Patent Application
20240269036
The present invention relates generally to the field of medical devices and, more specifically, to a handheld device that stimulates the meibomian glands of the eyelid mechanically.
For most people, once they develop meibomianitis, the condition lasts a lifetime. Untreated meibomian gland disease can lead to dry eye syndrome, ocular infection and/or inflammation of the eyelids (referred to as either or both anterior or posterior blepharitis). Posterior blepharitis, if untreated, can lead to corneal disease, which can lead to temporary, blurred vision, in severe cases, permanent loss of visual acuity.
Meibomian gland dysfunction, “Dry eye” and chronic marginal eyelid inflammation are widespread problems, especially in middle age and geriatric populations worldwide. In fact, “Dry eye” is the world's most common eye disease, and the problem is so widespread that this topic is covered in virtually every ophthalmic medical textbook and is the sole focus for groups of international researchers such as the Tear Film and Ocular Surface Society. “Dry eye” indicates the lack of quantity and/or quality of the tear film. In the human eye, the tear film covering the ocular surfaces is composed of three components creating two distinct layers. The innermost component which is in contact with the ocular surface is comprised of many mucins emanating from the goblets cells and is mixed with the aqueous secretions emanating from the aqueous gland. The aqueous component comprises the bulk of the tear film. and is secreted from the Aqueous/Lacrimal gland. The outermost layer is a thin (less than 250 nm) layer (“lipid layer”) comprised of many lipids secreted from the Meibomian Glands. The typical upper eyelid has about 25 meibomian glands and the lower eyelid has about 20 meibomian glands. The meibomian gland orifices open onto the eyelid margin at and around the junction of the inner mucous membrane and the outer skin of the eyelids; that junction is termed the mucocutaneous junction.
Dry eye disease is the result of a malfunction in the tear. Tears of the eye are made from different elements. The majority of the tear film is thin fluid that comes from the lacrimal gland, which is located directly above the eye. The quantity and quality of this fluid is usually not the problem. The meibomian glands, which are located throughout both the upper and lower eyelids and number in the range of twenty per lid, secrete an oily material (lipids), that keeps the watery part of tears (i.e., the fluid secreted by the lacrimal gland) from evaporating. This material is normally secreted/expressed with each blink. It is the dysfunction of these glands that is the problem for most people who suffer from dry eye conditions.
Dry eyes used to be viewed as problematic for patients and doctors alike. Historically, dry eye patients were seen by doctors as “high-touch and low-pay,” an unsustainable model for any practice. There were a limited number of effective treatments, all were expensive and payment for most in-office dry eye procedures remains out-of-pocket which can be frustrating and expensive for patients and doctors. Due to the cost and general lack of availability, Dry Eye patients were considered the nomads of the eye care world. These patients would see, on average, 3.5 different practices prior to choosing a given practice. The introduction of an avalanche of dry eye products, is resulting in competition that has created an environment where only the most effective products, priced within reach of the average patient in this fee-for-service market, are being adopted by this large and rapidly expanding market.
In individuals with healthy tear secretion, the oily material secreted by the meibomian glands is relatively warm and runny. As the normal human ages, the outflow of the meibomian glands decreases, thereby reducing tear contact time and causing a marked decrease in tear quality. In some individuals with long-standing meibomian gland dysfunction, secretions may cease altogether. As a result, the oily material that should have the consistency of olive oil, is instead semi-solid, like butter. When this happens, it is not easily secreted from the eyelid without being physically massaged.
The upward phase of blinking causes the upper eyelid to pull a sheet of the lipids secreted by the meibomian glands upward and over the other two layers of the tear film, thus forming a type of protective coating which limits the rate at which the underlying layers evaporate. Thus, a defective lipid layer or an incorrect quantity of such lipids can result in accelerated evaporation of the aqueous layer, which in turn, causes symptoms such as itchiness, burning, irritation, and dryness, which are collectively referred to as “dry eye”. When left untreated, the consequences of dry eye can be severe, and even result in loss of vision (e.g., from desiccation of the corneal epithelium, ulceration and perforation of the cornea, or an increased incidence of infectious disease).
Dry eye states have many etiologies. The most common cause of dry eye states is a disorder in which the glands are obstructed or occluded, usually referred to as “meibomian gland dysfunction” (“MGD”). Meibomian gland dysfunction is frequently the result of keratotic or biofilm obstructions which partially or completely block the meibomian gland orifices. Such obstructions compromise the secretory functions of the individual meibomian glands. More particularly, these obstructions can comprise combinations of bacteria, sebaceous ground substance, dead cells, and/or desquamated epithelial cells.
Additional causes of the dysfunction of the lipid layer are associated with eyelid margin inflammation (e.g., anterior and posterior blepharitis, hordeolum, sty, chalazion, and rosacea). The etiological factors of many of these inflammations include an overgrowth of bacteria (and/or parasites) and their toxic waste. These bacteria not only cause the lipid tear film to dysfunction, but they also destroy and block the very lipid-producing infrastructure by attacking the glands in the eyelid skin. Unfortunately, the particular types of bacteria and parasites that cause the inflammation/infections are common. The chance of having these on the eyelids is nearly 100%. By themselves, they are not dangerous, but it is the overgrowth of the biofilm and their toxic waste on the eyelid margin and the eyelashes that must be avoided. Allowing the bacteria and parasites to proliferate must be prevented, especially if one is diagnosed as a dry eye sufferer.
While the tear film operates as a singular entity and all of the layers are important, the lipid layer, which is secreted from the meibomian glands, is of particular significance as it functions to slow the evaporation of the underlying layers, to lubricate the eyelid during blinking, and to create an optically smooth surface which is responsible for approximately two thirds of the eye's refractive power; such slowing of evaporation and lubrication of the eyelid largely prevent “dry eye syndrome and/or Ocular Surface Disease”.
Thus, to summarize, the meibomian glands of mammalian eyelids (e.g., human), secrete oils that prevent evaporation of the tear film and provide lubrication to the eye and eyelids, and are primarily responsible for visual acuity. These glands can become blocked or plugged by various mechanisms leading to so-called “dry eye syndrome and/or Ocular Surface Disease”. While not the only cause, meibomian gland dysfunction is believed to contribute to or be the primary cause of approximately 86% of dry eye syndrome. Dry eye syndrome is characterized by a blockage of the meibomian glands, which prevents normal lipid secretions from flowing from the meibomian glands to form the lipid layer of the tear film.
Various treatment modalities have been developed to treat the dry eye condition, including drops which are intended to replicate and replace the natural tear film, and pharmaceuticals which are intended to stimulate the tear producing cells. Various heating devices are commercially available that are designed to assist in unclogging the meibomian glands by liquifying accreted meidbum blockages of the meibomian glands. Other techniques involve manual expression of the glands and manual scrubbing of the eyelid margins, which are difficult for a patient to actually accomplish without assistance of a trained professional.
Eye drops such as REFRESH®, SOOTHE®, and SYSTANE® brand eye drops are designed to closely replicate the naturally occurring healthy tear film. However, their use and administration are merely a treatment of symptoms and not of the underlying cause. The effect of applying eye drops is short-lived. Further, the use of drops is generally for an indefinite length of time and consequently, extended use can become burdensome and costly.
Since dry eye is exacerbated by eyelid margin debris and bacterial overgrowth, daily eyelid stimulation and hygiene is often prescribed by physicians and recommended by health institutions worldwide. This is for the life of the patient, because, as mentioned, dry eye is chronic, with no known cure. Unless proper eyelid stimulation and hygiene is instituted, meibomian gland dysfunction will likely progress and dry eye syndrome will only worsen with age.
Herein lie the unsolved problems. The existence of a safe and easy to use eyelid care device that enables self-administered eyelid treatment using a motorized handpiece is needed. Currently, the prior art associated with motorized appliances are for clinical use. A second problem is the risk of patient injury during training of eyelid care professionals, and of lay persons who use a motorized eyelid care appliance for cleaning their own eyelids (“self-administered cleaning” or “SA Cleaning”) or for cleaning others' eyelids (“second party cleaning” or “SP Cleaning”). The “second party” can be a pet (blepharitis and dry eye are common in dogs and cats). A third problem is that the prior art eyelid care devices with motorized handpieces use unidirectional rotary tools (aka “heads”) that become entangled with hair. A fourth problem is that eyelid care devices with rotary tools cause many patients to flinch when the tool first contacts the eyelid margin. Such flinching increases the risk of contact by the tool with the cornea, sclera, or other parts of the eye and resulting in laceration or other injury. A fifth problem is a lack of instrumentation of prior art motorized eyelid care devices, for which instrumentation (e.g., proximity monitoring, cleaning efficacy) and features (e.g., safety shutoff) would enable safer use of an eyelid care device as well as data collection and analysis of clinical signs and efficacy of cleaning. A fifth problem associated with high-speed rotational devices is the micro aerosolization of the pathogen containing biofilm which, in many cases, can spread live pathogens within a two-foot radius, thus creating a risk of contamination of the fellow eye, the operator, and any equipment that will be used on subsequent patients.
Additionally, the ability to massage and stimulate the meibomian glands while the eye is closed is beneficial to a majority of patients.
People tend to wash their face, but not their eyelids. Eyelid stimulation and hygiene should optimally be performed on a daily basis for maximum efficacy and optimal affect. Currently, only manual scrubbing methods with cloths, manual lids scrubs or fingers are available for daily home use, but such manual methods are incapable of generating sufficient vibration/stimulation to penetrate the eyelid to the level of the Meibomian glands. E.g., brushing one's teeth with a washcloth. Just as brushing one's teeth with a washcloth does not clean the gingival sulcus or mesio-distal aspects of teeth, an eyelid scrub typically contacts only the anterior ciliary margin and does not clean the entire confluence of the mucosal surface of the conjunctiva and the cutaneous epithelium. Even though daily eyelid hygiene is critically important for patients with an eyelid disease, there is typically poor compliance by patients for whom SA Cleaning is ordered by their ophthalmologist. Due to a lack of alternatives, “baby shampoo” and a washcloth or cotton-tipped swab is often recommended by ophthalmologists for a patient's SA Cleaning. This current “prescription” for eye hygiene has significant non-compliance issues, i.e., patients fail to perform SA Cleaning. For instance, in a “baby shampoo regimen”, the baby shampoo is mixed with warm or hot water in a prescribed ratio, and the solution is then applied with non-sterile applicators such as fingertips, cotton tips, or washcloths (typically, unsanitary). This results in an unsanitary process for the patient.
Although commercial “eyelid scrubs” are available in several forms, such as impregnated, pre-moistened towelettes or pads, or as bottled cleansers applied to a non-sterile applicator pad or to fingertips, such eyelid scrubs do not improve patient compliance or efficacy of the treatment. These rely on the individual to perform vigorous back and forth scrubbing of all four eyelid margins, which is cumbersome, time consuming, sometimes painful, and has uneven results. These factors are all strong disincentives to following an eyelid cleaning regimen.
Preventive and therapeutic interventions need to be more easily implemented at an earlier age or stage, of dry eye syndrome development, to decrease the likelihood of chronically scarred and/or dysfunctional meibomian glands. Lack of patient compliance is further evidenced by way of disproportionate commercial sales for eye care products. In contrast to the current US eyecare market for eye drops of $1 billion (excluding contact lens solutions), eyelid scrubs show less than $8 million in retail sales, which is a clear indication that people simply do not clean their eyelids.
Therefore, what is needed in the art is a system that is easy for the medical professional and patient to use to treat meibomianitis.
Currently the state of the art includes a number of devices and treatments that attempt to clean the openings of the meibomian glands as described above. These include various treatment modalities developed to treat the dry eye condition, including drops which are intended to replicate and replace the natural tear film, and pharmaceuticals which are intended to stimulate the tear producing cells. Various heating devices are commercially available that are designed to assist in unclogging the meibomian glands by liquifying accreted meidbum blockages of the meibomian glands. Other techniques involve manual expression of the glands and manual scrubbing of the eyelid margins, which are difficult for a patient to actually accomplish without assistance of a trained professional.
The invention in one form is directed to a device which comprises of a power supply (e.g., battery), motor, detachable head, drive system that causes oscillation of the head, controls, instrumentation, and a housing. “Distal” means herein toward the end of the eyelid care appliance on which the head is mounted. “Proximal” means herein toward the end of the eyelid care appliance in which the power supply and motor are mounted. This oscillation can create an orbital action that improves the scrubbing of the meibomian glands on the edge of the eyelids.
The device is specifically designed and configured to massage, vibrate, and stimulate the eyelids thereby eliminating any issue with damaging the eye by way of contact by the tool with the cornea, sclera, or other parts of the eye and resulting laceration or other injury.
A bristlehead or Soft-Tip that is detachably mated with the head receiver and protrudes from the housing along a second axis of the eyelid care appliance, the second axis being substantially perpendicular to the first axis, the bristlehead or Soft-Tip comprising a mount having a polygonal post configured to removably couple with a corresponding socket of the head receiver, the post and the socket oriented along the second axis, wherein friction between the post and the socket is configured to keep the bristlehead or Soft-Tip coupled to the head receiver during use. A bristlehead or Soft-Tip may be configured in a wide range of embodiments, some of which include various types of bristles, adjustable bristles, combinations of bristles and sponge, and other materials of varying topologies and degrees of abrasiveness.
The instant invention is a home-use eyelid hygiene system, MESHH (Mechanical Eyelid Stimulation and Home Hygiene), and is an example of this new, effective and affordable paradigm. Patients that use a device of the instant invention at home benefit from significantly reduced symptoms and clinical signs associated with dry eyes. In a thirty-day, multi-center trial clinical signs and symptoms improved on average by a factory of 2X as disclosed in Journal of Dry Eye, January 2020, Efficacy of Self-Administration of a Personal Mechanical Eyelid Device for the Treatment of Dry Eye Disease, Blepharitis and Meibomian Gland Dysfunction, Schanzlin, Olkowski, Coble et al.
