JP2010504769A - Melting of meibomian gland obstruction - Google Patents

Abstract

  According to some embodiments, the apparatus employs a heating unit (38) that includes a heating element (42) that generates heat that is transferred to the patient's eyelid when an electrical signal is applied, at least in the patient's eyelid. Gives one side regulated heat. A temperature regulator applies an electrical signal to the heating element (42) to achieve heating of the heating element (42) to a specified temperature range. This summary should not be considered limiting, and other embodiments may deviate from the features described in this summary.

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, filed May 15, 2006, by Korb et al., “Method and Apparatus”. and a continuation-in-part of US patent application Ser. No. 11 / 434,054 entitled “For Treating Meibomian Grand Dysfunction”, both of which are incorporated herein by reference.

  This application is also filed on May 15, 2006 by Grenon et al., US patent application Ser. No. 11 / 434,033, entitled “Method and Apparatus for Reading Grand Function Employing Heated Medium,” and May 2006. Also related to Korb et al., US Patent Application No. 11/434446, entitled “Method and Apparatus for Training Grand Dysfunction”, filed on the 15th, each of which is incorporated herein by reference in its entirety. Is.

(Copyright notice)
Part of the disclosure of this patent specification includes material that is subject to copyright protection. The copyright owner does not object to the reproduction of this patent specification or patent disclosure when it appears as a US Patent and Trademark Office patent file or record, but otherwise does not accept any copyright. It is to hold.

  The present invention relates generally to the treatment of mammalian eyes. More particularly, the present invention has been adjusted to the eyelid for treatment, including, but not limited to, mitigating or facilitating meibomian gland obstruction by the use of heat to dissolve certain obstructions It relates to applying heat.

  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, as shown in the above-mentioned patent application, 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 even severe obstructive meibomian gland dysfunction may not be found 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 without obvious eyelid inflammation include subtle changes in the meibomian gland opening, overgrowth of the epithelium of the eyelid margin covering the opening, and glandular opening of the gland due to a coagulant acting as an obstruction It can be limited to protrusions only. In severe cases of obstructive meibomian gland dysfunction without obvious eyelid inflammation, changes may be evident, such as serrated or wavy eyelid margins, retraction of the opening, and epithelium covering the opening. Obvious overgrowth as well as protrusion of the opening is included.

  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 Illnesses, especially diabetes.

  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 secretions can be obtained (Korb et al., “Increase in Tear Film Lipid Layer Thickness Flowing Treatment of Meibomian Gland Dysfunction”, LacrimD 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 all layers of the tear film are important, but the lipid layer secreted from the meibomian gland is particularly important. This is because the lipid layer underlies slow evaporation and lubricates the eyelids when blinking, which prevents dry eyes.

  Thus, in summary, the meibomian glands of the eyelids of mammals (such as humans) secrete oil that prevents tear film evaporation and lubricates the eyes and eyelids. These glands can be blocked or clogged by various mechanisms, resulting in 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 types of obstacles that prevent normal lipid secretions from flowing through the meibomian gland or at the surface of the meibomian gland to form the lipid layer of the tear film.

  Such secretions serve to prevent evaporation of the tear film and lubricate the eyes and eyelids, and without this secretion can cause dry eye syndrome. Meibomian gland occlusion or closure may occur in the main duct of a gland that is narrowed or blocked, or in some cases, including a passage from the acini to the main duct. It exists in the place of.

  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 may also occlude in some cases, leading to reduced or blocked flow from the acini. These occlusions or closures can have various components.

  In response to these circumstances, various therapeutic modalities 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.

  Drug modalities have also been presented, such as the use of tetracycline to treat meibomian gland dysfunction, and one such treatment is US Patent Publication No. 2003/2003 entitled “Method for Treating Meibomian Disease”. No. 011426, Pflugfelder et al., US Pat. No. 6,455,583, entitled “Method for Treating Meibomian Green Disease”, and “Use of Tetracyclines for Reading 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. Corticosteroids for the treatment of meibomian gland dysfunction have also been proposed, such as Pflagfelder et al., “Non-preserved Topical Corticosteroid for Treatment of Dry Eye, filamentary deratis, and Der. 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 locally used androgens or androgen analogs to treat signs and symptoms of acute dry eye in psoriatic keratoconjunctivitis has also been made, which is described in US Pat. No. 5,958,912 and US Pat. No. 6107289, both of which are patented by Sullivan under the name “Ocular Therapeutics 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 allow the gland to begin producing and draining free lipids and other fluids. However, at present, no suitable method has been commercialized to locally heat the eyelid and control the amount of heat applied.

