Methods, systems, and apparatus for heat treatment for treating meibomian gland dysfunction

(54) Title: METHODS, SYSTEMS AND APPLIANCES FOR TREATING MEIBONIAN GLAND DYSFUNCTION BY HEAT (30) Unionist Priority: 17/01/2007 us 60 / 880,850 (73) Holder (s): Tearscience, Inc.

(72) Inventor (s): Benjamin Tyson Gravely, Donald R. Korb, John Martin Jans, Jordan W. Hutchinson, Keith Gausmann, Stephen M. Grenon, Timothy R. Willis (74) Attorney (s): Orlando de Souza ( 86) International Order: pct US2008051309 of 17/01/2008 (87) International Publication: wo 2008 / 089327de 24/07/2008 (57) Abstract: methods, systems and devices for TREATING MYBONIAN GLAND DYSFUNCTION BY HEAT. Apparatus, systems and methods of treating meibomian gland dysfunction. Heat is directed to the patient's eyelid or the surrounding tissue to apply heat to the patient's meibomian glands. The application of heat helps to remove obstructions or occlusions in the meibomian glands to restore sufficient sebum flow to the lipid layer to treat dry eye. Force can also be applied to the patient's eyelid or surrounding tissue to optimize conductive heat transfer and reduce blood flow in the tissue which causes loss of convective heat. Thus, the application of force can also increase the temperature level and / or reduce the time to reach the desired temperature levels to remove obstructions. When higher temperature levels are reached, there is a possibility of an increase in dissolution, loosening or softening of the obstructions or occlusions of the meibomian glands, at the same time as there is a reduction in the time to reach the desired temperature levels and / or to assist in reducing patient discomfort during treatment.

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METHODS, SYSTEMS AND APPLIANCES FOR TREATING MYBONIAN GLAND DYSFUNCTION BY HEAT

Related Orders

The present application claims priority over US Provisional Patent Application No. 60 / 880,850, having the title Method and Apparatus for Treating Meibomian Gland Obstructive Disease, filed on January 17, 2,007 ,, which is incorporated into this application by reference in its entirety.

This order is also related to US Order Serial No. 11 / 434,033, under the title Method and Apparatus for Treating Glandular Dysfunction Using a Heated Medium, filed on May 15, 2006, which is incorporated into this order by reference in its wholeness.

The present order is also related to US Order Serial No. 11 / 434,446, under the title Method and Apparatus for the Treatment of Glandular Dysfunction, filed on May 15, 2 006, which is incorporated in this application by reference in its entirety.

The present order is also related to US Order Serial No. 11 / 434,054, under the title Method and Apparatus for the Treatment of Glandular Dysfunction, submitted on May 15, 2006, which is incorporated in this application by reference in its entirety.

This order is also related to the Order

US Serial No. 11 / 541,291, with the title Method and

Apparatus for the Treatment of Glandular Dysfunction, using a Jet of Fluid, deposited on September 29,

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2006, which is incorporated in this application by reference in its entirety.

The present order is also related to US Order Serial No. 11 / 541,418, having the title Treatment of Meiobomian Glands, filed on September 29, 2006, which is incorporated in this application by reference in its entirety.

The present order is also related to US Order Serial No. 11 / 541,308, under the title Liquidation of Obstructions of the Meiobomianas Glands, deposited on September 9, 2 0 06, which is incorporated in this application by reference in its entirety.

The present order is also related to US Order Serial No. 11 / 893,669, under the title Illumination and Imaging of Meiobomianas Glands, filed on August 17, 20 07, which is incorporated in this application by reference in its entirety.

Field of invention

The field of the invention relates in general to the treatment of mammalian eyes. More particularly, the present invention relates to the treatment of meibomian gland dysfunction (MGD), which can either be responsible or be a factor that contributes to the patient suffering from a dry eye condition. A patient's meibomian glands are treated to help facilitate a sufficient protective lipid layer, which is being generated and retained in the tear film of the eye for water retention. Background of the invention

In the human eye, the tear film that covers the ocular surfaces is made up of three layers. The layer

3/125 innermost in contact with the ocular surfaces is the mucous layer. The mucous layer is composed of several mucins. The middle layer, comprising the core of the tear film is the aqueous layer. The aqueous layer is important because it offers a protective layer and lubrication to prevent dryness of the eye. Dryness of the eye can cause symptoms such as itching, burning and irritation, which can result in discomfort. The outermost layer consists of many lipids known as meibum or cerumen. This outer lipid layer is very narrow, typically less than 250 nm in thickness. The lipid layer provides a protective covering over the aqueous and mucous layers, to limit the degree to which these underlying layers evaporate. A higher degree of evaporation from the aqueous layer can cause dryness of the eye. Therefore, if the lipid layer is not sufficient to limit the degree of evaporation from the aqueous layer, it may result in dryness of the eye. The lipid layer also lubricates the eyelid during blinking, which prevents the eye from drying out. Dry eye is a recognized eye condition, usually called dry eye. If the lipid layer can be improved, the evaporation rate will decrease, lubrication will improve and partial or complete relief of the condition of the eye will be obtained.

The cerumen that forms the outermost lipid layer is secreted by the meibomian glands 10 of the eye, as shown in Figs. 1-3 of this request. The meibomian glands are enlarged glands, specialized sebaceous glands (hence the use of cerumen to describe the secretion), located on both the upper eyelids 12, and the lower eyelids 14. The meibomian glands

4/125 contain channels, 16, designed to release lipid secretions to the margins of the eyelid, thus forming a lipid layer of the tear film when the mammal blinks, and spread lipid secretion. The typical upper human eyelid, 12, has about twenty-five (25) meibomian glands, and the lower eyelid, 14, has about twenty (20) meibomian glands, which are slightly larger than those located on the upper eyelid. Each meibomian gland, 10, has a straight and long central duct, 18, aligned with the epithelial layers on the inner surface of the duct, 18. Along the extension of the central duct, 18, there are many lateral structures outside the pouch, 20, dilations where the secretion of the gland is produced. The internal alignment of each dilation, 20, differs from the central central duct, 18, in which these specialized cells produce secretions from the meibomian glands. Secretions flow from each dilation 20, to duct 18.

While it is not established with certainty, it appeared to be a system of valves between each dilation, 20, and the central duct, 18, to retain secretion until needed, when it would then be released into the central duct, 18. Meibomian secretion it is then stored in the central duct, 18, and will be released through the channel of each gland to the margin of the eyelid. The blinking and compressing action of the Riolan muscle around the meibomian glands, 10, was believed to be the primary mechanism for opening the canal and releasing secretion from the meibomian gland, 10. The act of blinking determines that the upper eyelid , 12, pulls a drop of the lipids excreted by the meibomian glands 10, over the other two layers of the

5/125 tear film, thus forming a type of protective covering that limits the degree to which the underlying layers evaporate. However, an affected lipid layer or an insufficient amount of these lipids can result in accelerated evaporation of the aqueous layer which, in turn, causes symptoms such as itching, burning, irritation and dryness, which are collectively referred to as dry eye.

Several treatment modalities have been developed to treat the dry eye condition. These modalities include drops, which are designed to replicate and replace the natural watery tear film, as well as drugs designed to stimulate the tear-producing cells. For example, eye drops such as Refresh Endura ™, Soothe ™ and Systane ™ eye drop brands are designed to approximately replicate the naturally occurring healthy tear film. However, its use and administration are only treatments for symptoms and not the effective cause. More than that, the use of water droplets is generally prescribed for an indefinite period and, therefore, prolonged use can become harmful and costly.

Modalities of pharmaceutical procedures, such as the use of tetracycline, have also been suggested to treat meibomian gland dysfunction. Such a treatment is disclosed in US Patent Application Publication no. 2003/0114426 entitled Method for treating Conditions of the Meibomian gland (Method for Treating Meiboimian Gland Disease), US patent no. 6,455,583, entitled Method for Treating Meibomian Gland Diseases (Method for Treating Meiboimian Gland Disease) for Pflugfelder et al. and PCT Publication Application no.

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WO 99/58131 entitled Use of Tetracyclines to Treat Meibomian Gland Diseases (Use of Tetracyclines for Treating Meibomian Gland Disease). However, this treatment has not proven to be universally effective clinically and may be ineffective in cases where MGD is the result of gland obstruction without infection.

The use of corticosteroids has also been proposed to treat MGD, as demonstrated in the US patent no. 6,153,607 entitled Unpreserved tropical corticosteroids for treatment Dry eye, corneal filamentary inflammation and delayed tear release (or rotation) (Non-preserved Topical Corticosteroid for Treatment of Dry Eye, filamentary Keratitis and Delayed Tear Clearance (or Turnover) for Pflugfelder et al. Again, the proposed treatment appears to treat dry eye symptoms, in contrast to the underlying cause.

In addition, the topically applied use of androgens or androgen-like was also done to treat acute signs and symptoms of dry eye in siccan corneal conjunctivitis. This is shown in US patents no. 5,958,912 and 6,153,607, both entitled Ophthalmic therapy in sicca corneal conjunctivitis, using applied beta-TGF androgens

Keratoconjunctivitis Sicca Using

Androgens or TGF-beta), and both for Sullivan.

There is a correlation between the lipid layer of the tear film and the dry eye condition. The various different medical conditions and injury to the eye, as well as the relationship of the lipid layer to those conditions are reviewed in Surv Ophtamol 52: 369: 374, 2007. It is clear that (Ocular Therapy in Topically Applied

7/125 the condition of the lipid layer has the most considerable effect on the dry eye condition, when compared to the aqueous layer or other causes. Therefore, while dry eye conditions have many etiologies, the inability of the meibomian gland, 10, to generate the lipid layer is a common cause for dry eye condition. This condition is known as meibomian gland dysfunction (MGD). MGD is an irregularity where the meibomian gland 10 is blocked or occluded. Fig. 3 shows one of these obstructions. 22 and 24, or occlusions, 22 and 24. Clogged obstructions, 22, can occur in channel 16 of the central duct 18. Alternatively, obstructions and occlusions 22 and 24 can occur to particularly block dilation 20. Obstructions and occlusions 22 and 24 may mean that the meibomian gland 10 is partially blocked or blocked, totally blocked or blocked or any associated variation. Obstructions and occlusions 22 and 24 can be due to a solid, semi-solid or thick secretion and / or clogging, frozen, leading to a compromise or more specifically, to a decrease or cessation of the secretion. Also, with a reduced or limited secretion, the meibomian gland 10 can be compromised by an occlusive or obstructive condition, often evidenced by a yellowish color, indicating a possible state of infection. Alternatively, the meibomian gland 10 may otherwise be compromised so that the resulting protective lipid layer is not adequate to prevent evaporation of the underlying layers of the eye.

MGD is often the result of obstructions

8/125 keratinous cells, which partially or totally block the channels of the meibomian gland 16, and / or the central duct (channel) 18 of gland 10, or possibly dilations or dilation valves (assuming that they actually exist), or the junction of the dilations 20 with the central duct 18. These obstructions 22 and 24 compromise the secretion functions of the individual meibomian glands 10. More particularly, these keratinous obstructions may be associated with or result in various combinations of bacteria, basic fatty substances, death and / or skinned epithelial cells (see Meibonian Gland Dysfunction and Contact Lens Intolerance, Journal of the Ophtometric Association, v.51, no. . 3, Korb et al. 1980, pp.243-51)

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blocked glandular cells. More reduced estrogens can also accentuate conditions in which staph bacteria can proliferate. This can cause migration of bacteria to the glands, 10 compromising the glandular function and additionally contributing to occlusion, resulting in a reduced degree of secretion from the meibomian gland 10.

When the flow of secretion from the meibomian gland 10 is restricted, due to the existence of occlusion 22 and 24, it was observed that cells on the edge of the eyelid grew beyond the channel of the gland 16. This can additionally restrict the flow of cerumen and exacerbate a condition dry eye. Additional factors can also cause or

9/125 to exacerbate the dysfunction of the Meibomian gland, including age, maladjustment in blinking, activities such as computer use that compromise normal blinking, use of contact lenses, contact lens hygiene, use of cosmetics or other diseases, particularly diabetes. It has been theorized that gland 10 dilations 20 may have valves at their junctions with the main gland canal 10. The authors propose that if such a valve exists, it may also become blocked in some instances that lead to reduced or blocked flow since the dilations 20. The obstructions and occlusions 22 and 24 can have several compositions.

The state of an individual Meibomian gland 10 can vary from optimal, when clear Meibomian fluid is produced, to mild or moderate dysfunction of the Meibomian gland, when milky fluids or creamy or thick secretions are produced; until complete blockage, when no secretion of any kind can be obtained (see Increase to Tear Film Lipid Layer Thickness Followinçf Treatment of Meibomian Gland Dysfuntion, Lacrimal Gland, Tear Film and Dry Eye Syndromes, Korb, et al. pp. 293-98 , edited by DA Sullivan, Plenum Press, NY, 1994). Significant chemical changes in the secretions of the Meibomian gland 10 occur with the dysfunction of the Meibomian gland, and, therefore, the composition of the tear film that occurs is naturally altered, which, in turn, contributes to dry eye.

MGD can be difficult to diagnose, because visible indicators are not always present. For example, meibomitis, an inflammation of the meibomian glands 10, can lead to MGD. Meibomite can also

10/125 be accompanied by blepharitis (inflammation of the eyelid). When meibomite is obvious by inspecting the outer eyelids, MGD may not become obvious even if examined with magnification by a slit lamp biomicroscope. This is because there are no external signals or the external signals can be so small that they are not observed. The external signs of MGD without obvious eyelid inflation can be limited to subtle changes in the channels of the meibomian gland 16, glands 10, with frozen material acting as obstructions. In severe instances of MGD without obvious eyelid inflation, changes may be obvious, including serrated and wavy eyelid margins, canal recession and obvious swelling of the epithelium over channels 16, and in the bags of channels 16.

To sum up, the meibomian glands 10 of the eyelids of mammals (for example, humans) secrete oils that prevent the evaporation of the tear film and provide lubrication for the eyes and eyelids. These glands can become blocked or clogged (occluded) by various mechanisms that lead to the so-called dry eye syndrome. When it is not the only cause, MGD is the known cause of dry eye syndrome. This condition is characterized by a block of various types within the meibomian glands 10, or on its surface, preventing normal lipid secretions from flowing from the meibomian glands 10 to form the lipid layer of the tear film. These secretions serve to prevent evaporation of the watery tear film and lubricate the eyes and eyelids 12 and 14, where their absence can cause dry eye syndrome. Obstructions or occlusions 22 and 24 of

11/125 meibomian glands 10 can be present on the channel or inside it, 16, from gland 10, in the main channel 18 of gland 10, which can be strangled or blocked, or possibly in another location, including the expansion passages 20 for main channel 18.

While the present state of the art offers a large number of treatments for dry eye, there is a need to address the underlying cause when the symptom manifests. Many patients suffer from dry eye as a result of obstructions or occlusions in the meibomian glands. However, there is a need to provide an adequate treatment of the meibomian glands to restore a sufficient flow of cerumen to the lipid layer of the eye, in order to limit the degree of evaporation of the underlying layers. This includes releasing and removing possible obstructions and occlusions 22 and 24 from the meibomian glands 10. Fig. 2 of this patent application shows the obstructions and occlusions 22 and 24 of Fig. 3 in the meibomian glands 10 removed, to restore the flow of the lipid layer.

Summary of Detailed Description An embodiment of the present invention includes overcoming and the previously unknown method of applying heat to the inner surface of the eyelid to treat dry eye caused by dysfunction of the meibomian gland (MGD). Applying heat to the inside of the eyelid can effectively and efficiently raise the temperature in the meibomian glands to a temperature sufficient to fuse, release or relieve more severe gland occlusions

12/125 meibomian. Occlusions and obstructions can be physically expressed to improve the flow of cerumen from the meibomian glands to reduce evaporation of the water layer.

Some patients have occlusions and obstructions in their meibomian glands that will not fuse, release or relieve sufficiently to be expressed without reaching the high temperature in the meibomian glands. In many instances, these temperatures cannot be achieved by applying heat to the outside of the eyelid, nor can these temperatures be reached, but only after applying heat to the outside of the eyelid for a significant period of time. Elevated temperatures can only be reached by applying heat to dangerous temperatures that will produce both an unacceptable painful response to the patient and injure the patient's eyelid. This happens because of the drop in temperature between the outside of the eyelid and the meibomian glands, due to the loss of heat by convection. 0 Heat applied to the outside of the eyelid must circulate by convection through the eyelid tissue and through the tarsal plate that fits the meibomian glands into the eyelid. For example, it takes twenty to thirty minutes for the temperature in the meibomian glands to reach only 41 ° C to 42 ° C, when applying heat to the outside of the eyelid that will not burn or injure the patient's eyelid or surrounding tissue. . It may be necessary to reach temperatures between 43 ° C and 45 ° C, for example, to fuse, release and relieve some obstructions or occlusions in the patient's meibomian glands.

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Until the present patent application, it was only known to apply heat to the outside of the eyelid to treat the dysfunction of the meibomian gland (MGD). Professional doctors thought it was illogical to apply heat to the outside of the eyelid. It was believed that applying heat to the outside of the eyelid would risk damaging the eyelid or the eyeball itself. Previous studies of the application of heat to the skin have shown that these lesions could occur at temperatures above 45 ° C. These studies were carried out on the external keratinized skin. The tissue of the inner eyelid is a non-keratinized epithelium, and as such it was not protected against heat, like keratinized skin. Therefore, it was naturally believed that applying heat to the inside of the eyelid would produce a pain response at lower temperatures than on the outer surface of the eyelid. However, it has been surprisingly discovered that applying heat to the inside of the eyelid is not only safe, but also effective for displacing, obstructions and / or occlusions in the meibomian glands as part of the treatment of MFD.

The hypothesis has been raised that the heat inside the eyelid may allow a more efficient conductive heat transfer to the meibomian glands. Achieving more efficient heat transfer may allow higher temperatures to be reached for the Meibomian glands, and / or a more efficient time to fuse, release or relieve obstructions or occlusions in the Meibomian glands. In addition, there is no tarsal plaque located between the inside of the eyelid and the meibomian glands. Therefore, it was discovered that the

14/125 Conductive heat transfer to the meibomian glands is more efficient when heating the inside of the eyelid

In this regard, an experiment was carried out where heat was applied to the inside of the eyelid (and more particularly in the palpebral conjunctiva) against known principles and traditional notions. It was discovered that heat could be applied to the inside of the eyelid without injuring the patient's eye, if the temperature is regulated. For example, it was determined that most patients were able to tolerate temperatures above 44.5 ° C without anesthesia. In addition, it was discovered that high temperatures in the meibomian glands could be reached and in less time, by applying heat to the inside of the eyelid, instead of outside the eyelid, due to conductive heat transfer and the proximity of heating on the surface of the eyelid. .

