Patent Application
20190117974
The present disclosure is directed to a transcutaneous nerve stimulation device and system for treating overactive bladder (OAB) and its symptoms. The devices and systems described herein are intuitively shaped to enable proper placement by the user to stimulate the user's tibial nerve.
Overactive bladder (OAB) is a common condition that affects millions of Americans. As many as 30% of men and 40% of women in the United States live with OAB symptoms. The most common symptom of OAB is a sudden urge to urinate that one cannot control (sometimes referred to as urge incontinence), which can lead to wetting accidents. Having to go to the restroom many times during the day is common for people suffering from OAB. And, the number of people suffering from OAB is likely larger than is thought, because many people living with OAB do not talk to their health care provider about the condition or ask for help to treat the condition. Some are embarrassed by the condition and others do not discuss the condition or ask for help because they believe there are not any treatments for OAB.
Management of OAB often begins with behavioral strategies, such as fluid schedules, timed voiding, and bladder-holding techniques using a person's pelvic floor. If these behavioral strategies do not help enough, medications are available. However, many people have reservations about taking medications and medications may have unwanted side effects. Another treatment for OAB requires the surgical implantation of a nerve stimulator by a doctor or, for women, an electrical stimulation treatment may be administered via an intravaginal probe or may be worn intravaginally or perineally. These treatments can be difficult to administer or uncomfortable for the user, particularly when used for a long period of time.
Thus, there is a need for an OAB treatment that is non-invasive, effective, can be applied by the user by herself or himself (without assistance from another person, including a medical professional), is less obtrusive, and is available without a prescription.
The present disclosure relates to a topical nerve stimulation device for treating overactive bladder in a human user, the device comprising: at least two electrode configured to contact a surface of the medial ankle; a power source in electrical communication with the electrodes; wherein the device is shaped and configured for placement proximate to the medial malleolus to stimulate the tibial nerve.
The present disclosure also relates to a topical nerve stimulation system for treating overactive bladder in a human user, the system comprising: (a) a body-facing layer; (b) a garment-facing layer; (c) at least two electrodes, the electrodes configured to contact a surface of the medial ankle, and a power source in electrical communication with the electrodes, the power source disposed intermediate the garment-facing layer and the body-facing layer; wherein the system is shaped and configured for placement proximate to the medial malleolus to stimulate the tibial nerve.
The present disclosure also relates to methods of treating overactive bladder and/or its symptoms comprising a) providing the device or system disclosed herein to a user experiencing a symptom of overactive bladder; b) affixing the device of claim 1 to one of the user's medial ankles; c) activating or stimulating the tibial nerve of the user.
The terms “stimulate” and “activate” will be used interchangeably throughout the application.
It will be understood that when an element is referred to as being “connected to” or “coupled to” or “in electrical communication with” to another element, it can be directly connected to, coupled to, or in electrical communication with the other element or intervening elements may be present. In contrast, if an element is referred to as being “directly connected” or “directly coupled” or “in direct electrical communication with” to another element, there are no intervening elements present.
To facilitate understanding, like or identical reference numerals have been used, where possible, to designate like or identical elements common to the figures.
The disclosure relates to an electrical stimulation or activation device and a related electrical stimulation or activation system for treatment of over active bladder (OAB) and its symptoms in a human user via transcutaneous electrical nerve stimulation. The devices described herein are small, light, and intuitively shaped to enable proper placement by the user to stimulate the user's tibial nerve 300. Advantages of the devices over existing transcutaneous electrical nerve stimulation devices are: easy and intuitive for the user to apply, without the assistance of a medical professional or other person; require less power to operate; lower overall profile and a smaller footprint over a surface, such as a user's skin surface; more compact; less obtrusive; discrete; fewer parts and easier to manufacture or assemble; integrated power, communications, stimulating, and optionally sensing; inexpensive; disposable; convenient; no wires to become entangled in clothing; showerproof and sweat proof; allows for control of stimulation parameters from a remote device such as a smartphone, either directly by the user or by stored programs. The devices described herein effectively activate a target nerve(s), while not affecting untargeted nerves. The devices described herein are expected to have service lifetimes of days to weeks and their disposability places less demand on power sources and battery requirements.
Reference is now made to
As seen in
The device may also include an amplitude modulator (not shown) in electrical communication with the electrical signal generator, such as the modulator having the designation On-Semi MC1496, which is sold by Texas Instruments. The modulator generates a modulated waveform that is transmitted to the electrodes 102, which in turn apply the modulated waveform to the target nerve.
As seen in
The electrodes 102 of the device are applied to the skin and provide electrical stimuli through the skin to the tibial nerve 300. At least one electrode is an anode and at least one electrode is a cathode, with current flowing from an anode to a cathode. Stimuli may typically be trains of voltage-regulated square waves at frequencies between 1 and 150 Hz with currents between 20 and 100 mA. Stimuli may be either initiated by the user when desired, or programmed according to a timed schedule, or optionally initiated in response to an event detected by a sensor 118 that monitors some biometric of the user. The electrodes 102 may optionally collect electrical signals from the body to provide data about body functions.