  One modality of heat treatment for meibomian gland dysfunction is disclosed in PCT Application No. PCT / GB2003 / 004782, entitled “Eyleid 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-Informed Obstructive Meibomian Gland 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.

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”

  An object of some embodiments consistent with the present invention is to provide a method and / or apparatus for controlled selective heating of a mammalian eyelid.

  Another object of some embodiments consistent with the present invention is to facilitate removal of certain types of occlusions in or around the meibomian glands, upper and / or lower eyelids for one or both eyes To provide a method and / or apparatus suitable for heating the meibomian glands.

  In one embodiment consistent with the present invention, an apparatus for supplying regulated heat for the treatment of a mammalian eyelid comprises a heating unit comprising a heating element that generates heat when an electrical signal is applied. A temperature regulator applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element. A lid contact mechanism couples a heating unit to the eyelid to achieve controlled heating of the eyelid within a specified temperature range.

  An apparatus for providing adjusted heat to at least one of a patient's eyelids in accordance with another embodiment includes heating with a first surface and a second surface that generate heat when an electrical signal is applied. A heat sink coupled to the first surface of the heating element to conduct heat from the heating element to the eyelid, and a second surface of the heating element to reduce heat loss from the second surface And a heating unit comprising a heat insulating material and a back plate coupled to the heat insulating material. A temperature regulator applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element. Protective eyeglasses suitable for attaching to the patient's head and covering the patient's eyelid with a threaded lens piece are provided. The heating unit at the back plate passes through the threaded lens piece so that the heating unit can be moved into contact with the eyelid by screwing the shaft into the hole until contact with the eyelid is achieved. Is bound to.

  In another embodiment, an apparatus for providing regulated heat to at least one of a patient's eyelids comprises a heating element that generates heat that is transferred to the patient's eyelid when an electrical signal is applied. A temperature regulator applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element. In some preferred embodiments, the heating element is a resistance heating element.

  In these embodiments, many variations are possible including, but not limited to, providing a sensor that senses temperature and provides temperature information to the temperature regulator. In certain embodiments, the eyelid contact mechanism comprises protective eyewear that is adjustably coupled to the heating unit to move the heating unit to achieve contact with the eyelid. The protective glasses may be adjustably coupled to the heating unit by a screw connection so that the position of the heating unit can be adjusted by a screwing operation. In some embodiments, the heating unit comprises a thermal heat sink coupled to the surface of the heating element to conduct heat from the heating element to the eyelid. The thermal heat sink can be, for example, at least one of a thermally conductive rubber member, a thermally conductive silicon member, an encapsulated fluid containing member, and a solid conductive member. In order to improve the heat transfer from the heat sink to the eyelid, a heat conducting gel, cream or liquid can be placed between the heat sink and the eyelid.

  In some embodiments, the heating unit comprises a thermal insulator coupled to the surface of the heating element to reduce heat loss from the heating unit in directions other than toward the eyelid. The thermal insulation may in some embodiments be one of a non-thermally conductive foam element, a non-thermally conductive rubber element, and a non-thermally conductive solid element. The temperature regulator applies a pulse width modulated electrical signal to the heating element to regulate the heat generated by the heating element, and the pulse width modulated electrical signal is generated under the control of the control processor.

  In some embodiments, the temperature regulator may incorporate a switch that selectively applies an electrical signal to the heating element to regulate the heat generated by the heating element. The electrical signal can be at least one of a current or a voltage that is selectively applied to the heating element under the control of the control processor. The heating unit may have a flexible part that contacts the eyelid to fit the eyelid, or a hard part that contacts the eyelid shaped to fit the shape of the eyelid, a combination of both. May be good. The heating unit may have an adhesive for attaching the heating unit directly to the eyelid, and may be attached to the eyelid using an adhesive tape.

  In some embodiments, the user interface allows the user to set a treatment time and / or temperature. In some embodiments, a mechanical energy generator generates eyelid vibration, pulsation, and / or squeezing motion to stimulate secretion from the meibomian gland, and the vibration generator causes the eyelid to be of amplitude and frequency. Give mechanical energy with both.

  In some embodiments, the specified temperature range is greater than 37 ° C, more preferably from 44 ° C to 47 ° C with a target temperature of about 45 ° C. In some embodiments, after a specified treatment time, a timer blocks the signal to the heating element. The treatment time can be, for example, from about 10 minutes to 60 minutes, preferably about 15 minutes. In some embodiments, a pressure sensor measures the pressure when the heating unit is applied to the eyelid.