Although not limited to the present invention, the possibility of raising the temperature more efficiently and effectively in the channels of the meibomian glands, by applying heat to the interior of the inner surface of the eyelid, may prove useful, achieving fusion, release or the relief of obstructions and occlusions. Applying heat to the inside of the eyelid may also include applying heat to the channels of the meibomian glands that are located on the inner surface of the eyelid, on the edges of the eyelid. The channels can also be blocked or occluded. The application of heat to the inside of the eyelid, near or directly over the meibomian glands can also prove to be useful in restoring sufficient flow of cerumen to the lipid layer. When the phrase or phrase

15/125 applying heat to the inside or to the inner surface of the eyelid of the eyelid is referenced in this patent application, this also covers the application of heat to the channels of the meibomian glands.

The application of heat can be regulated, meaning that a heating medium or element is controlled to stay within temperatures, and means that they are free to the inner surface of the eyelid and at a temperature sufficient to fuse, release and relieve an occlusion or obstruction in the meibomian gland. The heat is maintained for a time sufficient to melt, release and alleviate the occlusions or obstructions. Whether during or after the application of heat has been removed, occlusions or obstructions in the meibomian glands are expressed to remove occlusions or obstructions, thus providing an improved way to restore or improve the gland's cerumen flow.

In one embodiment, increasing the surface temperature of the palpebral conjunctiva to at least 37 ° C may begin to yield therapeutic effects for more benign cases of MGD. A therapeutic temperature can be any temperature above body temperature. A preferred range for treatment is between 43 ° C and 45 ° C with a target of 43 ° C to 44.5 ° C. A time interval for applying heat can be between 1 and 10 minutes and can be limited to between 3 and 6 minutes. The temperature in this range is considered to be effective and comfortable for the patient when treating MGD.

In an execution mode, the application of heat can be regulated. The regulated heat can include, control

16/125 the heat according to the temperature profile. The temperature profile can be a constant temperature, including peaks and valleys increases and decreases. More than that, the temperature profile can include pulses of heat or be modulated with various characteristics, including the use of on-off or thickness modulation techniques (PWM), for example. The use of modulated heat can allow the temperature to be raised high above the eyelid, without injury to the patient's eyelid, as long as the elevated temperatures are applied for shorter intervals of time. Obstructions or occlusions in the meibomian glands can have points of fusion, release and relief that are beyond the temperatures that can be applied without the use of modulated heat. The temperature required to fuse, release and relieve obstructions or occlusions may depend on how keratinized the obstructions or occlusions are. No obstruction or occlusion has the same points of fusion, release and relief.

Just as an example, high temperatures between 43 ° C and 45 ° C may become possible when regulated heat is applied, especially if the eyelid has been anesthetized. However, heat should always be applied to the eyelid, at temperatures that take into account the patient's response to pain, as well as whether injuries will occur to the patient's eyelid and / or to surrounding tissues. Depending on the severity of the patient's MGD or the patient's tolerance for pain, high temperatures can be used with patients on an individualized basis when applying heat. It was found that lighter-skinned patients can generally tolerate less heat than patients with lighter skin

17/125 dark, and patients with darker skin tend to exhibit less inflammation as a result of exposure to heat. Other factors, including humidity, can contribute to the patient's tolerance for the temperature to become higher. For example, humans can generally tolerate temperatures up to 70 ° C or 80 ° C in dry saunas when humidity is low. Application of heat in higher humidity environments can cause pain and / or burn at lower temperatures.

Severe cases of MGD that cause substantial irritation or risk to the patient, may require temperatures that would produce degrees 1 and 2 burns to the patient's eyelid, as these burns usually heal. Temperatures that cause grade 3 burns should be avoided. In summary, the treatment times and / or the temperature must be well adjusted taking into account these differences. The present invention is not limited to any particular temperature or time intervals, insofar as the therapeutic temperature is being applied to the meibomian gland.

The regulated heat can be maintained at a therapeutic temperature for a period of treatment. The treatment period can be approximately 1 to 10 minutes, for example. The heat can be applied repeatedly and maintained for a desired time, to ensure that obstructions or occlusions are in a state of fusion, release and relief. Whether during or after this regulated heat treatment, the mechanical expression of lipids and other fluids from the meibomian gland has been identified to clear obstructions that have

18/125 essential have been cast or replaced in a state of suspension (due to melting materials joining solids).

In an execution mode, after the pressure to remove obstructions or occlusions has been obtained, an optional pharmacological agent can be applied to the meibomian gland to promote the free flow of cerumen and / or reduce or prevent inflammation or infections of the eyes or eyelids. Many pharmacological agents have been proposed for the treatment of dry eye syndrome, any of which may be effective or more effective by clearing obstructions within the meibomian gland. Some of these pharmacological agents that can be used include: antibiotics such as topical or oral tetracycline or chemically modified tetracycline, testosterone, topical or oral corticosteroids, topical and analogous androgens, compounds of omega 3 fatty acids, such as fish oils, Laennec, enzymes that promote lipid production, and / or any agent that acts as a secretion stimulant to accentuate the secretion of the meibomian gland, or the secretion of other components of the tear. For example, androgens or analogs of androgens and TGF-beta have been identified to act as secretion stimulants to enhance the secretion of the meibomian gland

These compounds are illustrative examples of appropriate pharmacological agents, but those skilled in the art will appreciate that other pharmacological compounds may be used.

Also, agents like Restasis (cyclosporine A), which

19/125 replace or promote the production of tear components can be applied more effectively, after treating the meibomian gland according to the present invention. The treatment of the meibomian gland improves the lipid layer, thus reducing evaporation and conserving the aqueous layer. The preservation of the aqueous layer reduces the need for tear substitutes to be applied together with the tear's component agents. However, tear component agents may not have been used many times when employing the present invention for treating the patient's MGD.

In the course of the experiment with applying heat to the inside of the eyelid, it has also been found that heat losses by convection occur due to the flow of blood in the blood vessels located inside the eyelids. The flow of blood in the blood vessels located inside the eyelids produces heat losses by convection. The blood flow serves as a natural heat sink created by the body. Convection heat loss is minimized when heat is applied to the inside of the eyelid, rather than when heat is applied to the outside of the eyelid. This is because fewer blood vessels are located between the meibomian gland and the inside of the eyelid, than outside the eyelid. The meibomian glands are located close to the inside of the eyelid. However, heat loss by convection occurs when the inside of the eyelid is heated. It has been found, however, that if blood flow is reduced, heat losses by convection can be minimized, allowing temperatures to be reached and sustained in the meibomian gland, and in an even more

20/125 more efficient, as well as in less time.

Accordingly, an embodiment of the present invention also includes the subsequent application of force to the patient's eyelid in addition to heat. The application of force can additionally help to obtain higher temperatures more efficiently inside the eyelid, in the palpebral conjunctiva and in the meibomian gland, in a shorter period of time and therefore, more efficiently. This is because the application of force can reduce the flow of blood to the eyelid to reduce heat loss by convection, as discussed above.

Applying force can also result in a more efficient conductive heat transfer from an applied heat source, because the pressure created by the force determines that the heat source is compressed against the eyelid tissue. This compression can have several benefits. Compression spreads over the fabric to which the heat is applied, thereby making it finer and improving conductive heat transfer. Compression can also empty the air pocket on the surface of the eyelid, due to microscopic skin wrinkles. However, the compression of the heat source against the eyelid increases the contact surface between the heat source and the eyelid surface (which increases the heat transfer equation), to provide a more efficient heat transfer to the meibomian glands. This causes the meibomian glands to be heated to the desired temperature level in a shorter period of time, due to these efficiency gains. In addition, temperatures

Increased 21/125 can be achieved as they could not otherwise be obtained, or obtained using less heat or thermal energy. Because the heating is placed in close proximity to the eyelid surface, and the heat is compressed against the eyelid surface, heat transfer becomes very efficient, allowing the temperature on the eyelid surface to be very close to the temperature of the meibomian glands.

The applied force can be regulated, meaning that the means for generating force is controlled to stay within the pressure ranges that are safe to be applied to the eyelid, and to the pressure sufficient to allow the temperature in the Meibomian gland to rise sufficiently. The force can also be a constant force produced manually. The force can be applied during heating, after heating or both during and after heating. In any case, the force can help to press the obstructions and occlusions when in a state of fusion, release or relief of the meibomian glands. The force may include vibratory types of force. including others mechanically generated or others using fluid type devices or mechanisms. 0 level of force required to press obstructions or occlusions in the glands can be significantly reduced when heat is applied to obstructions or occlusions to put them in a state of fusion, release or relief

The application of force can also stimulate the movement of fluids or suspensions from obstructions or occlusions, which generally apply a regulated force or extraction action to the eyelid to press fluids or suspensions or stimulate

22/125 mechanically otherwise the movement of fluids from the glands. In some instances, a gentle, small, continuous force applied to the eyelid will help to press fluids and suspensions. Vibration can also be used when applying force, simultaneously and immediately after heating to subsequently help to press.

Any device, tool or device can be used to apply heat and / or force to the eyelids, to treat MGD. In an execution mode, force can be applied to the outside of the eyelid when heat is applied to the inside of the eyelid to treat MGD. Heating of the inner surface of the upper or lower eyelid can be done by any convenient method. The eyelids can be heated one at a time or both together, depending on the time available to remove the occlusions once heated, and the device or method for heating being used is removed. Various devices for applying force are available.

A device for heating the palpebral conjunctiva is available from US Provisional Patent Aplication Serial no. 60 / 880,850, referred to above, and for which the present patent application requests priority. In this patent application, an eyelid heater containing a heating element is placed in an intermediate position between the eyeball and against the eyelid conjunctiva. 0 The heating element is equipped with energy or force to generate heat into the eyelids when the lenses are placed on the eyeball. The eyelid heater can also contain an integrated insulator that prevents heat

23/125 substantial reaches the eyeball, and thus protects the cornea and sclera. The heating element can be biased according to its location on the eyelid heater, and in particular, be located behind the insulator close to the eyelid to produce more heat inside the eyelid than in the eyeball. The eyelid heater may also contain a platform. The platform has a handle for inserting or adjusting the heating element and an area for encapsulating the heating components, including an electrical interface to allow an attached heating controller to generate an electrical signal for the heating element to produce regulated heat into the eyelid.

The eyelid heater can also be used in conjunction with a device that generates a regulated force inside the eyelid when heat is applied to the inside of the eyelid. In an execution mode, an eye wash cup with an inflatable bladder is placed on the outside of the eyelid while the lens is located on the eyeball. The eye wash cup can include an interface that allows the eyeball to be placed on the platform that extends from the eyelid heater. In this way, when the eyeball is attached to the platform and the bladder is inflated, a regulated force is applied to the outside of the eyelid, thus compressing the eyelid against the eyelid heater inside the eyelid. Then, the meibomian glands are compressed between the eyeball and the eyelid heater, surrounded by them, where the eyeball applies a force vector over the eyelid heater, to

12/24 create pressure on the eyeball and the meibomian glands with the eyeball. This helps to release obstructions or occlusions in the meibomian glands, as well as reduces blood flow in the eyelids, to prevent heat loss by convection of heat by the heat generated by the eyelid heater.

Alternatively, a membrane can be attached to the eyeball and used to generate force. The membrane can be made of different materials, and materials that stretch and are elastic. Many execution modalities are revealed, involving an eyelid warmer and the eyeball, to be used to apply heat and strength to the eyeball as part of the treatment of MGD. The present invention is not limited to any particular type of eyelid heater and / or power generating device or device

In another mode of execution, strength and heat can be applied to tissues close to the meibomian glands for the treatment of MGD. As discussed above, applications of force can also help to bring high temperatures to the meibomian glands and in a shorter interval of time, and therefore more efficiently. The application of force can improve the efficiency of convection heat transfer and / or reduce convection heat loss. Any device, device or tool can be used to apply heat to the tissue near the meibomian glands. The application of force can also allow the heat to be maintained for a longer period of time. This is because the application of force can reduce blood flow to the eyelid, thereby reducing heat loss.

25/125 by convection and increasing convection heat transfer to the eyelid and glands. The force and / or heat applied to the fabric can be regulated, as discussed above. The force can be applied during heating, after heating or both during and after heating. The force can continue after the heating is removed, thus increasing the time before the body's heat dissipating effect returns the eyelid to normal temperature. The application of force can also help to press obstructions or occlusions when in a state of fusion, release and relief of the meibomian glands.

In another mode of execution, force can be applied to the inside of the eyelid and heat applied to the outside of the eyelid to treat MGD. As discussed above, the application of force can also help to obtain higher temperatures to the meibomian glands and in a shorter interval of time, and therefore more efficiently. The application of force can improve the efficiency of convection heat transfer and / or reduce convection heat loss. Any device, tool or device can be used to apply heat and strength to the outside of the eyelid. The application of force can also allow the heat to be maintained for a longer period of time. This is because the application of force can reduce blood flow to the eyelid, thereby reducing heat loss by convection, and increasing heat transfer by convection to the eyelid and glands. The heat applied to the inside of the eyelid can be regulated, as discussed above. The force can be applied during heating, after heating or both

26/125 for as long as after heating. The force can continue after the heating is removed, thus increasing the time before the body's heat dissipating effect returns the eyelid to normal temperature. The application of force can also help to press obstructions or occlusions when in a state of fusion, release and relief of the meibomian glands.

In another mode of execution, strength and heat can be applied to the outside of the eyelid to treat MGD. As discussed above, the application of force can also help to obtain higher temperatures in the meibomian glands and in a shorter interval of time, therefore, more efficiently. The application of force can improve the efficiency of convection heat transfer and / or reduce convection heat loss. Any device, device or tool can be used to apply heat and strength to the outside of the eyelid. The application of force can also allow heat to be kept outside for a longer period of time. This is because the application of force can reduce blood flow to the eyelid, thereby reducing heat loss by convection and increasing heat transfer by convection to the eyelid and glands. The heat and / or force applied to the outside of the eyelid can be regulated, as discussed above. The force can be applied during heating, after heating or both during and after heating. The force can continue after the heating is removed, thus increasing the time before the body's heat dissipating effect returns the eyelid to normal temperature. The application of force can also

27/125 help to press obstructions or occlusions when in a state of fusion, release and relief of the meibomian glands.

In yet another modality of execution, heat can be applied both outside and inside the eyelid for the treatment of MGD. The force can be applied to the eyelid. As discussed above, the application of force can also help to obtain higher temperatures in the meibomian gland and in a shorter interval of time, therefore, more efficiently. The application of force can improve the efficiency of convection heat transfer and / or reduce convection heat loss. Any device, tool or device can be used to apply heat and strength to the outside of the eyelid. The application of force can also allow heat to be kept outside for a longer period of time. This is because the application of force can reduce blood flow to the eyelid, thereby reducing heat loss by convection and increasing heat transfer by convection to the eyelid and glands. The heat and / or force applied to the outside of the eyelid can be regulated, as discussed above. The force can be applied during heating, after heating or both during and after heating. The force can continue after the heating is removed, thus increasing the time before the body's heat dissipating effect returns the eyelid to normal temperature. The application of force can also help to press for obstructions or occlusions

Those skilled in the art will assess the scope of the present invention and add additional aspects in order to read the following details of the description of the modality of

12/28 execution in association with the accompanying figures. Brief description of the figures

The accompanying figures, incorporated and forming part of these specifications, illustrate various aspects of the invention, and together with descriptions serve to explain the principles of the invention.

Figure 1 illustrates examples of lower and upper human eyelids, showing the meibomian glands.

Figure 2 illustrates an example of a sectional view of a meibomian gland.

Figure 3 illustrates an example of a sectional view of a meibomian gland having several obstruction mechanisms.

Figure 4 illustrates an example of an eyelid temperature profile of an external and internal temperature, compared to the time in which heat is applied to the outside of the eyelid.

Figure 5 illustrates an example of an eyelid temperature profile, of temperature inside and outside the eyelid, compared to the time in which heat is applied to the inside of the eyelid.

Figure 6 is a diagram illustrating an example of a process of applying heat to the inner eyelid, relating to the treatment of the meibomian glands.

Figure 7 illustrates an example of an eyelid temperature profile of eyelid temperature, compared to the time in which heat and force are applied to the inside of the eyelid.

Figure 8 contains a diagram illustrating an example of a process of applying heat to the inner eyelid, with the

29/125 increase in force applied to the outer or outer surface of the eyelid, related to the treatment of the meibomian glands.

Figure 9 illustrates a device for applying heat and force to an embodiment relating to the present invention, to facilitate the application of heat inside and force to the outside of a patient's eyelid, relating to the treatment of the meibomian glands.

Figure 10 illustrates an eyelid heater component of the device for applying heat and force illustrated in Figure 9, which is adapted to be adjusted to the patient's eye to release heat in a controlled manner into the patient's eyelid, according to the embodiment of the present invention.

Figure 11 illustrates the process of placing the eyelid heater in the patient's eye inside the eyelid, to install the device for the application of heat in the patient's eye, for treatment of the meibomian glands according to the execution mode related to the present invention. .

Figure 12 illustrates a cross sectional view of the eyelid heater illustrated in Figures 9 to 11, to later illustrate the components and characteristics for heat release from the eyelid heater, according to the embodiment of the present invention.

Figures 13A and 13B illustrate the modalities for executing an eyelid heater and the device for applying force and heat to the eyeball to secure the eyepiece to the eyelid heater as part of the

30/125 installation of the device for applying force to the patient's eye to treat the meibomian glands.

Figure 14 illustrates an interface adapted to be installed between the eyeball and the controller of Figures 9-13B, to facilitate selective and controllable communication of heat and / or force to the eyelid, according to the embodiment of the present invention. .

Figure 15 illustrates a diagram of the top-level pressure control system and device communication components for applying heat and power, to selectively and controllably communicate to the eyelid heater and eyeball components, to apply heat to the inside of the patient's eyelid and / or the strength to the outside of the patient's eyelid, according to an embodiment of the present invention.

Figure 16 illustrates an interface circuit diagram for the device for the application of power and heat, according to an embodiment of the present invention.

Figure 17 illustrates a pressure control system of the device for the application of force and heat in a selective and controllable way to the outside of the patient's eyelid, according to an execution mode related to the present invention.

Figure 18 illustrates a temperature control system for the device for the application of force and heat, to apply heat selectively and controllably to the interior of the patient's eyelid, according to an embodiment of the present invention.

Figure 19 contains a diagram illustrating the process

31/125 basic used by the device for the application of force and heat, to apply heat selectively and controllably to the inside of the patient's eyelid and / or force to the outside of the patient's eyelid according to an execution mode related to the present invention .