Recently, eye care professionals have begun taking a page from their dentists' play books. The dental model, where patients visit the dentist every six months for a deep-cleaning and then perform ongoing maintenance with daily brushing and flossing at home, has been therapeutically and financially successful for decades. With the recent introduction of Device of the instant invention PRO, MESH, (Mechanical Eyelid Stimulation and Hygiene,) (MESH), to the already successful Device of the instant invention home-use product, Mechanical Eyelid Stimulation and HOME Hygiene, (MESHH), more and more ECP's are adopting the dental model for their patients with dry, red, irritated eyes.
Initially, ECP's hesitated to recommend a mechanical device to be used at home by patients on the eyelids due to safety concerns. Studies on donor corneas demonstrated that the Instant Invention is safe even if the tip inadvertently contacts the cornea. Well over two million at-home procedures and two additional safety studies later, the Instant Invention has maintained a perfect safety record with no valid complaints filed with the FDA. The change to the Indirect Method in early 2019, (using the Instant Invention device over closed eyelids, centered on the eyelashes), has virtually eliminated any remaining safety concerns, and demonstrated that the massaging and vibrating effect associated with the instant invention's unique oscillating motion was equally effective to in-office methods performed directly on the eyelid margins.
All aspects of The Instant Invention System's design philosophy and execution support the desired endpoints.
The unique oscillating movement of the instant invention is responsible for many of the improvements in effectiveness, hygiene, patient safety, and comfort. Unlike high-speed rotational devices designed only to remove accumulations of biofilm from the eyelid margins, the parallel positioning of the Instant Invention's disposable tip over the closed eyelids creates a 7-8 mm treatment zone along the external eyelids that delivers sub-sonic vibrations through the eyelids directly to the long axis of the Meibomian glands. The Instant Invention's “So Safe You Can do it with Your Eyes Closed” and “Good Vibrations!” campaigns speak to the primary mechanism of action; using subsonic oscillations in concert with a solid, flexible, disposable tip, and a gel to generate vibrations that penetrate the eyelid and vibrate the Meibomian glands to systematically break down meibum accretions within the Meibomian glands and allow the pristine meibum formerly trapped behind the accreted meibum plugs to work around and through the newly created fractures in the accretions and to ultimately expel the accreted material. This action is believed to be primarily responsible for the 82% improvement in MGYLS, (Meibomian Glands Yielding Liquid Secretions) demonstrated in the multi-center trial, as noted in the Journal of Dry Eye, January 2020, Efficacy of Self-Administration of a Personal Mechanical Eyelid Device for the Treatment of Dry Eye Disease, Blepharitis and Meibomian Gland Dysfunction, Schanzlin, Olkowski, Coble et al.
Additionally, oscillation is used in many devices to create a massaging effect. In Instant Invention, the massaging action is thought to reduce inflammation by helping to optimize capillary perfusion in the small vessels of the eyelid. Many doctors report that red, hot, swollen, and painful eyelids, (Rubor, tumor, calor and dolor are the primary signs of inflammation.), improve significantly after Instant Invention procedures. Elderly patients with grey, translucent, ischemic eyelids demonstrate improved lid color and comfort post-Instant Invention home-treatment. Removal of debris and biofilm is only a side-benefit of Instant Invention use. Care should be taken to monitor usage frequency and duration with all patients and particularly with elderly patients exhibiting fragile epidermis.)
The Instant Invention Gel is an important component of the procedure. Not only does the gel enhance patient comfort, but it is also necessary to improve efficient transmission of the therapeutic vibrations/sound waves. In a similar fashion to diagnostic ultrasound, the Instant Invention Gel improves transmission of vibrations thus enhancing the sub-sonic vibrations that are responsible breaking up accreted meibum plugs in situ.
The instant invention also provides a high level of safety need for a device that can be used at home by a patient. To ensure credibility, proper patient selection, and, above all, safety, the Instant Invention was only available to patients through their eye doctor during the first year of market availability. Probably the most edifying statement regarding Instant Invention safety is that Instant Invention, with over two million home users, has zero validated complaints to the FDA. (Between May of 2018 and April Of 2023 (the time of this writing), the FDA had received one complaint.) Upon investigation by the FDA, the complaint was found to be invalid.) Instant Invention uses sound and vibration in a unique way to improve dry, red, irritated eyes and eyelids. There are a number of design features that ensure safe self-treatment and/or safe treatment by doctors and staff:
The instant invention also provides a higher level of hygiene than traditional devices. Hygiene is an important consideration for any medically related procedure performed in the exam room or in the home. High-speed, rotational microblepharoexfoliation devices, (at the time of this writing, high-speed rotational microblepharoexfoliation devices were only available for professional use, not for use at home by patients.), develop significant centripetal forces which are responsible for micro aerosolization/micro splatter of the accumulated debris which collects on the swab. Some high-speed rotational microblepharoexfoliation devices splatter debris containing pathogens and parasites in the biofilm as far as two feet from the point of treatment. The combination of Instant Invention sub-sonic oscillating mechanism of action and the design of the Instant Invention disposable tip contribute to significant improvements in hygiene over all high-speed rotational devices. The sub-sonic, 200 Hz, oscillation cycle time does not create significant splatter. In addition, the circumferential wall surrounding the entirety of the tip traps most of the remaining lubricant and loosened debris. Finally, the low cost of the Instant Invention Procedure Pack materials makes it cost effective to use a fresh tip for every treatment.
The instant invention provides mediation for blepharitis. case study from Dr. Eric Brooker is consistent with the findings of other doctors that have added the Instant Invention home-patient-use version of MESHH (Mechanical Eyelid Stimulation and Home Hygiene), to their armamentarium. Note that the patient had experienced only partial mediation of his blepharitis using manual lid scrubs with tea tree oil and having undergone in-office microblepharoexfoliation. Only when the patient used Instant Invention (MESHH) at home on a daily basis did his chronic blepharitis resolve.
Dr. Eric Brooker is the founder of the Advanced Vision Institute in Las Vegas, NV which features a dry eye specialty clinic. He is an adjunct clinical professor for the Southern California College of Optometry, where he received his Doctor of Optometry.
Dr Brooker notes that chronic blepharitis is an ocular condition, which is primarily a chronic inflammation of the eyelid margin and also the cause of chronic ocular inflammation. Blepharitis can be anterior affecting the lid margins and skin and the base of the lashes or it can be posterior affecting the Meibomian glands and their orifices. Meibomian Gland Dysfunction (MGD) is chronic changes to the Meibomian glands which are caused by duct obstruction and changes to the meibum secretions. The changes result in tear film alterations that lead to evaporative dry eye and eventually chronic tissue damage. Some signs of blepharitis are; chronic redness of eye and lids, loss of eyelashes, distorted lid margins, granular tissue formation, marginal keratitis, limbal opacification, neovascularization of cornea, prominent vessels at lid margin, frothy discharge at eyelid margin, blocking of Meibomian orifices, turbid or absent excretions from Meibomian glands, trichiasis and eventual atrophy of Meibomian glands. Symptoms can present as red eyes, itchy eye lids, swollen eye lids, eyelashes sticking together, burning eyes, fluctuating vision, foreign body sensation, redness of the eyelids, or reoccurring styes. Doctors report 37-47% of patients present with some form of blepharitis and 50% of these patients have an associated dry eye condition.
Patient History: a 62-year-old white male. He presented complaints of fluctuating vision and occasional redness of eyelids and redness of the nasal conjunctiva. Also reported occasionally eyelashes feel sticky in the morning. He had not tried any additional treatments for this condition, nor had he been diagnosed with any ocular diseases in the past.
Initial Assessment: On the initial examination that patient was found to have UCDVA of OD 20/25 and OS 20/20 in the distance. Biomicroscopy examination revealed 3+ blepharitis superior OD with collarets and a biofilm on the superior and inferior lid.
Examination OS revealed 3+ blepharitis with collarets with a biofilm on the superior and inferior lid. Nasal conjunctiva presented with 1+ injection and nasal conjunctival sodium fluorescein staining bilateral in both eyes.
He also had an early progressive pterygium nasally in both eyes with trace superior punctate staining bilateral. His TBUT in the right eye was 8 seconds and 9 seconds in the left eye. The patient was diagnosed with chronic blepharitis with an associated evaporative dry eye condition that has begun to cause chronic tissue damage.
Treatment Strategy: This patient had recently retired and being prior military was very regimented in his lifestyle. He vowed that he was going to eliminate the blepharitis from his eyelids. He started on a tea tree-based lid scrubs QHS OU following his normal face washing regimen along with preservative free Oasis Tears. He was also instructed to change his pillowcases once a week. After one week of dedication to using lid scrubs the patient returned to clinic. On this visit he had improved the condition to 2+ blepharitis and the biofilm was still present. The manual lid scrubs despite the consistent usage were not effective at maintaining his condition. The patient was recommended to undergo an in-office blepharoexfoliation treatment with a doctor to get rid of the biofilm and get the patient back to baseline. Following the patient's consent, the procedure was performed successfully, and the patient was discharged in good condition. The patient was also started on Tobradex drops bid OU to keep down inflammation and attempt to improve the presentation of his ptergium that had developed over several years. The patient was also instructed to continue with manual lid scrubs bid OU. Upon his 2-week return visit, the patient had improved significantly but the blepharitis had already returned to a level 1+ bilaterally in the upper lashes. Patient education was given regarding the chronic aggressive nature of his condition. The doctors explained the need for a more aggressive solution that could address his blepharitis while also promoting improvement of his Meibomian gland secretions. We recommended Instant Invention automated MESHH treatment combined with Hypochlorous gel. Due to the regimented nature of this patient, we had reason to believe that, equipped with the appropriate at home treatment, he would be successful.
Outcomes: Following 1 week of treatment with the Instant Invention device prior to sleep, the patient returned to clinic for a follow up assessment. On assessment, the patient was found to have completely eliminated the blepharitis on both the superior and inferior lids of both eyes and his conjunctival injection had reduced. His TBUT had increased to 16 seconds in both eyes. The patient reported that his eyes felt rejuvenated and moister and were no longer stuck together in the mornings. This case report demonstrates the effectiveness and superiority of Instant Invention automated MESHH versus manual lid scrubs.
With respect to oMGD and Demodex Dr. Crystal Brimer a graduate of UNC-Chapel Hill and Southern College of Optometry, a Fellow of the AAO, and a primary clinical investigator.
Dr. Brimer noted that when speaking to the average clinician, you will find that opinions vary as to how prevalent Demodex is in everyday practice and how invasive it is to the ocular surface.
Demodex was first identified in 1841: Demodex folliculorum (0.3-0.4 mm) is the larger of the two mites that affect the skin. It is more prevalent in blepharitis and is found congregated in the hair follicle. Demodex brevis (0.2-0.3 mm) is found in the sebaceous gland and is more prevalent in chalazia.
As far back as 1979, Roth noted that, after examining 100 biopsies of the eyelid skin, there was an 84% overall prevalence for Demodex folliculorum and a 100% occurrence in those over 70 years old.2 A recent study of 1499 patients found the overall prevalence was 47%, an astonishing figure to many.3
Other studies have broken it down according to the co-existence.
Regardless of the variations, multiple studies were included here to emphasize that Demodex is much more prevalent than we diagnose, recognize, or typically would fathom.
Demodex folliculorum devour epithelial cells at the follicle, and their claws create micro abrasions that cause further hyperplasia and keratinization of the epithelium.
Demodex brevis burrow into the meibomian glands, blocking meibum secretion and initiating a granulomatous cascade,1 potentially causing both MGD and chalazia.5 To further insult the ocular surface, Demodex transport Streptococci, Staphylococci, and Bacillus oleronius. Additionally, their debris and waste product produce a secondary inflammatory reaction.1
Though additional research is needed, evidence is certainly accumulating with multiple accusations directed at the Demodex mite. Confusion occurs when we see patients with Demodex that are completely asymptomatic. It is assumed that symptoms and lid changes only arise when there is a minimal number of mites, but that threshold has not yet been established.1 Luo, et al. looked at the correlation between Demodex and MGD. They compared 60 subjects under the age of 35 that were positive for demodicosis to 45 similar dry eye subjects that tested negative for Demodex. They found MGD to be much more prevalent in those with demodicosis (90% vs 64%). There was an even bigger differential in those with moderate to severe MG, presenting with more than one-third meibomian gland loss (58.4% vs 2.2%). In addition to MGD, SPK (49.1% vs 36.9%), eyelash abnormalities (85% vs 4.4%) and blepharitis (78.3% vs 4.4%) were all more prevalent in those that were Demodex positive. Luo, et al. noted Demodicosis in 69.2% of those with chalazions verses 20.3% of those without chalazions, and recurrence was 33.3% vs. 10.3%, respectively.
While we are fortunate to have an abundance of over-the-counter products available in the US, self-medicating patients can delay professional treatment and allow for significant disease progression, especially considering the ultra-fast replication cycle of Demodex.
Typically, our biggest challenge in treating OSD is in gaining patient compliance. Patients are often embarrassed when told about their inhabited lashes. This can motivate compliance in some cases, but in others, it may have the opposite effect, once they feel improvement, they often have a false mindset that they have been “cured,” instead of understanding this is something that has to be managed. Anterior segment photos are essential to induce ongoing compliance, especially once a patient's symptoms subside. I have found the photocollage on the Oculus 5M keratograph to be most effective.
D. folliculorum can be diagnosed by examining an epilated lash under the microscope for the presence of mites. Short of that, collarette dandruff is a reliable indication that Demodex is present. However, realize that especially in the cases of D. brevis, it may be present without collarette dandruff.1 Fully understanding this, as well its link to rosacea and the damage that can be done, it is essential that we be aggressive in our treatment plans.
Tea tree oil cleans the physical collarette, but also encourages exodus of the mite onto the skin. Tea tree oil is also advantageous because of it antibacterial,6 antifungal,7 and anti-inflammatrory8 properties.
Hypochlorous acid and Cliradex have long been embraced as a successful ancillary method of treatment.
