Patent Application
20200155830
The subject matter described herein relates to a handheld nasal stimulator and related methods of use.
Dry Eye Disease (“DED”) is a condition that affects millions of people worldwide. More than 40 million people in North America have some form of dry eye, and many millions more suffer worldwide. DED results from the disruption of the natural tear film on the surface of the eye, and can result in ocular discomfort, visual disturbance and a reduction in vision-related quality of life. Activities of daily living such as driving, computer use, housework and reading have also been shown to be negatively impacted by DED. Patients with severe cases of DED are at risk for serious ocular health deficiencies such as corneal ulceration, and can experience a quality of life deficiency comparable to that of moderate-severe angina.
The etiology of DED is becoming increasingly well understood. DED is progressive in nature, and fundamentally results from insufficient tear coverage on the surface of the eye. This poor tear coverage prevents healthy gas exchange and nutrient transport for the ocular surface, promotes cellular desiccation and creates a poor refractive surface for vision. Poor tear coverage typically results from: 1) insufficient aqueous tear production from the lacrimal glands (e.g. secondary to post-menopausal hormonal deficiency, auto-immune disease, LASIK surgery, etc.), and/or 2) excessive evaporation of aqueous tear resulting from dysfunction of the meibomian glands. Low tear volume causes a hyperosmolar environment that induces an inflamed state of the ocular surface. This inflammatory response induces apoptosis of the surface cells which in turn prevents proper distribution of the tear film on the ocular surface so that any given tear volume is rendered less effective. This initiates a vicious cycle where more inflammation can ensue causing more surface cell damage, etc. Additionally, the neural control loop, which controls reflex tear activation, is disrupted because the sensory neurons in the surface of the eye are damaged. As a result, fewer tears are secreted and a second vicious cycle develops that results in further progression of the disease (fewer tears cause nerve cell loss, which results in fewer tears, etc.). Accordingly, effective treatment for dry eye is desired.
Aspects of the current subject matter include various embodiments of a handheld stimulator system configured to provide a stimulation to a subject. The handheld stimulator system may include a nasal stimulator probe and a stimulator body. In one aspect, an embodiment of a nasal stimulator probe is configured to releasably couple to a stimulator body for providing a stimulation to nasal tissue of a subject. The stimulator probe may include a first extension of a first nasal insertion prong configured for insertion into a nasal cavity. Additionally, the stimulator probe may include a first electrode configured to provide the stimulation and coupled to a distal end of the first extension. In addition, the first electrode may include a conductive plastic material.
In some variations one or more of the following features can optionally be included in any feasible combination. In some embodiments, the conductive plastic material may include a carbon black material. In some embodiments, the conductive plastic material may include one or more of a graphene material, carbon fibers, and a metal polymer. The conductive plastic material may assist with providing a conductive pathway between a power source in the stimulator body and nasal tissue. The first electrode may include a shape having an arc of a cylindrical surface. The first electrode may include an outer contact wall including a radius of approximately 3 mm to approximately 7 mm.
In some embodiments, at least a part of the first electrode may be covered with a biocompatible conductive coating and/or a titanium material. In some embodiments, the conductive plastic material may include one or more of a polyethylene material, an ethylene vinyl acetate material, and a polypropylene material. In some embodiments, the conductive plastic material of the first electrode may include a volume comprising approximately 3% to approximately 30% carbon black filler.
In some embodiments, the first electrode may be in electrical communication with a power source positioned in the stimulator body when the nasal insertion probe is coupled to the stimulator body. In some embodiments, the nasal insertion probe may further include a second extension of a second nasal insertion prong configured for insertion into a nasal cavity, as well as a second electrode coupled to a distal end of the second extension and including the conductive plastic material.
