JP5137956B2 - Method and apparatus for treating meibomian gland dysfunction using a fluid jet - Google Patents

Description

(Cross-reference of related literature)
This application claims the benefit of the priority of US Provisional Application No. 60 / 700,003, filed July 18, 2005, to Grenon et al., “Method and Apparatus for, filed May 15, 2006. This is a continuation-in-part of US patent application Ser. No. 11 / 434,033 entitled “Treating Meibomian Grand Dysfunction Exploding Fluid Jet”, both of which are incorporated herein by reference.

  This application is also filed by Korb et al., US patent application Ser. No. 11 / 434,054, entitled “Method and Apparatus for Training Meibomian Grand Dysfunction,” filed May 15, 2006, and Korb et al., May 2006. Also related to US patent application Ser. No. 11 / 434,446, entitled “Method and Apparatus for Training Gland Function”, filed on the 15th, each of which is incorporated herein by reference.

  The present invention relates generally to the field of human meibomian gland therapy aimed at restoring the natural secretory function of lipids with the tear film of the eye.

  The human body includes several glands, including the lacrimal and meibomian glands of the eye, the sebaceous or hair follicle sebaceous glands under the face and the heel, and the mammary gland of the breast. These glands may not work properly due to age, irritation, environmental conditions, cell debris, inflammation, hormonal disorders and other causes. One common disease state of the eyelid gland is restriction or cessation of the natural flow of fluid from the gland caused by obstruction.

  In the human eye, the tear film covering the surface of the eyeball is composed of three layers. The innermost layer in contact with the eyeball surface is a mucus layer composed of many mucins. The middle layer that makes up the majority of the tear film is an aqueous layer, and the outermost layer is a thin layer (less than 250 nm) composed of many lipids known as “Meibum” or “Sebum”. Sebum is an enlarged special sebaceous gland located in both the upper and lower eyelids (thus using “sebum” to describe secretions) and drains lipid secretions on the lid margin Secreted by the meibomian glands with openings made to form the lipid layer of the tear film. The typical upper eyelid has about 25 meibomian glands, the lower eyelid has about 20 meibomian glands, and the lower eyelid meibomian glands are somewhat larger than those located in the upper eyelid. The meibomian gland comprises various sac-like acini that drain secretions into the main central duct of the gland. The secretion then proceeds to an opening surrounded by smooth muscle tissue and llyolan muscle which is thought to promote sebum exudation. The meibomian gland opening is open on the inner mucosa and outer skin junction called the mucocutaneous skin transition and on the margin of the eyelid around it.

  Specifically, each meibomian gland has a straight, long central conduit whose inner surface is covered with four epithelial layers. Along the longitudinal direction of the central conduit are a number of outwardly inflated structures called acini where gland secretions are produced. The inner lining of each acini differs from the main central conduit in that these special cells supply the meibomian gland secretions. Secretions flow from each acini to the conduit. Although not yet established, it is believed that there is a valve mechanism between the acinar and the central conduit to keep secretion until it is needed when the secretions are drained into the central conduit. Meibomian gland secretions are then stored in the central conduit and released through the opening of each gland onto the lid margin. The blinking and compression of the Lyorang muscle surrounding the meibomian gland is thought to be the primary mechanism that opens the opening for the release of secretions from the meibomian gland.

  Blinks cause the upper eyelid to pull up a thin layer of lipid secreted by the meibomian glands over the other two layers of tear film, forming a kind of protective coating that reduces the rate at which the underlying layer evaporates . Therefore, if the lipid layer is incomplete or an inappropriate amount of such lipids, the evaporation of the water layer is promoted, and eventually itching, cauterization, and irritation, collectively referred to as “dry eye” You will find that it can cause symptoms such as dryness.

  There are many etiologies for dry eye conditions. A common cause of a common dry eye condition is a condition known as “Meibomian gland dysfunction” (MGD), a disorder in which the gland is blocked or closed. A common cause of common dry eye conditions is a condition commonly referred to as “Meibomian gland dysfunction” (MGD), a disorder in which the gland is blocked or closed. As used herein, the terms “ocluded” and “obstruction” refer to solid, semi-solid, or if they are associated with meibomian gland dysfunction, Meibomian gland, or meibomian, which has concentrated clotted secretions and / or plugs, leading to compromise, more specifically partially or completely blocked or clogged, leading to secretion reduction or cessation Defined as any component of the gland. Also, when secretion is reduced or restricted, the meibomian glands can be damaged by closure or obstruction, as indicated by the yellowing that indicates an infectious condition, or by another cause, and as a result The protective lipid protective film may be insufficient.