The industry has had a great need of an at home mechanical cleaning device for the lid margin. At that point, I had also gotten disheartened by the number of people that would return after their (microblepharoexfoliation) treatment, presenting much like they did before the treatment. It seemed that to effectively eradicate the problem, I would have to make the in-office treatment intervals too short to be a feasible expense for the patient.
Knowing how invasive and invisible Demodex can be, I now demo Instant Invention® for at home care any time I see primary blepharitis, collarettes, scurf, or an inflamed lid margin with scalloping or hyperemia. It makes perfect sense to the patient that mechanically cleaning the lid margin will help reduce contamination and thereby improve the lid health. Additionally, the oscillating action stimulates circulation and may motivate stagnant meibum.
Patients are thrilled that it only takes 15 seconds per lid per day, and this is a significant influencing factor to ensure their compliance. The other key factor to success is to build their confidence. Operating the Instant Invention® is simple, but some patients are hesitant to use anything moving near their eyes therefore, we have the patient try Instant Invention® in the office before their purchase. We coach them to apply the appropriate amount of pressure and follow the contour of the lid to reach the nasal and temporal aspect of the lids. This is important to build confidence, and also ensures excellent results.
After treatment there was follow up with patients approximately a month later and typically heard them report on the ease of use and symptomatic improvement. At the slit lamp I am always pleased to see a pristine and dry lid margin. I have also seen improvements in the tear film composition, which I attribute to the minimization of biofilm and scurf migrating into the tears. Overall, the patient feedback has been positive, and I have been more than happy with the objective results I see when they use the Instant Invention® system daily.
The perspective has certainly changed over the past several years. I have high expectations for how the lid margin should appear and I implement treatments early and aggressively when needed. If my OSD treatment is not responding according to my expectations, I consider the presence of Demodex and make recommendations accordingly.
Another problem is contact lens intolerance. Recent Independent Consumer Use Study—The Benchmarking Company (TBC). The Benchmarking Company (TBC) conducted a 28 day in home use test to evaluate the efficacy and sensory appeal of the device of the instant invention.
102 consumer panelists participated, using Device of the instant invention daily as directed over the 28-day study period.
Panelists completed online extensive self-evaluation and user experience surveys after Day 1, Day 14 and Day 28.
TBC is a recognized leader, employing best practices for statistically evaluating findings as defined by ASTM Standard Guide for Sensory Claim Substantiation E1958-18.
The data below is based on a 28-day consumer perception study of 102 participants conducted by The Benchmarking Group.
Reported that their contacts felt more comfortable 79%.
My eyes feel more comfortable 93%.
The treatment feels beneficial to my overall eye health 92%.
My eyes feel less irritated 92%.
I feel relief from bothersome symptoms of dry eye 91%.
Decreases frequency of irritated eyes 91%
Decrease frequency of episodes of dry eyes 89%
Felt some degree of relief from dry eye from using this product 89%.
Helps to properly remove eye makeup 88%.
Experienced improvement with night driving difficulty 85%
Pre and Post Surgical use of Device of the instant invention
Derek H. Ohlstein, MD completed his Ophthalmology Residency training at Shands Medical Center at the University of Florida. This was preceded by an Internship in Internal Medicine at the University of Florida.
He notes that Cataract surgery is very results oriented and with that comes high expectations from patients in terms of outcomes and improvement in vision. Due to this, we tend to place much emphasis on pre-operative decisions such as the type of IOL to use. However, we need to place equal importance on looking at the ocular surface and meibomian glands to detect any possible dry eye disease and address this prior to surgery in order to avoid inaccurate pre-surgical lens calculations, sub-optimal lens choices, and compromised outcomes.
About 70% of patients have some form of dry eye, with at least 50% being moderate to severe. In many cases of dry eye, the tear film is deficient, and if this is not addressed prior to surgery, the patient most likely will have more blurred vision and glare. Particularly with premium or advanced lens patients, we want to make sure we do everything possible to produce good results quickly. When I initially see patients for cataract surgery, I always do a dry eye evaluation, which includes looking at the meiobomian glands, and conducting an osmolarity test and a tear breakup time (TBUT) test.
If a patient is diagnosed with dry eye disease, the next step is to determine the best treatment option. Many patients use artificial tears, but these only address their symptoms not the root cause of their dry eye. If a patient's tear film is deficient, there are options such as warm compresses and also prescription medications such as cyclosporine, lifitegrast, or an antibiotic. However, these treatments do not treat the root cause and can also take months to see meaningful improvement in the tear film. This can delay the patient's surgery, leading to unsatisfied patients and practice disruptions.
The ability to use a Device of the instant invention that is a doctor directed at home treatment for patients with dry eye changes the patient experience. A device of the instant invention effectively alleviates symptoms by stimulating and rejuvenating the meibomian glands back to a healthy state. A device of the instant invention is safe and clinically effective, and in addition to treating dry eye is good for ocular hygiene, Blepharitis and Demodex.
Studies demonstrated a 65% improvement in tear film breakup time (TBUT) and an 81% increase in Meibomian Gland Yielding Liquid Secretions in less than 30 days with Device of the instant invention.1 Additionally, Device of the instant invention has been shown to remove scurf, improve Meibomian Gland effectiveness, and increase Meibomian Gland output by 2 times.1 With daily use, our patients typically see a noticeable difference within one to two weeks of using the device, with improved TBUT, markedly less capping of the meibomian glands, and reduced inflammation from Blepharitis. A device of the instant invention is quick and easy to use and only takes about 15 seconds per lid each day. It is also cost-effective for patients.
Patients with irregular IOL calculations who return after using Device of the instant invention for just a few weeks and get good measurements and lens calculations in preparation for cataract surgery. In fact, a patient that uses the device of the instant invention practitioners rarely get coherent lens calculations after using Device of the instant invention. Additionally, when repeating topography for phaco measurements, there are less artifacts associated with dysfunctional tear films.
One example is a recent cataract patient who wanted a Technis Symfony® lens (Abbott). At her pre-operative appointment, her left eye topography was 3 D of cyl and the IOL master only read 0.5 D. Since the basic lens formula is P=A-0.9K-2.5AL, this could have resulted in a 2.5 D of error in lens choice.
The practitioner repeated the measurements and had similar unreliable readings. She was already on Restasis and artificial tears. She needed the phaco performed in a narrow window of time, so we started warm compresses and the Device of the instant invention System. One week later we repeated calculations, and all the measurements were within 0.25 diopter of cyl. with POD #1 20/20 vision.
The Device of the instant invention System has truly been a game changer for our practice. We are getting cleaner lens calculations, so there is less chance of being off on astigmatism measurements and a better chance of getting good lens calculations the first time. We are also getting a better view through the cornea during surgery, which makes it easier and our calculations cleaner. Ultimately this all leads to better patient outcomes and satisfaction.
A preferred embodiment of the eyelid care appliance is an “integral” eyelid care appliance comprising a power supply, motor, drive system that transmits motive force from the motor to oscillate a head receiver, motor controls, a proximity system, and proximity annunciator contained in a housing, wherein a bristlehead or Soft-Tip is detachably mated with the head receiver and protrudes from the housing and oscillates when the motor is powered on. A drive module (defined below) and an eyelid care module (defined below) are the principal elements contained in the housing. An alternate “two-piece” embodiment comprises a detachable neck that mates with a handpiece; the handpiece comprises the power supply, motor, and part of the drive system; the detachable neck comprises the head and remainder of the drive system. In a two-piece embodiment, the components of the eyelid care appliance can be distributed in whole or in part between the handpiece and the detachable neck, depending upon the component and configuration involved. As used herein, “handpiece” means the proximal portion of a two-piece embodiment of the invention, which proximal portion is gripped by a user.
An alternate “two-piece” embodiment of the eyelid care appliance comprises a handpiece and a detachable head and/or neck, a power supply, motor, proximity annunciator, and motor control being contained in the handpiece, a head receiver being contained in the neck and connected to the motor through a drive system with portions of the drive system distributed in the neck and in the handpiece and with a coupler at the interface of the handpiece and neck, which drive system transmits motive force from the motor to oscillate the head receiver, wherein a bristlehead or Soft-Tip is detachably mated with the head receiver, protrudes from the neck, and oscillates when the motor is powered on, and portions of a proximity system are distributed in the detachable neck and in the housing.
In the embodiments of the invention, the power supply (typically a replaceable and/or rechargeable battery) powers a DC motor, and when the motor is powered on, the motor (and drive translator, if the motor outputs unidirectional rotary motion, which motion is translated to oscillating motion) causes the oscillation of a driveshaft (or equivalent means of transmitting motive force, e.g., in a two-piece embodiment, an electric motor in a handpiece with magnetic or mechanical coupling to a detachable neck). The oscillating driveshaft causes the head receiver to oscillate, which causes the bristlehead or Soft-Tip mounted in the head receiver to oscillate. The eyelid care appliance is typically battery powered but can be powered by a power supply connected to an electrical outlet.
To use the eyelid care appliance claimed herein, a user grips the proximal portion of the appliance, powers on the appliance, and applies the oscillating head on the distal end of the appliance, together with a solvent or cleanser, to the eyelid to scrub the eyelid. In a preferred embodiment for SA Cleaning and SP Cleaning, the eyelid care appliance comprises a drive module, drive controls and annunciator, eyelid care module with adjustable head angle, proximity sensor, proximity controls and annunciator, and related data channels. A preferred configuration of proximity sensor and annunciator is a video camera, a Bluetooth®, or similar near field communication channel (Zigbee, Bluetooth, Bluetooth BLE, ANT+, WIFI, NFC or near field communications channel), and a smartphone or tablet computer with near field communications capability and display (collectively, “smart device”), that is paired with the eyelid care appliance. The video image from the eyelid care appliance is transmitted through the communication channel and displayed on the smart device. A user of the eyelid care appliance essentially “flies” the head onto the eyelid and moves the head across the eyelid. By focusing on the display, the user becomes immersed in control of the head rather than fearful of poking himself or herself in the eye. The proximity system can evaluate or score user performance as if the use of the eyelid care appliance were a video game. The interface between the device and smartphone application can monitor use of device, time, date, location and integrate the collected data through the smartphone application into the NSM portal for their reference and doctor compliance management.
Alternatively the instant invention for stimulating the meibomian glands of the eyelid comprising a handle/Main Housing; a head that is removable and neck and handle/Main Housing, the head comprising an bristlehead or Soft-Tip that oscillates to provide a massaging action to an eyelid and that comprises a front end that is concave in shape to fit over an eyelid; a heater located inside of the bristlehead or Soft-Tip; a temperature sensor located inside of the bristlehead or Soft-Tip, wherein the temperature sensor causes the bristlehead or Soft-Tip to heat to a predetermined temperature and then stop heating; and a charging base that supplies power to a motor that causes the bristlehead or Soft-Tip to oscillate, wherein the motor comprises a motor shaft.
In an alternative preferred embodiment, the device further comprises a switch that allows the bristlehead or Soft-Tip to oscillate with or without heating. Preferably, the handle/Main Housing comprises a light emitting diode that indicates to a user whether the batteries are being charged and whether the bristlehead or Soft-Tip is heating.
In yet another preferred embodiment, oscillation of the bristlehead or Soft-Tip is effectuated by an oscillation assembly located within the handle/Main Housing and comprising of a cam system which can be described as: a first stationary arm extending inward from an inner wall of the head; a rotating wheel that is connected to a rotating shaft that is in turn connected to the motor shaft; a second stationary arm extending inward from the inner wall of the head directly opposite the first stationary arm, the second stationary arm comprising a horizontal slot; and a connecting member with a first horizontal extension that is inserted into an aperture located off-center on the rotating wheel and a second horizontal extension that is inserted into the horizontal slot in the second stationary arm, wherein the connecting member comprises a center and pivots about a shaft that extends through an aperture in the center of the connecting member and that is fixedly attached to the bristlehead or Soft-Tip; wherein as the motor shaft rotates, the rotating shaft also rotates, causing the rotating wheel to rotate, the first extension on the connecting member to rotate in a circular motion, the second extension to move laterally within the slot on the second stationary arm, and the connecting member to pivot about the shaft that extends through the center of the connecting member, thereby causing the bristlehead or Soft-Tip to oscillate in an elliptical path.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip cover that surrounds the front end of the bristlehead or Soft-Tip and that is comprised of a soft elastomer, thermoplastic elastomer, silicone or mixture of silicone and thermoplastic elastomer.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which is irreplaceably configured to attach and detach from the neck or handle/Main Housing and is capable of being held captive to the neck or handle/Main Housing by a magnet, clasp, cam, or locking mechanism.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which comprises of a soft elastomer, thermoplastic elastomer, silicone or mixture of silicone and thermoplastic elastomer or other soft plastic and has bristles surrounding a hollow cavity or recess on the head. The hollow cavity or recess on the head being centered on the primary axis through the center of the head face so as to facilitate the application of topical agents selected from the group comprising of liquids, gels, ointments, cleansers, solvents, gases, powders or other fluid or fluidizable medicaments deposited in the recess of the tip to be applied to the eyelid surface when the device of the invention is in use.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which comprises of a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer or other soft plastic and has an anti-inflammatory agent added to the matrix that makes up the bristlehead or Soft-Tip, such that the anti-inflammatory agent is applied to the eyelid surface when the device of the invention is in use.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which comprises of a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer or other soft plastic and has an anti-infective agent added to the matrix that makes up the bristlehead or Soft-Tip such that the anti-infective agent is applied to the eyelid surface when the device of the invention is in use.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which comprises of a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer or other soft plastic and has an aminoglycosides agent added to the matrix that makes up the bristlehead or Soft-Tip such that the aminoglycosides agent is applied to the eyelid surface when the device of the invention is in use.
In a preferred embodiment, the bristlehead or Soft-Tip further comprises a bristlehead or Soft-Tip which comprises of a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer or other soft plastic and has bristles surrounding a hollow cavity on the head so as to be able to massage the eyelid without damaging or irritating it wherein the cavity provides a reservoir that helps maintain lubricity during the treatment by capturing lubricant which would otherwise escape during operation.