In another aspect of the current subject matter, an embodiment of a handheld stimulator system is configured to provide a stimulation to nasal tissue of a subject and includes a stimulator body including a power source. The handheld stimulator system may further include a nasal stimulator probe configured to releasably couple to the stimulator body. The nasal stimulator probe may include a first extension of a first nasal insertion prong configured for insertion into a nasal cavity, as well as a first electrode configured to provide the stimulation and coupled to a distal end of the first extension. The first electrode may include a conductive plastic material
In another interrelated aspect of the current subject matter, a method includes delivering, via a conductive plastic material of a nasal stimulator probe of a handheld stimulator system, a stimulation to a nasal tissue of a subject. The nasal stimulator probe may include a first extension of a first nasal insertion prong configured for insertion into a nasal cavity, as well as a first electrode configured to provide the stimulation and coupled to a distal end of the first extension, the first electrode including a conductive plastic material. In some embodiments, the method can further include releasably coupling the nasal insertion probe to a stimulator body including a power source.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.
The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawings,
When practical, similar reference numbers denote similar structures, features, or elements.
This disclosure describes devices, systems, and methods for treating one or more conditions (such as dry eye) by providing stimulation to nasal or sinus tissue. The devices and systems may be configured to stimulate nasal or sinus tissue. In some variations, the devices may comprise a stimulator body and a stimulator probe, where the stimulator probe comprises one or more nasal insertion prongs. The stimulus delivered by the stimulators described herein may be electrical. When the devices and systems are used to treat dry eye, the methods may comprise stimulating nasal or sinus tissue to increase tear production, reduce the symptoms of dry eye, or improve ocular appearance and/or health.
Furthermore, embodiments of a stimulator are described that include conductive plastic electrodes. Such conductive plastic electrodes may be formed in a variety of shapes and sizes and configured to provide a desired resistance. As will be described in greater detail below, some embodiments of the conductive plastic electrodes may include a carbon black material that is added to a plastic material to thereby make the plastic material conductive. The conductive plastic electrodes may provide a variety of benefits, including improved cost and efficiency related to the manufacturing and assembly of the stimulator. Other benefits are also within the scope of this disclosure.
Some variations of the stimulation systems described here may comprise a handheld stimulator.
The stimulus may be delivered to a subject via the stimulator probe 104. In some variations, the stimulator body 102 and stimulator probe 104 may be reversibly attachable. In other variations, the stimulator probe may be permanently connected to the stimulator body. Some or all of the stimulator 100 may be disposable. In other variations, one or more portions of the stimulator 100 may be reusable. For example, in variations where the stimulator probe 104 is releasably connected to the stimulator body 102, the stimulator body 102 may be reusable, and the stimulator probe 104 may be disposable and periodically replaced.
In some variations, the stimulus may be electrical. In these instances, each nasal insertion prong may comprise at least one electrode. As shown, the stimulator probe 104 may comprise a first electrode 110 on nasal insertion prong 106 and a second electrode 112 on nasal insertion prong 108. As shown in the cut-away view of the stimulator 100 in
The power source may be any suitable power supply capable of powering one or more functions of the stimulator, such as one or more batteries, capacitors, or the like. In some embodiments, the stimulator body 102 comprises a power source, in other variations the stimulator body 102 need not comprise a power source. In some variations, the stimulator body may comprise a port, cord, or other mechanism for connecting the stimulator to an external power source (such as a wall outlet or separate battery pack), which in turn may be used to power one or more portions of the stimulator.
As shown in
As discussed above, the nasal insertion prongs 106 and 108 may be configured to be inserted in a subject's nostrils, however, the nasal insertion prongs 106 and 108 may be configured for stimulating other facial tissue. As shown in
When the stimulators described here are configured to deliver an electrical stimulus, at least one of the nasal insertion prongs may comprise one or more electrodes configured to deliver a stimulus to tissue. In variations where a stimulator comprises two nasal insertion prongs, each of the two nasal insertion prongs may comprise at least one electrode. For example, having multiple electrode-bearing prongs may allow the stimulator to provide bipolar stimulation (and/or bilateral stimulation of two nostrils).