Figure 20 illustrates a system state flow diagram for the device for the application of power and heat, according to an embodiment of the present invention.

Figures 21A and 21B illustrate the Religate status of a flow diagram, according to the system state flow diagram in Figure 20, according to an embodiment related to the present invention.

Figure 22 illustrates the Fuseblow state of the flow diagram, according to the system state flow diagram in Figure 20, according to an embodiment of the present invention.

Figure 23 illustrates the On state of the flow diagram, according to the system state flow diagram in Figure 20, according to an embodiment of the present invention.

Figure 24 illustrates the Pause status of the flow diagram, according to the system state flow diagram in Figure 20, according to an embodiment of the present invention.

<td>At</td><td>Figures 25A</td><td>and</td><td>25B illustrate</td><td>the state</td><td>Monitor</td><td>of</td>

<td>diagram</td><td>flow,</td><td>in</td><td>a deal with</td><td>diagram</td><td>flow</td><td>in</td>

<td>state</td><td>of the system</td><td>at</td><td>Figure 20,</td><td colspan="2">according</td><td>an</td>

embodiment of the present invention.

Figure 26 illustrates the Stop status of the

32/125 flow, according to the state flow diagram of Figure 20, according to an embodiment related to the present invention.

Figure 27 illustrates an exploded perspective view of an alternative device for the application of heat and force in the treatment of MGD, according to an embodiment of the present invention.

Figure 28 contains an illustration of an alternative device for applying heat and strength according to the cross section along line AA in Figure 27, according to an embodiment related to the present invention.

Figure 29 illustrates an exploded view of an alternative device for the application of heat according to Figure 27, according to an embodiment related to the present invention.

Figure 30 illustrates a sectional view of an alternative device for the application of heat and strength, according to Figure 27, according to an embodiment of the present invention.

Figures 31A and 31B contain illustrations of another alternative device for the application of heat and force, according to an embodiment of the present invention.

Figure 32 contains an illustration of another alternative device for the application of heat and strength, according to an embodiment of the present invention.

Figure 33 contains an illustration of another alternative device for applying heat and strength, according to

33/125 with an embodiment of the present invention.

Figure 34 contains an illustration of another alternative device for the application of heat and strength, according to an embodiment of the present invention.

Figure 35 contains an illustration of another alternative device for the application of heat and heat, according to an embodiment of the present invention.

Figures 36A and 36B contain illustrations of another alternative device for the application of force and heat, according to an embodiment related to the present invention.

Figure 37 contains an illustration of another alternative device for the application of heat and strength, according to an embodiment of the present invention.

Figures 3 8A and 3 8B contain illustrations of another alternative device for the application of force and heat, according to an embodiment related to the present invention.

Figure 39 contains an illustration of another alternative device for the application of heat and strength, according to an embodiment of the present invention.

Figure 40 contains an illustration of another alternative device for the application of heat and strength, according to an embodiment of the present invention.

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Figure 41 contains a diagram illustrating an alternative treatment for the Meibomian gland employing application of heat and strength to the tissue near the Meibomian gland, to reduce heat loss when heat is applied to fuse, release and relieve obstructions or occlusions

Figure 42 contains a diagram illustrating an alternative treatment for the meibomian gland, using heat to the outside of the patient's eyelid, and force to the inside of the patient's eyelid for treatment for the meibomian gland.

Figure 43 contains a diagram illustrating an alternative treatment for the meibomian gland, employing application of heat and strength to the outer side of the patient's eyelid to treat the meibomian gland.

Figure 44 contains a diagram illustrating an alternative treatment for the meibomian gland, using heat to both sides of the patient's eyelid to treat the meibomian gland.

Detailed Description of Preferred Modalities

The modalities described below represent the information necessary to enable persons skilled in the art to practice the invention and illustrate the best way to practice the invention. By reading the description below in the light of the corresponding figures, persons skilled in the art will understand the concepts of the invention and recognize the applications of these concepts not particularly described in this device. It should be understood that these concepts and applications are within the scope of the disclosure and corresponding claims.

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One embodiment of the present invention includes the advance and previously unknown method of applying heat to the inner surface of the eyelid to treat dry eye caused by dysfunction of the meibomian glands (MGD). The application of heat inside the eyelid can effectively and efficiently increase the temperature in the meibomian glands to a temperature sufficient to melt, soften or soften more serious occlusions and obstructions in the meibomian glands. Occlusions or obstructions can then physically improve the flow of secretion from the meibomian glands in order to reduce evaporation from the water layer.

Some patients have obstructions or occlusions in their meibomian glands, which will not fuse, release and relieve sufficiently to be expressed without reaching high temperatures in the meibomian glands. In many instances these temperatures cannot even be reached by applying heat to the outside of the eyelid, or these temperatures can be reached, but only after applying heat to the outside of the eyelid for a significant period of time. Elevated temperatures can only be reached by applying heat to dangerous temperatures, which can produce unacceptable responses in the form of pain for the patient, or injury to the patient's eyelid. This happens because of the drop in temperature between the outside of the eyelid and the meibomian glands, due to conductive heat loss. The heat applied to the outside of the eyelid must conductively travel through the eyelid tissue and through the tarsal plate that fits the meibomian glands inside the eyelid. For example,

36/125 it may take twenty or thirty minutes for the temperature in the meibomian glands to reach just 41 ° C to 42 ° C, by applying heat to the outside of the eyelid that does not burn or injure the patient's eyelid or tissue around. Temperatures may need to reach between 43 ° C to 45 ° C, for example, to fuse, release and relieve certain obstructions and occlusions in the patient's meibomian glands.

Until the present patent application it was only known to apply heat to the outside of the eyelid to treat dysfunction of the meibomian glands (MGD). Medical professionals would have thought it illogical to apply heat to the inside of the eyelid. It was thought that applying heat to the inside of the eyelid could injure the eyelid and the eyeball itself. Previous studies of the application of heat to the skin showed that lesions could occur at temperatures above 45 ° C. These studies were done on the outer keratinized skin. The tissue of the inner eyelids is a non-keratinized epithelium, and as such, is not as well protected from heat as keratinized skin. Therefore, it was naturally believed that by applying heat to the inside of the eyelid, a painful response would be produced at a lower temperature than outside the eyelid. However, it has been surprisingly discovered that applying heat to the inside of the eyelid is not only safe, but it is also effective in displacing obstructions or occlusions in the meibomian glands as part of the treatment of HGD.

The hypothesis has been raised that heat from the inside of the eyelid may favor a conductive transfer of

37/125 more efficient heat to the meibomian glands. Achieving a more efficient heat transfer can allow higher temperatures to be reached in the Meibomian glands in a more efficient time to fuse, release and relieve in the Meibomian glands. In addition, there is no tarsal plaque located between the inside of the eyelid and the meibomian glands. Therefore, it has been found that conductive heat transfer to the meibomian glands becomes more efficient when the heat is inside the eyelid. The heat conduction grows with the thicker tissue.

In this regard, an experiment was undertaken where heat was applied to the inside of the eyelid (and more particularly, in the palpebral conjunctiva) against known principles and traditional notions. It was found that heat can be applied to the inside of the eyelid without injuring the patient's eye, if regulated. For example, it has been determined that most patients can tolerate a surface temperature of 43 to 44.5 ° C without anesthesia and without significant pain. It has been found that some patients can tolerate temperatures above 44.5 ° C without anesthesia. More than that, it was found that high temperatures can be achieved and in less time, by applying heat to the inside of the eyelid than outside the eyelid, due to the more efficient conductive heat transfer and the proximity of the heating device.

An exemplary temperature profile 32 on the eyelid that can be generated when heat is applied to the inside of the eyelid is illustrated in Figure 5. Then, a graph displays what the temperature on the inner surface of the

38/125 eyelid can be as a function of time when the constant heat source is applied over a subject patient as an example. A heat source placed inside the patient's eyelid is turned on for a period of time. For this patient, it takes approximately 30 seconds for the inner surface of the eyelid to reach about 44 ° C. Unlike the temperature profile illustrated in Figure 4, the inner surface of the patient's eyelid does not reach a higher temperature when heat is applied to the inside of the eyelid. For example, it can take just two to three minutes to bring the temperature in the meibomian glands to 43-45 ° C or more, heat is applied to the inside of the eyelid. While not limited to the present invention, the possibility of raising the temperature in the meibomian glands can prove instrumental in the state of fusing, releasing and relieving in the meibomian glands, to obtain state of melting, releasing and relieving obstructions or occlusions in the meibomian glands to obtain the point of fusing, releasing and relieving obstructions or occlusions

In this regard, an embodiment of the present invention for applying heat to the interior or to the inner surface of the eyelid close to the meibomian gland for treating MGD in basic form is illustrated in the diagram in Figure 6. This has the advantage that it typically takes less time to raise the temperature in the Meibomian glands enough to be able to fuse, release and relieve obstructions or occlusions, than if the heat had been applied directly to the outside of the eyelid. More than that, heat the interior

39/125 of the eyelid may allow higher temperatures to reach, than if the outside of the eyelid had been heated.

First, heat is applied to the inside of the eyelid at a temperature suitable for melting, releasing and relieving obstructions or occlusions in the meibomian glands (step 40). For example, heat can be applied to raise the temperature inside the eyelid to 43 to 47 ° C, although the present invention is not limited to that temperature range. A time interval for applying heat can be between 1 and 10 minutes, and can be limited to 3 to 6 minutes. Heat can be regulated, meaning that a heating medium or element is controlled to stay within temperatures, and means that they are safe for the inner surface of the eyelid and at a temperature sufficient to fuse, release and relieve obstructions or occlusions in the gland meibomian. For sufficient temperature this refers to the intensity of heat necessary to heat the eyelid conjunctiva to obtain the desired fuse, release and relieve obstructions or occlusions (step 42). For example, heat can be applied for 1 to 10 minutes, although the present invention is not limited to any particular intensity of time for the application of heat. Then, during or after heating, obstructions or occlusions in the meibomian glands can be pressed from the glands so that the cerumen flow is restored from the glands to establish sufficient lipid layer (step 44).

While not limited to the present invention,

40/125 the possibility of raising the temperature in the meibomian glands more effectively and efficiently can prove instrumental in the state of fusing, releasing and relieving points of obstructions or occlusions in the meibomian gland to obtain melting, releasing and relieving points of obstructions or occlusions

As used here, the terms fuse, release and relieve and their variants must be interpreted broadly. These terms broadly cover any change in the shape or state of the obstructive or occlusive material causing or contributing to obstructions or occlusions associated with disorders of the eye or eyelid structure in such a way that obstructions or occlusions can be easily released or squeezed. . This includes a change of form from a more or less solid state to a more liquefied state or form, including the dissolution, release, liquefaction and / or relief of obstructive or occlusive material to be removed and / or released, liquefied or alleviated of material that keeps aggregated particular materials causing or contributing to obstructions or occlusions associated with disorders of the eye or eyelid structure, or other modalities.

The application of heat can be regulated, which means that a heating medium or element is controlled to stay within the temperatures and media that are safe for the inner surface of the eyelid and at a temperature sufficient to fuse, release and relieve obstructions or occlusions in the meibomian gland. The temperature is maintained for a sufficient time to melt, release and relieve obstructions or

41/125 occlusions. Whether during or after the heat application is removed, obstructions or occlusions in the meibomian glands are pressed to remove obstructions or occlusions, thus providing an improved way to restore or improve the flow of cerumen from the gland.

In an execution mode, increasing the surface temperature of the palpebral conjunctiva to at least 37 ° C may begin to offer propedeutic effects for more benign cases of MGD. A preferred treatment range is between 43 and 45 ° C, with a target of 43 to 44.5 ° C. A time interval applied to warm up can be between 1 and 10 minutes, and can be limited to the interval of 3 to 5 minutes. It was concluded that the temperature in this range is effective and comfortable for the patient when being treated for MGD.

In an execution mode, the application of heat can be regulated. Regulated heat may include controlling the temperature according to the temperature profile. The temperature profile can be a constant temperature, including increase and decrease, peaks and valleys. More than that, the temperature profile can include pulses of heat or be modulated with various characteristics, including the use of on-off or thickness modulation techniques (PWM), for example. 0 The use of modulated heat can allow the temperature to be raised high above the eyelid, without injury to the patient's eyelid, as long as the elevated temperatures are applied for shorter intervals of time. Obstructions or occlusions in the meibomian glands can have points of fusion, release and relief that are beyond the temperatures that can be applied

42/125 without the use of modulated heat. The temperature required to fuse, release and relieve obstructions or occlusions may depend on how keratinized the obstructions or occlusions are. No obstruction or occlusion has the same points of fusion, release and relief

Just as an example, high temperatures between 45 and 55 ° C may become possible when applying regulated heat, especially if the eyelid has been anesthetized. However, heat should always be applied to the eyelid, at temperatures that take into account the patient's response to pain, as well as whether injuries will occur to the patient's eyelid and / or to surrounding tissues. Depending on the severity of the patient's MGD or the patient's tolerance for pain, high temperatures can be used with patients on an individualized basis when applying heat. It has been found that lighter-skinned patients can generally tolerate less heat than darker-skinned patients, and darker-skinned patients tend to exhibit less inflammation as a result of exposure to heat. Other factors, including humidity, can contribute to the patient's tolerance for the temperature to become higher. For example, humans can generally tolerate temperatures up to 70 or 80 ° C in dry saunas when humidity is low. Application of heat in higher humidity environments can cause pain and / or burn at lower temperatures.

Severe cases of MGD that cause substantial irritation or risk to the patient, may require temperatures that can produce degrees 1 and 2 burns to the patient's eyelid, as these burns usually heal.

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Temperatures that cause grade 3 burns should be avoided. In summary, the treatment times and / or the temperature must be well adjusted taking into account these differences. The present invention is not limited to any particular temperature or time intervals, insofar as the therapeutic temperature is being applied.

The regulated heat can be maintained at a therapeutic temperature for a period of treatment. The treatment period can be approximately 1 to 10 minutes, for example. Heat can be applied repeatedly and maintained for a desired period of time, to ensure that obstructions or occlusions are in a state of fusion, release and relief. Whether during or after this regulated heat treatment, the mechanical pressure of lipids and other fluids from the meibomian gland has been identified to clear obstructions that have essentially been fused or replaced in a suspended state (due to melting materials that join solids).

Optionally, after destroying obstructions or occlusions (step 44), an optional pharmacological agent can be applied to the meibomian gland to promote free flow of cerumen and / or reduce or prevent inflammation or infections of the eyes or eyelids (step 46). Many pharmacological agents have been proposed for the treatment of dry eye syndrome, any of which may be effective or more effective by clearing obstructions within the meibomian gland. Some of these pharmacological agents that can be used include: antibiotics such as topical or oral tetracycline or

44/125 chemically modified tetracycline, testosterone, topical or oral corticosteroids, topical and analogous androgens, compounds of omega 3 fatty acids, such as fish oils, Laennec, enzymes that promote lipid production, and / or any agent that acts as a secretion stimulant to accentuate the secretion of the meibomian gland, or the secretion of other components of the tear. For example, androgens or analogs of androgens and TGFbeta have been identified to act as secretion stimulants to enhance the secretion of the meibomian gland. These compounds are illustrative examples of appropriate pharmacological agents, but those skilled in the art will appreciate that other pharmacological compounds may be used.

Also, agents such as Restasis (cyclosporine A), which replace or promote the production of tear components can be applied more effectively, after treating the meibomian gland according to the present invention. The treatment of the meibomian gland improves the lipid layer, thereby reducing evaporation and conserving the aqueous layer. The preservation of the aqueous layer reduces the need for tear substitutes to be applied together with the tear's component agents. However, tear component agents may not have been used many times when using the present invention for treating the patient's MGD.

In the course of the experiment with applying heat to the inside of the eyelid, it has also been found that heat losses by convection occur due to the flow of blood in the blood vessels located inside the eyelids. O

45/125 blood flow through blood vessels located inside the eyelids produces heat losses by convection. The blood flow serves as a natural heat sink created by the body. Convection heat loss is minimized when heat is applied to the inside of the eyelid, rather than when heat is applied to the outside of the eyelid. This is because fewer blood vessels are located between the meibomian gland and the inside of the eyelid, than outside the eyelid. The meibomian glands are located close to the inside of the eyelid. However, heat losses by convection occur when the inside of the eyelid is heated. However, if the blood flow is reduced, heat losses by convection can be minimized, allowing temperatures to be reached and sustained in the Meibomian gland, and an even more efficient way, as well as in less time.

In this regard, an exemplary temperature profile 50 on the eyelid when heat is applied to the inside of the eyelid forces at various pressure levels is applied to the outside of the eyelid is illustrated in Figure 7. Then, a graph displays the temperature on the inner surfaces and outer eyelid as a function of time when a constant source of heat and temperature is applied to a subject patient as an example. Initially, no heat source is applied to the eyelid. In this example, the temperature inside the eyelid is approximately 36 ° C. When the heat source is turned on to apply heat to the inside of the eyelid, and the pressure of 70 mm Hg is applied to the outside of the eyelid, the temperature inside the eyelid rises quickly and dramatically. The pressure

46/125 applied to the eyelid is reducing blood flow, which reduces heat loss through convection and increases heat gain through convection. The temperature on the outside of the eyelid increases rapidly, but less dramatically than on the inside of the eyelid, since the heat source is inside the eyelid. A nominal temperature of approximately 40.5 and 38.3 ° C is reached inside and outside the eyelid, respectively.

If the pressure rises, higher temperatures are reached, as shown in Figure 4. Finally, when the heat source is completely turned off, the temperature drops. However, the temperature in the eyelid does not drop immediately, due to the force applied continuously. Once again, force reduces blood flow to prevent heat loss by convection. If both force and pressure are turned off after they are applied, the temperature in the eyelid will drop more quickly. This is because the blood flow in the eyelid is unobstructed, allowing the body's flow to quickly convect heat. Thus, the eyelid temperature profile 50 in Figure 7 illustrates that the temperature in the eyelid can be increased effectively and quickly by applying force beyond heat. Note that applying force to reduce heat loss by convection can be applied if heat is applied to the inside or outside of the eyelid. As shown in Figure 7, the application of force is effective in both scenarios.

Thus, an embodiment of the present invention also includes further application of force to the patient's eyelid in addition to heat. The application of force can

47/125 additionally help to obtain higher temperatures of more efficient mold inside the eyelid in the palpebral conjunctiva and in the meibomian gland, in a shorter period and therefore more efficiently. This is because the application of heat can reduce the blood flow to the eyelid, to reduce heat loss by convection, as discussed above.