In yet another embodiment, the present invention is a method for stimulating the meibomian glands of the eyelid comprising: providing a device with a handle/Main Housing and a head that is removable from the handle/Main Housing, the head comprising a bristlehead or Soft-Tip that oscillates to provide a massaging action to an eyelid; using a heater and temperature sensor located inside of the bristlehead or Soft-Tip to heat the bristlehead or Soft-Tip to heat to a predetermined temperature and maintain the bristlehead or Soft-Tip at the predetermined temperature; using a motor located inside of the handle/Main Housing and to cause the bristlehead or Soft-Tip to oscillate; and applying the bristlehead or Soft-Tip to an eyelid of a user.
It is therefore a primary objective of the invention to provide a means of massaging the eyelid to increase tear production of the meibomian gland and reduce the meibomian gland dysfunction.
A further understanding of the nature and advantages of particular embodiments may be realized by reference to the remaining portions of the specification and the drawings, in which like reference numerals are used to refer to similar components. When reference is made to a reference numeral without specification to an existing sub-label, it is intended to refer to all such multiple similar components.
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
While various aspects and features of certain embodiments have been summarized above, the following detailed description illustrates a few exemplary embodiments in further detail to enable one skilled in the art to practice such embodiments. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention.
In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the described embodiments. It will be apparent to one skilled in the art however that other embodiments of the present invention may be practiced without some of these specific details. Several embodiments are described herein, and while various features are ascribed to different embodiments, it should be appreciated that the features described with respect to one embodiment may be incorporated with other embodiments as well. By the same token, however, no single feature or features of any described embodiment should be considered essential to every embodiment of the invention, as other embodiments of the invention may omit such features.
In this application the use of the singular includes the plural unless specifically stated otherwise and use of the terms “and” and “or” is equivalent to “and/or,” also referred to as “non-exclusive or” unless otherwise indicated. Moreover, the use of the term “including,” as well as other forms, such as “includes” and “included,” should be considered non-exclusive. Also, terms such as “element” or “component” encompass both elements and components including one unit and elements and components that include more than one unit, unless specifically stated otherwise.
Lastly, the terms “or” and “and/or” as used herein are to be interpreted as inclusive or meaning any one or any combination. Therefore, “A, B or C” or “A, B and/or C” mean “any of the following: A; B; C; A and B; A and C; B and C; A, B and C.” An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.
As this invention is susceptible to embodiments of many different forms, it is intended that the present disclosure be considered as an example of the principles of the invention and not intended to limit the invention to the specific embodiments shown and described.
Given existing art methods and devices, it is not surprising that there is little or no compliance to eyelid hygiene by patients. Related art describes an “Eyelid and Anterior Orbit Swab” (to Hamburg, U.S. Pat. No. 4,883,454) and various eyelid cleansers, such as U.S. Pat. Nos. 8,535,736, 8,449,928, and 8,231,912 (to Gilbard), to clean the eyelids, but these rely solely on manual back and forth motion of a device on the eyelid margin and manual application of a cleanser, the entire contents all of which are hereby incorporated by reference.
A number of devices have been invented that apply compression to the anterior and or posterior surface of the eyelids, heat and/or apply electrical microcurrent or sonic energy (which the present invention does not do) to various parts of the body, but none of them is specifically tailored to address the problem of meibomian gland disease. For example, U.S. Pat. No. 4,387,707 (Polikoff, 1983), the entire contents all of which are hereby incorporated by reference, discloses an eye treatment device that applies a fluctuating massaging force against the eye through a flexible wall in a chamber that contains a fluid maintained under a fluctuating pressure. This device does not involve heating the eyelid.
U.S. Pat. No. 4,918,818 (Hsieh, 1990), the entire contents all of which are hereby incorporated by reference, describes a multi-purpose shaver with a face massaging component. In order to use the face massaging component, the razor holder is detached from the body of the device, and the face massaging component is attached to the body of the device where the razor holder had been. This device does not involve a heating element.
U.S. Pat. No. 6,275,735 (Jarding et al., 2001), the entire contents all of which are hereby incorporated by reference, involves an apparatus for electrical microcurrent stimulation therapy of a body part. This invention is intended to provide electrical microcurrent stimulation around an eye to combat visual system diseases such as age-related macular degeneration (AMD). The inventors claim that microcurrent stimulation will help rejuvenate the cells in the retina to slow or stop degeneration of the eye due to AMD. This invention does not involve any kind of a plate over the eyelid, nor does it involve heating. In a preferred embodiment, the electrical microcurrent is applied with a probe tip comprised of a cotton swab moistened or dampened with a conductive gel.
U.S. Pat. No. 7,069,084 (Yee, 2006), the entire contents all of which are hereby incorporated by reference, discloses a method for treating meibomianitis by massaging the muscle fibers in the eyelid that express the meibomian gland. The device is intended to cause the meibomian glands to expel any obstructing accreted meibum in the meibomian glands. According to the inventors, the obstructing plug may be composed of hardened lipids (as described above), cellular debris or some combination thereof. The invention involves the placement of electrical contacts on the eyelid and the application of an electrical current to the eyelids via the electrical contacts, which in turn induces muscular contractions within the eyelid. Unlike the present invention, this particular invention does not try to liquify or express accreted meibum from the internal Meibomian glands.
U.S. Pat. No. 7,122,013 (Liu, 2006), the entire contents all of which are hereby incorporated by reference, describes an eye massage device comprising a mask with left and right portions and left and right diaphragms in each eye portion. The mask is connected to a pneumatic-powered cylinder assembly via a plastic tube. The pneumatic-powered cylinder assembly comprises a cylinder that alternately delivers compressed air to the mask and draws air from the mask. In this manner, the eyes are massaged. In one embodiment, spacers are located between the diaphragms and the eyes as a means for absorbing tears secreted by the eyes during operation. This device is not handheld, and it does not provide heat to the eyelid.
U.S. Pat. No. 7,384,405 (Rhoades, 2008), the entire contents all of which are hereby incorporated by reference, involves a cosmetic instrument with a number of different interchangeable heads. These heads include abrasive attachments, oxygenating attachments, brush attachments, thermal attachments, and light radiating attachments. These various types of treatment attachments are moved over an area of skin and/or body part by the user manipulating the handle/Main Housing and also by a motion generator that moves the head portions. The motion generator may move the attachments by vibrating, spinning, oscillating, or propagating sonic waves through the head portions. The purpose of the thermal attachment is to facilitate the application of a cosmetic composition or solution onto the skin. The thermal attachment is moved over an area of skin or a body part in “upward circular or randomly directed strokes” until the composition or solution has been worked into, cleaned, and/or polished the skin or body part. This device is not specifically tailored to facilitate the application of a cosmetic composition or solution onto the skin of an eyelid disorder.
U.S. Pat. No. 7,637,878 (Lin, 2009), the entire contents all of which are hereby incorporated by reference, discloses an eye massaging device with built-in air pump and actuation elements, an inflatable fomentation member, and a belt member to which the main member and fomentation member are attached. The main member contains a number of slidably engaged pieces that elastically expand along with the belt member when the device is tied around a user's head. The fomentation member is shaped like an eyeshade and comprises a first outer piece, a second outer piece, an air bag and a thin heating element. The air pump and leakage valve inflate and deflate the air bag to press the warm heating element against the eyes with various levels of pressure. This device treats both eyes at once and would not be effective in treating a single eyelid.
U.S. Patent Application Pub. No. 2002/0156402 (Woog et al.), the entire contents all of which are hereby incorporated by reference, describes a device that applies sonic energy to various parts of the body for therapeutic purposes. The device comprises an applicator end at which a predetermined amplitude is generated under applied loads. This device does not involve massage of the eyelid.
U.S. Patent Application Pub. No. 2008/0200848 (Avni), the entire contents all of which are hereby incorporated by reference, involves a vibrating device that the inventor claims may be applied directly to a closed eyelid. This invention does not involve the application of heat to the eyelid, and the application does not include a single figure showing what the device would look like as applied to the eyelid.
None of the above inventions combine utilizing massage to effectively treat meibomian gland disease. What is needed is a handheld device that is easy to use, mechanically configured for placement over an eyelid, and that accomplishes massaging of the eyelid at the same time.
Accordingly, it is an object of the present invention to provide a handheld, battery-operated device with an oscillating, curved plate (for placement over the eyelid) that has a thermostatically controlled heating element within it. The oscillating motion of the curved plate applies a massaging action to the eyelid, and the heater is preferably controlled to achieve the optimum temperature. The present invention simultaneously liquefies and mobilizes the lipids in the meibomian glands, thereby causing them to move toward the gland orifices. With regular use, these oils remain less viscous, and the tear quality improves.
At least one eyelid cleaning device, the BlephEx® device described in US Published Patent Application Nos. 2014/0031845, 2014/0052164, and 2014/0214062, the entire contents all of which are hereby incorporated by reference, uses a design and unidirectional rotation virtually identical to that of ophthalmic burrs, but with a “sponge head” instead of a burr. Like ophthalmic burrs, the BlephEx® device drives a head with a full rotary motion and is for use by eyecare professionals. An “eyecare professional” is a person skilled in the art of ocular hygiene, such as ophthalmologists, optometrists, nurses trained in eyecare, and technicians trained in eyecare. The BlephEx® handpiece rotates a small sponge, is guided along the eyelid margin by an eyecare professional, removes scurf and debris, and exfoliates the eyelids. The key disadvantages of the BlephEx® device are its “motorized swab” design, unidirectional spinning (rotating) head (as distinct from an oscillating head moving in a reciprocally arcuate path), lack of instrumentation, and lack of safety features. Using an oscillating head to clean eyelids has significant advantages over existing art eyelid cleaning devices. Oscillating devices tend to be safer than rotary devices; an oscillating head does not have the directional “kick” (i.e., start-up torque) of a rotating head, so there is less chance of a user losing control of the device, e.g., the device jumping out of the user's hand. For that reason, devices with oscillating heads are easier to control than rotary devices. An oscillating eyelid care device does not induce a flinch response in the subject when the head initially contacts an eyelid. An oscillating head creates fewer flying debris than a rotary head, making an oscillating head a better choice for work in an area where excessive flying debris might be a nuisance, such as near the eye.
The BlephEx® device can only safely be used by an eyecare professional due to the ergonomics and dynamics (e.g., “motorized swab” form, flinch induction, unidirectional rotation) of the device. The stick-like design (i.e., cylindrical handpiece with long, rotating, longitudinally aligned head) of the BlephEx® device, prevents the use of a BlephEx® device for SA Cleaning, i.e., for a patient to use in performing eyelid cleaning on him/herself. A device with a stick-like design must be used by a second person, typically by an eyecare professional.
Existing powered eyecare devices have heads with a constant unidirectional rotation, which require that the operator manually change the rotational direction (e.g., from clockwise to counterclockwise) of the head and retrace the path of cleaning to ensure efficient cleaning. An oscillating head provides better removal of debris and more uniform results than devices with unidirectional head rotation, which is the reason that oscillating heads are used in powered toothbrushes. The head of the driven attachment of a commercial, off-the-shelf powered toothbrush has a “brush head”, and such driven attachment is called a “brush head attachment”. Clinical studies in the dental care literature have shown that powered toothbrushes with an oscillating brush head are significantly better in reducing plaque and gingivitis compared to a manual toothbrush and brushing technique, and also compared to powered rotary toothbrushes. Just as the oscillatory movement of a powered toothbrush brush head ensures better cleaning than manual scrubbing, because a brush head typically oscillates at about 7,000 to 9,000 strokes/minute, the oscillatory movement of a powered handpiece coupled to an eyelid care module ensures better cleaning than manual scrubbing of the eyelids. The following publications, the entire contents all of which are hereby incorporated by reference, describes the comparative advantages of powered, oscillating head toothbrushes.
A comparative study of plaque removing efficiency using rotary electric and manual toothbrushes. Swed Dent J. 1991; 15:229-234. Cochrane Database Syst Rev. 2005; 18(2):CD002281.
J Am Dent Assoc. 2003 September; 134(9):1240-4. Manual versus powered toothbrushes: the Cochrane review.
Niederman R; ADA Council on Scientific Affairs; ADA Division of Science; Journal of the American Dental Association. Source:
DSM-Forsyth Center for Evidence-Based Dentistry, The Forsyth Institute, Boston, Mass. 02115, USA. rniederman@forsyth.org CONCLUSIONS: Powered toothbrushes with a rotation-oscillation action achieve a significant, but modest, reduction in plaque and gingivitis compared with manual toothbrushes.
National Institutes of Health Cochrane Database Syst Rev. 2005 Apr. 18; (2):CD002281. Manual versus powered toothbrushing for oral health.
Robinson P G, Deacon S A, Deery C, Heanue M, Walmsley A D, Worthington H V, Glenny A M, Shaw W C. Source: Department of Dental Public Health, School of Clinical Dentistry, University of Sheffield, Claremont.
Crescent, Sheffield, UK. peter.g.robinson@sheffield.ac.uk, CONCLUSIONS: Powered toothbrushes with a rotation oscillation action, reduce plaque and gingivitis more than manual tooth brushing.
Powered/electric toothbrushes compared to manual toothbrushes for maintaining oral health—Cochrane Report June 2014. Yaacob M, Worthington H V, Deacon S A, Deery C, Walmsley A, Robinson P G, Glenny A. This article reviews 56 studies published from 1964 to 2011 in which 5068 participants were randomized to receive either a powered toothbrush or a manual toothbrush. The majority of the studies included adults, and over 50% of the studies used a type of powered toothbrush that had an oscillation mode of action (where the brush head rotates in one direction and then the other, aka reciprocally arcuate). CONCLUSIONS: The evidence produced shows benefits in using a powered toothbrush when compared with a manual toothbrush. There was an 11% reduction in plaque at one to three months of use, and a 21% reduction in plaque when assessed after three months of use. For gingivitis, there was a 6% reduction at one to three months of use and an 11% reduction when assessed after three months of use.