Various embodiments of electrodes are described herein. In some embodiments, the electrode is made from one or more conductive materials. In some variations, the electrode may comprise one or more materials configured to promote electrical contact between electrodes of the stimulator probe and tissue (i.e., all of an electrodes or a portion of the electrode, such as a covering). In some instances, the impedance provided by tissue may be at least partially dependent on the presence or absence of fluid-like materials (e.g., mucous) in the nasal cavity. The material(s) may help to minimize the impact of subject tissue impedance by providing a wet interface between the electrode and tissue, which may act to normalize the impedance experienced by the electrodes. This may in turn normalize the output and sensation experienced by the user.
As shown in
In some implementations, during manufacturing of the conductive plastic electrode, the carbon black filler may be uniformly dispersed using a melting and mixing process. Furthermore, the conductive plastic electrode may be formed using any one of a variety of molding techniques.
In some variations, at least one conductive plastic electrode may further be covered with a biocompatible conductive coating, such as along a surface of the conductive plastic electrode that is configured to contact a tissue surface. Such a conductive coating may allow current and/or stimulation to pass therethrough while providing a protective barrier between the user and the conductive plastic electrode. For example, the biocompatible conductive coating may be made out of a titanium material, however, other materials are within the scope of this disclosure.
As shown in
In variations in which the electrodes 110 and 112 comprise an arc of a cylindrical surface, such as in the variation shown in
Although the electrodes 110 and 112 described above may comprise an arc of a cylindrical surface, it should be appreciated that the electrodes described herein may have any suitable shape. In some other variations, for example, the electrodes 110 and 112 may comprise two or more adjacent arcs of a cylindrical surface. For example, the nasal insertion prongs 106 and 108 may comprise two semi-cylindrical electrodes. In yet other variations, the electrodes 110 and 112 may comprise a portion of an arc of a cylindrical surface, wherein the portion of the arc comprises rounded edges. In some other variations, for example, an electrode may be ellipsoid or spherical, ovoid, or the like. In yet other variations, the electrodes may comprise an array of electrodes. In some variations, having an array of electrodes may allow a stimulus to be delivered to tissue even if one or more of the electrodes in the array fails, and/or may facilitate unilateral stimulation with a single nasal insertion prong.
In some variations, the center of the electrodes 110 and 112 may face each other. In some variations, the center of the electrodes may be positioned at an angle relative to each other. As such, for example, when the stimulator probe 104 is positioned such that the first nasal insertion prong is positioned in a first nostril and the second nasal insertion prong is positioned in the second nostril, the electrodes 110 and 112 may be directed partially toward the front of the nose.
The electrodes 110 and 112 may be positioned on any suitable longitudinal portion or portions of the nasal insertion prongs. The position of the electrode along the prong may at least partially determine the placement of the electrode relative to tissue when the stimulator probe is advanced into the nose. In some variations, the electrodes may be positioned such that when inserted into the nasal cavity, the electrodes are capable of reaching the nasal mucosa or other area desired to be stimulated.
When a nasal insertion prong or prongs of the stimulators described herein comprise one or more electrodes, the electrodes may comprise leads. When the stimulator probe is connected to a stimulator body, the leads may contact the circuitry of the stimulator body to electrically connect the electrodes to the stimulator body circuitry, as described in more detail below. As such, the leads may extend at least partially through each of the nasal insertion prongs. The leads may be formed from one or more conductive materials (e.g., stainless steel, titanium, platinum or platinum-iridium, other alloys thereof, or the like), conductive ceramics (e.g., titanium nitride), and may be positioned such that at least a portion of each lead contacts a respective electrode to provide a conduction pathway between the lead and the electrode.
For example, as shown in
In the descriptions above and in the claims, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B;” “one or more of A and B;” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C;” “one or more of A, B, and C;” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.
The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail herein, other modifications or additions are possible. In particular, further features and/or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and sub-combinations of the disclosed features and/or combinations and sub-combinations of one or more features further to those disclosed herein. In addition, the logic flows depicted in the accompanying figures and/or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. The scope of the following claims may include other implementations or embodiments.
The current application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional patent application Ser. No. 62/768,584, filed on Nov. 16, 2018 and entitled “Nasal Neurostimulation Device With Electrically Conductive Plastic Electrode,” which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62768584 | Nov 2018 | US |