In this sense, an embodiment of the present invention for applying heat and forcing the eyelid to treat MGD is illustrated in the flowchart of Figure 8. First, heat is applied to the eyelid to raise the temperature in the meibomian glands to the desired level (step 60). For example, heat can be applied to raise the temperature inside the eyelid to 44-47 ° C. The heat can be applied to the inside or outside of the eyelid, or to both sides of the eyelid. Heat can also be regulated, meaning that a heating medium or element is controlled to be within the temperatures and medium that are safe for the eyelid and at a temperature sufficient to melt, detach or soften an occlusion or obstruction in the meibomian gland. A force is also applied to the eyelid to reduce blood flow to the eyelid to allow the heat applied to raise the temperature in the Meibomian and Meibomian glands more quickly (step 62). The force can be applied to the inside or outside of the eyelid.

Heat and / or strength can be maintained for a period of time long enough to raise the temperature in the Meibomian glands enough to melt, loosen or soften obstructions or occlusions (step 64). The power

48/125 can be maintained after the heat is removed, or vice versa depending on the desired treatment technique. Maintaining strength after the heat is removed can cause the temperature in the meibomian glands to dissipate more slowly than if the strength is removed. Maintaining heat without maintaining strength can be employed to allow blood to flow through the eyelids, as between successive treatments. For example, it may be desirable to maintain heat to decrease the total amount of treatment time by applying and removing force between treatments. Also, it may not be necessary to apply significant amounts of force or for the same duration as heat if the obstruction or occlusion is located in the immediate vicinity of the eyelid margin rather than in the deeper portions of the meibomian gland.

The application of force can also result in heat transfer by more efficient conduction of an applied heat source, because the pressure created by the force causes the heat source to be compressed against the eyelid tissue. This compression can have several benefits. Compression spreads the fabric to which the heating is applied, thus making it thinner and improving conduction heat transfer. Compression can also expel air pockets on the surface of the eyelid due to the microscopic roughness of the skin. Thus, the compression of the heat source against the eyelid increases the surface contact between the heat source and the eyelid surface (which increases the heat transfer equation) to provide a more effective conductive heat transfer to the meibomian glands.

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This results in the meibomian glands being heated to the desired temperature level in a shorter period of time due to this efficiency gain. In addition, higher temperatures can be achieved, which could not have been achieved otherwise, or achieved using less heat or thermal energy. As the heating is located in close proximity to the eyelid surface and the heating is additionally compressed against the eyelid surface, heat transfer is very efficient in making the temperature on the eyelid surface very close to the temperature in the meibomian glands.

Also, note that while the exact reduction in times to warm up the meibomian glands will vary from patient to patient when force is applied, and can be based on the amount of pressure applied to the patient's eyelid, in general, the change in heating times it can vary as much as several hundred percent, for example, when compared to previous methods. As an example, this can translate to five (5) or more minutes that are required to expel an obstruction or occlusion before it re-solidifies compared to previous methods.

The force can be regulated, meaning that the means of generating force is controlled to be within the pressure ranges that are safe to be applied to the eyelid and at sufficient pressure to allow the temperature in the Meibomian gland to rise sufficiently. The force can also be a constant force and be applied manually. For example, force can be applied by a

50/125 technician or the doctor's finger or thumb as the heat is applied. The force can be applied during heating, after heating, or both during and after heating. In each case, the force can help in the expression of occlusions or obstructions when in a detached, softened or melted state of the meibomian glands. The force may include vibratory-type forces, including those generated mechanically or those using fluid-type devices or mechanisms. The force can be applied to a specific position or vector of the patient's eyelid to be specifically directed at the meibomian glands. This can reduce the level of force needed to express obstructions or occlusions in the glands. The level of force required to express obstructions or occlusions in the glands can also be greatly reduced when heat is applied to the obstructions or occlusions to put them in a melted, softened or detached state.

The application of force can also stimulate the movement of fluids or the interruption of occlusions or obstructions of the glands. The present invention can be used with devices that generally apply a regulated force or milking action to the eyelid to express fluids or suspensions or to otherwise mechanically stimulate the movement of fluids from the glands. In some instances, a small, moderate, continuous force applied to the eyelid will assist in the expression of fluids and suspensions. Vibration can also be used by applying force simultaneously or immediately after heating to further assist in expression.

After that, during heating and / or application

51/125 of the force or afterwards, the obstructions or occlusions in the meibomian glands can be expressed so that the flow of sebum is restored from the glands to establish a sufficient lipid layer (step 66).

As discussed above in the flowchart of Figure 6 where only heating is applied, the application of heat can be regulated. The regulated heat can include heat control according to a temperature profile. The temperature profile can be a constant temperature, including ascents, descents, peaks and valleys. In addition, the temperature profile can include heat pulses or be modulated with various characteristics, including the use of on / off switching or pulse width modulation (PWM) techniques for example. The use of modulated heat can allow the temperature to be raised even higher in the eyelid without damage to the patient's eyelid as long as the increased temperatures are applied for shorter periods of time. Obstructions or occlusions in the meibomian glands can have melting points, detachment or softening that are beyond the temperatures that can be applied without the use of modulated heat. The temperature required to melt, loosen or soften obstructions or occlusions can depend on how keratinized the obstruction or occlusion is. Not all obstructions or occlusions have the same casting, detachment or softening points.

Just as an example, high temperatures between 45 ° and

55 ° C may be possible when applying regulated heat, especially if the eyelid has been anesthetized. However, heat should always be applied to the eyelid at temperatures

52/125 that take into account the patient's pain response, as well as whether damage to the patient's eyelid and / or surrounding tissues will occur. Depending on the severity of the patient's MGD or the patient's pain tolerance, elevated temperatures can be used with the patient individually by applying heat. It has been established that patients with lighter skin can generally tolerate less heat than patients with darker skin, and patients with darker skin tend to show less inflammation as a result of exposure to heat. Other factors, including humidity, can contribute to a patient's tolerance of higher temperatures. For example, humans can generally tolerate heat up to 70 ° to 80 ° C in dry saunas where humidity is low. The application of heat in higher humidity environments can cause pain and / or burns to occur at lower temperatures.

Severe cases of MGD that cause irritation or substantial risk to the patient may even require temperatures that would produce first or second degree burns on the patient's eyelid, as these burns usually heal. Temperatures that cause third degree burns should be avoided. In summary, treatment times and / or temperature can be adjusted to account for these differences. The present invention is not limited to any given temperature or time range while a therapeutic temperature is being applied.

The regulated heat can be kept at a therapeutic temperature for a period of treatment. 0 period

53/125 treatment can be approximately 1 to 10 minutes for example. Heat can also be applied and maintained repeatedly for a desired period of time to keep the occlusion or obstruction in a melted, detached or softened state. During or after such treatment by means of regulated heat, it has been established that the mechanical expression of lipids and other fluids from the meibomian glands clears obstructions that have essentially melted or been placed in a state of suspension (because the melting materials retain the solids together).

Optionally, after the expression of the occlusions or obstructions is performed (step 66), an optional pharmacological reagent can be applied to the meibomian gland to promote the free flow of sebum and / or reduce or prevent inflammation or infections of the eye or eyelids (step 68 ). The discussion regarding the use of pharmacological agents above for the flowchart in Figure 6 is equally applicable for this mode of execution and therefore will not be repeated here. Those compounds are illustrative examples of appropriate pharmacological agents, but those skilled in the art will appreciate that other pharmacological compounds can be used.

<td>In</td><td>an</td><td>modality</td><td>in</td><td>execution,</td><td>an</td><td>force</td><td>can</td><td>to be</td>

<td>applied</td><td>to</td><td>outside</td><td>gives</td><td>eyelid</td><td colspan="2">while the</td><td>heat</td><td>is</td>

<td>applied</td><td>to</td><td>inland</td><td>gives</td><td>eyelid</td><td>for</td><td>deal with</td><td>MGD.</td><td> 0</td>

Heating the inner surface of the upper or lower eyelid can be done by any convenient method. The eyelids can be heated one after the other or both at the same time, depending on the time available to remove the occlusions once heated. A device to heat the

54/125 eyelid conjunctiva is illustrated in Figures 9-14.

Figure 9 illustrates the complete device referred to as the device for applying heat and power 70. In this embodiment, the device for applying heat and power 70 consists of a portable controller, powered by battery 72 that contains regulating components and generation of heat and pressure. Controller 72 can also be a non-portable device that is mounted or rests on a table top, for example. 0 controller 72 as described herein is intended to describe and cover any device, including but not limited to electronic and pneumatic controls and support components, which is adapted to allow and control the application of heat and / or force to the patient's eyelid. The controller 72 is joined to a disposable component 74, via a controller interface 76, to generate heat and strength in the eyelid 78, as illustrated in Figure 9. The disposable component 74 consists of an eyelid heater 90 provided in the form of a lens (illustrated in Figures 10-12) that applies heat to the inside of the patent's eyelid and connects with an eye capsule to apply force to the outside of the eyelid of the patient (illustrated in Figures 13-14). Both can be used together to treat MGD for a single eye. The tubing 76 of the interface can be wrapped around the patient's ear 77 with any excess clipped to the patient's clothing. The force and heat application device 70 is intended for use by doctors to apply localized heat and pressure therapy to treat MGD.

Controller 72 contains user interface 80 to allow a doctor or other technician to control the

55/125 force and heat application device 70. The temperature and pressure that is applied to the patient's eyelid 78 can be seen on a temperature monitor 82 and a pressure display 84. Looking at the temperature and pressure displays 82, 84, the doctor can determine when the temperature and therapeutic pressure have been reached. For example, temperature and pressure displays 82, 84 can be bar graphs of segments so that both the temperature and pressure levels and the nature of the increase or decrease in temperature and pressure levels can be seen. The temperature level to be reached on the patient's eyelid can be adjusted to a static level within controller 72, or controllable by a doctor or technician. The force and therefore the pressure applied to the patient's eyelid can be controlled by pressing a force lever 86. When a doctor or technician wishes to apply force, the force lever 86 can be tightened. To release force and therefore reduce pressure, the force lever 86 is disengaged. The pressure created by the force applied to the patient's eyelid is displayed on the pressure monitor 84.

A chronometer display 88 can be provided on controller 72 to show the length of time that heat and / or force has been applied to the patient's eyelid 78. The stopwatch display 88 can show a cumulative time period elapsed or provide a countdown timer if the initial duration is set. For example, the stopwatch display 88 may consist of a number of seven segment displays. In an execution mode, the stopwatch 88 display will count

56/125 of one hundred and eighty (180) seconds and will flash in one hundred and twenty (120) seconds and sixty (60) seconds, which is an indicator for the doctor to release the force lever 86 and then apply force and pressure again pressing lever 86 again.

Figure 10 illustrates the disposable component 74 in more detail. The disposable component 74 consists of an eyelid heater 90 that includes a lens in the revealed embodiment. The lens 90 contains a heating element to apply heat to a patient's eyelids 91A, 91B, but it also provides an insulating plate against which force can be applied. As shown in Figure 11, lens 90 is placed on the patient's eye with the upper and lower eyelids of patient 91A, 91B leaning on the outer surface of lens 92. Prior to installation, the scleral side of lens 90 can be lubricated with saline drops or equivalent lubricants. Then, lens 90 is inserted into the patient's eye below the eyelids 91A, 91B. A heating element (not shown) is contained within the lens 90 which can apply heat to the inside of the patient's eyelid when installed. The material used to build the lens 90 is not electrically conductive, but is thermally conductive to allow heat from the heating element inside to be transferred to the patient's eyelid. Lens 90 can be constructed of plastic, including clear plastic, such as LEXAN HPS2 for example. In addition, lens 90 can be constructed of a biocompatible material, such as polymethylmethacrylate (PMMA), epoxy, or other materials well known to those skilled in the art.

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The lens 90 can be flexible, but ideally it should be only minimally compressible to fit against the patient's eyeball.

The lens 90 also contains an eyelid heating platform or plate 94 that is attached to the lens 90. The eyelid heating platform 94 can be attached perpendicularly to the lens 90 in such a way that it extends away from the patient's eye when being installed. The heated eyelid platform 94 offers several benefits. First, it provides an insertion and movement handle or adjustment of the lens 90 and its heating element. Second, it provides a guide post for a compression force device to be connected to apply force to the patient's eyelid while lens 90 applies heat to the inside of the patient's eyelid. It can also support an electrical lens interface 96 to allow the lens 90 to electrically connect the heating element within the lens 90 to the controller 72 by the interface 76. Controller 72 can then apply electrical energy to the heating element to generate heat within the lens 90 and thus inside the patient's eyelid when installed. Second, it provides a support structure for the interface 98 circuits. The interface 98 circuits provide electrical connections to energize the heating element and communicate the temperature measured on the lens 90 back to the controller 72 for heat regulation. Interface 98 circuits will be discussed later in this order and with reference to Figure 16.

Figure 12 illustrates a cross-sectional view of the eyelid heater using lens 90 illustrated in

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Figures 9-11 to further illustrate heat delivery components and characteristics of the eyelid heater, according to an embodiment of the present invention. The lens 90 is formed by a scleral side 93 connected to an eyelid side 92. The scleral side 93 of the lens 90 contains a curve 100 around its circumference edge to provide a fixing edge 102 to secure the fixation on the side of the lens. eyelid 92. Because of curve 100, a hollow chamber 104 is formed within the lens 90. The hollow chamber 104 holds a heater element 106 contained within the lens 90 to generate heat when energized. The heating element 106 adjoins the eyelid 92 of the lens 90 so that the heat generated is located adjacent to the inner eyelid to apply heat to the meibomian glands. The heating element 106 is connected to the circuitry of the interface 98 via the fuse connection 108, which is then connected to the controller 72 by the eyelid heating platform 94 connected to the interface of the controller 76. In this way, the controller 72 can cause the heating element 106 inside the lens 90 generates heat by applying an electrical signal to the circuitry of the interface 98, which are connected to the heating element 106. If the temperature exceeds the threshold temperature level of fuse connection 108, connection 108 would melt and create an open circuit to disable heating element 106 for safety reasons. Alternatively, fuse connection 108 can be a thermal connection provided as an integrated part of the heating element such that fuse connection 108 would melt and create an open circuit at a given threshold temperature.

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The heating element 106 can be supplied in any form or material. The heating element 106 can be a resistive type heater, a thick film heater, or any other type, such as a flexible circuit (metal etched on a flexible substrate) well known to those skilled in the art. The heating element 106 can be molded into the shape of the lens 90. In the illustrated example, the heating element 106 is a material that is both electrically and thermally conductive. This can be important. The electrical conductivity characteristic allows the current to be applied to the heating element 106 to generate resistive heat. The thermal conductivity feature serves to uniformly distribute resistive heat throughout the heating element 106 to distribute heat more evenly to the patient's eyelid. Without these characteristics, it may be more difficult to regulate the heat generated by the heating element to efficiently and effectively melt, release or soften obstructions or occlusions in the meibomian glands. Examples include E5101 carbon loaded polyphenylene sulfide and liquid crystalline polymer E2, both manufactured by Cool Polymers, Inc.

Lens size 90 can also play a role in the selection of heating element 106 and the amount of heat it must generate to be effective in treating MGD. The lens 90 distributes the heat generated by the heating element 106. A larger lens 90 can distribute the heat generated by the heating element 106 more evenly and over a larger surface area. Also note that the application of heat to the patient's eyelid does not

60/125 must necessarily include a heating element 106 inserted into the lens 90. The application of heat can be provided as part of the environment, such as air for example. The amount of heat applied, the temperature reached in the meibomian glands as a result, where heat is applied to the patient's eyelid or surrounding tissue, and the duration of the heat applied can control the selection of the heating source.

In addition to the insulation provided by the material used to construct the lens 90, the lens 90 may also contain an integrated insulator within the chamber 104 as an additional measure of insulation. The insulation prevents substantial heat from reaching the eyeball and thus protects the cornea and sclera. As used herein, the term isolate or isolation is intended to include any component or material and / or specific geometries of components or materials, where there is greater resistance to conduction or thermal radiation towards the surface of the eye than towards the eyelid. . Alternatively stated, thermal energy in the insulator radiates more easily towards the eyelid 91A, 91B than towards the surface of the eyeball to minimize the possibility of causing damage to the eyeball. In the lens 90 example of Figure 12, the integrated insulator is air and is formed by the natural opening that exists for the space left by the heating element 106 that does not fill the entire volume of the chamber 104. The heating element 106 is influenced according to its position on the lens 90, and especially to be located behind the integrated insulator, to produce more heat inside the patient's eyelid than in his

61/125 eyeball.

Figure 13A illustrates an eye capsule 110 which is adapted to allow controller 72 to apply force to patient's eyelids 91A, 91B in addition to heat. Eye capsule 110 is a curved carrier 112 that supports an inflatable bladder 114. Inflatable bladder 114 is attached to curved carrier 112. Inflatable bladder 114 is then connected to controller 72 via tubing 118 at controller interface 76 (see Figure 14) so ​​that controller 72 can pump air into tubing 118 to inflate inflatable bladder 114. When inflated, the eye capsule 110 applies force to the outside of the eyelid 91A, 91B while heat can be applied by the lens 90 and the heating element 106. To apply force to the eyelids of the patient 91A, 91B, the bladder 114 is inflated under the control of the controller 72. To release force and therefore reduce pressure, air in bladder 114 is released by controller 72.

When desired, the eyelid heating platform 94 is inserted into an eyelet orifice 113 in eyepiece 110 between a locking mechanism 116. Locking mechanism 116 provides a means of holding the eyelid heating platform 94 to the ocular capsule 110 when in use as well as providing an interface to electrically connect the electrical interface of the eyelid heater 96 to controller 72 via controller interface 76. The locking mechanism 116 is comprised of a carrier 117 which has a semicircular carrier base 119. The carrier base 119 receives an ocular capsule platform 121 attached to ocular capsule 110. The carrier base 119 and the capsule platform

62/125 eyepiece 121 can be tightened together as a clip to control an opening through which the eyelid warming platform 94 is inserted into carrier 117 when inserted into orifice 113 of eyepiece 110. When the carrier base 119 is not pressed against the ocular capsule platform 121, the opening of the carrier through which the eyelid heating platform 94 is inserted closes to secure the eyelid heating platform 94 to the carrier 117, and therefore the eye capsule 110. The ocular capsule platform 119 is adapted to allow the eyelid warming platform 94 to rest on the top when inserted into the eye capsule orifice 113. When inserted, the electrical interface 96 of the eyelid heater 74 contacts a carrier interface 123, which provides an electrical connection between the electrical interface 96 and the controller interface 76.