One advantage of oscillating brush head powered toothbrushes, in general, is their ability to remove a greater amount of plaque in a given period of time than manual brushes. One study (Preber H, Swed. Dent. J. 1991; 15:229-234) found that 75% of dental biofilm was removed in 15 seconds with an oscillating powered toothbrush; the same amount of plaque removal required twice as long with a manual brush. The results of a more thorough cleaning process with oscillating powered toothbrushes can be extrapolated to eyelid hygiene using an oscillating powered device. However, powered toothbrushes cannot be easily adapted to eyelid care, given the large size of the handpiece, brush head attachment, and brush head, the stiff bristles on toothbrush brush heads (which would lacerate the eyelid margin, cornea, and sclera if used to clean eyelid margins), and the expense of disposable “necks” (the “neck” is the detachable distal portion of a powered toothbrush that terminates in a non-removable brush head, which means the entire neck must be discarded when the brush head wears, rather than disposal of only the brush head). Because powered toothbrush necks are not easily removed and are used for months before replacement, the brush heads become unsanitary. For sanitary eyelid care, the head of a device must be easily replaceable and inexpensive, or durable and autoclavable.
There is need for an eyelid care appliance that enables “self-administered cleaning” or “SA Cleaning.”
Cleaning reduces risk of patient injury during training of eyelid care professionals, reduces risk of patient injury during SA Cleaning and SP Cleaning, provides an oscillating head, provides instrumentation and safety features that improve efficacy of eyelid care, provides an inexpensive and easily replaceable head (and alternatively, a durable and autoclavable head), and ideally provides an adjustable head angle and optionally provides control over oscillation frequency and angular sweep.
Recent research has concluded that meibomianitis is a condition that affects a vast number of individuals; some authors cite numbers as high as thirty percent of the population at fifty years of age. Researchers also agree that the condition becomes more common with age, which means that the percentages increase with an aging population. The disease is asymptomatic for some period of time—months to years—but almost always progresses. Eye physicians are well aware of this fact and the need to begin treatment as early as possible to alleviate damage from chronic disease. The very fact that the disease, in its early stages, is asymptomatic, coupled with the fact that treatments to date have their drawbacks or contraindications, leads doctors to allow the condition to go untreated until it becomes symptomatic, and damage is done. In the later stages of the disease, treatment is more complex, costly and less-effective. The present invention will allow physicians to direct patients to a treatment method that is noninvasive, simple to use, and should provide years of service without ongoing expense.
The eyelid care appliance described and claimed herein solves the proceeding problems by providing, in a preferred embodiment, an oscillating, detachable sponge head, adjustable head angle, an ergonomic powered handpiece, sensors and other controls and instrumentation (such as, controls, indicators, displays, video, and/or data transmission), and auxiliary functions (cleanser, solvent, and medicament dispensing, gas and liquid dispensing, heating, and suction) that improve professional eyelid care, SA Cleaning, and SP Cleaning. The system utilizes cleansing action applied to the eyelids to effectively clean the eyelid and stimulate the meibomian glands.
In addition to meibomian gland dysfunction, other more acute eyelid conditions, which can occur at any age, are treated with warm massage. They too could be treated with the present invention; such common conditions as hordeolum and chalazion fall into this category.
In this application the use of daily disposable head means a soft-tip, spongehead, bristlebrush, Soft-Tip, bristlehead, sponge mount, sponge mount/head receiver interface or a round polymer head; all refer to the removable head of the device, and the terms are used interchangeably.
In this application the use of the singular includes the plural unless specifically stated otherwise and use of the terms “and” and “or” is equivalent to “and/or,” also referred to as “non-exclusive or” unless otherwise indicated. Moreover, the use of the term “including,” as well as other forms, such as “includes” and “included,” should be considered non-exclusive. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components that comprise more than one unit, unless specifically stated otherwise.
In this application the term silicon refers to a silicone or polysiloxane which can be any of a number of polymers that include any synthetic compound made up of repeating units of siloxane, which is a chain of alternating silicon atoms and oxygen atoms, combined with carbon, hydrogen, and sometimes other elements.
In the application the term silicone means any a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer.
In the application the term sponge means any medical-grade polyurethane foams or cellulose sponge which can include low-density polyether, polyvinyl alcohol (“PVA”, which is highly absorbent), polyester (almost as absorbent as PVA, but more durable and has larger pores), and other polymers.
In this application the use of the term SA cleaning means “self-administered cleaning”.
In this application the use of the term SP cleaning means cleaning others' eyelids by a second party.
In this application the use of the term Microblephroexfoliation means in-office lid hygiene technique that exfoliates the eyelid margins Biofilm: aggregate of bacteria held together by a mucus matrix that adheres to a surface Collarettes: Demodex matter that accumulates at the base of eyelashes.
Numerical values for volumes and masses in this specification are shown in U.S. customary units. Teaspoons and tablespoons are taken as their volumetric equivalent units in the Avoirdupois system. Since accelerations and forces are not relevant to the description or use of the invention, U.S. customary units of weight such as ounces and pounds shall indicate their customary equivalent masses as stationary objects.
The present invention, the eyelid care appliance, is directed to novel devices and methods effective for restoring and maintaining good eyelid hygiene and capillary perfusion of the eyelids, lid margins and their adnexa, e.g., both prophylaxis and therapeutic treatment. The methods and devices disclosed herein include those for SA Cleaning and SP Cleaning, which enable better patient compliance with prescribed eyelid cleaning regimens, especially daily prophylaxis. The incidence of blepharitis increases as a function of age. If a person's neurological deterioration prevents them from performing SA Cleaning, a lay caregiver can perform SP Cleaning of such person's eyelids using the eyelid care appliance. These methods involve the easy and safe mechanical cleaning of an eyelid by eyecare professionals in clinical settings and by lay individuals in any location in which manipulation of the individual's eyelids or the eyelids of a second party is safe. The “Second party” includes animals, especially household pets, horses, and farm animals. The present invention provides improved cleaning and capillary perfusion of the eyelid margins and meibomian gland orifices and enables a patient to clean his or her eyelids without assistance. The invention solves the technical problems of improved eyelid cleaning and training in eyelid cleaning, especially the technical problems in SA Cleaning and SP Cleaning. Devices such as those described in U.S. Patent Publication 2015/0182415 and U.S. Pat. No. 10,314,763 by Olkowski et al. are designed to clean the eyelid margins and meibomian gland orifices of cellular and sebaceous debris, the disclosure is hereby incorporated by reference in its entirety.
The instant invention is specifically designed to improve eyelid hygiene and overall eye health when used in either at home by a patient or in office by a healthcare professional.
It was reported that blepharitis was found in 37% of patients in the ophthalmologist's clinical practice in the United States. One class of in-office therapies involves mechanical cleaning of the eyelid margins. Some devices use an on-axis rotational absorbent sponge soaked in a liquid foam solution to perform “microblepharon exfoliation” to the lid margins. The instant invention uses an oscillating non-absorbent silicone or thermoplastic elastomer, a gel or liquid foam to perform “mechanical eyelid stimulation and hygiene.” The instant invention is effective to aid in removal of eyelid biofilm, bacteria and other debris from the eyelid margins and lashes. One advantage of the oscillating nature of the instant invention is that it does not generate splatter. The splatter can move the debris and infectious agents that are part of the Biofilm, or the aggregate of bacteria held together by a mucus matrix that adheres to a surface Collarettes: Demodex matter that accumulates at the base of eyelashes.
The key advantage of the instant invention is safe and effective daily use in the home performed by the patient or non-professionally trained.
Referring to
The application of the instant invention is shown in
As defined by the instant invention the term “head” means a soft-tip, spongehead, bristlebrush, Soft-Tip, bristlehead, sponge mount, sponge mount/head receiver interface or a round polymer head and all, refer to the removable head of the device unless otherwise denoted, and are fabricated from any combinations sponge, silicone and bristle head, or head made with materials other than sponge and bristles such as a soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer. The motive action of the driving means is transmitted through from the motor through the drive system to the head receiver. The eyelid care appliance is always used with a cleanser and/or lubricant that is applied to the head and/or directly to the eyelids being cleaned. In addition to cleanser and/or lubricants, medicaments can be applied to the head and/or directly to the eyelids being cleaned. When a user turns on an eyelid care appliance, and applies the oscillating head to an eyelid, oscillation of the head cleans, massages, and stimulates the eyelash margins, eyelid margins and meibomian gland orifices of cellular and sebaceous debris. Such cleaning prevents, for an ensuing period, gland obstruction and promotes health of the glands in the eyelid. The oscillation frequency and angular sweep can optionally be user-selected and implemented via printed circuit board 11, control of motor 7. The Oscillation frequency of the head is nominally 7,000 to 9,000 strokes/minute and angular sweep of the head is nominally 70 degrees (i.e., the head travels 70 degrees forward followed by 70 degrees backwards). Higher frequency pulsation (nominally 20,000 to 40,000 pulses/min.) can optionally be generated by the motor 7 and fed to the head receiver 6. The ability to achieve cleaning of the patients meibomian gland orifices by applying the oscillating head to the eyelid, improves the patient cleaning experience of the eyelid margin. The oscillation can create an orbital action that improves the scrubbing of the meibomian glands on the edge of the eyelids.
Recently, researchers have been finding a high rate of ‘Blepharitis,’ or inflammation of the eyelids, is caused by Demodex Parasite infestation. Parasitic eye infections do not always cause symptoms, which can make them hard to recognize.
When symptoms do occur, they can include:
Therefore, an advantage of the instant invention is to provide a method of cleaning the eyelid without spreading biofilm and or parasites. The instant invention uses an oscillating head that has a truncated stroke and an oscillation frequency of the head between 7,000 to 9,000 strokes/minute and angular sweep of the head is approximately 70 degrees is that the short strokes and slower speed minimizes micro splatter which is associated with microblepharoexfoliation. A typical cleaning device uses a high-speed rotational device which is believed to result in significant cast off of material and biofilm present on the eyelid. This Microsplatter (micro splatter)/micro splatter occurs when treating the lids and margins with a high-speed rotational eyelid hygiene device. The treatment throws and or splashes the biofilm/debris in an uncontrolled fashion. The biofilm is a perfect medium for bacterial and/or parasite growth. Therefore, the micro splatter contains the bacteria and parasites normally found on the eyelids and lid margins. The splatter and the pathogens it spreads to other areas of the eye have resulted in the United Kingdom implementing an 18-month moratorium during the COVID pandemic on microblepharoexfoliation treatments performed with high-speed rotational devices.
The device of the instant invention can be modified such that the head is designed with an offset connector so that when the head oscillates it creates an orbital action that improves the scrubbing of the meibomian glands on the edge of the eyelids. The orbital action results in the following:
The Offset can be created by modifying the position of the connection point of the bristle brush or head such that the connection point to the electrical device to the disposable tip is moved off center by a fraction of a millimeter to create the orbital action. Currently the connection point is envisioned to be a pentagonal insertion stem, but any suitable stem configuration would be applicable.
Increase the mass of the treatment head portion of the flexible tip in the same vector as the displacement of the movement of the hexagonal insertion point by the same weight as the movement of the insertion point has created on the now heavier side of the treatment portion of the tip. (Or reduce the weight on the opposite side of the treatment head.)
Referring to
As shown in
The instant invention is designed to oscillate in a narrow arc at sub-sonic speeds for efficacy and safety purposes. As shown in
Both typical high-speed devices and a device of the instant invention were used with a cleansing foam. The cleansing foam was modified by adding a small amount of blue food coloring so that any splatter would be easily observable.
The investigator used a grape to simulate the eye lid and treatments were performed on the grape, in the same manner for 30 seconds.
Micro splatter patterns and radii were measured by visually observing the distribution of blue droplets that accumulated on paper towels.
The device of the instant invention did not create any visible microsplatter (micro splatter). As shown in
Micro splatter/micro splatter was seen by the investigator when using the high-speed rotational device out to a two-foot radius in a spherical cross-section. As shown in
It is clear from the experiment that a sub-sonic oscillating head produces less microsplatter (micro splatter)/micro splatter and therefore does not result in spreading or splashing biofilm/debris in an uncontrolled fashion as is done when using a high-speed device rotational device.
The investigator noted that when using the high-speed device rotational device that the energy creates at the circumference of the rotating head was able to throw or project the cleansing foam. As the head rotated the cleansing foam was moved from the center of the head to the outside of the head where the centripetal force caused the cleansing foam to be ejected from the head. Looking at
The sub-sonic oscillating head does not cause centripetal force and therefore the cleansing foam is not ejected from the head.
Therefore, the sub-sonic oscillating head has a number of benefits which include better cleaning or scrubbing process as documented with tooth cleaning and less splatter of biofilm/debris in an uncontrolled fashion which minimizes the possibility of transmitting bacterial and/or parasites.
The instant invention uses an oscillating action because:
The instant invention, when used can also be captured as a method to clean the eyelid without spreading biofilm and or parasites. The method comprises of:
The vibration and/or sonic action of the disposable tip facilitates stimulation of the Meibomian glands and capillary perfusion as previously described.
The vibration and/or sonic action facilitates use of the device over a closed eyelid and, therefore, in closer proximity to long axis of the Meibomian glands, thereby increasing the energy delivered to the entire length of the Meibomian glands. Compared to the direct method, applying the disposable tip to the eyelid margin, in which the energy is transmitted primarily to the openings of the Meibomian glands, this indirect method facilitates additional therapeutic effects by primarily delivering energy to the long axis of the Meibomian glands which can extend 4-5 mm into the body of the eyelid.
An additional use for the instant invention when the indirect method is used, for stimulation is improving capillary perfusion and cleaning the eyelash margins. Many patients suffer from blepharitis. Used in this fashion the instant invention has a greater therapeutic effect on the follicles of the lashes, promoting greater length and thickness of the eyelashes, while diminishing debris and parasites such as the Demodex mite.
Another embodiment of the device utilizes a piezo electric mechanism to create the therapeutic effect. The frequency of the piezo electric mechanism adds an ultrasound dimension to the treatment effect.