Suitable electrodes 102 include both dry and floating electrodes. Dry electrodes are in direct contact with skin, where as floating electrodes use an electrolytic gel as a chemical interface between the electrode and skin. The electrolytic gel may form reliable electrical interconnections between the electrodes 102 and a user's skin and may help affix the device to the surface of a user's skin, e.g., self-adhesive hydrogel electrodes. Electrodes 102 can comprise metal, conductive polymers, electrically conductive thin films, conductive carbon. Electrolytic gels are typically hydrogels. One such electrode is commercially available as Sticky Pad™ Surface electrode sold by Rhythmlink® TENS Pros Premium® TENS Stim Electrodes is another example. The hydrogel may be as thin as possible, in order to lower the profile of the device.
Each electrode 102 may have a body-facing surface area of from about 500 mm2 to about 1100 mm2. The electrodes 102 may have different or identical body-facing surface areas. The sum of the body-facing surface areas of the electrodes 102 may be less than 3,000 mm2, preferably from about 1050 mm2 to about 2200 mm2, more preferably from about 500 mm2 to 2200 mm2.
The electrodes 102 may be spaced about 1 mm apart to about 100 mm apart (edge to edge), preferably about 5 mm apart to about 80 mm apart, more preferably about 10 mm apart to about 60 mm apart. The distance between the electrodes 102 may be selected to maximize the effectiveness of the electrical signal at the target nerve and/or minimize the footprint of the nerve stimulation system (as described above).
Table 1 shows the number of pulses per treatment measured against two parameters, frequency and duration. Frequency is shown on the Y-axis and duration on the X-axis. Referring to Table 1, a frequency setting of 20 Hz and duration of 10 seconds produces 200 pulses.
The power source 112 may be a low voltage power source, providing a nominal voltage of at most 10.0 volts, at most 8.0 volts, at most 6.0 volts, at most 5.0 volts, at most 4.0 volts, or at most 3.0 volts. The power source 112 may be a battery. Batteries of different shapes and sizes may be used, where the shape and size of the battery may be selected based, at least in part, on the shape and size of the topical nerve stimulation device. Suitable batteries include alkaline batteries, silver batteries, zinc-air batteries, lithium ion batteries, lithium polymer batteries, nickel oxyhydroxide batteries, and mercury batteries. The batteries may be printable batteries, button batteries, or any other common batteries. The battery may be rechargeable.
The battery may have a capacity of less than about 1000 milliampere hours (mAh) or from about 1 mAh to about 1000 mAh, preferably from about 1 mAh to about 500 mAh, more preferably about 1 mAh to about 100 mAh, even more preferably about 1 mAh to about 50 mAh.
The electrical signal generator (also referred to as an electrical pulse generator) generates an electrical signal, preferably an electrical signal configured or adapated to stimulate a target nerve. When the electrodes 102 receive the signal from the generator, the electrodes 102 draw energy from the power source 112, e.g., battery, and generate an electrical field of suitable strength to stimulate the target nerve. The electrical field may intersect or overlap the target nerve. The electric field may activate the nerve by triggering its action potential, causing the nerve to send signals along its pathway. The electrical signal generator may be of any suitable type, such as those sold by Texas Instruments of Dallas, Tex. under model number NE555.
The signal activator may be coupled with the power source 112 for turning on the device. The signal activator may be a single-use activator that is configured to be turned on only one time. The signal activator may be a switch, such as a push button switch.
The electrodes 102 and the electrical components of the nerve stimulation device, as described herein, may be combined or assembled with any suitable materials to create a nerve stimulation system. Minimally, the system may consist of or consist essentially of the electrodes 102 and the selected electrical components (in appropriate electrical communication, as described above) and few, if any, other materials, for example, the electrodes in electrical communication with the power source 112, where the electrodes 102 and power source 112 are mounted on a film that is cut to fit the electrodes 102 and the power source 112.
The electrodes 102a, 102b may be integrated in the body-facing layer. The body-facing layer 510 may include openings 540 extending therethrough that accommodate the electrodes 102a, 102b and allow direct contact of the electrodes with the surface of the user's skin. Integrating the electrodes into the body-facing layer 510 may minimize the size and footprint of the system, e.g., lower overall profile and/or smaller footprint over the surface of the user's skin. The electrodes 102a, 102b may be held in place by the garment-facing 520 or non-body-facing 520 layer. The electrodes may be arranged in a variety of configurations. The distance between the electrodes may be selected to maximize the effectiveness of the electrical signal at the target nerve and/or minimize the footprint of the nerve stimulation system (as described above).