  A method of treating in at least one of a patient's eyelids using heat adjusted to be consistent with some embodiments includes disposing a heating unit comprising a heating element in contact with the patient's eyelid, and the heating element It involves applying a control signal to generate heat in the heating element and transferring heat generated to the eyelid over a specified period of time.

  In some embodiments, the method further involves removing the control signal after expiration of the specified period. In some embodiments, the method further includes attaching protective eyewear to the patient with an adjustable eye interface including a heating element and adjusting the eye contact to achieve contact with the eyelid It involves doing. In some embodiments, the method further involves tapering the eyepiece to the patient's eyelid using a strip of adhesive tape. In some embodiments, the method involves attaching an eyepiece to the patient's eyelid using a medical double-sided adhesive tape or using another form of adhesive. In some embodiments, the heat is emitted from about 40 degrees Celsius to 50 degrees. In some embodiments, vibration is applied to the patient's eyelid. In some embodiments, the prescribed period is about 10 to 60 minutes. The method can be applied to the upper eyelid, the lower eyelid or both of one or both eyes. In some embodiments, the method further involves measuring the pressure at which the heating unit contacts the eyelid. When executed on a programmed processor, the tangible computer-readable storage medium may store instructions that perform any suitable portion of these methods.

  In some embodiments, a method of treating a mammalian eyelid involves heating the eyelid to maintain a defined temperature for at least 4 minutes and less than 60 minutes while simultaneously applying mechanical energy and pressure to the eyelid. In another embodiment, a method of treating at least one mammalian eyelid applies sustained controlled heat to the at least one mammalian eyelid for a period of less than 60 minutes and removes meibomian gland obstruction This involves applying force to the eyelids during heating or within 3 minutes after heating.

  The foregoing objects and summary are intended to illustrate exemplary embodiments that are well understood when read in conjunction with the following detailed description, and are intended to limit the scope or meaning of the appended claims. Rather, the claims are to be construed in view of the entire teachings of the specification and the drawings. Many other variations will occur to those skilled in the art when considering the teachings of the invention using examples of several exemplary, non-limiting embodiments.

  Several exemplary embodiments illustrating configurations and methods of operation, together with objects and advantages, will be better understood when the following detailed description is taken in conjunction with the accompanying drawings.

It is the figure which drew the upper eyelid and lower eyelid which show the meibomian glands. 3 is a cut-away view showing an example of a meibomian gland 20. FIG. FIG. 6 is a cutaway view of the meibomian gland 20 showing several clogged mechanisms. It is a graph which shows temperature with respect to time. It is a graph which shows the temperature of an inner eyelid and an outer eyelid with respect to time. FIG. 6 is a block diagram illustrating a lid heating circuit consistent with some embodiments of the present invention. FIG. 6 is a block diagram illustrating another embodiment of an eyelid heating circuit consistent with some embodiments of the present invention. FIG. 4 shows a protective eyeglass assembly for applying heat therapy to an eyelid as consistent with some embodiments of the present invention. FIG. 2 shows a first embodiment of an eyelid interface assembly having a threaded interconnection to a protective eyeglass lens piece as consistent with some embodiments of the present invention. FIG. 3 is a cutaway view illustrating a first embodiment of a pressure measurement mechanism used in an eyelid contact assembly as consistent with some embodiments of the present invention. FIG. 5 shows a second embodiment of a pressure measurement mechanism used in an eyelid contact assembly as consistent with some embodiments of the present invention. FIG. 6 shows a third embodiment of a pressure measurement mechanism used in an eyelid contact assembly as consistent with some embodiments of the present invention. FIG. 6 illustrates a second embodiment of a lid contact assembly having a threaded interconnection to a protective eyeglass lens piece as consistent with some embodiments of the present invention. FIG. 5 shows a lid heating assembly in accordance with some embodiments of the present invention. FIG. 6 illustrates another eyelid heating assembly consistent with some embodiments of the present invention. FIG. 6 illustrates another eyelid heating assembly consistent with some embodiments of the present invention. FIG. 6 is a diagram illustrating an example of one embodiment of an eyelid heating assembly incorporating a vibrator control consistent with some embodiments of the present invention. FIG. 2 is a block diagram illustrating a heating element controller consistent with some embodiments of the present invention. FIG. 6 is a block diagram illustrating another heating element controller consistent with some embodiments of the present invention. FIG. 7 is a block diagram illustrating another heating element control device incorporating transducer control as consistent with some embodiments of the present invention. FIG. 6 illustrates one embodiment of a heating element consistent with some embodiments of the present invention. FIG. 6 illustrates another embodiment of a heating element consistent with some embodiments of the present invention. 6 is a flow diagram illustrating a treatment process consistent with some embodiments of the present invention.