  Meibomian adenitis is an inflammation of the meibomian glands that causes dysfunction of the meibomian glands and is usually accompanied by blepharitis (inflammation of the eyelids). Meibomian gland dysfunction may accompany meibomian adenitis, and meibomian gland dysfunction may develop without obvious eyelid inflammation. Meibomian gland dysfunction is a meibomian gland opening and / or central duct of the gland (canal), or possibly an acinar or acinar valve (as they actually exist) or central duct of the acinus Often is the result of keratotic occlusion that partially or completely blocks the junction. Such obstruction reduces the secretory function of individual meibomian glands. More specifically, these keratinous occlusions consist of bacteria, sebaceous matrix, dead cells and / or detached epithelial cells. See Korb et al., “Meibomian Grand Dysfunction and Contact Lens Intelligence”, Journal of the Optical Association, Vol. 51, No. 3, 1980, pages 243-151. Meibomian adenitis is revealed by visual inspection of the external eyelid, but may be mild to moderate, or even severe obstructive meibomian gland dysfunction, even when examined with a slit biomicroscope . This is because there are no apparent signs or the appearance signs are negligible and may be overlooked. Apparent signs of obstructive meibomian gland dysfunction are limited to fine changes in the meibomian gland opening, overgrowth of the epithelium of the lid margin covering the opening, and protrusion of the gland opening by a coagulant that acts as an obstruction. Apparent signs of obstructive meibomian gland dysfunction in severe to very severe cases are obvious, and the shape of the lid margin may include sawtooth morphology and distortion. Mild to moderate obstructive meibomian gland dysfunction usually does not cause inflammation, but severe to very severe obstructive meibomian gland dysfunction may cause inflammation.

  Hormonal changes that occur during menopause, particularly while estrogen levels change, can result in thickening of the oil secreted by the meibomian glands, resulting in clogging of the glandular opening. Furthermore, the reduction of estrogen levels also increases the conditions under which staphylococci can grow. This can result in the movement of bacteria into the gland resulting in a decrease in the secretion rate.

  When the flow of secretion from the meibomian gland is restricted due to the presence of an obstruction, cells on the margin of the eyelid grow over the gland opening, further restricting sebum flow and exacerbating dry eye conditions Has been observed. Other factors that cause or exacerbate meibomian gland dysfunction include behavior such as age, blink impairment, use of computers that weaken normal blinks, contact lens wear and hygiene, cosmetic use, or other Illness is included.

  Individual meibomian gland conditions range from optimal conditions that produce clear meibomian gland fluids to mild or moderate meibomian gland dysfunctions that produce milky fluids or concentrated or creamy secretions. Various, up to complete blockage where no secretion can be obtained (Korb et al., “Increase in Tear Film Lipid Layer Thickness Flowing Treatment of Meibomian Gland Dysfunction”, LacrimD Gland Dysfunction. A. Sullivan, Plenum Press, New York (1994)). Along with meibomian gland dysfunction, a large chemical change in meibomian gland secretions results, resulting in a change in the composition of the naturally occurring tear film, which in turn causes eye diseases commonly referred to as “dry eye”.

  The tear film functions as an individual entity, and each layer of the tear film is important, but the lipid layer secreted from the meibomian gland is particularly important. This is because the lipid layer slows the evaporation of the underlying layer and lubricates the eyelids at the blink of an eye, both preventing dry eye and epitheliosis.

  Thus, in summary, the meibomian glands of the eyelids of mammals (such as humans) secrete oil that prevents evaporation of the underlying tear film and lubricates the eye. These glands can be blocked or clogged by various mechanisms, leading to excessive evaporation of the tear film, reduced lubrication function and so-called “dry eye syndrome”. Although not the only cause, meibomian gland dysfunction (MGD) is known to be a major cause of dry eye syndrome. This disorder is characterized by certain obstacles that block the flow of normal lipid secretions within or at the surface of the meibomian glands. Such secretions act to lubricate the eyes, and without this secretion can cause dry eye syndrome. Meibomian gland occlusion or closure includes a passage from the acini to the main conduit that is above or in the opening of the gland, within the main conduit of the gland, or possibly narrowed or blocked Exists elsewhere. The theory is that the meibomian gland acini is equipped with a valve at the junction between the acinar and the main duct of the gland. The inventors believe that, if these valves are present, in theory, these valves will also sometimes occlude and flow from the acinar will be reduced or blocked. These occlusions or closures can have various components.