The soundwaves generated by the piezo electric mechanism and delivered by the disposable tip, penetrate the eyelids vibrating the Meibomian glands, creating an effect similar to lithotripsy, which contributes to breaking up the accreted meibum in the glands, facilitating the expulsion of the accretions.
A second experiment was conducted to evaluate the issues of microsplatter (micro splatter) and how the device head and motion contribute to microsplatter (micro splatter). As is common in the industry healthcare professionals have increased the in-office treatments to improve eyelid hygiene and overall eye health. The number of the treatment events continue to grow year over year. It has been reported that blepharitis was found in 37% of patients in the ophthalmologist's clinical practice in the United States. One treatment involves the in-office therapies involves mechanical cleaning of the eyelid margins. The healthcare professional uses a mechanical device and the appropriate liquid, foam, or cream to scrub the eyelid. The mechanical devices are used to aid in removal of eyelid biofilm, bacteria and other debris from the eyelid margins and lashes.
The second experiment explored the amount of transfer created by a mechanical device used to scrub the eyelid.
The experiment utilized an artificial lid margin made from a foam rubber strip that was placed in the center of a field of white paper as shown in
Each device is used as would normally be done on the lid or lid margin for 30 seconds. Any splatter is easily displayed on the white paper as shown in
Effect of type of device on number of droplets produced.
Effect of type of device on distance of droplets Splatter in cm
As one can see the oscillating head used with the instant invention created less splatter than a rotating head as shown in
The reduction in splatter means that during the removal of eyelid biofilm, bacteria and other debris from the eyelid margins and lashes is not transferred to other surfaces where they can cause infections.
This is a benefit to the patient because it limits infections and films being transferred to other parts of the eye and face.
A basic embodiment of the invention comprises a power supply (e.g., battery), drive module that causes oscillation of a head receiver, detachable head mounted in the head receiver, drive control, and a housing that contains the preceding elements. The housing has a proximal portion, preferably ergonomic, that is easily gripped by hand. The proximal portion of the housing in this embodiment also contains drive control (at least on/off, and optionally status LED(s), oscillation frequency, oscillation sweep angle, and timer). A status LED 207 can indicate simply power on (if lit), or one or more LEDs can additionally indicate battery charge level, head oscillation frequency, and other operational states.
The instant invention can also utilize the LED system for LED light therapy. The preferred therapy color is Red, as Blue decreases oil gland production. However, other LED light colors have been found to be beneficial. Red light therapy is commonly referred to as photo-biomodulation (PBM), low level light therapy (LLLT), soft laser therapy, cold laser therapy, biostimulation, photonic stimulation, low-power laser therapy (LPLT).
The theory behind Red light therapy is that the red light produces a biochemical effect in cells that strengthens the mitochondria. The mitochondria are the powerhouse of the cell—it is where the cell's energy is created. The energy-carrying molecule found in the cells of all living things is called ATP (adenosine triphosphate). Additionally, Red, or infrared, light is used for treating the epidermis, which is the outer layer of skin. When the light is applied to your skin, the epidermis absorbs it and then stimulates collagen proteins.
In theory, more collagen means that your skin will look smoother and fuller, which can reduce the appearance of fine lines and wrinkles. Red LED light is also thought to reduce inflammation while improving circulation, which can give you a healthier glow. A more detailed discussion can be found in https://www.healthline.com/health/red-light-therapy #how-does-it-work? and https://www.healthline.com/health/beauty-skin-care/led-light-therapy
A preferred embodiment of the invention comprises a power supply (e.g., battery), drive module that causes oscillation of a head receiver, detachable head mounted in the head receiver, drive control and annunciator, proximity system, and a housing that contains the preceding elements. The housing has a proximal portion, preferably ergonomic, that is easily gripped by hand. The proximal portion of the housing in this embodiment also contains drive control (described above) and proximity control and annunciator. The details of the proximity system, control, and annunciator depend upon the configuration of the proximity system. In a video proximity system, the control is at least on/off (and optionally typical video controls, such as manual or auto iris, and gain) and the annunciator is preferably a mobile display linked to the video camera by NFC. In this embodiment, proximity system control is preferably performed through one or more software applications (“smart apps”) running on the smart device and would enable recording video of the eyelid cleaning in the memory of the smart device or of the eyelid care appliance. Proximity system settings performed by smart apps or by applications running on the printed circuit board 11 can include the generation of audible tones that reflect distance between the head and the closest surface and optionally the second closest surface to the head (typically the eyelid margin is closest and the cornea or sclera is second closest surface), colors or icons on the smart device display that indicate distance, or the generation of a glideslope display on the smart device that guides a user in landing the head on an eyelid margin; preferably, one or more lights (e.g., LEDs) on the housing project light in front of the head in video-equipped embodiments of the invention. The output of the proximity system software can include the distance between head and eyelid, the distance between eyelid and eyeball, the battery level, the head oscillation frequency, and other data to assist the user; such output can be displayed on the smart device, as shown in
A further development of the device includes a touch pad and/or activator switch built into the base of the device. Many dry eye disease sufferers are elderly, and their hands and fingers may be affected by arthritis and or reduced dexterity. By placing the activator switch or touch pad in the base of the instrument, the instrument can be turned on/off, and operation modes can be changed by grasping the instrument and depressing the base on a hard surface, such as a countertop. When a touchpad is used, simply touching the base of the instrument with the hand/fingers will facilitate operation.
A “bristlehead or Soft-Tip”is preferred for eyelid care, but other materials and configurations of heads can be used in the invention, particularly for treating areas other than eyelid margins. A spongehead is an alternative configuration and it means a synthetic sponge in a disc, cylindrical, globular, and other shape that is adhered to a “sponge mount”. A head of the invention comprises (i) a bristlehead or Soft-Tip mount with a male or female portion (preferably a male mating portion, such as a post) that mates with a “head receiver” (preferably with a female mating portion, such as a socket) and (ii) a bristlehead or Soft-Tip (or other material adapted for cleaning the eyelid or other areas), selected for use for cleaning a target surface, such as the eyelid. Key selection factors for the bristlehead or Soft-Tip are surface topology, elasticity, shape memory, degree of smoothness, level of porosity, and hydrophilic nature of the head. Material selection determines whether the head is inexpensive, or durable and autoclavable.
The instant invention can be used with any head configuration including bristlehead or Soft-Tip, spongehead, silicone, thermoplastic elastomer or round polymer head, as shown in
A head mount mates with a head receiver that is connected to and driven by the drive system so that the head mated with the head receiver oscillates when the motor is powered on. Friction between the post and socket in the sponge mount/head receiver interface are typically more than adequate to keep the head firmly affixed to the head receiver, but still removable for replacement of the head. Alternatively, a weak adhesive can be applied, or a physical detent used in the plug and socket, to more firmly retain the head in the head receiver yet permit removal of the head without tools. The sponge mount and head receiver are typically made of a plastic selected to withstand rapid oscillation and devoid of small cavities that can be colonized by bacteria. A post can have any shape that prevents rotation or slippage of the sponge mount when the sponge mount is mated with the head receiver. In addition, a permanent magnet or electromagnet mounted inside the chuck, “pulls” the sterile tip into place by means of a steel rod inside the shaft of each soft tip. The post shape is preferably a polygonal shape, such as a hexagon, triangle, rectangle, or star-shape.
The sponge material, porosity, shape, and other parameters are selected based on treatment objectives, e.g., maintaining eyelid health, treating eyelid conditions and diseases, dermabrasion, polishing, etc.
Sponge materials may be low-density polyether, polyvinyl alcohol (“PVA”, which is highly absorbent), polyester (almost as absorbent as PVA, but more durable and has larger pores), and other polymers. A head can have various surface textures, topologies, porosities, permeabilities, dimensions, inlet (e.g., suction) channels, and outlet (e.g., dispensing) channels. The bristlehead or Soft-Tip can be pre-impregnated with topical pharmacologic or cleansing agents to better facilitate application and efficacy of the agents. Alternatively, topical agents can be applied to the daily disposable soft-tip, bristlebrush, or Soft-Tip before applying the head to an eyelid or can be applied using a reservoir-equipped embodiment of the invention.
Other embodiments of the daily disposable soft tip include forming the disposable from plant starch and/or gelatin, which retains the favorable characteristics of pliability, softness, and smoothness, yet erodes or “melts” as the disposable comes into contact with either or both the lubricant and/or the patient's tears. As the tip melts, active ingredients disperse evenly throughout the matrix; anti-infectives, anti-inflammatory agents, and analgesics are released in a controlled fashion, thus causing the active ingredient to be released at a desired rate throughout the duration of the nanomites. This provides a programmed release based on duration of mechanical, chemical, or electrical effect which are mixed into the tip matrix (and therefore held in a non-oxygenated state), thus preserving their designed treatment effect for an extended period of time.
Typical anti-inflammatory agents can be added to the tip matrix either individually or in combination and are selected from the group including aspirin, acetylsalicylic acid, salicylic acid, celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren-XR, Zipsor, Zorvolex), diflunisal (Dolobid—discontinued brand), etodolac (Lodine), ibuprofen (Motrin, Advil), Ketorolac tromethamine, indomethacin (Indocin) and drugs that meet the definition of NSAIDs—nonsteroidal anti-inflammatory drugs. The anti-inflammatory agent has to be mixed by high energy sonification to form a suspension with the selected oil. The oils can be selected from various oils which will mix with the RTV silicone rubber (room-temperature-vulcanizing silicone), which include flax seed oil, silicone oil, cannabidiol (CBD oil), olive oil, peanut oil and other natural oils. Silicone oils are any liquid polymerized siloxane with organic side chains. The silicone is used to mean any soft elastomer, thermoplastic elastomer, silicone, mixture of silicone and thermoplastic elastomer.
First, an anti-inflammatory agent and oil mixture must be created to suspend the anti-inflammatory agent in the oil. The anti-inflammatory agent as shown in
To create an anti-inflammatory agent bristlebrush or Soft-Tip 200 utilizing aspirin, acetylsalicylic acid and oil mixture, one would add the anti-inflammatory agent and oil mixture into the silicon at a concentration of 0.5-8 mg/ml. The following process is used: take the appropriate amount of the acetylsalicylic acid and oil mixture needed to arrive at a 0.5-8 mg/ml mixture of anti-inflammatory agent and silicone (the preferred concentration is 2.5 mg/ml) and add it to the silicone mixing it completely. Then utilize the mixture to mold the bristlebrush or Soft-Tip 200, followed by curing the bristlebrush or Soft-Tip 200 in an oven which is heated to 200 degrees C., and allow the bristlebrush or Soft-Tip 200 to cure for 4 hours or until the bristlebrush or Soft-Tip 200 is firm yet supple.
The addition of acetylsalicylic acid into the matrix results in a bristlebrush or Soft-Tip 200 that has anti-inflammatory properties which will minimize the problems of inflammation which could affect the eye health of the patient. The bristlebrush or Soft-Tip 200 is utilized by the patient applying the oscillating bristlebrush or Soft-Tip 200 on the distal end of the appliance to the eyelid, to scrub the eyelid and the meibomian glands on the edge of the eyelid.
Anti-infectives describe any medicine that is capable of inhibiting the spread of an infectious organism or by killing the infectious organism outright. This term encompasses antibiotics, antifungals, anthelmintics, antimalarials, antiprotozoals, antituberculosis agents, and antivirals. Typical anti-infective agents can be added to the tip matrix either individually or in combination, and can be selected from the group including:
Aminoglycosides are a class of antibiotics used mainly in the treatment of aerobic gram-negative bacilli infections, although they are also effective against other bacteria including Staphylococci and Mycobacterium tuberculosis. They are often used in combination with other antibiotics. Typical aminoglycosides agents can be added to the tip matrix either individually or in combination, and can be selected from the group including paromomycin, tobramycin, gentamicin, paromomycin sulfate, amikacin, amikacin liposome, kanamycin, neomycin and plazomicin.
To create an anti-infective bristlebrush or Soft-Tip 200 using an aminoglycosides agent one must create an aminoglycosides agent and oil mixture. The aminoglycosides agent as shown in
To create an anti-infective bristlebrush or Soft-Tip 200 utilizing an aminoglycosides agent such as paromomycin and oil mixture, one would add the paromomycin and oil mixture into the silicone at a concentration of 0.4-9 mg/ml. The following process is used: take the appropriate amount of the paromomycin and oil mixture needed to arrive at a 0.4-9 mg/ml mixture of paromomycin and silicone (the preferred concentration is 3 mg/ml) and add it to the silicone mixing completely. Then utilize the mixture to mold the bristlebrush or Soft-Tip 200, followed by curing the bristlebrush or Soft-Tip 200 in an oven heated to 200 degrees C., and allow the bristlebrush or Soft-Tip 200 to cure for 4 hours or until the bristlebrush or Soft-Tip 200 is firm yet supple.
The addition of paromomycin into the matrix results in a bristlebrush or Soft-Tip 200 that has anti-infective properties which will minimize the problems of inflammation, which could affect the eye health of the patient. The bristlebrush or Soft-Tip 200 is utilized by the patient applying the oscillating bristlebrush or Soft-Tip 200 on the distal end of the appliance to the eyelid to scrub the eyelid and the meibomian glands on the edge of the eyelid.
To create an anti-infective bristlebrush or Soft-Tip 200 using a natural product such as curcumin, one must create a curcumin and oil mixture. The curcumin and oil mixture as shown in
To create an anti-infective bristlebrush or Soft-Tip 200 utilizing curcumin and oil mixture, one would add the curcumin and oil mixture into the silicon at a concentration of 0.4-9 mg/ml. The following process is used: take the appropriate amount of the curcumin and oil mixture needed to arrive at a 0.4-9 mg/ml mixture of curcumin and silicone (the preferred concentration is 4 mg/ml) and add it to the silicone mixing completely. Then utilize the mixture to mold the bristlebrush or Soft-Tip 200, followed by curing the bristlebrush or Soft-Tip 200 in an oven which is heated to 200 degrees C., and allow the bristlebrush or Soft-Tip 200 to cure for 4 hours or until the bristlebrush or Soft-Tip 200 is firm yet supple.