  While the present invention allows for many different forms of embodiments, such embodiments of the present disclosure should be considered as an example of principles and limited to only the specific embodiments illustrated and described. With the understanding that it is not intended to do so, specific embodiments are shown in the drawings and are described in detail herein. In the following description, like reference numerals are used to indicate the same, similar or corresponding parts in the several views of the drawings.

  The term “plurality” as used herein is defined as “two or more”. The term “another” as used herein is defined as “at least one second or more”. The terms “including” and / or “having”, as used herein, are defined as “comprising” (ie, non-exclusive wording). The term “coupled” as used herein is defined as “connected” but is not necessarily directly connected and is not necessarily mechanically connected. Not necessarily. The term “program” or “computer program” or similar terms, as used herein, is defined as “an instruction sequence designed to execute on a computer system”. Is done. "Program" or "computer program" includes subroutines, functions, procedures, object methods, object implementations, executable applications, applets, servlets, source code, object code, shared libraries / dynamic load libraries and / or computers Other instruction sequences designed to execute on the system may be included.

  Throughout this specification, reference to “one embodiment”, “some embodiments”, “one embodiment” or similar phrases means that a particular feature described in connection with the embodiment, It is intended that the structure or characteristic be included in at least one embodiment of the invention. Thus, the appearances of such phrases in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner without limitation in one or more embodiments.

  As used herein, the term “or” should be construed as inclusive or in any one or any combination. Thus, “A, B or C” means “A; B; C; A and B; A and C; B and C; any of A, B and C”. An exception to this definition occurs only when a combination of elements, functions, steps or actions is in some way inherently mutually exclusive.

  As mentioned above, meibomian gland dysfunction (MGD) is known to be a major cause of dry eye syndrome. The disorder is characterized by some sort of blockade within the meibomian gland that prevents normal lipid secretions from flowing out. Meibomian gland occlusion or closure may be overlying or present in the glandular opening, in the main duct of the narrowed or blocked gland, and possibly led from its acini It may be present at other locations including the passage to the tube.

  The meibomian gland acini is equipped with valves at the junction of the acinar and the main duct of the gland, and these valves may become occluded, leading to reduced or blocked flow from the acinar There is a theory that it sometimes happens. These occlusions or closures can have various compositions.

  Referring now to FIG. 1, the location of the meibomian gland 10 is shown on the upper eyelid 12 and the lower eyelid 14, respectively. As briefly mentioned above, the upper eyelid contains about 25 meibomian glands and the lower eyelid contains about 20 meibomian glands, but there is considerable variation. As shown in the cross-sectional view of one gland 10 in FIG. 2, each gland is open to the eyelid margin with a central conduit or tube 18 through which secretions flow from the acinus 19, and the secretions are there during blinking. And an opening 20 that flows out of the tear film and is added to the tear film. It can be seen that each gland varies in size depending on its position in the eyelid and the opening 20 is narrower than the central conduit 18. The opening is an opening, not a conduit or tube. The opening is normally closed. That is, the opening or opening is similar to other openings through which fluid or secretions pass and remains closed until opened for drainage. Technically, therefore, the conduit close to the opening is narrower than the main conduit.

  The occlusion composition depends on the etiology that caused the occlusion. However, occlusion is a combination of dead cells, bacteria, exfoliated cells, exfoliated cells that have aggregated as keratinous clumps, emulsion, concentrated or creamy secretions in most cases observed to date. Or any combination of these in solid, semi-solid, and concentrated form. Referring to FIG. 3, a simplified diagram of an example of an occlusion for gland 10 is shown. This example is not necessarily representative of any meibomian gland obstruction as described above, but depicts a solid or semi-solid or concentrated plug 24 that completely closes the conduit leading to the opening 20 of the gland 10. It is. Another occlusion 26 is shown at the junction with the central conduit from one of the acini. As mentioned above, this can be the site of a valve within the glandular structure, but embodiments consistent with the present invention should not be limited to the theory of actual meibomian glandular structure.

  Although several treatments have been proposed to restore these glands to normal function, most physicians recognize that heating is beneficial in treating MGD. Depending on the nature of the occlusion, heating may be beneficial to actually dissolve or loosen the occlusive material and allow the gland to freely initiate production and excretion of lipids and other fluids. However, no suitable method has yet been shown to apply local heat to the eyelid and adjust the amount of heat applied.