  In response to these conditions, various treatment methods have been developed to treat dry eye conditions, including drops to replicate and replace the natural tear film, and cells that produce tears. A variety of heating devices designed to facilitate the removal of clogged meibomian glands, stimulating medications. Another technique involves manually squeezing the gland.

  Brand eye drops such as Refresh (R), Soothe (R), and Systeme (R) are designed to closely replicate the naturally occurring healthy tear film. However, the use and administration of these eye drops is merely a symptom treatment and does not address the root cause. In addition, the use of drops is generally over an indeterminate period, and as a result, long-term use can be cumbersome and expensive.

  Also presented are drug modalities, such as the use of tetracycline to treat meibomian gland dysfunction, and one such treatment is US Patent Publication No. 2003/2003, titled “Method for Treating Meibomian Grand Disease”. No. 011426, Pflagfelder et al., US Pat. No. 6,455,583 entitled “Method for Treating Meibomian Green Disease”, and “Use of Tetracyclines for Treating 131”. Is disclosed. However, this treatment has not proven to have universal clinical efficacy and is unnecessary when meibomian gland dysfunction is the result of gland obstruction without infection. The use of corticosteroids for the treatment of meibomian gland dysfunction has also been proposed, as described by Pflugfelder et al., “Non-preserved Topical Corticosteroid for Treatment of Dry Eye, filamentary deratitis” In U.S. Pat. No. 6,153,607. Again, this treatment seems to treat the symptoms of dry eye, not a response to the root cause. In addition, the use of topically applied androgens or androgen analogs to treat signs and symptoms of acute dry eye in psoriatic keratoconjunctivitis has also been made, including US Pat. No. 5,958,912 and US Pat. Both are disclosed in Japanese Patent No. 6107289, both of which are patented by Sullivan under the name “Ocular Therapeutic in Keratoconjunctivities Sicca Using Topically Applied Androgens or TGF-β”.

  Most knowledgeable physicians recognize that heating is beneficial in treating MGD. Depending on the nature of the occlusion, heating is beneficial to actually melt or loosen the occlusive material and cause the gland to begin producing and draining more free lipids and other fluids. However, at present, no suitable method for applying local heating to the eyelid and controlling the amount of heating applied has been commercialized.

  One mode of heat treatment for meibomian gland dysfunction is disclosed in PCT Application No. PCT / GB2003 / 004782, entitled “Eyelid Margin Wipes Comprising Chemical Means for Temperature Adjustment”. As disclosed in this patent application, wiping means are provided to activate chemicals that heat the wiping means from about 32 ° C. to about 40 ° C. prior to use. A hot wiping means can then be applied to the eyelid and then squeezed by hand to remove clogging of the conduit. This method is also not without defects in that it can exacerbate eyelid irritation due to non-specific heating.

Another method of heating the eyelids and meibomian glands uses near infrared (NIR) radiation. More specifically, two hard eyepatches were attached to the eye mask according to the subject's interpupillary distance. The eye mask was held in place with an elastic headband. Each eye patch used 19 light emitting diodes emitting near infrared radiation from 850 nm to 1050 nm peaking at 940 nm. This device produced 10 mW / cm ² of energy that was powered. Goto, E .; Et al., “Treatment of Non-Infrared Obstructive Meibomian Grand dysfunction by an Infrared War Compression Device,” p. Pp. 140, British Journal of 140. This device is designed as a non-contact infrared heating mask using IR light emitting diodes. However, there are many potential problems with the use of infrared heating mechanisms. For example, IR heating can penetrate to the cornea in the back of the eyelid, which is detrimental and ultimately can cause cataracts and other damage. In addition, the IR mask heater applies any pressure on the eyelid that we have determined to be useful in removing obstructions (despite being described as a pressurizing device). is not. Moreover, tests performed on samples of this mask revealed that the mask actually produced very little heat, despite the potential danger.