The addition of curcumin into the matrix results in a bristlebrush or Soft-Tip 200 that has anti-infective properties which will minimize the problems of infection which could affect the eye heath of the patient. The bristlebrush or Soft-Tip 200 is utilized by the patient applying the oscillating bristlebrush or Soft-Tip 200 on the distal end of the appliance on the eyelid to scrub the eyelid and the meibomian glands on the edge of the eyelid.
Another method of making a head with anti-infective and anti-inflammatory properties, the flax seed oil is prepared with tea tree oil in a concentration of 5%-50%. First tea tree oil is placed in a beaker of 200 ml of flax seed oil and ultrasonically mixed until the tea tree oil is mixed into the flax seed oil and the flax seed oil and tea tree oil mixture is then added to silicon and/or thermoplastic elastomer such that the concentration of flax seed oil and tea tree oil to silicon and/or thermoplastic elastomer for the silicon and/or thermoplastic elastomer mixture is 3 mg/ml and flax seed oil and tea tree oil silicon and/or thermoplastic elastomer mixture is molded into a head and cured for 4 hours at 200 degrees C.
A method of making a head with anti-infective and anti-inflammatory properties where in hypochlorous acid 0.01% is placed in a beaker of 200 ml of flax seed oil and ultrasonically mixed until the hypochlorous acid is mixed into the flax seed oil and the flax seed oil and the hypochlorous acid mixture is then added to silicon and/or thermoplastic elastomer such that the concentration of flax seed oil and hypochlorous acid to silicon and/or thermoplastic elastomer for the silicon and/or thermoplastic elastomer mixture is 3 mg/ml and the flax seed oil and hypochlorous acid silicon and/or thermoplastic elastomer mixture is molded into the head and cured for 4 hours at 200 degrees C.
The head used in the invention is preferably sterile and can be easily replaced. The head is sterilized and distributed to users in packaging that maintain sterility. Sterility is desired since a head is used to clean eyelids and in close proximity to the cornea and other exposed parts of the eye, and in other embodiments is used in debridement and wound treatment. A magnetic chuck could be used to grasp and hold the head to the drive mechanism of the instant invention. Another embodiment affixes the steel pin permanently to the chuck of the hand-held device. A head can be easily replaced by pulling it off the head receiver. Periodic replacement of a disposable head is typically daily in a home use setting (i.e., for SA Cleaning), or for each patient in a clinical setting.
Alternative embodiments of the instant invention comprise one or more of the following elements: (i) illumination source(s) with on/off and optionally with light intensity control, (ii) one or more refillable reservoirs, pumps, and outlet channels for solvent, cleanser, medicament, and other liquids, powders, and gases (the gases may be heated, cooled, or room temperature and may be used to create an aerosol from a liquid or powder), (iii) means of metering and application of liquids, powders (and other solids), and gases, (iv) a suction pump that creates suction in or near the head to remove debris, cleanser, and other matter from a surface being cleaned or treated, (v) sensors and optionally processors to assay the distance from head to target area, materials in target area, and/or materials in suction waste stream, (vi) indicators (visual and aural) and displays, (vii) video camera, and data communication channels (wired and/or wireless). The hardware and software used to perform an assay may be located in the handpiece or located remotely and linked with the eyelid care appliance by NFC. A head can also comprise bristles, typically very small diameter bristles, alone or in combination with a sponge. In some head embodiments, the bristles terminate very close to the surface of a head. Refilling a reservoir is performed by connecting a liquid, gas, or powder source to an inlet connector on the housing in communication with the reservoir. Alternatively, a reservoir can be removed from the housing for refilling. An eyelid care appliance can comprise one or more reservoirs, reservoir inlet connectors, pumps, output tubing, and nozzles for dispensing solvent, cleanser, medicament, and other liquids, powders, and gases. Configurations with two reservoirs, associated pumps and tubing can be filled with agents that create heat when combined. When such agents are dispensed and combine on the eyelid surface, the eyelid surface is heated, thereby helping to “melt” blockages of meibomian glands posterior to the anterior surface or an eyelid.
Alternatively, to heat the head an electric current can be routed through the tip, so as to allow the system to heat in tip, by using conductive material/wires in the tips.
A preferred embodiment further comprises one or more reservoirs, reservoir inlet connectors, pumps, output tubing, and nozzles for dispensing liquids selected from the group comprising cleaning agents, Betadine, antiseptics, antimicrobials, anti-inflammatories, anesthetics, saline solution, water, solvents, taggants, stains, pharmaceuticals, nutraceuticals, and monoclonal antibodies. Another preferred embodiment further comprises one or more reservoirs, reservoir inlet connectors, housing inlets, pumps, output tubing, and nozzles for dispensing gases, wherein optionally the gases are heated or cooled by a thermal device in the output tubing can optionally be used to create an aerosol from a liquid or powder sourced from a different reservoir and can optionally be used to create an aerosol from a liquid or powder each stored in a different reservoir. The gas can be ambient air fed to the pump from an inlet in the housing rather than from a reservoir.
The preferred embodiment is an “integral” eyelid care appliance in which all elements of a given configuration are contained in a single housing. A drive module (defined below) and an eyelid care module (defined below) are the principal elements contained in the housing. A preferred embodiment comprises a power supply, motor, drive system that transmits motive force from the motor to oscillate a head receiver, motor controls, a proximity system, and proximity annunciator contained in a housing, wherein a head is detachably mated with the head receiver and protrudes from the housing and oscillates when the motor is powered on. An alternate “two-piece” embodiment comprises a handpiece and a detachable neck, a power supply, motor, proximity annunciator, and motor control being contained in the handpiece, a head receiver being contained in the detachable neck and connected to the motor through a drive system with portions of the drive system distributed in the detachable neck and in the handpiece, and with a coupler at the interface of the handpiece and detachable neck, which drive system transmits motive force from the motor to oscillate the head receiver, wherein a head is detachably mated with the head receiver, protrudes from the detachable neck, and oscillates when the motor is powered on. In a two-piece embodiment, each of the components recited in items (i) to (vii) above can be distributed in whole or in part, between the handpiece and the detachable neck, depending upon the component and configuration involved. In two-piece embodiments of the invention, the detachable neck comprises an eyelid care module, the neck is detachably mated with a handpiece containing a drive module and the interface between the detachable neck and the handpiece includes a drive system interface (e.g., a mechanical coupling such as a male shaft mating with a female receiver, wherein the shaft and receiver have mating geometries, such as a D-shape, triangle shape, star shape, etc., or a magnetic coupling).
In all embodiments of the invention, a power supply (typically a replaceable and/or rechargeable battery) powers a DC motor, and when the motor is powered on, the motor (and drive translator, if the motor outputs unidirectional rotary motion) causes the oscillation of a driveshaft (or equivalent means of transmitting motive force, e.g., in a two-piece embodiment, an electric motor with magnetic or mechanical coupling to a detachable neck). The oscillating driveshaft causes the head receiver to oscillate, which causes the head mounted in the head receiver to oscillate. The eyelid care appliance is typically battery powered; however, it can be powered by a power supply connected to an electrical outlet.
A “drive module” comprises a power supply, motor, on/off control, drive shaft, and related transmission elements. If the motor outputs unidirectional rotary motion, such unidirectional rotary motion is translated so that the driveshaft causes the head to oscillate. The combination of the motor, driveshaft, and related transmission elements (such as a drive translator) is called a “drive system”. A well-known drive translator has a motor-driven driveshaft with pinion gear driving a geared disc or cam. An eccentric follower link on the geared disc or cam causes a shaft linked to the geared disc or cam to oscillate. The drive system couples the motive force of the motor to the head.
An “eyelid care module” comprises at least a head, head receiver, and associated drive system. Integral and two-piece embodiments of the invention can be configured to provide the same functionality. However, functionality of two-piece embodiments may be limited by the functionality of the handpiece. For instance, a detachable neck (containing an eyelid care module) that mates with a generic powered handpiece, e.g., an electric toothbrush handpiece, would have to have additional functionality configured in the detachable neck.
As shown in
In embodiments in which the head angle (the angle between the axis of oscillation of the bristlebrush or Soft-Tip 200 and the longitudinal axis of the housing 1) is non-adjustable, the head angle is fixed between zero and 90 degrees. In embodiments in which the head angle is adjustable (see
An alternative configuration of the head receiver and drive system places an adjustable head receiver at the distal tip of the eyelid care appliance, and the head angle can be adjusted through a range up to 180 degrees (i.e., +90-degree head angle to −90-degree head angle) and fixed at a given head angle through detents and/or locking mechanism. Such an expanded range of head angles avoids the need to invert the eyelid care appliance when cleaning the upper eyelid margins, and also keeps the on/off button in the same location within the user's grip. An adjustable head receiver embodiment of the eyelid care appliance facilitates different angulations of treatment and therapy. A preferred adjustable head receiver embodiment has detents in the head receiver at specific angulations, e.g., 45, 90, 135 and 180 degrees of head angle. The head can be locked in place at each detent position. A second preferred adjustable head receiver embodiment can be locked in place, e.g., by a clamping means, at any angulation with the range of head angulation.
As shown in
In a preferred embodiment for SA Cleaning and SP Cleaning, the eyelid care appliance comprises a drive module, drive controls and annunciator, eyelid care module with adjustable head angle, proximity sensor, proximity controls and annunciator, and related data channels. The proximity sensor determines or depicts the distance between the surface of the head and the eyelid margin. The proximity annunciator can be a light or a light array, a display, a generated voice, or tactile. A preferred configuration, as shown in
As shown in
A preferred gel would contain Argan oil, Pomegranate Fruit Extract, Norway Spruce tree sap (Picea Abies Extract), and Jojoba Esters. The gel can be formulated from Aqua, Glycerin, 1,2-Hexanediol, Argania Spinosa (Argan) Kernel Oil, Punica Granatum (Pomegranate) Fruit Extract, Picea Abies Extract, Hydrolyzed Jojoba-Esters, Butylene Glycol, Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydroxyacetophenone, Sodium Hydroxide.
Argon Oil—Packed full of hydrating essential fatty acids and anti-inflammatory vitamin E and sterols, Argan oil is a nutrient powerhouse.
Pomegranate Fruit Extract—Is known for cell regeneration and helps to protect the epidermis.
Norway Spruce tree sap (Picea Abies Extract)—A pharmaceutical grade ingredient in Finland for various applications. This ingredient is extremely unique and provides anti-inflammatory, antioxidant, wound healing, and anti-bacterial properties.
Jojoba Esters—Derived from the seeds of a desert shrub, this oil is an emollient ester with excellent spreading, lubricating and penetrating properties.
However, the head could also be configured as a bristlebrush or Soft-Tip 200 and the recessed tip or hollow cavity 202 as shown in
Another embodiment of the device of the invention, as shown in
Embodiments of the eyelid care appliance with reservoirs are equipped with dispensing controls and associated sensors, valves, and optional data channels that report sensor output and valve status. Controls in the eyelid care appliance are activated by buttons on the housing (or handpiece) and implemented by a processor on a printed circuit board 11 in
As shown in
The sponge mount 5 with affixed sponge 45 or more preferable bristlebrush or Soft-Tip 200 fits firmly (either by friction or by detent) into a head receiver 6 and oscillates in a fixed relationship to the head receiver 6. Light pipe and light ring 19 provide light in the direction of the head post axis from an LED 207 mounted on and controlled by printed circuit board 11. Alternatively, power controlled by printed circuit board 11 can be provided to LEDs near the head receiver 6 or to LEDs on the distal portion of the eyelid care appliance. If a rechargeable battery is used as the power source in the handpiece, a battery charger (e.g., inductive, or conductive terminals) can be incorporated into a stand or holder for the device of the invention; alternatively, the battery can be removed through battery cover 3 for recharging in a charging dock. One or more lighting LEDs can project light in front of the head, thereby providing adequate illumination for the user and/or a video camera.
As shown in
As shown in
As shown in
Furthermore, as noted
The main housing 1 preferably comprises a power button 24, which, in a preferred embodiment, allows the massaging action of the bristlebrush or Soft-Tip 200 to be activated either alone or in combination with heat. The main housing 1 also preferably comprises a light emitting diode (LED) 207. In a preferred embodiment, the LED 207 is a dual LED with both a green LED and a red LED in the same light. The green LED indicates that the batteries are being charged. The red LED indicates that the unit is heating the bristlehead or Soft-Tip. The main housing 1 can also have a selector switch which allows the patient to select cleaning modes comprising of a circular motion, an elliptical path or oscillating motion depending on the selected mode. The system can also be configured as a wired device or with a rechargeable battery and charger.
Alternatively, one could heat the head, by placing some conductive material/wires in the tips and utilize either AC or DC current to heat the head. The device can also be configured to use electromagnetic induction to transmit electricity to sealed head thereby eliminating the need for conductors.
Alternatively, the invention can also use induction heating to heat the head.
In one embodiment, the motor shaft (not shown) of the motor 7 is connected to a flexible shaft 17, which extends from the top of the motor 7 to inside of the head receiver 6 so that as the motor shaft rotates, the flexible shaft 17 also rotates. In an alternate embodiment (not shown), two non-flexible shafts connected by a first universal joint could be used in lieu of the flexible shaft. In the latter embodiment, the first shaft would be connected to the motor shaft, and the second shaft would be connected to the oscillation assembly inside the head receiver 6. A second universal joint would be located at the point at which the second shaft connects to the oscillation assembly.
The bristlebrush or Soft-Tip 200 is preferably made of a soft elastomer or silicone. In a preferred embodiment, the bristlebrush or Soft-Tip 200 is shaped so as to be comfortable when placed over the eyelid.
In a preferred embodiment, the bristlebrush or Soft-Tip 200 is removable from the Main Housing 1.
