Patent Application
20220085628
The following disclosure relates generally to stimulus-based therapeutic devices, systems, and methods. In particular, the disclosure relates to systems and methods for applying heat, vibration, electrical, and other stimulus to a patient's body for therapeutic purposes.
In 1965, Melzack and Wall described the physiologic mechanisms by which stimulation of large diameter non-pain sensory nerves could reduce the amount of unpleasant activity carried by pain nerves. This landmark observation published in Science was termed the “gate control theory” and offered a model to describe the interactions between various types of the sensory pathways in the peripheral and central nervous systems. The model described how non-painful sensory input such as mild electrical stimulation could reduce or gate the amount of nociceptive (painful) input that reached the central nervous system.
The gate-control theory stimulated research that lead to the creation of new medical devices such as transcutaneous electrical nerve stimulators (TENS). In brief, TENS works by electrically “blocking” pain impulses carried by peripheral nerves. Receptors to cold and heat are located just below the surface of the skin. Heat receptors are activated through a temperature range of about 36° C. to 45° C. and cold receptors by a temperature range about 1-20° C. below the normal skin temperature of 34° C. (Van Hees and Gybels, 1981). The stimuli are transmitted centrally by thin poly-modal C nerve fibers. Activation of heat receptors are also affected by the rate of rise of the heat stimuli (Yarnitsky, et al., 1992). Above 45° C. warm receptor discharge decreases and nociceptive response increases producing the sensations of pain and burning (Torebjork et al., 1984).
Activation of poly-modal thermal receptors causes significant pain relief in controlled experimental conditions. Kakigi and Watanabe (1996) demonstrated that warming and cooling of the skin in human volunteers could significantly reduce the amount of reported pain and somatosensory evoked potential activity induced by the noxious stimulation of a CO2 laser. The authors offered that the effects seen could be from a central inhibitory effect produced by the thermal stimulation. Similar inhibition of pain from thermal simulation was reported in a different Human experimental pain model (Ward et al., 1996). The study authors (Kakigi and Watanabe 1996 and Ward et al., 1996) proposed that the thermal analgesia was in part from a central inhibitory effect (gating) from stimulation of small thin C nerve fibers. This contrasts with TENS which produces at least part of its analgesia through gating brought on by activation of large diameter afferent nerve fibers.
A number of recent clinical studies strongly support the use of heat as an analgesic in patients who suffer from chronic pain and offer potential mechanisms by which heat produces analgesia. Abeln et al. (2000) in a randomized controlled single-blinded study examined the effect of low level topical heat in 76 subjects who suffered from low back pain. Heat treatment was statistically more effective in relieving pain and improving the quality of sleep than that produced by placebo.
Weingand et al. (2001) examined the effects in a randomized, single blinded, controlled trial of low level topical heat in a group of over 200 subjects who suffered from low back pain and compared heat to placebo heat, an oral analgesic placebo, and ibuprofen 1200 mg/day. The authors found heat treatment more effective than placebo and superior to ibuprofen treatment in relieving pain and increasing physical function as assessed by physical examination and the Roland Morris disability scale.
A separate group (Nadler at al., 2002) found similar results in a prospective single blinded randomized controlled trial of 371 subjects who suffered from acute low back pain. The authors found that cutaneous heat treatment was more effective than oral ibuprofen 1200 mg/day, acetaminophen 4000 mg/day or oral and heat placebos in producing pain relief and improving physical function. The authors offered several hypotheses for the mechanism(s) of action which includes increased muscle relaxation, connective tissue elasticity, blood flow, and tissue healing potential provided through the low-level topical heat. Similar beneficial effects of topical heat were show in patients who suffered from dysmenorrhea (Akin et al., 2001), and temporomandibular joint pain TMJ (Nelson et al., 1988).
A recent study used power Doppler ultrasound to evaluate the effects of topical heat on muscle blood flow in Humans (Erasala et al., 2001). Subjects underwent 30 minutes of heating over their trapezius muscle and changes in blood flow were examined at 18 different locations over the muscle. Vascularity increased 27% (p=0.25), 77% (p=0.03) and 104% (p=0.01) with 39° C., 40° C., or 42° C. temperature of the heating pad. Importantly increases in blood flow extended approximately 3 cm deep into the muscle. The authors concluded that the increased blood flow likely contributed to the analgesic and muscle relaxation properties of the topical heat. Similar increases in deep vascular blood flow were noted using magnetic resonance thermometry in subjects treated with mild topical heat by two separate groups (Mulkern et al., 1999, and Reid et al., 1999).