  US Patent Publication No. 2004/0237969, entitled “Therapeutic Eye and Eye Lid Cover”, also describes the delivery of heated saturated air to the eyelids and in particular to the meibomian glands to heat the meibomian glands. Protective eyeglasses are included. Regarding the heat treatment of the eye, “Tear Film Lipid Layer Thickness and Oximal Strain of Human Medicine” was published on pages 1-4 of Eye (2004) by Mitra et al. Is also discussed.

  In US Patent Publication No. 2003/0233135, named Yee's “Method and Apparatus for Presenting and Treating Eyelid Problems”, the present invention is intended to promote exudation of meibomian gland secretions. I am trying to remove clogging of meibomian glands by electrical stimulation.

  Manual squeezing of glands can be painful, invasive, and produces inconsistent results due to variations in manual control and / or manipulation. This method of treating MGD is also very uncomfortable for the patient. This is because this method causes the doctor to squeeze the gland. In addition, there are about 40 to 50 glands between the upper and lower eyelids, and therefore it takes a very long time to squeeze each gland. This method is inefficient for doctors and it is painful for patients to endure.

US Patent Publication No. 2003/011426 US Pat. No. 6,455,583 WO99 / 58131 pamphlet US Pat. No. 6,153,607 US Pat. No. 5,958,912 US Pat. No. 6,107,289 PCT Application No. PCT / GB2003 / 004782 Specification US Patent Publication No. 2004/0237969 US Patent Publication No. 2003/0233135

Korb et al., “Meibomian Grand Dysfunction and Contact Lens Intelligence”, Journal of the Optical Association, Vol. 51, No. 3, 1980, pages 243-151. Korb et al., “Increase in Tear Film Lipid Layer Thickness Flowing Treatment of Meibomian Gland Dysfunction, page 29, Lacrimal Gland, Der. A. Sullivan, Plenum Press, New York (1994) Goto, E .; , “Treatment of Non-Infrared Obstructive Meibomian Grand dysfunction by an Infrared War Compression Device,” p. 3-140, British Journal of Op. Mitra et al., “Tear Film Lipid Layer Thickness and Ocular Comfort after Meibomian Therapeutic Via Lent Heat with a Novel Device in Year 4”

  Accordingly, it is an object of the present invention to provide a meibomian gland treatment that overcomes the deficiencies and deficiencies of the prior art.

  Another object of the present invention is to provide a meibomian gland treatment that is a single step treatment and thus does not require manual squeezing.

  Another object of the present invention is to provide a meibomian gland treatment that treats meibomian gland disease as well as symptoms of meibomian gland disease.

  Another object of the present invention is to provide a meibomian gland treatment that restores the natural sebum flow exiting the meibomian gland, rather than simply replacing or replicating the naturally occurring tear component.

  Another object of the present invention is to provide a meibomian gland treatment that minimizes the possibility of infection.

  Another object of the present invention is to provide a meibomian gland treatment that is simple, inexpensive and easy to use for health care providers and patients.

  In accordance with the present invention, there is provided a method of treating meibomian gland dysfunction in a mammal, wherein at least a portion of the naturally occurring secretion stream from the duct opening is blocked by closure. The present invention involves selecting an apparatus capable of delivering a jet of heating medium. The apparatus applies a jet of heating medium to the outer surface of the eyelid proximate the gland duct opening at a pressure of about 2 psi to about 30 psi when the jet is applied to the outer surface of the eyelid proximate the gland duct opening. Are positioned as follows. Applying a jet of heating medium is maintained for a time sufficient to loosen, subdivide, break, soften, or liquefy at least a portion of the closure such that at least a portion of the closure is removed. .

It is a schematic cutaway view of the upper and lower eyelids showing a cross section of the meibomian glands. It is a cross-sectional view showing a single meibomian gland. 1 is a perspective view showing a system plan for treating meibomian gland diseases according to the present invention. FIG. It is a front perspective view which shows the protective glasses by this invention. 1 is a rear perspective view showing protective glasses according to the present invention. FIG. 3 is a front perspective view of the fluid delivery component as seen from below. 1 is a rear perspective view showing a fluid jet opening according to the present invention. FIG. FIG. 2 shows a motor and fluid jet assembly for use with one eye according to the present invention. It is a front view which shows the rotor distribution valve by this invention. 2 is a side view showing an inlet and an outlet of a rotor distribution valve according to the present invention. FIG. 5 shows the path of fluid flowing into the rotor distribution valve through the rotor and corresponding distributor outlet. FIG. 5 shows the path of fluid flowing into the rotor distribution valve through the rotor and corresponding distributor outlet. FIG. 5 shows the path of fluid flowing into the rotor distribution valve through the rotor and corresponding distributor outlet. FIG. 5 shows the path of fluid flowing into the rotor distribution valve through the rotor and corresponding distributor outlet.

