series of unique configurations. Once a patient attaches a patch to the device, the device will sense the patch and record the location, medication, percentage depleted and dosage of patch.
During each session, the system will record the duration, the type of stimulus, the intensity of the stimulus, the medications used, the amount of medication depleted and location on the body. The system has the ability to modify its gel matrix to control the rate of medication depletion. For instance, a doctor might recommend using a heat stimulus to increase the skins permeability and therefore, absorbing more medication. On the contrary, a patient may use a cold stimulus to slow the rate of absorption to extend the patch's duration. This will come from the devices drug dose controller, that can create a custom treatment plan based on the type of medication and the custom required rate of depletion.
The system will be able to measure drug depletion via an optical sensor. The colorimeter will determine how much medication is left in the patch and will recommend to the patient to switch it out. Each patch will contain a dye, that when exposed to an external stimulus (heat, cold, electric) will change color. The optical sensor will analyze the color change and determine the percentage of medication left.
Sensor Subsystem
Skin Stimulator Subsystem
Electrical Stimulation Portion
Thermal Stimulation Portion
Cold Stimulation Portion
Mechanical Stimulation Portion
In alternative embodiments, the time-varying force oscillates such that it is periodic in time. Such an oscillating force the frequency of oscillation may be in the audio range from 20 Hz to 15 kHz, or in the sub-audio range from 0.1 Hz to 20 Hz, or in the ultrasonic range from 15 kHz to 1 MHz.
Drug Delivery Subsystem
Control Subsystem
User Interface Subsystem
In some embodiments, their perceptions may comprise perceptions of the level of pain they are experiencing. In other embodiments their perceptions may include their tolerance for the experience of using the MMPMD. In some embodiments, their preferences may comprise the time duration during which they wish to use the MMPMD. In some embodiments, the user interface subsystem may solicit input from the user in concert with one or more alterations in the control of either the skin stimulator subsystem or the drug delivery subsystem. The soliciting of input may occur at any suitable time relative to the one or more alterations in control.
A person may attach the assembly in vicinity of where pain relief is desired, through the use of a releasable skin safe adhesive.
If a person were to use the assembled configuration, then the person would be able to fully and customize and control the assembled configuration, by means of the stimulator treatment, intensity, and duration.
If a person were to use the user subsystem, then the person would be able to access their account personal account, which gives them further access to their sensor data history, the ability to order more medicated patches, communicate with a pain physician, access the community page and access white pages.
If a person were to use medication A in conjunction with the assembly, then that person would take out the patch labeled medication A, remove the medicated patch, take off the release liner and attach it to the bottom of the assembly.
If a person uses medication A, stimulation B and Intensity C, then the sensor subsystem's data output D, is stored, analyzed, and historically compared for better treatment recommendations and medication options.
If a person experiences pain in area A where pain relief is desired, then a recommendation is presented, which includes stimulation B with medication C for duration D. However, if a person experiences pain in area W, then a recommendation is presented, which includes stimulation X with medication Y for duration Z.
If a person desires that medication A is to be depleted at a rapid pace, then a person would choose thermal stimulation B and intensity C for rapid medication depletion.
If a person desires that medication A is to be depleted at an inert pace, then a person would not choose thermal stimulation B and intensity C for inert medication depletion.
While specific embodiments of, and examples for, the system are described above for illustrative purposes, various equivalent modifications are possible within the scope of the system, as those skilled in the relevant art will recognize. For example, while processes or steps are presented in a given order, alternative embodiments may perform routines having steps in a different order, and some processes or steps may be deleted, moved, added, subdivided, combined, and/or modified to provide alternative or sub-combinations. Each of these processes or steps may be implemented in a variety of different ways. Also, while processes or steps are at times shown as being performed in series, these processes or steps may instead be performed in parallel or may be performed at different times.
The various embodiments described above, are presented as examples only, and not as a limitation. The descriptions are not intended to limit the scope of the present technology to the forms set forth herein. To the contrary, the present descriptions are intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the present technology as appreciated by one of ordinary skill in the art. Thus, the breadth and scope of a preferred embodiment should not be limited by any of the above-described exemplary embodiments.
The present application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 63/082,245 filed on Sep. 23, 2020, and titled “A System and Method for Multi Modal Personalized Topical Pain Relief,” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63082245 | Sep 2020 | US |