The eyelid cleaning action occurs from the bristlebrush, or Soft-Tip 200 being placed in communication with the patient's eyelid and the main housing 1 mechanisms causing the bristlebrush or Soft-Tip 200 to rotate in a circular motion or oscillate depending on the selected mode. The bristlebrush or Soft-Tip 200 can oscillate or follow an elliptical path.
It is the combination of the cleaning motion for the eyelid that the device provides, that allows it to provide stimulation for the meibomian glands. Alternatively, the bristlebrush or Soft-Tip 200 can also be heated which would provide additional stimulation to the meibomian glands. However, the heat needs to be limited from 75 to 104 degrees Fahrenheit so as not to harm the eyelid. When utilizing a heated bristlebrush or Soft-Tip 200, the main housing 1 contains a controller for modulating the heat of the bristlebrush or Soft-Tip 200.
Alternatively, the bristlebrush or Soft-Tip 200 or a round polymer head as shown in
The addition of curcumin into the matrix of the bristlebrush or Soft-Tip 200 has antimicrobial properties, which will minimize the problems with transferring bacteria, which could affect the eye heath of the patient. The bristlebrush or Soft-Tip 200 is utilized by the patient applying the oscillating bristlebrush or Soft-Tip 200 on the distal end of the appliance, together with a solvent or cleanser to the eyelid, to scrub the eyelid and the meibomian glands on the edge of the eyelid.
Alternatively, a package which minimizes the handling of the bristlebrush or Soft-Tip 200 by the patient would also minimize the problems of transferring bacteria which could affect the eye health of the patient. The bristlebrush or Soft-Tip 200 can also be made of an antimicrobial material to further improve the sterile properties of bristlebrush or Soft-Tip 200.
An integral manufacturing and shipping system 500 shown in
Alternatively, the instant invention could also be a smart device by adding a WiFi, NFC, Bluetooth or a ZigBee interface which would collect data and provide it to a cloud database. The smart instant invention would communicate with an application loaded on a smart phone, tablet or computer and upload treatment times and pressures to an integrated cloud 620 application which could be shared with the healthcare provider to monitor treatments. The communication could be a means such as Zigbee, Bluetooth, Bluetooth BLE, ANT+, WiFi or NFC. The data that could be collected would be clinically significant such as treatment time, pressure and date. The collection of pressure data would require the integration of a pressure transducer into head receiver 6. You could also create a chip that comes with each head, which is a read writeable device as shown in
Software applications and sensors used with embodiments of the eyelid care appliance (including embodiments with a system on a chip within the eyelid care appliance or with a smart device linked by a communication method such as Zigbee, Bluetooth, Bluetooth BLE, ANT+, WiFi or NFC to the eyelid care appliance), can detect and report: how often and for how long one has scrubbed an area, battery condition, how much pressure is applied at the head, patency of the meibomian glands, health of the eyelid margin, etc. A video and/or sensor equipped eyelid care appliance can also provide images and/or assay reports of other body surfaces, e.g., skin lesions, wounds. The software applications can run on a computer integral with the eyelid care appliance, on a remote device, or on networked devices, including the eyelid care appliance as a client in a network.
Embodiments of the invention with lighting and a video proximity system can be equipped with band-limited light sources, either by selection of LED emitters and/or by filtering, and with multispectral image analysis software. Such an embodiment further comprises one or more band-limited light sources that project light in front of the head, wherein the proximity system is a video camera with lens mounted near the head and in near field communication with a smart device, wherein the video output from the video camera is fed to multispectral image analysis software in the smart device or in the appliance, and the output of the multispectral image analysis software is displayed on the smart device. Using multispectral image analysis well known in the art and implemented in software applications running on an integral processor or on a smart device with an NFC link to the eyelid care appliance, provides a non-invasive, real-time method of determining the health of an eyelid (or other skin area).
In addition to routine eyelid cleaning, SA Cleaning, and SP Cleaning, the invention may also be used to clean other areas and types of tissue where, or in other applications in which, a surface needs to be thoroughly cleaned, such as:
The eyelid care appliance can be made in various sizes, e.g., pediatric and adult. An eyelid care appliance can be made in various sizes of drive module, e.g., different glove sizes, different pistol grip sizes, and in different sizes of head, e.g., pediatric and adult. Two-piece embodiments of the eyelid care appliance can be made with a standard interface between detachable neck and handpiece so that different sizes of detachable necks can be mated with different sizes of handpieces. Any embodiment of the eyelid care appliance can include an accelerometer that detects that the appliance has been dropped and that causes the motor to be powered off. Any embodiment of the eyelid care appliance can also use NFC to report its location to a smart device.
Alternative embodiments of the invention designed to care for body surfaces other than eyelids are called herein “surface care devices” and, like eyelid care appliances, comprise a drive module and an eyelid care module, and include the alternative embodiments described above (e.g., proximity systems, fluid and fluidized agent dispersal systems, suction systems and communication links to smart devices. The communication could be a means such as Zigbee, Bluetooth, Bluetooth BLE, ANT+, WiFi or NFC. etc.). Heads of various diameters and topologies are tailored to the skin area to be treated, e.g., a large concave head to treat elbows, a small concave head to treat fingertips. Surface care devices also include wound care devices adapted for various types of wounds to be cleaned or otherwise analyzed or treated using a surface care device; one embodiment of a surface care device for wounds is a mechanical debridement device.
A surface care appliance can be used for pre-operative scrubbing of small areas of skin before surgery, in particular for scrubbing of eyelid margins. Pre-operative scrubbing is currently done manually with swabs and sponges.
An alternative embodiment of the invention can be configured by choice of head to clean makeup off eyelids; a sterile head could be mounted for each use. Current methods of using moistened towelettes or cotton balls may not thoroughly clean eyelids of all residual makeup. This device could be used either primarily or as an adjunct to the above-described methods to more thoroughly and rapidly remove eye makeup.
To generalize the preceding description, like eyelid care appliances, surface care devices of the invention are of two types: (1) an integral appliance, with an eyelid care module and drive module within a single housing, optionally with a pivoted grip, or (2) a two-piece appliance, comprising a handpiece and detachable head. Embodiments of surface care devices, e.g., for skin care and wound care, are adapted for areas to be cleaned or otherwise analyzed or treated.
The instant invention could be made more ergonomic. To do this, the design could include a head and Soft-Tip that protrudes further out from the handpiece and helps ensure easy contact with the eyelid margins.
The instant invention could also use a consumer replaceable and/or rechargeable battery.
The handpiece design could be designed such that it would be easier for arthritic patients to turn on/off. Such a design could include a larger grip and an improved switch.
The instant invention could also be made Waterproof. The design would have to account for the need to provide serviceability.
The instant invention could also include a redesign of the handpiece so that the shaft and the round plate currently a part of the bristlebrush or Soft-Tip become a permanent/semi-permanent part of the handpiece. This would reduce the cost of the Soft-Tip by making the tip and base plate reusable/semi-permanent.
It would allow the manufacturer to offer the bristlebrush or Soft-Tip in different lengths so as to provide a length most comfortable to the patient (and avoid a fixed redesign of the handpiece), allow press-on attachment of the bristlebrush or Soft-Tip to the handpiece and thus much easier for elderly patients to attach; reduce the size and weight of the packaging—hence reduce freight costs.
The instant invention can also be described as a method of cleaning the eyelid margins and meibomian gland orifices of a patient and the patient having a patient's eye and the patients eye comprised of a lid portion and meibomian gland orifices and the cleaning cleans cellular and sebaceous debris from the meibomian gland orifices comprising of:
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head stem is located on the center of the head and on the opposite side of the head surface.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head stem is located off center of the head and on the opposite side of the head surface.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the angular sweep motion is selected from the 90 degrees to 270 degrees if viewed from the face of the head.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the angular sweep motion speed is selected from 4,000 to 15,000 strokes/minute.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents;
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from silicone and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents;
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the topical agent selected from the group comprising of liquids, gels, ointments, cleansers, solvents, gases, powders or other fluid or fluidizable medicaments.
The instant invention can also be described as a method of cleaning the eyelid margins and meibomian gland orifices of a patient and the patient having a patient's eye and the patients eye comprised of a lid portion and meibomian gland orifices and the cleaning cleans cellular and sebaceous debris from the meibomian gland orifices comprising of:
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the piezo electric mechanism has a piezo electric frequency, and the piezo electric frequency creates an ultrasonic motion.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head stem is located on the center of the head and on the opposite side of the head surface.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head stem is located off center of the head and on the opposite side of the head surface.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the angular sweep motion is selected from the 90 degrees to 270 degrees if viewed from the face of the head.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the angular sweep motion speed is selected from 4,000 to 15,000 strokes/minute.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from materials selected from the group comprising sponge, soft elastomer, thermoplastic elastomer, silicone and a mixture of silicone and thermoplastic elastomer.
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from thermoplastic elastomer and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents;
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the head is made from silicone and anti-infective agents selected from the group comprising of Curcumin, Silver, Copper, Amebicides, Aminoglycosides, Azole antifungals, Echinocandins, Polyenes and Antiviral agents;
The method of cleaning the eyelid margins and meibomian gland orifices of a patient of the instant invention wherein the topical agent selected from the group comprising of liquids, gels, ointments, cleansers, solvents, gases, powders or other fluid or fluidizable medicaments.
By attaching the plate to the shaft, it would allow for a Soft-Tip to be attached to the plate which is part of the handpiece.
Further modifications will also suggest themselves to those skilled in this art, and such are considered to fall within the spirit and scope of the invention as defined in the appended claims.
Although the preferred embodiment of the present invention has been shown and described, it will be apparent to those skilled in the art that many changes and modifications may be made without departing from the invention in its broader aspects. The appended claims are therefore intended to cover all such changes and modifications, as they fall within the true spirit and scope of the invention.
While various aspects and features of certain embodiments have been summarized above, the following detailed description illustrates a few exemplary embodiments in further detail to enable one skilled in the art to practice such embodiments. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention.
In the above description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the described embodiments. It will be apparent to one skilled in the art, however, that other embodiments of the present invention may be practiced without some of these specific details. Several embodiments are described herein, and while various features are ascribed to different embodiments, it should be appreciated that the features described with respect to one embodiment may be incorporated with other embodiments as well. By the same token, however, no single feature or features of any described embodiment should be considered essential to every embodiment of the invention, as other embodiments of the invention may omit such features.
While certain features and aspects have been described with respect to exemplary embodiments, one skilled in the art will recognize that numerous modifications are possible. Further, while various methods and processes described herein may be described with respect to particular structural and/or functional components for ease of description, methods provided by various embodiments are not limited to any particular structural and/or functional architecture.
Hence, while various embodiments are described with or without certain features for ease of description and to illustrate exemplary aspects of those embodiments, the various components and/or features described herein with respect to a particular embodiment can be substituted, added, and/or subtracted from among other described embodiments, unless the context dictates otherwise. Consequently, although several exemplary embodiments are described above, it will be appreciated that the invention is intended to cover all modifications and equivalents within the scope of the following claims.
While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains, and which fall within the limits of the appended claims.
Since many modifications, variations, and changes in detail can be made to the described embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Furthermore, it is understood that any of the features presented in the embodiments may be integrated into any of the other embodiments unless explicitly stated otherwise. The scope of the invention should be determined by the appended claims and their legal equivalents.
In addition, the present invention has been described with reference to embodiments, it should be noted and understood that various modifications and variations can be crafted by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing disclosure should be interpreted as illustrative only and is not to be interpreted in a limiting sense. Further it is intended that any other embodiments of the present invention that result from any changes in application or method of use or operation, method of manufacture, shape, size, or materials which are not specified within the detailed written description or illustrations contained herein are considered within the scope of the present invention.
Insofar as the description above and the accompanying drawings disclose any additional subject matter that is not within the scope of the claims below, the inventions are not dedicated to the public and the right to file one or more applications to claim such additional inventions is reserved.
Although very narrow claims are presented herein, it should be recognized that the scope of this invention is much broader than presented by the claim. It is intended that broader claims will be submitted in an application that claims the benefit of priority from this application.
While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
This application claims priority from U.S. provisional patent application 63/505,710, filed on Jun. 2, 2023, entitled Device And Method For Stimulating The Melbomian Glands Of The Eyelid, U.S. Non provisional application U.S. Provisional patent application Ser. No. 16/852,329, filed Apr. 20, 2020, entitled Device And Method For Stimulating The Melbomian Glands Of The Eyelid, U.S. provisional application 62/835,868, filed Apr. 18, 2019 entitled Device and method for stimulating the meibomian glands of the eyelid; this application claims priority from U.S. patent application Ser. No. 16/402,143, filed May 2, 2019, entitled Eyelid Care Appliance; this application claims priority from U.S. patent application Ser. No. 16/431,631, filed Jun. 4, 2019, entitled Eyelid Care Appliance, U.S. patent application Ser. No. 16/402,143 claims priority to U.S. patent application Ser. No. 14/588,392 now U.S. patent Ser. No. 10/314,763 issued on Jun., 11 2019, U.S. patent application Ser. No. 14/588,392 now U.S. patent Ser. No. 10/314,763 claims the benefit of provisional patent application 62/011,591 filed Jun. 13, 2013, and U.S. patent application Ser. No. 14/588,392 now U.S. patent Ser. No. 10/314,763 claims the benefit of provisional patent application 61/922,791 filed Dec. 31, 2013, all of which are hereby incorporated by reference herein for all purposes. A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. Trademarks used in the disclosure of the invention, and the applicants make no claim to any trademarks referenced.
| Number | Date | Country | |
|---|---|---|---|
| 63505710 | Jun 2023 | US | |
| 62835868 | Apr 2019 | US | |
| 62011591 | Jun 2014 | US | |
| 61922791 | Dec 2013 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14588392 | Dec 2014 | US |
| Child | 16402143 | US | |
| Parent | 14588392 | Dec 2014 | US |
| Child | 16431631 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16852829 | Apr 2020 | US |
| Child | 18628935 | US | |
| Parent | 16431631 | Jun 2019 | US |
| Child | 16852829 | US | |
| Parent | 16402143 | May 2019 | US |
| Child | 16431631 | US |