  The present invention is described in more detail below, but it should be understood first that those skilled in the art will be able to modify the invention described herein and achieve the preferred results of the invention. It is. The following description is, therefore, to be taken as a broad teaching disclosure directed to those of ordinary skill in the art, and not as a limitation on the present invention.

  Referring now to FIG. 1, the location of the meibomian glands M is shown on the upper and lower eyelids. As briefly mentioned above, the upper eyelid contains about 25 meibomian glands and the lower eyelid contains about 20 meibomian glands. As shown in FIG. 2, each gland opens onto the duct C into which the secretions flow, and the eyelid margin, and an opening through which the secretions must pass in order to be added to the tear film when blinking O is included. Each gland has a different size depending on the position in the eyelid, and it can be seen that the opening O is narrower than the tube C.

  As briefly mentioned above, the occlusion composition depends on the etiology that caused the occlusion. However, occlusions are most often in dead cells, keratins, bacteria, exfoliated cells, sebaceous matrix, emulsions, concentrated or creamy secretions, or solid, semi-solid, and concentrated forms. It consists of these arbitrary combinations. Occlusion can occur in the duct, on the gland opening, on the gland opening, or a combination thereof. As used herein, occlusion refers to any of the above.

  Therefore, it is obvious that any blockage of the tube will limit or prevent the secretions from exiting the gland, and furthermore, to remove such a blockage or “closed”, the blockage will cause excessive pain. Obviously, the occlusion can be relaxed from the gland wall and / or subdivided, ruptured, softened or liquefied so as to pass through the gland opening without. Finally, the remnants of the obstruction must be squeezed out of the gland. The present invention provides a method and apparatus for accomplishing these tasks.

  According to the present invention, the occlusion P (or at least a portion thereof) needs to be loosened, fragmented, softened or liquefied before attempting extraction or squeezing. In this connection, the terms “loosened”, “broken up”, “softened” or “liquefied” are used to refer to “non-solid”. "Means at least part of a state having fluidity. In addition, to be clinically satisfactory, the softening or liquefaction of the obstruction P should be performed as quickly as possible, and the adjusted heat treatment time should be as short as possible, Typical patients require treatment for less than 20 minutes, but depending on the type and extent of obstruction, longer treatment periods or even multiple treatments may be required. It will be appreciated that this treatment does not cause damage to the eyeball or surrounding tissues, even with longer treatment times. According to the present invention, such heat treatment is provided by a heated fluid jet applied to the outer surface of the eyelid. This inevitably means that, according to current practice, a greater amount of energy (heat) is transmitted than can be transmitted by applying a conventional heating pad that is applied for 3 to 15 minutes before the clinician attempts to remove the occlusion. Need to add. One problem with current techniques, such as when using a hot compress, is that the temperature of the heat source begins to drop almost immediately, and we have a temperature of about 42 ° C. to soften the blockage. It has been found that it must be maintained between 1 and about 46 ° C.

  The closure is relaxed (this is defined as being partially or partially subdivided, broken, softened or liquefied so that at least a portion of the closure is removed from the gland wall) And the closure can be manipulated through the opening O in such a way as to cause little or no pain or discomfort to the patient. This can be achieved by heating the occlusion to a range of 37 degrees Celsius (37 ° C.) to 50 degrees Celsius (50 ° C.) to soften or liquefy it so that the obstruction can easily pass through the opening ( The preferred operating range (or with minimal painless expansion of the opening) is from 40 degrees Celsius (40 ° C.) to 48 degrees Celsius (48 ° C.), and the desired mode is from 42 degrees Celsius (42 ° C.) to Celsius. Up to 46 degrees (46 ° C).

  In the following, the present invention will be described in the context of using water as the preferred medium, but the present invention covers various other jets such as gases (ie air), other liquids (glycerin, oil, etc.), creams. It can also be performed using possible media. As shown in FIG. 3, the apparatus comprises means for applying heated fluid to the outer surface of the eyelid adjacent to the closed meibomian gland. The means generally comprises a pump 100, protective glasses 200, and means for delivering a fluid jet to the meibomian glands.