Figure 13B illustrates an alternative locking mechanism

116A to one illustrated in Figure 13A. The locking mechanism 116 is compressed in the horizontal plane while the eye capsule 110 is moved along the heating plate of the eyelid 94 until it rests against the outside of the eyelids of patient 91A, 91B. When the locking mechanism 116 is released, the eyepiece 110 is fixed in place in its position along the eyelid heating plate 94. In this way, the eyelids of patient 91A, 91B are sandwiched between the lens 90 and the eyepiece 110 . More information and details regarding locking mechanism 116 are illustrated in Figures 27-30 and will be described later in this application.

Figure 14 illustrates more detail regarding the interface of the

63/125 controller 76. Controller interface 76 couples controller 72 to lens 90 and eye capsule 110 to allow controller 72 to apply controlled heat and / or force to the patient's eyelid as part of a MGD treatment. Controller interface 76 contains a connector

120 at one end that joins controller 72. The connector

120 includes both an electrical interface 122 and a pneumatic interface 124. Electrical interface 122 allows controller 72 to send and receive electrical signals over an electronic connection connecting 126 to and from the eyelid heater 90, as will be described in more detail below. The electronic connection 126 connects with an electrical connector of the eye capsule 128 in the eye capsule 110 so that the electrical interface of the eyelid heater 96 of the eyelid heater 90 is connected to the electronic connection 126 when the eyelid heater platform 94 is inserted into the ocular capsule 110, as illustrated in the examples in Figures 13A and 13B. The pneumatic interface 124 allows controller 72 to pump into tubing 118 to inflate inflatable bladder 114 into ocular capsule 110 to apply force to the patient's eye and deflate air in inflatable bladder 114 to release force and relieve pressure. In the illustrated embodiment, the pneumatic interface 124 is securely connected to the inflatable bladder 114 in the ocular capsule 110.

Figure 15 supplements Figure 14 to illustrate the interface components between the controller 72 and the disposable component 74 and the eye capsule 110, at a system level. The controller 72 of the power and heat application device 70 contains a control system

64/125 pressure 130 and a temperature control system 132. The pressure control system 130 is the control component within the controller 72 that controls the pressure pressure applied to the patient's eye by the 110 capsule. temperature control 132 is the control component within controller 72 that controls the heat applied to the patient's eye via the eyelid heater 90. The pressure control system 130 also communicates the pressure in the pipe 118 to a pressure sensor 134 within the pressure control system 130. The pressure sensor 134 is used to determine the pressure level in the pipe 118 to show the pressure in the pressure display 84 as well as providing feedback to controller 72 to provide various functions and system controls, as will be described in more detail below. Pressure sensor 134 also allows pressure data recording to be recorded by controller 72, or an external data acquisition device (not shown) connected to controller 72, if desired.

Figure 15 also illustrates more detail regarding locking mechanism 116 in eyepiece capsule 90. Locking mechanism 116A facilitates the provision of a connection between eyelid heater 90 and eyelid heater platform 94 and eyepiece 110, and the eyelid heater 90 to the electronic connection 126 when the eye capsule orifice 113 is slid onto the lens platform 94 to secure the eye capsule 110 to the patient's eyelid. Two different types of locking mechanism 116, 116A were previously illustrated in Figures 13A and 13B, each of which can be used to secure platform 94 to the capsule

65/125 eyepiece 110, or any other type can be used.

Figure 16 illustrates the specific electrical installation and support circuit that comprises the electronic connection 126 to connect the controller 72, and in particular the temperature control system 132, to the eyelid heater 90 to apply heat to the patient's eye in the modality of execution revealed. Six wires make up the electronic connection 126. The six wires of the interface are connected to the circuitry of the interface 98 which is inserted in the disposable component 74. HEATER + and HEATER- are connected to heating element 106 on eyelid heater 90 when platform 94 is connected to controller interface 76. THERMI + and THERM2 + are connected to two thermistors 136A, 136B. The two thermistors 136A, 136B provide a temperature indication on the patient's eyelid as part of a temperature feedback mechanism to allow the temperature control system 132 to control the temperature for control. As in the preferred execution mode, the temperature drop between the heating element 106 and the inside of the patient's eyelid is minimal, regulating the temperature is simpler. This is because the thermistors 136A, 136B register temperatures closer to the actual temperatures in the glands and thus excess temperatures are minimized. It is important to try to minimize excess temperature so as not to damage the patient's tissue. Temperature thermostats or other more complicated regulation circuits can be used to regulate the temperature too if desired, especially if over temperature is a problem. In addition, the size of the heating element and the power supply

66/125 can also be selected so that only a known maximum amount of heat can be generated even if the heating element 106 has been energized all the time. This would avoid the use of a regulation circuit to prevent excess temperature.

Two thermistors 136A, 136B are provided for redundancy and error checking if one fails. Both thermistors 136A, 136B must provide the same signal indicating the temperature. Both thermistors are connected to a common RETURN to provide a common current return / ground. Finally, a FUSE line is provided and connected to a fuse 138, which is also connected to the RETURN line. As will be discussed later in this application, controller 72 can send a current over the FUSE line sufficient to blow fuse 138. Controller 72 can blow fuse 138 to provide an indication that eyelid heater 90 has previously been used. Thus, if the eyelid heater 90 is reused, controller 72 can detect the open circuit in the FUSE line and know that fuse 138 has been previously blown.

Figure 17 illustrates additional components of the pressure control system 130 to provide more detail of the revealed embodiment. The pressure control system 130 contains an electric pump 139 to pump air into the pipe 118. Other types of pumps can be used. A non-return valve 140 is provided connected in line on pipeline 118 between electric pump 139 and inflatable bladder 114 to allow controller 72 to pump air into the system to use to inflate inflatable bladder 114 without

67/125 reflux release. A relief valve 141 is also provided as a safety measure to ensure that line pressure to ocular capsule 110 does not exceed maximum pressure settings on controller 72. As shown in Figure 15 and discussed above, pressure sensor 134 is turned on to tubing 118 to communicate pressure in tubing 118 to pressure control system 130 for various functions.

Figure 18 illustrates the temperature control system 13 2 in more detail for the preferred execution mode. The temperature control system 132 includes a power system 142 to supply power to the system components. In the revealed mode of execution, batteries 144 are used as a power source. Battery power 144 is supplied to a reverse battery protection and low battery detention circuit 146. If batteries 144 are low in power, a low battery signal is communicated by a low battery signal line 14 to a timer and display controller 150. The timer and display controller 150 is responsible for controlling therapy timers and show them on the timer display 88. The timer controller and display 150 is also used to communicate other codes to the user regarding controller 72, including the low battery signal. Power from batteries 144 is also routed to various CD-CD converters 152 to provide various voltage levels required by controller 72 and its components for operation. Note that the present invention is not limited to any particular type of

68/125 energy or specific energy components.

The temperature control system 132 can also contain a data interface 154 to supply pressure and temperature data to a data record 156. Data record 156 can also contain a timer interface 158 to the timer controller and display 150 for that times can be recorded for the data. The data record 156 can be used to record data regarding patient treatments for analysis and / or to provide data for testing purposes. The data record 156 can be connected to a test connector 160 so that the data recorded in the system record can be examined and / or recorded via an external device (not shown) connected to the test connector 160.

The rest of the temperature control system 132 is made up of various components of the controller 72, which provide full operation and control of the heat and power application device 70. These components are provided in the form of various control circuits and components, including programmable door arrangements (PGA). The components interact together to provide system logic for system operation. These components will be described together with Figures 21-26 below, which describe the logical control of the system. Note that these components can be provided by analog or digital circuits, and can be provided using a microprocessor-based architecture, including software, if desired.

Figures 21-26 illustrate the state machine of controller 72 and various operations performed in states

69/125 that provide the operation and logic of the heat and power application device 70. However, before turning the state machines and the multi-state logic, a general high-level operation of the controller 72 is described with respect to the flow chart of Figure 19. Figure 19 will be discussed together with several states that make up the state machine of controller 72 illustrated in Figure 19.

Figure 19 illustrates a flow chart describing the general operation and logic of the force and heat application device 70 which is performed by controller 72 and its systems, including pressure control system 130 and temperature control system 132, according to an embodiment of the present invention. The process starts with controller 72, resetting to the reset state (step 200 in Fig. 19, reset state 220 in Fig. 2 0). Controller 72 always starts in a reset state in the revealed execution mode. The reset state can occur as a result of a power cycle or if a new disposable component 74 is connected to controller 72. After restart, controller 72 performs a series of tests before starting treatment to determine whether the controller 72 and its components are acting appropriately (decision 202 in Fig. 19). If not, an error is observed and the controller 72 stops the operation by establishing the stop state (step 204 in Fig. 19, stop state 224 in Fig. 20). The stop state disables the heater. If controller 72 is acting appropriately (decision 202 in Fig. 19), controller 72 proceeds with operations to begin treatment by entering the run and monitoring states (states 226 and

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228 in Fig. 20).

As an option, controller 72 can first blow a fuse in the eyelid heater 90 to create an open circuit in a fuse blast state (step 205 in Fig. 19, fuse blast state 222 in Fig. 20). So that an eyelid heater 90 cannot be reused for subsequent treatments for reasons of contamination and safety. As part of the operation check in decision 202, controller 72 can determine whether the fuse in the eyelid heater 90 has been blown in the reset state (220 in Fig. 20). In that case this would be an indication that the eyelid heater 90 has already been used, and controller 72 would enter the stop state (step 204 in Fig. 19, stop state 224 in Fig. 20). Controller 72 will continue to allow operation with the eyelid heater installed 90 after the fuse is blown until eyelid heater 90 is removed. In such a case, controller 72 will enter the reset status (step 200 in Fig. 19, reset status 220 in Fig. 20).

Thereafter, controller 72 prepares for therapy. Controller 72 can first start therapy timers on the timer controller and display 150. The timers allow the user of controller 72 to track the time period in which the therapy took place, including applying force and heat. Different patients may need different periods of time to apply heat and strength during treatments. For example, a treatment cycle may include the application of heat for three minutes, but the force may need to be applied, turned off and returned to

71/125 apply several times during the three-minute therapy time period.

Thereafter, controller 72 allows temperature control system 132 and pressure control system 130 to apply heat and strength to the patient's eyelid as part of a functioning state (step 208 in Fig. 19, operating state 226 in Fig 20). In the revealed execution mode of the eyelid heater 90 and ocular capsule 110, heat is applied to the inside of the patient's eyelid, and the force is applied to the outside of the patient's eyelid, as previously discussed. However, note that controller 72 can also be used to apply heat and / or force to any part of the patient's eye or support structure, including but not limited to both the outside of the patient's eyelid, as well as heat to the outside and strength to the inside. of the patient's eyelid. Controller 72 then monitors the temperature and force applied to the patient's eyelid as part of the heat and pressure regulation in a monitor state (step 210 in Fig. 19, monitor state 228 in Fig. 20). Operating states and monitor 226, 228 operate simultaneously in the preferred execution mode so that heat and force are constantly applied and temperature and pressure monitored during therapy. If during operation or monitor 226, 228, an error is discovered (decision 212 in Fig. 19), controller 72 enters the stop state to discontinue therapy (step 216 in Fig. 19, stop state 224 in Fig. 20). If an error is not discovered, operating states and monitor 226, 228 continue until any error is discovered (decision

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212 in Fig. 19) or the therapy is completed (decision 214 in Fig. 19).

Figures 21-26 illustrate flowcharts that detail the operation of various states performed by controller 72 to control temperature and pressure to provide MGD treatment, according to the revealed mode of execution. Each of these states was generally described above with respect to the flowchart in Figure 19 and the state diagram in Figure 20. In this way, each state and its specific operations and features as they contribute to the operation of the power and heat application device 70 and its controller 72 will be described in more detail. As some operations require information from several components in the pressure and temperature control systems 130, 132, references to these various components will be made according to the operations of the states are described. This includes references to components previously and not previously introduced in the temperature control system 132 in Figure 18.

Figure 21 shows a flowchart of the reset status 220 (step 230). Controller 72 enters reset state 220 when a power cycle occurs or a new disposable eyelid heater 90 (with an intact fuse 138 as an optional feature) is installed (step 232). Thereafter, controller 72 checks to determine if the power supply voltage is above a minimum adjustment voltage level (decision 234). In the revealed mode of execution, batteries 144 must supply at least 2.4 volts. If they do not, a battery error (eg bAt) is displayed on the

73/125 stopwatch 88 (step 236). With respect to Figure 19, the low battery error is displayed by the timer controller and display 150 on the timer display 88 in response to the low battery signal sent from the low battery detection circuit 146 over the low battery signal line.

148 .

If batteries 144 are producing sufficient voltage, controller 72 remains in reset state 220, then determining whether disposable component 74 is installed (decision 238). If not, controller 72 is not ready for operation. However, before going to stop state 224 (step 246), controller 72 takes the opportunity to perform a pressure diagnostic test. With respect to Figure 18, the signal indicating the pressure sensor 134 of pressure measured in the pipe 118 is communicated to a pressure level comparator 162, which communicates the pressure level to the pressure display 84 and to a control system for checking the pressure. error 164. Ideally, the pressure in pipeline 118 should not be greater than the ambient pressure. If pressure sensor 134 does not provide a signal indicating ambient pressure (decision 240), this is an indication that pressure sensor 134 may not be functioning properly. Thus, an error message from pressure sensor 134 (eg E 4) can be shown on the stopwatch display 88 (step 244), via the ERRORS 171 signal line (see Figure 18), before the controller enters in stop state 224 (step 246). If pressure sensor 134 is properly measuring pressure, timer display 88 remains in the reset display state (p.

74/125 ex. (step 244) and controller 72 waits until a disposable component 74 is installed (decision 238). Note that since the ambient pressure may not be 0 mm Hg depending on where the heat and power application device 70 is located, a threshold pressure level is used. In the revealed execution mode, the threshold pressure level is 1 psi.

Once disposable component 74 is installed, controller 72 can then optionally determine whether fuse 138 in eyelid heater 90 is blown (decision 248). This check is only performed if the eyelid heater 90 is equipped with a fuse 138 that can be blown by the controller 72 to indicate when the disposable component 74 has previously been used for a treatment. In this example and referring to Figure 18, a fuse detection and blowing circuit 168 communicates a fuse detection signal via the FUSE DETECTION line 173 of the interface 98 circuits on the disposable component 74 to the error checking controls system. 164. This is how the controller 72 can determine if the disposable component 74 has been used previously. If fuse 138 is blown, controller 72 will not allow therapy to be delivered using the disposable component 74 currently installed for safety and sterility reasons until disposable component 74 is replaced with a previously unused disposable component (which will have a fuse intact 138 on interface 98 circuits). Controller 72 will display an error message (eg E_l) on the timer display 88, via the FUSE signal line

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170 to indicate to the user that the disposable component 74 must be replaced (step 250) before going to stop state 224 (step 252).

If fuse 138 is not blown in disposable component 74 (decision 248) or if the fuse check feature is not included in controller 72, controller 72 below determines whether heater element 106 is connected (decision 253). If not, the controller displays a connection message (eg Con) on the timer display 88 to indicate to the user that the heating element 106 (i.e., the eyelid heater 90) is not connected to controller 72 and therefore therapy cannot begin (step 255). Once the heating element 106 is connected to the controller 72, the controller 72 next determines whether the temperature level in the eyelid heater 90 is lower than the temperature of the room or room (decision 254). In this case, this is an indication that the disposable component 74 cannot be installed on a patient's eyelid such that the user is ready for the controller 72 to begin therapy. With respect to Figure 18, thermistor conditioning circuits 172A, 172B communicate signals from each of the thermistors 136A, 136B on the disposable component 74 to the error checking control system 164. In response, the message connect (eg. Con) can be displayed again on the timer display 88 (step 255). Controller 72 will continue to check the connection of heating element 106 and the temperature in eyelid heater 90 until thermistors 136A, 13B read the temperature as room temperature or higher (decision 254). This provides

76/125 some guarantee that the disposable component 74 is installed on the patient.

The controller 72 will then check to determine if the temperature level in the eyelid heater 90 is lower than the body temperature (eg 30 ° C) (decision 254). This allows the controller 72 to determine whether the component is disposable. 74 is installed in the patient's eye, because if it is installed, the temperature in the eyelid heater 90 must be at least the body temperature. If the temperature in the eyelid heater 90 is not at least body temperature, an error message (eg LO) may be displayed on the timer display 88 in response to indicate to the user that the temperature in the eyelid heater 90 is abnormally low (step 256). Controller 72 will thereafter perform the verification series again to ensure that the eyelid heater 90 is properly installed and ready for use in therapy (decisions 253, 257, 254, 258).

Once the temperature of the eyelid heater 90 is at or above room temperature (decision 254), controller 72 then determines whether the temperature in the eyelid heater 90 is at a temperature level that is higher than would be expected before the therapy has started (ie an over-temperature level, eg 30 ° C) (decision 258). This may be indicative of an ambient temperature that is considered high to start therapy. In this case, an error message (p. ex. E_6) can be displayed on the timer display 88 by the error checking control system 164 (step 260) before controller 72 enters stop state 224 (step

77/125

262). If not, the controller will check the pressure level in tubing 118, using pressure sensor 134, to ensure that the pressure level is at ambient pressure since controller 72 has not inflated bladder 114 to generate pressure on the patient's eyelid ( decision 264), If the pressure level is lower than the ambient pressure, this may be an indication of an error, such as an error with the pressure sensor 134 or the power source. If the pressure level is lower than the ambient pressure, controller 72 will check to determine if the battery voltage is sufficient (decision 261) and repeat the series of checks (decisions 253, 257, 254, 258, 264) before to allow therapy to begin. Once these series of checks have been satisfied, therapy can begin. In response, controller 72 will reset timer display 88 to indicate the start of a therapy session (eg. 180 seconds countdown) (step 265). Controller 72 will then check to ensure that the pressure level in pipeline 118 is not higher than the ambient pressure or a desired pressure level that would be indicative of a pressure sensor 134 or other problem (decisions 267, steps 269, 271 ) before proceeding with operating state 226, or blown fuse state 222, if provided (step 268).

After leaving the reset state 220, controller 72 can enter the fuse blown state 222 (step 272), which is illustrated in Figure 22. If provided, controller 72 blows fuse 138 in eyelid heater 90 so that cannot be reused after the

78/125 controller 72 is reset (step 273). With respect to Figure 18, the error checking control system 164 causes sufficient current to be sent to the FUSE BURNING line 174 and the fuse detection and burning circuits 168 to blow the fuse 138 on the disposable component 74. The controller 72, through the error verification control system 164, then checks to see if the fuse 13 8 has been successfully blown by the FUSE DETECTION line 173 (decision 274). If not, and after seven unsuccessful attempts to do so (decision 276), an error message (eg E_7) can be generated on the timer display 88 (step 278) before going to stop state 224 (step 280). If fuse 138 is blown successfully, controller 72 is ready to deliver therapy. Controller 72 introduces operating status and monitor 226, 228 (step 282) to be performed simultaneously to apply heat and force to the patient's eyelid, as well as to control the temperature and pressure applied for control purposes.