The electrical components, including the power source 112, the optional electrical signal generator 106, the optional signal activator 108, and any other optional components as described herein, are disposed intermediate the body-facing layer 510 and the garment-facing layer 520 layer. The other electrical components may be arranged in any configuration, provided that the optional electrical signal generator is in electrical communication with the electrodes, the optional signal activator is coupled to or in electrical communication with the optional electrical signal generator, and the power source 112 is in electrical communication with the optional electrical signal generator and the optional signal activator.
The body-facing layer 510 may be a layer of one or more materials that forms at least a portion of the inside of the system and faces a wearer's skin when the system 500 is worn by the wearer. A body-facing layer is sometimes referred to as an adhesive layer. The body-facing layer 510 may be configured to be flexible and to carry the adhesive. A body-facing layer 510 may include a woven material, a nonwoven material, plastic material, latex material, hydrogel material, hydrocolloid material, and/or other materials as long as the materials are suitable for carrying adhesive.
The garment-facing or non-body-facing layer 520 may be a layer formed of one or more materials that form at least a portion of an outside of the system 500 and may face a wearer's garments, e.g., pants, socks, when the system 500 is worn by the wearer. A garment-facing layer 520 is sometimes referred to as a backsheet or backing layer. The garment-facing layer 520 may be configured to be flexible and may be liquid impermeable or may be breathable. A garment-facing layer 520 may include plastic material (injection molded, blow molded, thermoformed etc.), coated or uncoated paper, a nonporous film, a porous film, a woven material, a non-woven fibrous material or combinations thereof. The outer cover may also be stretchable, extensible, elastically extensible, or elastomeric. The garment-facing layer 520 may also be vapor permeable and yet liquid impervious.
The system can also be made more comfortable by the addition of material between the garment-facing layer 520 and the body-facing layer 510, such as cushioning material 530 that can cushion the electrodes 102a, 102b and electronic components. The cushioning material 530 may be disposed subjacent to the body-facing layer 510 and superjacent to the garment-facing layer 520, in at least a portion of the system 500. A cushioning material may include cellulosic fibers (e.g., wood pulp fibers), other natural fibers, synthetic fibers, woven or nonwoven sheets, scrim netting or other stabilizing structures, superabsorbent material, foams, binder materials, or the like, as well as combinations thereof.
Any conventional adhesive layer materials may be used within the device system. Suitable adhesive layers may be made from plastic materials, nonwoven materials, silicone, acrylic, hydrogel, or latex, including polyvinylchloride, polyethylene, polyurethane. Polymeric materials suitable for use in forming nonwoven materials include polyolefins such as polyethylene and polypropylene, polyesters, nylons, ethylene vinyl acetate, ethylene methacrylate, copolymers of the above materials, and the like.
Pressure sensitive adhesives have been commonly found to work well for this purpose. The adhesive may be continuous or intermittent. For example, the adhesive may be applied in strips or across the entire surface of the backing layer. The adhesive may be applied via any suitable method, including, but not limited to spraying, printing, kiss coating, and direct slot coating.
Any conventional backing layer materials may be used, such as polyolefinic films or nonwoven webs. The backing layer may or may not be breathable. The backing layer may be suitable for printing.
Any conventional cushioning materials may be used within the device system. Suitable cushioning materials include comminuted wood pulp which is generally referred to as airfelt; creped cellulose wadding; absorbent gelling materials including superabsorbent polymers such as hydrogel-forming polymeric gelling agents; chemically stiffened, modified, or cross-linked cellulose fibers; meltblown polymers including co-form; synthetic fibers including crimped polyester fibers; tissue including tissue wraps and tissue laminates; capillary channel fibers; absorbent foams; absorbent sponges; synthetic staple fibers; peat moss; or any equivalent material; or combinations thereof.
Typically, selectivity in activating nerves has required electrodes to be implanted surgically on or near nerves or, for transcutaneous stimulation, has required electrial beam steering. The device and system described herein, however, provides selective activation to the tibial nerve 300 transcutaneously, without the need for beam steering. The effectiveness of the device and system described herein for treating and/or managing the symptoms of OAB depends, in large part, on positioning the electrodes at the appropriate location on the user's body in order to stimulate the tibial nerve 300. Without proper positioning of the electrodes, the user may not get the full benefit or, in some cases, any benefit from the device.
The tibial nerve 300 is a branch of the sciatic nerve that passes alongside the tibia and into the foot. At the ankle, the tibial nerve 300 is relatively close to the surface of the skin. Positioning the electrodes at a location where the tibial nerve 300 is close to the skin allows for the device itself to be smaller and lighter, because less battery power is required to stimulate the nerve close to the skin. Also, there are few other (untargeted) nerves in the ankle, making it less likely that the generated electric field affects untargeted nerves.