  Furthermore, the phrase “proximate the grand” or “proximate to the grand” is used herein to squeeze to encourage the fluid jet to push the occlusion out of the gland, or It is meant to be directed to a patient location close enough to the gland to be treated. The location may vary from patient to patient and may be close or remote from the gland to be treated, but it is within the skill of the doctor to find the position for each gland in each patient where removal of the occlusion is achieved. Is within.

  As shown in FIG. 1, the apparatus comprises a pump 100 that can be powered by AC (wall outlet) or DC (battery) (not shown). The pump should be from 1/32 horsepower to 1/8 horsepower, and 1/16 horsepower is preferred according to currently available data. One such pump is Fluid Metering, Inc., located in Syosset, NY. Is a model STQP having a head Q3CKC manufactured by The pump 100 has a fluid suction port 110 and a discharge port 112, respectively. Each of the suction port 110 and the discharge port 112 is provided with a conduit such as a Polyester (R) pipe 114 or 116 that is connected to a protective eyeglass-type mask 200 as a whole. The pump 100 may further include a heater (not shown) that heats the medium to a desired temperature. It will be appreciated that the preferred temperature from 42 degrees Celsius (42 ° C.) to 46 degrees Celsius (46 ° C.) is not the fluid temperature at the pump outlet, but the temperature of the fluid at the outlet of the fluid delivery means 300. Let's go. Therefore, if the heater is located close to the pump 100, the temperature needs to be higher to accommodate the temperature drop as the fluid travels to the protective glasses. Alternatively, the heater is close to the meibomian gland and close to the fluid inlet of the protective glasses or mask 200 where the temperature drop should be minimized due to the short transit time through the device to the meibomian gland It may be located on the pipe. Depending on the type of heating medium used and the position of the heater itself, heating is supplied by conduction, convection or radiation as appropriate.

  Mask 200 includes a headband 210 coupled to the outer edge of mask eyepiece 220. The headband 210 needs to be made of a flexible material such as rubber, and it is also necessary to keep the eyepiece in place relative to the orbital and cheek areas surrounding the eye. The structure and function of the individual eyepieces are substantially the same, and for ease of explanation, reference will be made hereinafter to “one eyepiece” or a component thereof. The eyepiece 220 includes an elliptical ring or ring 230 of flexible material such as rubber, plastic, neoprene that is large enough to cover the eye socket and eyelid and create a seal around it. The individual eyepieces are interconnected by a nose pad or nose bridge 240, which in a preferred embodiment is integrally formed with the eyepiece. Similarly, nose bridge 240 can be a separately mounted component, such as conventional swimming safety glasses. One side of the ring 230 is configured to closely contact the user's skin and the opposite side is configured to attach the lens 250 by conventional means (such as adhesive bonding or overmolding) to form a water seal. Has been. Lens mounting techniques are well known to those skilled in the art. The lens 250 is integrally molded as a single transparent unit and has a bottom wall 255, a side wall 260, a top wall 265 and a front wall 270 that together define a cavity. A drain port 275 is formed in the bottom wall 255 and the front wall 270 has a slit opening for mounting means for delivering a jet of heating medium or jet means 300 to the meibomian gland G, which will be described in more detail below. There are 280.

  The jet means or rotary dispensing valve 300 includes a cylindrical manifold 305 having a lumen (not shown) extending in the longitudinal direction thereof. Swirl jet openings 310 are disposed along a portion of the length of the manifold 305, and each individual opening 310 is in fluid communication with a lumen. The manifold 305 may also have a “neutral” position that does not allow any fluid to drain from the opening 310. The manifold 305 has an integrally formed gear 315 at one end and nipples 320 at both ends. Manifold 305 is mounted to rotate between the nipples. One nipple serves as a fluid inlet and the other nipple serves as a fluid outlet. A housing 325 having a lumen surrounds a manifold 305 that is mounted without clearance for rotation within the housing. The housing 325 has a longitudinal slit 330 that allows fluid to flow from the individual jet openings 310 into the housing so that the jet openings 310 are sequentially exposed to the slits 330 as the manifold rotates. To be directed to the eyelid. A small electric or hydraulic motor 340 is attached to the protective glasses so that the motor drive shaft rotates the gear 315.