Figure 23 illustrates operating status 226 (step 300). Controller 72 enters operating state 226 to start therapy from any reset state 220 (step 268 in Fig. 21) or optionally from the blown fuse state 222 (step 282 in Fig. 22). Operating state 226 will be discussed before the state of monitor 228, which is illustrated in Figures 25A and 25B. Returning to Figure 23, operating state 226 starts with controller 72 starting a cycle timer and starting a timer countdown from the programmed countdown value in the system

79/125 (step 3 02). Returning to Figure 18, the timer controller and display 150 reset the timers. The countdown timer is shown on the stopwatch display 88. The cycle stopwatch will cause the stopwatch display 88 to flash at the end of a cycle so that the stopwatch display 88 is used to provide information on the stopwatch cycle and stopwatch countdown to a user.

In the revealed execution mode, the cycle timer is the period of time that the force must be applied continuously to the patient's eyelid before being released. In the revealed execution mode, this is established in one minute. The countdown timer is the total therapy time for the heat to be applied to the patient's eyelid. In the revealed execution mode, the countdown timer is set to three minutes. Thus, there will be three cycles during therapy. Stopwatches are not only used to provide the user with a visual timing indicator, but are also used to control heat and force application to the patient's eyelid as will be further discussed. These timer values ​​can also be based on programming instructions provided by the user to controller 72.

Thereafter, the temperature control system 132 allows heat to be applied to the patient's eyelid via the eyelid heater 90 and its lens (step 304). The start of heat therapy is signaled to the user by lighting the decimal point on the display of stopwatch 88 in the revealed execution mode (step 304). Referring to Figure 18, the therapy timer controller 150

80/125 causes an activation signal to be generated on an ACTIVATION line 176 to activate an eyelid heater controller 178 to apply an electrical signal to the HEATER + and HEATER- lines on the electronic connection 126 (see Figure 16). This causes the heating element 106 in the eyelid heater 90 to energize and generate heat to the patient's eyelid. The eyelid heater controller 178 controls the heating element by turning the electrical signal to heating element 106 on and off. However, any type of heater control can be employed, including but not limited to PWM techniques. Thereafter, the timer and display controller 150 determines whether the cycle timer has not expired (decision 306). If it has expired, the therapy timer is paused (step 308) and pause status 229 is introduced (step 310). This is because the force must be released before the therapy can continue. The paused state 229 is illustrated in Figure 24 and will be discussed later below.

If the cycle timer has not expired (decision 306), indicators for starting, alerting, therapeutic temperature and therapeutic pressure are checked (decisions 312, 314, 316, 318). These indicators are established by monitor state 228 as part of the error check, which is illustrated in Figures 25A and 25B and will be discussed later below. At this point, all that must be understood is that the establishment of these indicators means that thermal therapy can continue. If not, any state of stop 224 (step 317) or the state of the paused therapy timer 229 (step 308, 317) will be entered before returning to the state of

81/125 operation 226. If the indicators are properly adjusted, the therapy timer will be decreased in time as each second passes (steps 319, 320) with heating element 106 continuing to be energized to produce heat in the eyelid heater 90 until the time of therapy is completed (decision 322). When the therapy time ends, meaning that the therapy timer time has been counted down to the null time in the revealed run mode, the therapy timer is stopped (step 3 24) and the stop state 224 is introduced to discontinue warming up of the patient's eyelid (step 326).

Before describing the monitor state 228, which is illustrated in Figures 25A and 25B, the pause state 229 will be described below. The pause state 229 is illustrated in Figure 24. The pause state 229 is introduced to disable the energization of the heating element 106 and wait for the user to release the power lever 86 (or other pressure control mechanism) before reintroducing the operating state 226. This ensures that the force is not continuously applied to the patient's eyelid throughout the therapy session without any relief to allow blood flow to the eyelids for reasons of

<td>precaution</td><td>in</td><td>safety</td><td colspan="2">0 controller</td><td>stopwatch</td><td>and</td>

<td>display</td><td> 150</td><td>first</td><td>disable</td><td>the element</td><td>heater</td><td> 106</td>

<td>pulling out</td><td>O</td><td>sign of</td><td>activation</td><td>of the line</td><td>ACTIVATE 176</td><td>to</td>

eyelid heater controller 178 (step 332). The stopwatch display 88 is paused from the shift mode, and the cycle time flashes indicating that the cycle has ended (steps 334, 338). The start indicator is checked

82/125 (decisions 336, 340) to ensure that the user released the force so that the therapy can be restarted, in which case the system returns to operating state 226 (step

342). The start indicator is adjusted and reset to monitor state 228.

If the start indicator is set (decision 336, 340), controller 72 can also check to determine if the temperature in the eyelid heater 90 is above a defined threshold temperature level. In that case, this may be indicative of the heating element 106 producing heat that exceeds a higher temperature level than the heat being applied to the patient (decisions 337,

343). In the revealed mode of execution, this upper temperature threshold is 43 ° C. However, this threshold temperature level can be made to be any desired temperature level threshold. If the threshold temperature level is exceeded, temperature display 82 may flash to indicate this condition to the user as well as an error (eg E_3) displayed on timer display 88 (step 341, 343) before controller 72 enter stop state 224 (steps 343, 349).

Monitor status 228 is illustrated by the flowchart of Figures 25A and 25B. Monitor status 228 will continuously check the temperature and pressure applied to the patient's eyelid. The temperature is checked using thermistors 136A, 136B, and the pressure is checked using pressure sensor 134 connected to the pipe 118. The results of the measured temperature and pressure are displayed on the controller 72, via the temperature and pressure displays 82, 84. The

83/125 temperature and pressure measurements are analyzed to ensure that no incorrect conditions have occurred. In addition, monitor state 228 will signal to operating state 226, which is running concurrently with monitor state 228, when therapeutic temperatures and pressures have been reached.

Returning to Figure 25A, the temperature control system 132 determines whether the temperature is above a fail-safe maximum threshold temperature level for safety reasons (decision 352). This maximum threshold temperature level can be set at 45 ° C. In this case, the over-temperature condition flashes on the temperature monitor 82 to indicate to the user that the temperature is above the allowable temperature setting (step 354). In addition, an error message (eg E_3) can be displayed on the timer 8 8 display in the same consideration (step 356). Controller 72 will enter stop state 224 (step 358) to stop therapy. If the temperature in the eyelid heater 90 is not above the set safe temperature threshold, the error checking controller checks to see if the two temperature thermistors 136A, 136B are different in value (decision 360). Thermistor 136A, 136B that provides the highest reading is used for temperature control as an additional precaution to prevent a dangerous temperature from being applied to the patient's eyelid (steps 362, 364). The measured temperature is then displayed on the temperature monitor 82 (step 366).

The temperature on the 136A, 136B thermistor used to measure the temperature is checked again to ensure that the

84/125 temperature in the eyelid heater 90 has not exceeded the maximum allowable temperature again as a safety precaution (decision 368). If the temperature has exceeded the maximum allowable temperature, the same steps previously performed for this check are performed (steps 354, 356, 358). If not, the heater switch controller on the eyelid heater controller 178 can be optionally checked to ensure it is working properly to ensure that heat will not be applied to the patient's eyelid when the switch is switched off by the ON / OFF signal line 180 in Figure 18 (decision 370). If the heater switch controller malfunctions, an error message (eg E_7) can be generated on the timer display 88 to indicate the hardware failure to the user (step 372). The system then enters the stop state (224) to disable the application of heat (step 374).

If the heater switch controller is acting appropriately (decision 370), the system determines whether the pressure level in pipeline 118 is above the maximum allowable pressure as a safety precaution to prevent too much pressure from being applied to the patient's eyelid (decision 376). In this case, the overpressure condition is displayed on the pressure monitor 84 and on the stopwatch display (eg. E_5) to indicate the user overpressure condition (step 378, 380) before entering stop state 224 (step 382). If no overpressure condition exists, the measured pressure is displayed on the pressure monitor 84 (step 384).

Then, as illustrated in Figure 25B, the system

85/125 determines whether the temperature in the eyelid heater 90 is above the therapeutic temperature setting (decision 386). This is an indication that the temperature has increased in the eyelid heater 90 required to deliver therapy and for the therapy timer to accumulate in operating state 226. The therapeutic temperature setting is established by the system. Alternatively, it can be programmed by the user in controller 72. If the temperature is above the therapeutic temperature setting (decision 386), the therapeutic temperature indicator is set (step 388). If not, the therapeutic temperature indicator is unlocked (step 390).

In a manner similar to temperature, the system also determines whether the pressure in tubing 118 indicative of the pressure applied to the patient's eyelid is above the therapeutic pressure setting (decision 392). This is an indication that the pressure has increased to a level necessary to deliver therapy and for the therapy timer to accumulate in operating state 226. The therapeutic pressure setting is established by the system. Alternatively, it can be programmed by the user in controller 72. If the pressure level is above the therapeutic pressure setting (decision 392), the therapeutic pressure indicator is set (step 394). If not, the therapeutic pressure indicator is unlocked (step 3 96). The system also checks to determine whether the pressure level has increased to a minimum threshold level indicative of the force lever 86 engaged by the user to allow therapy to begin (decision 398). In that case the start indicator is set (step 400). If not, the

86/125 start is unlocked (step 402).

The system also controls temperature thermistors 136A, 136B to determine whether their measured signals follow each other as an indication of whether thermistors 136A, 136B may have malfunctioned (decision 404). Two thermistors are unlikely to produce the same output for a given temperature, but they change similarly in response to the same conditions. If they are following each other properly, the alert indicator is unlocked indicating that no incorrect conditions exist for the thermistors (step 406). If not, an error message (eg E_2) can be displayed on the timer display 88 (step 408) before the alert indicator is established (step 410). As previously discussed, health 226 checks the alert indicator as a condition to allow therapy to continue. Monitor state 228 continues to operate in a loop until a condition occurs to place controller 72 in stop state 224.

Figure 26 illustrates the last state of the state control machine, the stop state 224. The stop state 224 is initiated when the total therapy time has reached its maximum predefined time or any error condition occurs (step 420) . Once in stop state 224, controller 72 cannot be restarted with the same disposable component 74 for safety reasons. The heating signal for heating element 106 is deactivated to prevent heat from being applied to the patient's eyelid (step 422). In addition, the energy source for heating element 106 can

87/125 can also be disabled as a further measure to ensure that heat is no longer applied to the patient's eyelid (step 423). An optional test connector can be installed to write the sensor or operational data to memory for data or test records. If it is installed (decision424), the data can be written to memory (step 426). Once the data treatment is written to memory, controller 72 will be able to check the battery condition until controller 72 is reset to enter reset state 230 (see Figure 21), as long as controller 72 is not undergoing therapy and is somehow disabled (decision 428, step 430). If the test connector is not installed, controller 72 will continue to check for installing the optional test connector as well as performing a battery level check (decision 425, step 427), until it is installed or controller 72 is rewired to initiate reset state 220 (see Figure 21). Thereafter the system initiates execution state 226, in which case the therapy may start again once error conditions are eliminated and a new disposable component 74 is installed.

Figures 27-30 illustrate an alternative embodiment of disposable component 74B that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the treatment of MGD. As Figures 27 and 28 illustrate, the apparatus comprises an insulator 44 0 and a means for applying force to the eyelid 91A, 91B, or lens 440. In the most basic form, the insulator 440 is concave in the form of curvature mirrors of the

88/125 eyeball 442, substantially similar to contact lenses. As applied here, the term insulator is intended to include any component or material in which there is greater resistance to thermal conduction or radiation towards the surface of the eye than to the eyelid. Put aiternatively, in the thermal insulator the energy radiates more easily towards the eyelid than to the surface of the eyeball in order to minimize the possibility of causing damage to the eyeball 442. In the model that was built, the diameter was more than enough to cover the cornea or in the approximate range of 15 to 25 mm would be sufficient for most eyes, assuming that the relief of the corneal area is approximately 16 mm. It should be noted, however, that the diameter of insulator 440 may vary beyond the ranges mentioned above.

In addition, insulator 440 is constructed with biocompatible material such as polymethylmethacrylate (PMMA), or in the case of the prototype that was built, epoxy or other materials well known to those skilled in the art. Insulation 44 0 may be flexible, but ideally it should be minimally compressible, as will be clear from the discussions that follow. According to the invention, insulator 440 is inserted on the surface of the eye 442, behind the posterior surface of the eyelid and must include soft protrusions so as not to injure or cut the eyelid or the eye. As used herein, the terms eyelid or eyelids are intended to include the upper and lower eyelids, either alone or in combination. Insulating 440 offers a backplate against which force can be applied. In

89/125 limited circumstances, when the obstruction of the canal of the meibomian gland is minimal, the meibomian gland can be cleaned merely by applying force applied from the outside to the eyelid, such as light pressure from the finger. More specifically, with insulator 440 behind the eye, finger pressure is applied to the outer surface of the eyelid, which is being compressed between the finger and the insulator

440 .

In other instances, the obstruction of the meibomian gland can be blocked to a greater degree than when treated with simple pressure alone. In such cases, it is necessary to apply thermal energy to the eyelid, to release, break, fracture, relieve or liquefy at least part of the occlusion. Thermal energy can be applied by any of the well-known means to apply thermal energy, such as resistive modes, infrared, ultrasonic heat, microwave, any of the hot blocks that chemically produce an exothermic reaction or in the simplest way, a compress of heat. Experiments have shown that to be clinically effective, the eyelid must be heated to a temperature between about 35 ° and 47 ° C. The length of time that thermal energy is applied, that is, heat, to the eyelid, depends on the importance of the blocks of obstruction in the meibomian gland, as well as the composition of the obstruction. In much less important cases, heat can be applied to the eyelid for less than three minutes or even as little as five or fifteen seconds. On the other hand, extreme blocking may require more than thirty minutes of heat to melt, release and relieve the obstruction before applying force

90/125 to the eyelid, to squeeze out the softened obstruction. Subsequent experiments revealed that the eyelids are efficient heat exchangers, with the circulating blood acting as a cooling mechanism, and that the temperature returns to normal in less than two minutes, during which time the obstructions harden again, making extraction difficult. Therefore, it is necessary to apply the expressive force mentioned above to the eyelid within that time for the treatment to be successful. Therefore, light pressure with the finger, preferably as a milking action to pull the obstruction up and out of the meibomian gland canal should be employed. Again, depending on the nature and placement of the obstruction, only a compressive force will be effective in these instances.

The insulator 440 is inserted between the bottom of the eyelid on the surface of the eyeball 442, as previously described. A 447 cup is used to generate force and pressure on the eyelid. In an embodiment of the invention, thermal energy is applied as described above to compress with heat and then, within a minute or two, a cup (which should not be heated) is placed on the outer surfaces of the eyelid and a force is applied to squeeze the softened block. As illustrated, the cup follows the size and shape of the eyelids when closed.

In Figures 2 9 and 3 0 the insulator 44 0 is provided with thermal means or heater 448. In this embodiment, the insulator 440 (ie, lenses) is concave in shape; however, the curvature is greater than that of the eyeball 44 2 so that an air pocket is formed between the

91/125 concave in shape and eyeball 442. The air bag has additional insulation to prevent the applied heat from being carried to the surface of eyeball 442 during the treatment time. In addition, terminals 450 of insulator 440 will be the only parts that actually come into physical contact with eyeball 442. The 440 insulation section can be constructed with biocampable material that does not scratch or irritate the surface of the eyeball, such as soft rubber, plastic or possibly even soft metal. It should be noted that the bottom surface 452 (that is, the part below heater 448) and the top surface (the part above heater 448) can be made of different materials in order to minimize thermal conduction to the eyeball and facilitate thermal conduction for eyelid. One method to accomplish this is to provide small air pockets on the bottom surface 452 that will add additional insulation to that layer

The heater 448 can be a resistive type heater, a thin heating film, or any of many other types, such as flexible circuit (etched metal or flexible substrate) well known to those skilled in the art. As shown in Figure 30, the insulator 440 has the means to adhere, handle, or the platform 4 56 on which the heater terminals 458 connect to heater 448, battery 460, to the thermal controller (ie, temperature regulator) ), and the on / off switch. The circuit comprises heater 448, a power source such as battery 460, thermal controller 462, and the on / off switch that are connected in series. The controller / regulator unit

92/125 thermal is selected so that the temperature can be limited to an upper limit temperature like 42 ° C, for example. The thermal control unit 462 may also be designed to shut down the circuit when the temperature exceeds, in order to avoid injury to the eyes and surrounding tissue. In an alternative execution mode, heater 448 can be connected to the device off the power source, using appropriately placed contacts 466 and 468 (see Figure 29)

Referring now to the disposable component 74B of Figures 26-29, a pair of spaced lever arms 470 extends perpendicularly from the outer surface B of the insulator 440 and together with the handle 456 define the means for coupling the eyeball 447 to the insulator 440. The respective arms 470 are projected outwards and each includes a notch 472 whose purpose will become evident as described. As Figure 6 best illustrates, heater 440 adjusts to a corresponding depression in insulator 440, so that the two surfaces fit together, in order to offer a smooth surface to the inner eyelid to avoid irritation and friction when blinking. Alternatively, heater 440 can be fitted within insulator 440, or applied or connected to the surface and with a soft covering being added.

Eyeball 447 is adapted to cover the outer surface of the eyelid, conforms substantially to the shape of the surface and is adapted to cooperate with insulator 440. Eyeball 447 includes a central stem placed longitudinally 474, Placed above and below the stem 4 74 and extending perpendicularly out of the

93/125 eyeball body 44 7 is a pair of opposing flexible arms on lever 476, which includes clips and handles on integrally molded fingers 478, and extensions 468. Placed on the underside of eyeball 44 7 is a pair of

5 · diaphragms 480, which are in fluid communication with each other, and which includes internal means 482. Diaphragms 480 are attached to eyeball 447 by conventional means, such as a glue, (not shown). In addition, it is noted from the drawings that there is sufficient space between the diaphragms 480 to allow the arms 470 to pass between them.

Although not illustrated, it will be seen that the eye wash cup 447 could be provided with a single division 480 with an orifice that defines an opening through which the rods 470 can pass. Division 480 can be manufactured from a biocompatible material, such as polyurethane foam (open or closed cell), a sealed air balloon, or a gel-filled bladder. Again, depending on the type and degree of obstruction, the diaphragm will vary in thickness and / or stiffness. In an alternative embodiment, divisions 480 can include 480 bladders that can be manufactured from any flexible, expandable material such as rubber or plastic. However, it is preferable that the expansion coefficient is linear with respect to the amount of liquid added. Bladders 480 can be partially filled or inflated with a constant amount of liquid or they can be provided with a rudimentary pump connected to inlet 482, as used with an aerosol perfume. The fluid is

0 preferably air, but it can also be a liquid like

94/125 water, saline, etc. In addition, although not demonstrated, the liquid can also be heated to help soften any obstructions possibly present in the meibomian gland. It should be noted that for a given patient, the insulator and the fluid, separately or together, can be heated as needed to soften any obstructed meibomian glands.