Recent studies demonstrated the analgesic effectiveness of heat and provided potential mechanisms of action. The mechanisms include a reduction of pain through a central nervous system interaction mediated via thin c-fibers (Kakigi and Watanabe, 1996, Ward et al. 1996), enhancement of superficial and deeper level blood flow (Erasala et al., 2001, Mulkern et al., 1999, Reid et al., 1999), or local effects on the muscle and connective tissue (Nadler et al., 2002, Akin et al. 2001). TENS is thought to act through inhibition of nociception by increasing endogenous opioids or by a neural inhibitory interaction of nociception via large diameter fibers. It is likely that TENS and heat act partly through different mechanisms with the potential for enhanced or even synergistic interactions. TENS is widely used and endorsed by the pain management guidelines of both the AHCPR and American Geriatric Society (Gloth 2001). However, a significant number of patients fail to achieve adequate relief with TENS or fail within six months of starting treatment (Fishbain et al., 1996).
Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology.
The present technology is directed generally to systems, devices, and associated methods for applying stimuli to various parts of the body of a human subject or patient using a series of modular pods. The pods can be controlled by a remote controller in the form of a computer (e.g., a desktop computer, a laptop computer, etc.), or a mobile device (e.g., a mobile phone, tablet, MP3 player, etc.). The pods can releasably attach to disposable anchors that adhere to the body at various locations to which the patient desires to direct heat therapy.
The present technology is further directed to charging stations for recharging the pods. In several of the embodiments described below, a charging station is configured to mechanically prevent the simultaneous charging of a pod and attachment of the pod to a skin surface of the patient.
Several details describing thermal and electrical principles are not set forth in the following description to avoid unnecessarily obscuring embodiments of the present technology. Moreover, although the following disclosure sets forth several embodiments of the present technology, other embodiments can have different configurations, arrangements, and/or components than those described herein without departing from the spirit or scope of the present technology. For example, other embodiments may have additional elements, or they may lack one or more of the elements described in detail below with reference to
The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the claims, but are not described in detail with respect to
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
The terms used herein are not intended—and should not be taken—to exclude from the scope of this present technology other types of heat sources that are designed to be placed on the skin to enable pain relief. Illustrative embodiments will be shown and described; however, one skilled in the art will recognize that the illustrative embodiments do not exclude other embodiments.
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
In some embodiments, as described in greater detail below with reference to
In some embodiments, multiple ones of the stimulus pods 110 can be used in concert at different places on the patient's body. In some embodiments, the stimulus pods 110 can also be used to deliver medicine to a patient through electrophoresis, iontophoresis, and/or heat-enhanced perfusion due to capillary dilation. Electrophoresis is the motion of dispersed particles relative to a fluid under the influence of a spatially uniform electric field. Electrophoresis is ultimately caused by the presence of a charged interface between the particle surface and the surrounding fluid. Iontophoresis (a.k.a., Electromotive Drug Administration (EMDA)) is a technique using a small electric charge to deliver a medicine or other chemical through the skin. It is basically an injection without the needle. The technical description of this process is a non-invasive method of propelling high concentrations of a charged substance, normally a medication or bioactive agent, transdermally by repulsive electromotive force using a small electrical charge applied to an iontophoretic chamber containing a similarly charged active agent and its vehicle. One or two chambers are filled with a solution containing an active ingredient and its solvent, also called the vehicle. The positively charged chamber (anode) will repel a positively charged chemical, whereas the negatively charged chamber (cathode) will repel a negatively charged chemical into the skin.
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The stimulus pod 110 can be attached to (e.g., secured against, retained by, etc.) the anchor 120 such that the stimulus surface 150 is secured against the patient's skin.