  With reference now to FIGS. 8-11a-11d, another embodiment of a rotary dispensing valve 300 is shown in detail. The valve 300 includes a housing 325 and a rotor or manifold 327 having three vanes 355 and mounted in the housing for rotation. A plurality of holes or openings in fluid communication with the rotor are disposed on the surface of the housing 325 facing the eyelid. The fluid enters the valve 300 through the supply port 350 and enters the rotor blade 355. Rotor 327 is rotated by motor 340 and aligned so that fluid exits outlet 365 through blade 355. The motor 340 may be a 324: 1 reduction ratio DC motor, such as series 1512 available from FTB. Fluid leakage around the rotor 327 is discharged from the drain 360. The operation of the rotary distribution valve 300 is schematically illustrated in FIGS. 11a to 11d. FIG. 11a shows the wing 355 aligned with the hole 365a and the holes 365c, d, e being closed. As wing 355 rotates (FIG. 11b), holes 365a and 365b open and 365c and 365d remain closed. The next rotation of the wing 355 opens 365a, b, c and d remains closed (FIG. 11c). Finally, the subsequent rotation closes hole a and opens holes b, c, d. In FIGS. 11a to 11d, each open hole is indicated by an arrow. The treatment should consist of multiple wing rotations and corresponding massage pressures from individual jets. However, care should be taken that the jet pressure is lower than the pressure that would damage the surface of the cornea if the jet unintentionally contacts the surface of the cornea.

  In another aspect of the invention, a thin flexible membrane 400 (such as a plastic membrane (not shown) shown in one eyepiece of FIG. 5) is placed in a protective eyeglass cavity and pre-determined over the patient's eye. When in position, the membrane can be positioned to fully contact the eyelid and cover the eyelid. The membrane acts to define a closed cavity in which the fluid jet is directed and impinges. The force of the fluid jet is then transmitted to the meibomian gland through the intervening membrane and the eyelid in order to soften and squeeze the occlusion.

  In operation, the patient or health care provider spreads the headband 210 around the head to hold the protective glasses in place, positions the device, i.e. the protective glasses 200, over the patient's eyes, and heats When the jet of media is delivered, the jet is applied to the outer surface of the eyelid in proximity to the meibomian gland to be treated. As mentioned above, the eyeglasses should be positioned securely and well so that they do not move when the device is in operation. Alternatively, the device may be held in place by hand against the head. When the pump 100 is activated, the heated fluid begins to move through the piping 114, 116. During the initial startup of the device, the fluid is circulated by the pump 100 and heated to the required temperature. When the preferred operating temperature is reached, motor 340 is activated and gear 315 begins to rotate, which further rotates manifold 305. As the manifold 305 rotates, the jets sequentially align with the slits and the fluid jet is directed onto the outer surface of the eyelid proximate the closed meibomian gland. In addition, fluid jets and slits provide movements like “milking” or upward “massage” to soften the obstruction, move the obstruction towards the upper gland opening, and allow it to exit the gland. It is constructed such that the fluid jet is directed from the lower part of the meibomian gland to the upper opening edge. Furthermore, the fluid jet may be of a pulsating nature in which the fluid jet occurs intermittently. This intermittency may be implemented in a jet that acts on a single gland upward from the bottom towards the opening or may pulsate across multiple glands. Other pulsating configurations are also possible. As the manifold 305 rotates, the eyelids are continuously scanned left and right with a hot water jet, and at each moment only one jet is actuated on each eye, maximizing effective massage pressure and causing discomfort. Minimized. After the fluid acts on the eyelid, it is collected in the drain 275 and drained from the system loop. In another embodiment of the present invention, a hot water jet is applied to the surface of the eyelid as a “raster” pattern, where the meibomian glands are actually scanned from side to side as lines from top to bottom to soften the occlusive material Is squeezed along the meibomian gland from the opposite end of the meibomian gland opening toward the gland opening. Therefore, scanning this eyelid with this raster pattern or directing the jet to just one or a small area of the eyelid creates a pulsatile force, which reduces the level of pain perceived by the patient, Increases the pain threshold. A jet pulse frequency of less than 300 Hz is considered effective. Depending on the composition of the occlusion, it may be necessary to repeatedly apply heated fluid to the affected gland. The jet of heating medium needs to be maintained for a time sufficient to loosen, subdivide, break, soften or liquefy at least part of the closure so that at least part of the closure is removed. .