Although not illustrated, bladders 480 could be manufactured in such a way that, once inflated, pressure is applied, which forces the softened obstructive material from the gland above the gland canal and outside the gland orifice to release the gland. One method would be to increase the thickness of the bladders 480 so that there is less resistance (less thickness) to inflation close to the lower part of the gland and to increases in resistance (greater thickness) as the orifice of the gland is reached.

In operation, insulator 440 is placed over the sclera of eye 44 2 in the same way that a contact lens is inserted. When correctly positioned, the stems 470 will extend outward between the lids 91A, 91B. The eye wash cup 447 is then positioned with the hollow facing the eyelid 91A, 91B, so that the notch ends of the stems 470 are inserted into the slot 474. The eye wash cup 470 is directed along the rods 470 until the notches 472 engage the stem extensions 4 68, thereby coupling the eye wash cup 447 to the insulator 440 and connecting the contacts 466, 468. The heater 448 is , then activated by switch 446 or by another means to which the heated fluid in the bladders 480

95/125 can be added simultaneously or in series for the pre-selected period of time, for example, two minutes. Afterwards, or simultaneously with the application of heat, the bladders 480 can be expanded, which will urge the softened sebum of the meibomian gland above and outside the gland channel towards the gland orifice, thereby unblocking the gland. When the treatment is complete, the clamps 478A, 478B are then pressed against each other, so that the eye wash cup 447 is free to slide and be removed from the rods 470. Subsequently, insulator 440 is removed from the globe eyepiece 442 and treatment is complete.

It will be noted that several mechanisms for locking the insulator in the eye wash cup could be employed, such as a ratchet-type mechanism on the rods 470, which is released by compressing the clips 478A, 478B, a pressure adjustment of the rods 470 in the slot 474, as well as other mechanisms well known to those skilled in the art, not discussed here. Manual control and release and strength as well as manual adjustment of the eye wash cup can be employed during treatment and / or until removal of the obstruction or occlusion in the meibomian glands is achieved. Although not specifically required, it is preferable that the locking mechanisms are close to zero insertion force to decrease the potential for eye damage. In addition, different eye wash cups with different shapes and different degrees of stiffness can be used. Some of these alternative disposable components 74 are disclosed in figures 3140 of the present application and will be discussed below.

96/125

Figures 31A and 31B illustrate another alternative embodiment of the disposable component 74C that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the DGM treatment. In this embodiment, the eyelid heater 90C it is firmly attached to the 110C eye wash cup without the ability to separate the two or make adjustments to change the distance between the 90C lens and the 110C eye wash cup. The only moving component is an inflatable 114C bladder, which is controlled to apply force to the outside of the patient's eyelid. This 74C disposable component can be employed as the simplest way to install and use by technicians during therapy as no adjustment to the 110C eye wash cup position with respect to the warm 90C eyelid heater is necessary.

The disposable component 74C comprises an eyelid heater 90C in the form of a lens similar to the eyelid heater previously discussed 90A, 90B. The 90C eyelid heater contains a heating element (not shown) to apply heat to the inside of the patient's eyelid when the 93C lens surface is placed over the patient's eye. 0 90C eyelid heater also contains a 94C eyelid heater platform to allow the technician or doctor to hold the 90C eyelid heater and install it over the patient's eye. A 110C eye wash cup is also provided to apply force to the outer side of the patient's eyelid. The 110C eye wash cup is made up of 471A upper and lower concave cups,

97/125

471Β. Aperture 473 is provided between the two cups 471A, 471B around a horizontal central line of the 90C lens to facilitate adjustments and because the meibomian glands are located above and below the center of the lens. Thus, it may not be necessary to apply force to the center of the 110C eye wash cup when the patient's upper and lower eyelids come together when the disposable 74C component is installed. The eyelid heater platform is firmly attached to the 110C eye wash cup in an interface section 4 75 to provide a fixed distance between the inside of the 110C eye wash cup and the outside of the 92C lens.

Fig. 32 illustrates another alternative embodiment of the 74D disposable component that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the DGM treatment. In this embodiment, the 110D eye wash cup contains a 116D closing mechanism that allows the 110D eye wash cup to be attached to the 94D eyelid heater platform and the distance between an inflatable bladder 479A, 479B and the outer surface of the 92D lens. adjusted.

In this embodiment, the 110D eye wash cup design contains the divided upper and lower eye wash cups 481A, 481B similarly to the 110C eye wash cup design illustrated in Figure 31, except that the 48IA, 481B eye wash cups that support the membranes or bladders 479A, 479B to apply force to the patient's eyelid are completely separated from each other. The washing cups

98/125 split eyepieces 4 81A, 481B allow the 481A eye wash cup to be raised independently of the lower 481B eye wash cup so that it is possible to release the 110D eye wash cup from the 94D eyelid heater. In this context, the eyelid heater platform 94D contains supports 483 which are adapted to secure the eyewash cup platform 485 in order to secure the eyewash cup 110D to the eyelid heater 94D. The eyewash cup 485 platform contains a clamp 484A attached pivotally to the 94D eyelid heater platform by hinge 487. The 94D eyelid heater platform contains an opposite clamp 484B, such that when clamps 4 84A and 4 84B are pressed together, the eye wash cup platform 4 85 is released from the brackets 483 to release the eye wash cup 110D from the eyelid heater 94D. The 94D eyelid heater platform also contains a clamp handle 4 93 that can be held while the clamps 484A, 484B are pressed to hold the 94D eyelid heater when the eye wash cup

110D is released.

Fig. 33 illustrates another alternative embodiment of the disposable component 74E that can be employed by the present invention to apply heat and / or force to the patient's eyelid, as part of the treatment of DGM. This embodiment is similar to the disposable component 74E of Figure 32, except that the closing mechanism 116E for fixing and releasing the eyewash cup 110E from the eyelid heater 90E is provided completely as part of the eyewash cup 110E. The 116E closing mechanism

99/125 allows the 110F eye wash cup to be attached to the 94E eyelid heater platform and the distance between an inflatable bladder 490A, 490B and the outer surface of the 92E lens to be adjusted.

In this embodiment, the 110E eye wash cup design contains divided upper and lower eye wash cups 491A, 491B similar to the 110E eye wash cup design shown in Figure 32. The top and bottom 491A, 491B eye wash cups support the 490A, 490B membranes that apply force to the patient's eyelid. The eye wash cup platforms 492, 496 extend from the eye wash cup 110E and contain clamps 494A, 494B fixed to each other by the hinge 493. When the clamps 494A and 494B are pressed together, the cup platforms eye wash 492, 496 move away from each other to release the eyelid heater platform 94E. The eyelid heater platform 94E was compressed between the eyewash cup platforms 4 92, 4 96, when the clamps 494A, 494B were not pressed to secure the eyelid heater 90E to the eye wash cup 110E. The eye wash cup 110E can be adjusted with respect to the eyelid heater 90E by pressing the clips 4 92 and 4 96 to the desired location on the eyelid heater platform 94E. The 94E eyelid heater platform can also contain a 489 jaw at its end to provide better fixation of the 94E eyelid heater platform when the 110E eye wash cup is placed in an adjustable position at the desired location along the eyelid heater platform. 94E.

100/125

Fig. 34 illustrates another alternative embodiment of the 74F disposable component that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the DGM treatment. This embodiment has a 116F closing mechanism similar to the disposable component 74E of Figure 33, except that the 110F eye wash cup is a single piece containing an 504 eye wash cup that does not contain separable components. The 116F closing mechanism allows the 110F eye wash cup to be attached to the 94F eyelid heater platform and the distance between the inflatable bladder 502, 490B and the outer surface of the 92F lens to be adjusted. The eye wash cup 110F contains a pneumatic interface 508 to allow controller 72 to inflate bladder 502.

The 110F eye wash cup also contains an 510 eye wash cup platform that supports the 116F closing mechanism. The eye wash cup platform 510 supports the eye wash cups 504A, 504B which holds a membrane or bladder 502 to apply force to the patient's eyelid. The closing mechanism 116F is composed of eye wash cup clips 512A, 512B which are pivotally attached to each other by the pivot 513. When clamps 512A and 512B are pressed together, a hole 514 in the eyewash cup 5101 platform is unlocked to allow the eyelid heater 94F platform to be moved crosswise along the 510F eyewash cup platform. In this way, the 94F eyelid heater can be attached to the 110F eye wash cup and

101/125 moved to the desired distance from the 110F eye wash cup. If the eyelid heater 90F and its platform 94 F are pulled out of the eyewash cup 110F, the eyelid heater 90F can be released from the eyewash cup 110F when platform 94F is pulled through hole 514. As with the 94F platform in Figure 33, the 94E eyelid heater platform may also contain a clamp 50 0 at its end to provide better fixation of the 94F eyelid heater platform when the 110F eye wash cup is placed in an adjustable position. desired location along the 94F eyelid heater platform.

Fig. 35 illustrates another alternative embodiment of the 74G disposable component that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the DGM treatment. This modality has a 116G closing mechanism that operates similarly to the way the syringe operates. The 110G eye wash cup is formed from one piece. The outer surface of the eye wash cup 522 is attached to a cylindrical tube 524 with a platform 526 at its end. The eyelid heater platform 94G extends through the tube 524 and an orifice 528 through the platform 526 and contains a platform of the eyelid heater 94G in the form of a plunger 520 at its end that rests the platform 524, when fully pushed into place. low or engaged. To move the 90g eye wash cup to the furthest point from the 90G eyelid heater, the plunger 520 is fully engaged forwards or downwards. To move the

102/125 eyelid heater 90G closer to the 110G eye wash cup, plunger 520 is pulled up or back. The plunger 520 controls the movement of the 90G eyelid warmer and thus the distance between the 90G eyelid warmer and the 110G eye wash cup to deliver therapy.

Figures 36A and 36B illustrate another alternative embodiment of the disposable component 74H that can be employed by the present invention to apply heat and / or force to the patient's eyelid, as part of the DGM treatment. This modality is similar to the disposable component 74E of Figure 33 in that the separate upper and lower eye wash cups 530A, 530B are provided to apply force to the patient's upper and lower eyelid. However, both 530A, 530B eye wash cups do not need to be engaged. Each can be hitched separately. For example, it may be advisable to treat the meibomian glands only on the upper or lower eyelid and not both at the same time. In this way, the 94H eyelid heater platform contains a 534 hinge. The upper and lower eye wash cups 530A, 530B are attached to the hinge 534 in such a way that they can rotate on the eyelid heater platform 94H. When not in use, the 580A, 580B eye wash cups can be rotated out of the 94H eyelid heater platform, as shown in Figure 36A. The eyelid heater platform 94E contains a notched surface 531 that allows the eye wash cups 530A, 530B to be rotated around the hinge 534 and moved to the

103/125 outer surface of the 92H lens, as shown in Figure 3 6B. When in use, the eye wash cups 58 0A, 580B move after a notch 533 on the eyelid heater platform 94H to lock in place.

Figure 37 illustrates another alternative embodiment of the disposable component 741 that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the DGM treatment. In this embodiment, the eye wash cup 1101 is formed by the eye wash cup 540, which holds a membrane or bladder 541 to apply force to the patient's eyelid. Eye wash cup 540 contains an opening 542 through the eyelid heater platform platform 941 and extends to affix eye wash cup 1101 to the eyelid heater platform 941 when disposable component 741 is installed. The eyelid heater platform 941 contains a thickened surface 54 3 that locks the eyelid heater platform 941 in division 542 and prevents the eyewash cup 1101 from moving around the eyelid heater platform 941 to obtain a fit safe when in use. The handle 544 is also attached to the eye wash cup 540 to allow a technician to hold the eye wash cup 540 by adjusting the eyelid heater 901 in relation to the eye wash cup 540.

Figures 38A and 38B illustrate another alternative materialization of the disposable component 74J that can be employed by the present invention to apply heat and / or force to the patient's eyelid as part of the treatment of MGD. In this alternative, the 110J eye cup is supplied as

104/125 one piece. The 110J eye cup supports a membrane or bladder 551 to apply force to the patient's eyelid and contains a groove 552 through which an orifice 554 protrudes. A bladder advance mechanism 554 is placed through orifice 554, where the eyelid heating platform 94J extends through orifice 554 in the bladder advance mechanism 556. The bladder (not shown) is connected to the advance mechanism of the bladder 556. When it is necessary to advance the bladder (not shown), to the patient's eyelid to apply force, the bladder advance mechanism 556 is rotated so that the notch 558 fits into the slot 557 in the groove 552 to allow the bladder advance 556 moves forward through orifice 552 towards the eyelid heater 90J and locks in place. When you need to move the bladder away from the 90J eyelid heater, the bladder advance mechanism 556 is pulled back so that notch 558 is removed from slot 557 and can be rotated away from slot 557 to rest on groove 552 .

Figure 39 illustrates another alternative materialization of the 74K disposable component that can be used by the present invention to apply heat and / or force to the patient's eyelid as part of the treatment of MGD. In this alternative, the 110K eyepiece cup is supplied as one piece. The 110K eye cup supports a 561 membrane or bladder that applies force to the patient's eyelid. The 110K eyepiece cup contains an outer surface 560 containing fluted structures 562A, 562B to support an orifice chamber 564 with an orifice 566 through which the eyelid heater platform 94k extends to

105/125 attach the 110K eyepiece cup to the 90k eyelid heater. The compressible platforms of the eyepiece cup 568 and 570 are coupled on each side of the orifice 566 to the fluted structures 562A, 562B, at one end in a single hinge 572 at the other end. When the ocular cup platforms 568 and 570 are compressed, this allows the eyelid heater platform 94k to move across the orifice 566. When the 110K eyeglass cup is placed against the patient's eyelid, a claw 578 is pulled so that a neck 576 of the 94k eyelid heater platform is inserted and locked in a slot 574 formed on the lower eyeglass platform

570 .

Figure 40 illustrates another alternative materialization of the disposable component 74L that can be used by the present invention to apply heat and / or force to the patient's eyelid as part of the treatment of MGD. In this alternative, the 110L eyepiece cup and 94L eyelid heater are supplied as two separate pieces. The finger fins 588A, 588B, attached to the hinge 590, can be lowered to make room for an opening 482 in the eyepiece cup 110L to be inserted over the top of the eyelid heater platform 94L next to the opening 582 in the eyepiece cup 580 where desired . When the 110L eyepiece cup is placed on the 94L eyelid heater platform in the desired location, the 588A, 558B finger fins are released and the 588A, 588B fins position and hold the 110L eyepiece in place.

Although this application discusses and provides devices to apply heat to the inside of the eyelid

106/125 and force on the outside of the eyelid to treat MGD, other configurations are possible. Heat and strength can be applied in a number of different combinations and ways to treat MGD. For example, Figure 41 illustrates an alternative embodiment of the present invention for applying heat and strength to tissue near the patient's Meibomian gland to treat MGD. In this alternative, heat is applied and force is applied. Heat is applied, providing conductive heat transfer to the meibomian glands to the desired temperature level (step 600). For example, heat can be applied to increase the temperature inside the eyelid between 43 ° 47 ° C. Heat can also be regulated, which means that a heating medium or element is controlled to stay within temperatures and mediums that are safe for the eyelid and at a temperature sufficient to melt, loosen or soften an occlusion or obstruction in the gland meibomian.

Force can also be applied to tissue near the patient's Meibomian gland to increase the efficiency of heat transfer. As previously described, applying force towards the heat source with the patient's eyelid in sandwich provides a greater contact surface between the heat source and the eyelid for a more efficient conductive heat transfer. In addition, the application of force reduces blood flow in the eyelids to reduce heat loss by convection through the eyelids and allow the temperature of the meibomian glands to not only rise to higher levels, but to do so more quickly and efficiently

107/125 (step 602).

Heat and / or strength can be maintained for a period of time long enough to raise the temperature of the meibomian glands and melt, loosen, or soften obstructions or occlusions (step 604). The strength can be maintained after the heat is removed, or vice versa, depending on the treatment technique required. Maintaining strength after heat is removed can reduce heat loss by convection in the meibomian glands and thus maintain the temperature level in the meibomian glands at therapeutic levels for longer than if the strength were removed. Maintaining heat without maintaining strength can be used to allow blood flow in the eyelids, between successive treatments, for example. For example, it may be desirable to maintain heat to reduce the total amount of treatment time, while applying and removing force between treatments. In addition, it may not be necessary to apply a significant amount of force, or at the same time as applying heat, if the obstruction or occlusion is located near the margin of the eyelid and not in the deepest part of the meibomian gland. Subsequently, either during heating and / or applying force or afterwards, obstructions or occlusions in the meibomian glands can be expressed so that the sebum flow is restored but the glands in order to establish a sufficient lipid layer (step 606) .

The force can be regulated, which means that a force-generating medium is controlled to stay within pressure gradients that are safe to be applied to tissue near the meibomian glands and at pressure

108/125 enough to allow the temperature in the meibomian gland to be raised sufficiently. The force can be applied during heating, after heating, or both, during and after heating. In both cases, force can assist in the expression of occlusions or obstructions or when in a loose, softened or melted state of the meibomian glands. The force may include forces of the vibratory type, including those generated mechanically or using fluid devices or mechanisms. The level of force required to express obstructions or occlusions in the glands can be greatly reduced when heat is applied to obstructions or occlusions to put them in a melted, softened or loose state.

The application of force can also stimulate the movement of fluids or suspensions of occlusions or obstructions of the glands. The present invention can be used with devices that generally apply a regulated force or milking action to the eyelid to express fluids or suspensions or to otherwise mechanically stimulate fluid circulation in the glands. In some cases, a small, smooth, continuous force applied to the eyelid will assist in the expression of fluids and suspensions. Vibration can also be used to apply force simultaneously or immediately after heating to further assist expression.

Any device can be used to generate heat on the outside of the patient's eyelid, including those described here. Other devices can be used, such as the device disclosed in the Registry Publication

109/125

US Patents No. 2007/1016254, entitled Method and apparatus for the treatment of glandular dysfunction using heated medium (Method and apparatus for treating gland dysfunction employing heated medium), and incorporated herein by reference in their entirety. In this application, a device is used to apply heat to the outside of the patient's eyelid via transfer of heated fluid. In addition, a gas can be used as opposed to the fluid to apply heat to the patient's eyelid.