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Any of the attachment mechanisms illustrated in
During operation of the system 100, multiple ones of the stimulus pods 110 can be interchanged between different ones of the anchors 120, and vice versa. A patient can use a stimulus pod 110 until the battery is depleted, and then simply swap in another stimulus pod 110 with a fresh battery. The attachment means can be strong enough and the dimensions of the stimulus pod 110 can be small enough that the stimulus pod 110 can be worn under the patient's clothing easily. The placement of the anchors 120 can vary greatly according to a predetermined diagnostic pattern or personal preference. In some embodiments, one or more of the stimulus pods 110 can be placed at an area of discomfort, such as a painful lower back. Some research suggests that placing additional stimulus pods 110 at an area remote from a problem area can also provide analgesic effects. For example, a patient may place one of the stimulus pods 110 at the lower back—where their pain is—but they can also use a second one of the stimulus pods 110 near the shoulders or on the legs. Multiple stimulus pods 110 can be used in concert to produce an aggregate affect. Because different areas of the human body have different nerve densities, in certain areas two of the stimulus pods 110 placed near one another can be perceived as a single, large stimulus pod. For example, the patient's back has much lower nerve density than the face, neck, or arms. Accordingly, the patient can use a pair of small stimulus pods 110 (e.g., one or two inches in diameter) at the lower back and spaced about three or four inches apart to achieve the same sensory result as a larger stimulus pod covering the entire area. An unexpected benefit of this arrangement is that much less power is required to provide the stimulus in two small areas than would be required to stimulate the entire area.
In the illustrated embodiment, the stimulus pod 110 also includes a stimulus cycle switch 206 configured to, for example, switch between different levels of an applied stimulus (e.g., a low, medium, or high temperature). The stimulus pod 110 can also include indicators 208A-C such as LEDs that can light up in response to a particular setting of the stimulus cycle switch 206. In other embodiments, a single indicator 208 capable of changing its color, intensity, or other property can be used to indicate different settings of the stimulus pod 110. A push-type stimulus cycle switch 206 is illustrated in
In some embodiments, one or more of the stimulus pods 110 can communicate with a control station to, for example, coordinate the delivery of stimulation to a patient at one or multiple locations.
The control station 230 can be a desktop or laptop computer, a smartphone, a tablet, or other device. In some embodiments, the control station 230 can be included with or integrated into a charging station, and/or can share components such as a power source, circuitry, etc., with a charging station. The control station 230 can instruct one or more of the stimulus pods 110 to apply heat, electric stimuli, vibration, or other stimulus or combination of stimuli in various patterns to the patient's body. In other embodiments, the pods 110 include a button or series of buttons through which the pods 110 can be manually operated. The possible applications are many, and include various combinations of ramp up operations, maximum intensity operations (e.g., maximum temperature or maximum electrical current, etc.), ramp down operations, stimulus soak operations, and lockout period operations (e.g., as described in detail below with reference to
In several embodiments, the control station 230 can detect or receive information regarding the location of the stimulus pods 110 on the patient's body, and can vary the stimulus pattern accordingly. In one embodiment, the stimulus pods 110 can be built with certain body positions in mind. In some embodiments, the stimulus pods 110 can carry body position labels to instruct the patient to apply the stimulus pods 110 according to the label. For example, in a set of four stimulus pods, two can be marked “shoulders,” a third can be marked “lower back,” and a fourth can be marked “upper back.” In some embodiments, the anchors 120 can communicate their location to the stimulus pod 110. For example, the anchors 120 can include passive identifiers such as RFID tags or other simple, passive devices for communicating with the stimulus pods 110 and/or the control station 230. In such embodiments, the anchors 120 can remain in place even when different stimulus pods 110 are swapped in and out of the anchors 120. Therefore, the stationary anchors 120 can accurately provide location information to the control station 230 independent of which specific ones of the stimulus pods 110 occupy the anchors 120.
In other embodiments, the patient can inform the control station 230 where the stimulus pods 110 are situated, and with this information the control station 230 can apply the desired stimulus pattern to the stimulus pods 110. For example, the stimulus pods 110 can fire sequentially, and the patient can indicate the location of the stimulus on a user interface. Through the user interface, the patient can also operate the system 100 and apply treatment. In some embodiments, the control station 230 can graphically display a depiction of the patient's body, and the patient can indicate to the control station 230 where the stimulus pods 110 are located on their body. Alternatively, the patient can directly control the stimulus application through the stimulus pods 110 by moving a pointing device along the graphical depiction of their body to create a virtual stimulus-massage that the patient, or a healthcare professional, controls directly. In some embodiments, the control station 230 can include a touch screen that the patient can touch to apply heat or other stimulus to various portions of their body (or to the body of another patient).