  The present invention may also use chemicals to clean the glandular border and remove or detach cells from the meibomian gland opening. For example, removal of epithelial cells from the glandular opening may be facilitated using Ophthine® or similar drugs. The inner tube delivers chemicals and uses a suction applied by the sheath to probe similar to that shown in Figure 5 except that the spent chemical and cellular material mixture is expelled from the glandular border May be used. Similarly, the aforementioned heating mechanism and vibration mechanism can also be used.

  Another embodiment of the invention involves the use of chemicals or drugs to open or dilate the gland or gland opening, where the occlusion is naturally squeezed and normal gland secretion is restored. Alternatively, chemicals or pharmaceuticals can also be used to soften or subdivide occlusions, and such occlusions may be squeezed out using a device as described above or a combination thereof. . Chemicals or drugs may also be used after treatment with the device. After the gland has opened, chemicals or drugs may be used to improve normal production or secretion and keep the gland unblocked.

  The obstruction may also be relaxed or peeled off from the gland wall using meibomian gland ducts and opening dilation. Expansion can be achieved by chemical, pharmacological, or mechanical means.

  Also, the meibomian gland stimulation may be used in conjunction with the other methods described above to loosen or break the occlusion.

  As described above, the present invention is described in detail herein in conjunction with the figures associated with the meibomian glands of the eye. The principles of the present invention can be applied with equal efficacy to other glands of the human body and potentially to valuable domesticated livestock to treat various diseases. Readers will understand.

Claims (16)

A device for treating meibomian gland dysfunction in mammals, wherein at least part of the flow of secretions that naturally occurs from the meibomian duct opening is blocked by closure,
A device capable of delivering a jet of heating medium, the deliverable device comprising:
When applied to the outer surface of a closed eyelid, it delivers a jet of heating medium in the vicinity of the meibomian duct opening,
A jet of heated medium, to the outer surface of the closed eyelids close to the meibomian glands, against over pressure, and such that at least a portion of the closure is removed, loosen at least part of the closure, segmented Said therapeutic device configured to maintain a jet of heating medium applied to a closed eyelid for a time sufficient to rupture, soften or liquefy.   The therapeutic device of claim 1, wherein the deliverable device is configured to pulsate a jet.   The therapeutic device of claim 2, wherein the deliverable device is configured to impinge the jet at either a frequency of 1 Hz to 300 Hz or a frequency of 5 Hz to 60 Hz.   The treatment apparatus according to claim 1, wherein the deliverable device is configured to apply a jet at a temperature of at least 42 degrees Celsius.   The therapeutic device of claim 1, wherein the deliverable device is further configured to be manually positioned.   The treatment device of claim 1, wherein the deliverable device is further configured to be repositioned when the jet is hitting a jet.   The treatment device of claim 1, wherein the deliverable device is further configured so that it does not have to be repositioned when the jet is hitting the jet. The treatment device according to claim 1, wherein the deliverable device is adapted to apply a jet to an outer surface of a closed eyelid through an intervening membrane. The treatment device according to claim 1, wherein the deliverable device is adapted to directly apply a jet to the outer surface of a closed eyelid. The deliverable device is further closed for a time sufficient to loosen, fragment, break, soften or liquefy at least a portion of the closure such that at least a portion of the closure is removed . The treatment device according to claim 1, which is adapted to maintain intermittently applying a jet of heating medium to the eyelid .   The treatment device of claim 1, wherein the deliverable device is adapted to be positioned by attaching the device to a mammal.   The therapeutic device of claim 1, wherein the deliverable device is further configured to heat the heating medium in a manner selected from the group consisting of conduction, convection and radiation.   The deliverable device is further configured to apply a jet to the meibomian gland in a manner that moves the jet to squeeze the meibomian gland duct from the opposite end of the meibomian gland opening toward the meibomian gland opening. The treatment device according to claim 1.   The treating device according to claim 1, wherein the jet is selected from the group consisting of a fluid, a gas, and a flowable cream. The deliverable device is further configured to position a protective film covering the eye and apply a jet of the heating medium to the protective film such that jet pressure is transmitted through the protective film and absorbed by a closed eyelid. The treatment device of claim 1. The deliverable device is configured to apply a jet of heating medium to the outer surface of a closed eyelid adjacent to the meibomian glands at a pressure of about 2 psi (13.8 kPa) to about 30 psi (207 kPa). The treatment device according to claim 1.

Images