As previously discussed in the flowchart of Figure 6, where only heat is applied, the regulated heat can include thermal control according to a temperature profile. The temperature profile can be a constant temperature, including ascents, descents, peaks and valleys. In addition, the temperature profile can include heat pulses or be modulated with several characteristics, including the use of pulse width modulation (PWM) techniques. The use of heat modulation can allow the temperature to be increased without damaging the patient's eyelid since the increased temperatures are applied for shorter periods of time. Obstructions or occlusions in the meibomian glands can have points of melting, loosening or softening that are beyond temperatures that can be applied without the use of heat modulation. The temperature required to melt, loosen, or soften obstructions or occlusions may depend on how keratinized the obstruction or occlusion is. Not all obstructions or occlusions have the same melting, loosening or softening point. Just as an example, temperatures

110/125 elevations between 47 ° and 55 ° C can be achieved when modulated heat is applied, especially if the eyelid has been anesthetized.

The regulated heat can be kept at a therapeutic temperature for a treatment period. The treatment period can be about 1 to 10 minutes, for example, since the application of force can reduce the amount of time it takes for the heat source to raise the temperature in the meibomian glands to the desired level. Heat can also be applied repeatedly and maintained for a desired period of time to keep the occlusion or obstruction in a melted, loose, or softened state. During or after this regulated heat treatment, the mechanical expression of lipids and other fluids from the meibomian glands usually clears obstructions that have essentially melted or entered a state of suspension (due to materials melting together solids).

Optionally, after the expression of the occlusions or obstructions is performed (step 606), optional pharmacological can be applied meibomian to promote the free flow of sebum and / or reduce or prevent infections or inflammation of the eye or eyelids (step 608). The previous discussion in the flowcharts of Figures 6 and 8 regarding the use of pharmacological agents above, is equally applicable for this alternative and, therefore, will not be repeated here. These compounds are illustrative examples of suitable pharmacological agents, but those skilled in the art will appreciate the fact that other pharmacological compounds may be an agent for the gland.

111/125 used.

Figure 42 illustrates an alternative embodiment of the present invention for applying heat and strength to a patient's eyelid to treat MGD. In this alternative, heat is applied to the outside of the eyelid and force is applied to the inside of the eyelid. Heat is applied to the outside of the eyelid to provide conductive heat transfer to the meibomian glands at the desired temperature level (step 610). For example, heat can be applied to increase the temperature inside the eyelid to 43 ° -47 ° C. Heat can also be regulated, which means that a heating medium or element is controlled to stay within the temperatures and medium that are safe for the eyelid and at a temperature sufficient to melt, loosen or soften an occlusion or obstruction in the meibomian gland. .

Force can also be applied to the inside of the eyelid to increase the efficiency of heat transfer. As previously described, applying force towards the heat source with the patient's eyelid in sandwich provides a greater contact surface between the heat source and the eyelid for a more efficient conductive heat transfer. In addition, applying force reduces blood flow to the eyelids to reduce convection heat loss through the eyelids and allow the temperature of the meibomian glands to not only rise to higher levels, but to do so more quickly and efficiently (step 612 ).

Heat and / or strength can be maintained for a period of time sufficient to raise the temperature of the glands

112/125 enough.

meibomian to a level sufficient to melt, loosen or soften obstructions or occlusions (step 614). The strength can be maintained after the heat is removed, or vice versa, depending on the intended treatment technique. Maintaining strength after heat is removed can reduce heat loss by convection in the meibomian glands and thus maintain the temperature level in the meibomian glands at therapeutic levels for longer than if the strength were removed. Maintaining heat without maintaining strength can be used to allow blood flow to the eyelids, between successive treatments, for example. For example, it may be desirable to maintain heat to reduce the total amount of treatment time, while applying and removing force between treatments. In addition, it may not be necessary to apply a significant amount of force, or at the same time as applying heat, if the obstruction or occlusion is located near the margin of the eyelid and not in the deepest part of the meibomian gland. Thereafter, either during heating and / or applying force or after both, obstructions or occlusions in the meibomian glands can be expressed so that the flow of sebum is restored from the glands to create a sufficient lipid layer (step 616) .

The force can be regulated, which means that a force generating means is controlled to stay within the pressure gradients that are safe to be applied to the eyelid and at sufficient pressure to allow the temperature of the meibomian gland to be raised o The force can be applied during heating, after heating, or both, during and after the

113/125 heating. In both cases, force can assist in the expression of occlusions or obstructions or when in a loose, softened or melted state of the meibomian glands. The force may include forces of the vibratory type, including those generated mechanically or using fluid devices or mechanisms. The level of force required to express obstructions or occlusions in the glands can be greatly reduced when heat is applied to the obstructions or occlusions to put them in a melted, softened or loose state.

The application of force can also stimulate the movement of fluids or suspensions of occlusions or obstructions of the glands. The present invention can be used with devices that generally apply a regulated force or milking action to the eyelid to express fluids or suspensions or to otherwise mechanically stimulate fluid circulation in the glands. In some cases, a small, smooth and continuous force applied to the eyelid will assist in the expression of fluids and suspensions. Vibration can also be used to apply force simultaneously or immediately after heating to further assist expression.

Any device can be used to generate heat on the outside of the patient's eyelid, including those described here. Other devices can be used, such as the apparatus disclosed in US Patent Publication Publication No. 2007/1016254, entitled Method and apparatus for treating gland dysfunction employing heated medium (Method and apparatus for treating gland dysfunction employing heated medium) is here

114/125 incorporated by reference in their entirety. In this application, a device is used to apply heat to the outside of the patient's eyelid via transfer of heated fluid. In addition, a gas can be used as opposed to the fluid to apply heat to the patient's eyelid.

As discussed previously in the flowchart of Figures 6, where only heat is applied, regulated heat may include thermal control, according to a temperature profile. The temperature profile can be a constant temperature, including ascents, descents, peaks and valleys. In addition, the temperature profile can include heat pulses or be modulated with several characteristics, including the use of pulse width modulation (PWM) techniques. The use of heat modulation can allow the temperature to be increased without damaging the patient's eyelid since the increased temperatures are applied for shorter periods of time. Obstructions or occlusions in the meibomian glands can have points of melting, loosening or softening that are beyond temperatures that can be applied without the use of heat modulation. The temperature required to melt, loosen, or soften obstructions or occlusions may depend on how keratinized the obstruction or occlusion is. Not all obstructions or occlusions have the same melting, loosening or softening point. Just as an example, high temperatures between 47 ° and 55 ° C can be reached when modulated heat is applied, especially if the eyelid has been anesthetized.

The regulated heat can be kept at a temperature

115/125 therapy for a treatment period. The treatment period can be about 1 to 10 minutes, for example, as the application of force can reduce the amount of time it takes for the heat source to raise the temperature in the meibomian glands to the desired level. Heat can also be applied repeatedly and maintained for a desired period of time to keep the occlusion or obstruction in a melted, loose, or softened state. During or after this regulated heat treatment, the mechanical expression of lipids and other fluids from the meibomian glands usually clears obstructions that have essentially melted or entered a state of suspension (due to materials melting together solids).

Optionally, after the expression of the occlusions or obstructions is performed (step 616), optional pharmacological can be applied meibomian to promote the free flow of sebum and / or reduce or prevent infections or inflammation of the eye or eyelids (step 618). The previous discussion in the flowcharts of Figures 6 and 8 regarding the use of pharmacological agents above, is equally applicable for this alternative and, therefore, will not be repeated here. These compounds are illustrative examples of suitable pharmacological agents, but those skilled in the art will appreciate the fact that other pharmacological compounds can be used.

Figure 43 illustrates an alternative embodiment of the present invention for applying heat and strength to a patient's eyelid to treat MGD. In this incarnation, an agent to the gland

116/125 heat and strength are applied to the outside of the eyelid. The heat is applied to the outside of the eyelid to provide conductive heat transfer to the meibomian glands at the desired temperature level (step 620). For example, heat can be applied to increase the temperature inside the eyelid by 43 ° -47 ° C. Heat can also be regulated, which means that a heating medium or element is controlled to stay within temperatures and mediums that are safe for the eyelid and at a temperature sufficient to melt, loosen or soften an occlusion or obstruction in the gland meibomian.

Force can also be applied to the outside of the eyelid to increase the efficiency of heat transfer. As previously described, the application of force can provide a greater contact surface between the heat source and the eyelid for a more efficient conductive heat transfer. In addition, applying force reduces blood flow to the eyelids to reduce heat loss from convection through the eyelids and allow the temperature of the meibomian glands to not only rise to higher levels, but to do so more quickly and efficiently (step 622 ).

Heat and / or strength can be maintained for a period of time sufficient to raise the temperature of the meibomian glands to melt, loosen or soften obstructions or occlusions (step 624). The strength can be maintained after the heat is removed, or vice versa, depending on the treatment technique required. Maintaining strength after heat is removed can reduce convection heat loss in

117/125 meibomian glands and thus maintain the temperature level in the meibomian glands at therapeutic levels for longer than if the force were removed. Maintaining heat without maintaining strength can be used to allow blood flow in the eyelids, between successive treatments, for example. For example, it may be desirable to keep the heat on to reduce the total amount of treatment time while on. apply and remove force between treatments. In addition, it may not be necessary to apply a significant amount of force, or at the same time as applying heat, if the obstruction or occlusion is located near the margin of the eyelid and not in the deepest part of the meibomian gland. Thereafter, either during heating and / or applying force or after both, obstructions or occlusions in the meibomian glands can be expressed so that the flow of sebum is restored from the glands to create a sufficient lipid layer (step 626) .

The force can be regulated, which means that a force-generating medium is controlled to stay within the pressure gradients that are safe to be applied to tissue near the Meibomian glands and at enough pressure to allow the temperature in the Meibomian gland to be adjusted sufficiently increased. The force can be applied during heating, after heating, or both, during and after heating. In both cases, force can assist in the expression of occlusions or obstructions or when in a loose, softened or melted state of the meibomian glands. The force may include forces of the vibratory type, including

118/125 generated mechanically or using devices or fluid mechanisms. The level of force required to express obstructions or occlusions in the glands can be greatly reduced when heat is applied to the obstructions or occlusions to put them in a melted, softened or loose state.

The application of force can also stimulate the movement of fluids or suspensions of occlusions or obstructions of the glands. The present invention can be used with devices that generally apply a regulated force or milking action to the eyelid to express fluids or suspensions or to otherwise mechanically stimulate fluid circulation in the glands. In some cases, a small, smooth, continuous force applied to the eyelid will assist in the expression of fluids and suspensions. Vibration can also be used to apply force simultaneously or immediately after heating to further assist expression.

Any device can be used to generate heat on the outside of the patient's eyelid, including those described here. Other devices may be used, such as the apparatus disclosed in U.S. Patent Registry Publication No. 2007/1016254, entitled Method and apparatus for the treatment of glandular dysfunction using heated media, and incorporated herein by reference in their entirety. In this application, a device is used to apply heat to the outside of the patient's eyelid via transfer of heated fluid. In addition, a gas can be used as opposed to the fluid to apply heat to the patient's eyelid.

119/125

As discussed previously in the flowchart of Figures 6, where only heat is applied, regulated heat may include thermal control, according to a temperature profile. The temperature profile can be a constant temperature, including ascents, descents, peaks and valleys. In addition, the temperature profile can include heat pulses or be modulated with several characteristics, including the use of pulse width modulation (PWM) techniques. The use of heat modulation can allow the temperature to be increased without damaging the patient's eyelid since the increased temperatures are applied for shorter periods of time. Obstructions or occlusions in the meibomian glands can have points of melting, loosening or softening that are beyond temperatures that can be applied without the use of heat modulation. The temperature required to melt, loosen, or soften obstructions or occlusions may depend on how keratinized the obstruction or occlusion is. Not all obstructions or occlusions have the same melting, loosening or softening point. Just as an example, high temperatures between 47 ° and 55 ° C can be reached when modulated heat is applied, especially if the eyelid has been anesthetized.

The regulated heat can be maintained at a therapeutic temperature for a treatment period. The treatment period can be about 1 to 10 minutes, for example, as the application of force can reduce the amount of time it takes for the heat source to raise the temperature in the meibomian glands to the desired level. Heat can also be applied repeatedly and

120/125 maintained for a desired period of time to maintain the occlusion or obstruction in a melted, loose, or softened state. During or after this regulated heat treatment, the mechanical expression of lipids and other fluids from the meibomian glands usually clears obstructions that have essentially melted or entered a state of suspension (due to materials melting together solids).

Optionally, after the expression of the occlusions or obstructions is performed (step 626), an optional pharmacological agent can be applied to the meibomian gland to promote the free flow of sebum and / or reduce or prevent infections or inflammation of the eye or eyelids (step 628) . The previous discussion in the flowcharts of Figures 6 and 8 regarding the use of pharmacological agents above, is equally applicable for this alternative and, therefore, will not be repeated here. These compounds are illustrative examples of suitable pharmacological agents, but those skilled in the art will appreciate the fact that other pharmacological compounds can be used.

Figure 44 illustrates an alternative embodiment of the present invention for applying heat and strength to a patient's eyelid to treat MGD. In this alternative, heat is applied to the inner and outer surface of the patient's eyelid. Force can also be applied to the patient's eyelid. Heat is applied to the outer and inner side of the eyelid, providing even more efficient conductive heat transfer to the meibomian glands to the desired temperature level (step 630). Per

121/125 example, heat can be applied to increase the temperature inside the eyelid between 43 ° -47 ° C. Heat can also be regulated, which means that a heating medium or element is controlled to stay within temperatures and mediums that are safe for the eyelid and at a temperature sufficient to melt, loosen or soften an occlusion or obstruction in the gland meibomian.

Force can also be applied to the eyelid to increase the efficiency of heat transfer. As previously described, the application of force can provide a greater contact surface between the heat source and the eyelid for a more efficient conductive heat transfer. In addition, applying force reduces blood flow to the eyelids to reduce heat loss from convection through the eyelids and allow the temperature of the meibomian glands to not only rise to higher levels, but to do so more quickly and efficiently (step 632 ).

The heat and / or strength can be maintained for a period of time sufficient to raise the temperature of the meibomian glands and melt, loosen, or soften obstructions or occlusions (step 634). The strength can be maintained after the heat is removed, or vice versa, depending on the treatment technique required. Maintaining strength after heat is removed can reduce heat loss by convection in the meibomian glands and thus maintain the temperature level in the meibomian glands at therapeutic levels for longer than if the strength were removed. Maintaining heat without maintaining strength can be employed

122/125 can to allow blood flow in the eyelids, between successive treatments for example. For example, it may be desirable to maintain heat to reduce the total amount of treatment time, while applying and removing force between treatments. In addition, it may not be necessary to apply a significant amount of force, or at the same time as applying heat, if the obstruction or occlusion is located near the margin of the eyelid and not in the deepest part of the meibomian gland. Subsequently, either during heating and / or applying force or afterwards, obstructions or occlusions in the meibomian glands can be expressed so that the flow of sebum is restored but the glands in order to establish a sufficient lipid layer (step 636) .

The force can be regulated, which means that a force-generating medium is controlled to stay within the pressure gradients that are safe to be applied to tissue near the Meibomian glands and at enough pressure to allow the temperature in the Meibomian gland to be adjusted sufficiently increased. The force applied during heating, be after

heating, or both, during and after heating. In both cases, force can assist in the expression of occlusions or obstructions or when in a loose, softened or melted state of the meibomian glands. The force may include forces of the vibratory type, including those generated mechanically or using fluid devices or mechanisms. The level of force required to express obstructions or occlusions in the glands can be greatly reduced when heat is applied to the obstructions

123/125 or occlusions to put them in a melted, softened or loose state.

The application of force can also stimulate the movement of fluids or suspensions of occlusions or obstructions of the glands. The present invention can be used with devices that generally apply a regulated force or milking action to the eyelid to express fluids or suspensions or to otherwise mechanically stimulate fluid circulation in the glands. In some cases, a small, smooth, continuous force applied to the eyelid will assist in the expression of fluids and suspensions. Vibration can also be used to apply force simultaneously or immediately after heating to further assist expression.

Any device can be used to generate heat on the outside of the patient's eyelid, including those described here. As discussed previously in the flowchart of Figure 6, where only heat is applied, regulated heat can include thermal control according to a temperature profile. The temperature profile can be a constant temperature, including ascents, descents, peaks and valleys. In addition, the temperature profile can include heat pulses or be modulated with several characteristics, including the use of pulse width modulation (PWM) techniques. The use of heat modulation can allow the temperature to be increased without damaging the patient's eyelid since the increased temperatures are applied for shorter periods of time. Obstructions or occlusions in the meibomian glands may have points of melting, loosening or softening that are beyond

124/125 temperatures that can be applied without the use of heat modulation. The temperature required to melt, loosen, or soften obstructions or occlusions may depend on how keratinized the obstruction or occlusion is. Not all obstructions or occlusions have the same melting, loosening or softening point. Just as an example, high temperatures between 47 ° and 55 ° C can be reached when modulated heat is applied, especially if the eyelid has been anesthetized.

The regulated heat can be kept at a temperature

<td>therapy for</td><td>one</td><td>period of</td><td colspan="2">treatment. 0 period</td><td>in</td>

<td>treatment can</td><td>to be</td><td>of fence</td><td>in</td><td colspan="2">1 to 10 minutes, for</td>

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amount of time it takes for the heat source to raise the temperature in the meibomian glands to the desired level. Heat can also be applied repeatedly and maintained for a desired period of time to keep the occlusion or obstruction in a melted, loose, or softened state. During or after this regulated heat treatment, the mechanical expression of lipids and other fluids from the meibomian glands usually clears obstructions that have essentially melted or entered a state of suspension (due to materials melting together solids).

Optionally, after the expression of the occlusions or obstructions is performed (step 636), an optional pharmacological agent can be applied to the meibomian gland to promote the free flow of sebum and / or reduce or prevent infections or inflammation of the eye or eyelids (step 638) . The previous discussion in the flowcharts of

125/125

Figures 6 and 8 regarding the use of pharmacological agents above, is equally applicable for this alternative and, therefore, will not be repeated here. These compounds are illustrative examples of suitable pharmacological agents, but those skilled in the art will appreciate the fact that other pharmacological compounds can be used.

Those skilled in the art will recognize improvements and modifications to the preferred embodiments of the present invention. The heat as used in this application can mean the application of thermal energy. Heat can be applied to the patient's eyelid, related structure, or adjacent tissues using any type of thermal energy. Force can be applied to the patient's eyelid to apply pressure to the patient's eyelid, related structures and / or adjacent tissues using any type of force or force generating device. All such improvements and modifications are considered within the scope of the concepts disclosed here and in the claims that follow.

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