In some embodiments, the index pod 110a and the control station 230 can discern when two or more of the stimulus pods 110 (e.g., dummy pods 110b or index pods 110a) are near enough to one another that they can work in aggregate. If the control station 230 knows where the stimulus pods 110 are placed on the patient's body, the control station 230, through the index pod 110a, can vary the threshold distance between the stimulus pods 110 as a function of nerve density at different locations on the body. For example, if the control station 230 discerns that two or more of the stimulus pods 110 are three inches apart and on the lower back, the control station 230 can operate those ones of the stimulus pods 110 together to effectively cover the area between the stimulus pods 110 as well as the area directly contacting the stimulus pods 110. By comparison, if two or more of the stimulus pods 110 are three inches apart, but are placed on a more sensitive area, such as the patient's face or neck, the control station 230 can determine that the aggregate effect may not be perceived to reach the area between those ones of the stimulus pods 110 because of the greater nerve density. This information can be used when applying a treatment plan that calls for stimulus on a prescribed area. In some embodiments, the control station 230 can determine whether one of the stimulus pods 110 is on or near the prescribed area, and if not, whether the aggregate effect from two or more of the stimulus pods 110 can be used to carry out the treatment plan, and can execute the plan through the stimulus pods 110.
The charging station 780 can further include a pair of contacts or pins 781 configured to engage and electrically contact corresponding contacts on the stimulus pod 110 for transmitting power and/or communication signals to/from the stimulus pod 110. For example,
Referring to
Notably, because the (e.g., mating) arrangement of the charging station 780 and the stimulus pod 110 prevents the stimulus pod 110 from being applied to the patient's body during charging, the present technology can protect the patient against the dangers of leakage currents and/or the transmission of high currents resulting from, for example, lightning strikes. Leakage current is ubiquitous within electrical and electronic systems and can be defined as the flow of current from a system's conductors to ground, either (i) directly via a properly grounded conductor, or (ii) through direct or indirect coupling to other elements of a system—for example, a human body. For supplies connected to AC power mains like battery rechargers, sources of leakage current can include capacitive couplings from electromagnetic interference (EMI) filters and from the primary to the secondary winding—or even to nearby circuits from the power transformer.
A leakage current of only 30 mA can cause breathing difficulty and ventricular fibrillation for healthy humans. Accordingly, various means of protection for protecting users of electronic devices from leakage currents and electric shocks can be built into electronic devices. These means of protection include, for example, ground fault circuit interrupter (GFCI) fail-safe protectors, insulators, air gaps, a defined ‘creepage’ (e.g., the shortest distance between two conductive paths, or a conductive path and chassis/enclosure), high-impedance isolation barriers between an electrical input and the output, etc. More generally, means of protection have been developed for various categories of products based on their electrical characteristics and the level of risk they present to users. The most stringent standards are often applied to medical technologies because of their inherent proximity to direct human contact through sensors and probes. Specifically, the International Electrotechnical Commission (IEC) technical standard 60601 covers a range of medical device safety requirements including the prevention of leakage currents. To comply with the IEC 60601 standards, the design and manufacturing of battery recharging systems requires robust protection against risks like lightning strikes translating through AC lines to users.
Consumer healthcare devices—such as the stimulus systems of the present technology—are products that fall between consumer products and medical devices, and that often rely on rechargeable battery power. Consumer healthcare devices frequently must comply with the IEC 60601 standards because of their intended direct and prolonged contact with humans. As noted above, consumer USB battery chargers are low-cost solutions for recharging batteries on a broad range of devices like mobile phones, portable speakers, electronic tablets, and other battery-powered devices. However, consumer USB battery chargers are not required to meet the requirements of the IEC 60601 standards because they are not intended for attachment to the body. Accordingly, many consumer healthcare devices cannot be compatible with USB battery chargers or else the devices would not comply with the IEC 60601 standards (and, e.g., cannot be cleared by the Food and Drug Administration (FDA)) —and thus require more complicated and relatively high cost battery charging systems.
As described in detail above, the present technology advantageously prevents a wearable device (e.g., the stimulus pod 110) from being attached to the body of a patient while it is being recharged. This eliminates the risks associated with AC line power leakage and shocks, and thus permits the utilization of lower cost consumer battery recharging systems (e.g., by eliminating the requirement that the battery recharging station comply with the IEC 60601 standards). The cost savings associated with being able to use lower cost consumer battery recharging systems (e.g., USB chargers) can be significant. For example, it is expected that the present technology will decrease the burden of factory cost by $10 on a device's battery charging system, which can translate to a retail pricing reduction of $40. Such cost savings can permit a larger segment of the population to access such wearable medical devices—even where healthcare plans may not reimburse their purchase.