The electrodes may be positioned on the ankle in a variety of ways, however, not all positions are effective. For example, it is not preferred to position one or more of the electrodes on the lateral side of the ankle, as the tibial nerve 300 is not close to the skin on the lateral side of the ankle. Also, positioning on the lateral side of the ankle may activate pain nerves. Positioning the electrodes above the ankle is not preferred, as the tibial nerve 300 is covered by muscle above the ankle, which requires more energy is required to activate the nerve. Positioning the electrodes on the top or bottom of the foot is not preferred, as the tibial nerve 300 branches out in the foot, making it more difficult to activate at this location (also such positioning may cause discomfort while walking or standing).
Also, the electrodes may be positioned transversely across the path of the tibial nerve 300 or axially along the path of the tibial nerve 300. If the electrodes are arranged transversely across the nerve, then more battery power may be required to stimulate the nerve. The electrodes are preferably arranged axially along the nerve (as shown in
For a comparative example, a tibial nerve stimulation system, where at least four electrodes are placed around the circumference of the ankle, is known. This configuration may require more precise electrode placement, likely by a medical professional, and electrical beam steering technology to reliably stimulate the tibial nerve 300. This approach may also require significantly more electrical energy, e.g., higher voltage, which can negatively activate the pain nerves.
It has been found that communicating to the user to align and affix the device or system, such that the electrodes are positioned in the desired locations on the ankle, is a challenge. Instructions including writing, illustrations, or orientation marks for properly aligning and affixing the device or system may be included on the device or system itself, in the packaging for the device or system, or on the packaging of the device or system. However, users may dispose of the instructions without reading them, for example, when disposing of the packaging, or simply ignore the instructions. A very effective way to communicate to a user to properly affix the device or system, such that the electrodes are positioned in the desired location on the ankle, is by selecting one or more anatomical landmarks on the ankle and making the shape of the device or system complement or complete the anatomical landmark(s). By selecting an appropriate anatomical landmark(s) on the ankle and then by designing the shape of the device or system to complement or complete the landmark, a device or system that is intuitive for the user to align and affix properly is provided. Suitable anatomical landmarks include the achilles tendon (310), the heel 330, the arch (340), the medial malleolus (320), the lateral malleolus (not shown), or combinations thereof, as seen in
The sides and edges of the ankle are generally nonlinear. As used in the context of the present specification, the term “nonlinear” refers to any of various curved, as opposed to straight, lines. As shown in
As shown in
The device or system may weigh less than about 30 g, preferably from about 1 g to about 30 g, more preferably from about 5 g to about 20 g, even more preferably from about 2 g to about 15 g. The area of the body-facing surface of the device or system may range from about 500 mm2 to about 9000 mm2, preferably about 750 mm2 to about 4100 mm2, more preferably about 750 mm2 to about 3500 mm2. The ratio of the body-facing surface area of the device or system to the sum of the body-facing surface areas of the electrodes may be from about 1:1 to about 5:1, preferably about 1:1 to about 4:1, more preferably about 1:1 to about 3:1. The device or system may have a maximum thickness of about 0.10 mm to about 15 mm, preferably about 0.10 mm to about 10 mm, more preferably 0.10 mm to about 5 mm Thickness may be measured using any number of known methods.
The topical nerve activation system described herein may be camouflaged to make the system less obtrusive and more discrete. Camouflaging includes matching the color of the system to the skin tone of the user, matching the color of the system to a user's garment, or disguising the system as something less upsetting to the user, such as a blister pad. Camouflaging may also include a very colorful, bright system or a system having a colorful design, to make the system look like an accessory or a tattoo.
The present disclosure also relates to a method of treating overactive bladder and/or its symptoms comprising: a) providing the device or system as disclosed herein to a user experiencing a symptom of overactive bladder; b) affixing the device or system as disclosed herein to one of the user's medial ankles, preferably proximate to and posterior to the medial malleolus; c) optionally turning on the device or system of any one of the preceding paragraphs; d) activating or stimulating the tibial nerve of the user.
A. A topical nerve stimulation device for treating overactive bladder in a human user, the device comprising:
This application claims the benefit of U.S. Provisional Application Ser. No. 62/574,625, the entirety of which is incorporated by reference herein. Also, numerous suitable nerve stimulation devices, including components of the devices and protocols for operating the devices, are described in U.S. patent application Ser. No. 15/912,058, and U.S. Pat. No. 10,016,600, both of which are hereby incorporated by reference.
The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 mm” is intended to mean “about 40 mm.”
Every document cited herein, including any cross referenced or related patent or application and any patent application or patent to which this application claims priority or benefit thereof, is hereby incorporated herein by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with respect to any invention disclosed or claimed herein or that it alone, or in any combination with any other reference or references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.
While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.
| Number | Date | Country | |
|---|---|---|---|
| 62574625 | Oct 2017 | US |