In other embodiments, the present technology can include other arrangements/configurations of a wearable device and charging station that prevent the wearable device from being worn and/or contacting a user during charging.
The stimulus pod 1010 and charging station 1080 can include some features generally similar to the features to the stimulus pod 110 and charging station 780 described in detail above. For example, referring to
In the illustrated embodiment, the pins 1081 are positioned within a recess 1087 formed in the body 1082. The stimulus pod 1010 (or another wearable device) can have a corresponding protrusion 1089 on which the pins 1083 are positioned for electrically contacting the pins 1081 when the stimulus pod 1010 is positioned on (e.g., mounted on) the charging station 1080. More particularly, the protrusion 1089 can be configured to extend into the recess 1087 such that the pins 1081, 1083 electrically contact one another. The recess 1087 can be specifically configured (e.g., sized and shaped) to prevent or at least substantially inhibit a user from (i) directly contacting the pins 1081 with their fingertip (e.g., an artificial fingertip as defined by the IEC 60601 standards) and/or (ii) indirectly receiving an electrical shock during a lightning strike while the charging station 1080 is coupled to an AC power source. In the illustrated embodiment, for example, the recess 1087 is sized to provide at least 5 mm of air clearance with respect to a 12 mm (artificial) fingertip, and to provide at least 8 mm of surface separation distance (i.e., creepage). Accordingly, in some embodiments the charging station 1080 is specifically configured to meet the requirements of the IEC 60601 standards.
In some embodiments, the charging station 1980 can be configured as a portable, cordless station that includes one or more batteries. For example,
In some embodiments, the charging station 1980 can include a lid 1994 that can be removably or permanently coupled to the body 1982 for enclosing the stimulus pods 110 during charging and/or protecting the sockets 1984 from debris or contamination. For example,
From the foregoing, it will be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the spirit and scope of the present technology. For example, in particular embodiments, details of the disclosed charging stations and/or stimulus pods or other wearable devices may be different than those shown in the foregoing Figures. For example, a charging station and a stimulus pod or other wearable device according to the present technology can have any suitable arrangement for preventing a user from wearing or contacting a stimulus surface of the pod during charging. In some embodiments, for example, a stimulus pod can have a power plug incorporated into a stimulus surface that contacts the patient during use. In such embodiments, the position and orientation of a charging cord (e.g., a USB cord) can interfere with or entirely prevent the user from wearing the stimulus pod during use.
The stimulus delivery systems of the present technology can be used to apply therapeutic stimuli to a patient in many different patterns, magnitudes, cycles, etc. For example, a control unit (e.g., the control station 230) can be used to activate and control one or more wearable devices (e.g., the stimulus pods 110) to apply stimuli according to a predetermined heating cycle and/or pattern. In some embodiments, the stimulus pods 110 are configured to be placed in various locations on the skin of the patient to provide therapeutic heat treatment for relieving pain. The following disclosure details a few specific methods of applying stimuli using the delivery systems of the present technology. However, one skilled in the art will appreciate that the present technology can be used in many different manners to alleviate pain, treat ailments, etc., without deviating from the scope of the present technology. Moreover, while reference is made herein to the stimulus pod system 100, one skilled in the art will appreciate that the following methods can be carried out using other suitable devices—for example, those described in detail in U.S. Pat. No. 7,871,427, tilted “APPARATUS AND METHOD FOR USING A PORTABLE THERMAL DEVICE TO REDUCE ACCOMMODATION OF NERVE RECEPTORS,” and filed Feb. 8, 2006; and U.S. Pat. No. 8,579,953, titled “DEVICES AND METHODS FOR THERAPEUTIC HEAT TREATMENT,” and filed Dec. 8, 2008, each of which incorporated herein by reference in its entirety.
In some embodiments, the present technology can be configured to apply a continuous amount of low-level heat combined with discrete amounts or intermittent bursts of high-level heat to a patient. As described below, the bursts of heat can be at distinct locations within or around the areas producing the low-level heat. The low-level heat can be maintained as a constant application of heat while the high-level heat is applied in intermittent bursts (e.g., milliseconds in some embodiments).
To better appreciate the benefits of the combination of the continuous low temperature heat and the intermittent high temperature heat, it is helpful to understand the body's reaction to heat. The human body is generally sensitive to heat, with certain body parts having a higher sensitivity than other body parts. The body's sensitivity to heat is recognized by thermal receptors located in the skin and subcutaneous tissue.
The thermal receptors located throughout the body can be excited or activated at different temperatures.
In some embodiments, a method of applying heat to a living body includes applying a constant amount of heat to a first defined region of the body at a first temperature (e.g., via a first one of the stimulus pods 110). The method can also include applying intermittent amounts of heat to a second defined region of the body (e.g., via a second one of the stimulus pods 110). The intermittent amounts of heat may be applied at a second temperature greater than the first temperature. According to further embodiments, the second region overlaps the first region. According to still further embodiments, the intermittent amounts of heat are delivered at pre-selected, focused points wherein the surface area of the second region is smaller than the surface area of the first region.
A method configured in accordance with another embodiment of the disclosure includes a method of exciting thermal receptors in a living organism. The method includes heating a first portion of skin with a generally constant amount of heat at a baseline temperature (e.g., via a first one of the stimulus pods 110), and heating a second portion of skin with a burst of heat at a temperature above the baseline temperature (e.g., via second one of the stimulus pods 110) while heating the first portion of skin with the generally constant amount of heat.
The combination of the continuous low-level heating and intermittent high-level heating at discrete, focused regions provides several advantages over conventional heating systems. The augmentation of the continuous heating (or cooling), for example, provides enhanced pain relief by promoting blood flow, increasing flexibility, and relaxing muscles, ligaments, and other tissues. The illustrated configuration achieves enhanced pain relief by providing a strong stimulation of the thermal receptors in the skin and subcutaneous tissues of the body by rapidly changing temperatures. The variations of the temperatures from the thermal bursts reduce or eliminate the accommodation of the receptors to the stimuli. For example, when heat is applied to the body at a constant temperature, the receptors can accommodate the constant heat thus reducing the stimulation. The intermittent bursts of heat, however, can at least partially prevent the receptors from adjusting to the heat by not providing sufficient time for accommodation. This is especially effective when the intermittent bursts of heat are provided by stimulus pods of a relatively small surface area, for example 2″ by 2″, or more particularly 1″ by 1″, or even more particularly, ½″ by ½″. This is unlike conventional heating systems that do not provide the ability to disrupt the accommodation of the receptors. Accordingly, the intermittent focused bursts of heat, combined with the constant heat, provide for better receptor stimulation resulting in better analgesic results.
In some embodiments, the present technology can be used to provide heat to a patient to reduce accommodation of thermal nerve receptors of a subject. The method includes increasing the temperature of a heating element (e.g., one or more of the stimulus surfaces 150 of the stimulus pods 110) to provide a first temperature ramp-up period, holding the temperature of the heating element at a predetermined therapeutic level, decreasing the temperature of the heating device during a ramp-down period, and holding the temperature of the heating device at a predetermined soak level, wherein the soak level temperature is above a basal temperature, and wherein the soak level temperature is less than the therapeutic level temperature by at least 1° C.
In operation, the heating device (e.g., one or more of the stimulus pods 110) may deliver heat intermittently. The heat may be applied for a period long enough to heat the skin to a desired level; upon reaching the desired skin temperature the device turns off and the skin is allowed to cool; after a preprogrammed interval the device may reactivate the heat unit and the cycle repeats. Alternatively, multiple cycles may be delivered sequentially for a predetermined duration.
Without being bound by theory, the present technology provides thermal stimulation to the skin of a user; the thermal stimulation provides pain relief to the nervous system by stimulating the nervous system, but not allowing the thermal nerve receptors time to accommodate to the stimulation. In general, the nervous system is continuously attempting to accommodate to stimulants. When presented with a stimulant, the nervous system will react to the stimulant with a nerve response. Over time, the nervous system accommodates to the stimulation and provides a lesser response to the stimulation. However, if the stimulation is applied and then removed or reduced to allow the nervous system to reset or return to a baseline response mode, the thermal nerve receptors are not given the opportunity to accommodate to the stimulation and thus react anew to each introduction of the stimulation.
Another advantage of the variable heat cycles of the present technology is that multiple therapeutic methodologies are applied in one cycle, namely, inhibiting nociception and increasing blood flow. The direct thermal stimulation in the peak time or therapeutic temperature hold provides direct stimulation of the nerves through heat and thus provides a counter-irritant to pain. Additionally, the soak phase is held at a temperature higher than the basal body temperature of the user, thus allowing continued therapeutic effects by improving the blood flow to the region and providing muscle relaxation while allowing the thermal nerve receptors to return to a baseline response mode. Yet another advantage of the variable heat cycles is reduced power demand and consumption during the ramp-down or release phase when the thermal device does not draw power from the power supply, or draws reduced power from the power supply. Reduced power consumption results in a more efficient device with a longer life cycle and provides cost savings.
One expected advantage of the present technology is that the heating devices are portable and can be conveniently worn by the subject such that pain relief is available as needed. According to aspects of the present technology, the heating devices are designed to relieve pain or assist with healing in a variety of medical conditions such as low, mid, or upper back pain, muscular pain, dysmenorrhea, headaches, fibromyalgia, post-herpetic neuralgia, nerve injuries and neuropathies, injuries to extremities, and sprains and strains. Another expected advantage is that greater pain relief will be realized by the user because they will be able to control the frequency and duration of the treatment. Another expected advantage is increased efficacy of TENS when used in combination with the system described herein.
The following examples are illustrative of several embodiments of the present technology:
1. A system, comprising:
2. The system of example 1 wherein the device includes a stimulation surface configured to be placed against the user to provide a stimulus to the user.
3. The system of example 2 wherein the device includes a plug for receiving the power, and wherein the plug extends through the stimulus surface to inhibit the device from being worn by the user.
4. The system of example 2 wherein the charging station is configured to physically surround the stimulation surface when the device is positioned on the charging station to inhibit the device from being worn by the user.
5. The system of any one of examples 1-4 wherein the charging station is configured to physically encompass the device when the device is positioned on the charging station to inhibit the device from being worn by the user.
6. The system of any one of examples 1-5 wherein the charging station is configured to be connected to a power source via a USB connector.
7. The system of any one of examples 1-5 wherein the charging station is configured to be connected to a power source via a connector that is not a USB connector.
8. The system of any one of examples 1-7 wherein the charging station includes electrical contacts configured to mate with corresponding electrical contacts of the device, and wherein the charging station is configured to prevent an artificial fingertip as defined by IEC-60601 from coming within a specific distance of the electrical contacts either (a) through the air or (b) along a surface of the charging station.
9. The system of example 8 wherein the charging station defines an air gap proximate to the electrical contacts of about 5 mm.
10. The system of example 8 or example 9 wherein the charging station defines a creepage from the electrical contacts of about 8 mm.
11. The system of any one of examples 8-10 wherein—
12. The system of any one of examples 1-11 wherein the charging station includes one or more batteries configured to supply power to the device.
13. A device configured to charge a stimulus pod having a stimulation surface configured to be positioned adjacent the skin of a user to provide a stimulus to the user, the device comprising:
14. The device of example 13 wherein the housing further includes a recess, and wherein the contacts are positioned within the recess.
15. The device of example 14 wherein the recess defines a creepage from the contacts of about 8 mm.
16. The device of any one of examples 13-15 wherein the recess defines an air gap proximate to the contacts of about 5 mm.
17. The device of any one of examples 13-16 wherein the power circuitry is configured to be electrically coupled to an external power source via a USB connector.
18. The device of any one of examples 13-16 wherein the power circuitry includes a power source.
19. A method of charging a wearable device having a stimulation surface, the method comprising:
20. The method of example 19 wherein positioning the wearable device on the charging station includes positioned the stimulation surface of the wearable device in a socket of the charging station such that the user cannot contact the stimulation surface while the device is receiving power.
Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. The word “or,” in reference to a list of two or more items, covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list.
The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. While specific embodiments of, and examples for, the present technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the present technology, as those skilled in the relevant art will recognize. The teachings of the present technology provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments. All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the present technology can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the present technology.
These and other changes can be made to the present technology in light of the above Detailed Description. While the above description details certain embodiments of the present technology and describes the best mode contemplated, no matter how detailed the above appears in text, the present technology can be practiced in many ways. Details of the system may vary considerably in its implementation details, while still being encompassed by the present technology disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the present technology should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the present technology with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the present technology to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the present technology encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the present technology.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2019/068477 | 12/24/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62785526 | Dec 2018 | US |