  One treatment method that applies heat to the eyelid is to use hot water pressure. Alternatively, a small hot mass (such as rice or flaxseed) with material in the envelope just like a bean bag can be used. In that case, these bean bags can be heated in a microwave oven and applied to the eyelid.

  These techniques are not satisfactory enough to apply localized heat to the eyelids. The hot compress is larger in size than the eyelids. Hot compresses are filthy, uncontrolled and time consuming. Furthermore, heating of the area surrounding the eyelid caused by a large size heating pad can make the procedure uncomfortable and in some cases even filthy and counterproductive.

  There is also a theory that local heating of the eyelids alone is more beneficial than heating both the eyelids and the face surrounding the eyelids. Heating the area outside the eyelid dilates more blood vessels in the face and theoretically increases blood flow to the eyelid and surrounding areas. Unfortunately, this increased blood flow tends to lower the temperature of the eyelids by thermal convection through the blood flow. This is because the body naturally tries to adjust the temperature of the eyelids. It is desirable to keep the eyelid at a constant treatment temperature above normal body temperature, so of course, heating a large area will dilate more blood vessels and allow more blood to flow, thus raising the temperature However, since more heat is required, this is possibly counterproductive.

  Due to the nature of hot compresses and bean bags, proper temperature control is not possible. Therefore, the temperature of these packs varies from patient to patient and from application to application. This is potentially dangerous or uncomfortable for the patient if the temperature is too hot and may be ineffective if the temperature is too low. To make matters worse, the poultice begins to cool as soon as it is placed on the eyelid, staying in the therapeutic temperature range only for a very short period of time before becoming ineffective, and perhaps even serves to absorb heat from the eyelid.

  One way to avoid the problem is to use a small conformal hot mass that is placed inside a “bean bag” and heated in a microwave oven. An example is the use of rice in a cloth bag for this purpose. Although this is cleaner than a hot compress, it is still less effective because heat transfer in dry heat is much lower than heat transfer in wet heat. This is due to the fact that the air trapped between the heater and the surface to be heated acts as a thermal insulator compared to the fluid boundary that provided very good heat transfer. In addition, these devices rely on the hot mass of the device for heat transfer, so the smaller the device, the less heat is drawn from the device. Thus, by definition, any device that is heated prior to application has a considerably larger size to accommodate the hot mass required to raise the eyelid temperature before the device cools substantially. There is a need.

  According to some embodiments, the surface applied to the eyelid preferably has the property of maintaining a film of moisture between the heating device and the eyelid. Accordingly, the heat sink preferably maintains moisture at the eyelid contact portion to further facilitate heat transfer to the eyelid.

  FIG. 4 illustrates this problem as a graph of temperature versus time. The therapeutic temperature range has been determined to be above 37 ° C. The range from about 44 ° C to 47 ° C is most preferred. This is because temperatures generally approach 50 ° C., making them unbearable for humans and can cause unnecessary pain or minor burns. The proposed target treatment temperature is 45 ° C. as shown by curve 25 (which shows the proper balance between comfort and efficacy). Curve 25 shows a relatively constant treatment temperature of 45 ° over a specified treatment time (eg, in an embodiment consistent with the present invention, 10 to 20 minutes is preferred, with most showing mild to moderate MGD). The patient currently considers 15 minutes as an appropriate designated time). For more severe MGD, about 30 to 45 minutes has been found to be more effective. For very severe MGD, about 30 to 60 minutes is more effective. These times are at a temperature of about 45 degrees Celsius, and may increase or decrease at other temperatures. In the test, generally a range of 10 minutes to 60 minutes is effective.

  When a hot compress or bean bag device is used, the result looks like curve 28 and curve 30, starting from a temperature level that is even higher than the treatment temperature range and may be uncomfortable, which may even cause injury. The temperature begins to drop immediately and falls quickly below the therapeutic temperature range. If the compress is considered too cold, a new compress or bean bag is used, resulting in a short gap when the heat source is changed, followed by the temperature curve 30. Again, this curve starts from the top of the treatment temperature range and eventually falls below the treatment temperature range. A test measurement of eyelid temperature rise time while heated using the sustained regulated heat source shown in FIG. 5 shows that the hot compress or bean bag device remains warm within the therapeutic temperature range for at least about 4 minutes. It shows that there must be. When a hot compress or bean bag device is removed from the eyelid for reheating, the eyelid temperature drops very rapidly, usually within 90 seconds (perhaps within about 30 seconds), thus warming the eyelid. It is necessary to reheat from the beginning with a compress. Clearly this method is extremely inefficient and there is little prospect of raising and maintaining eyelid temperature to the higher therapeutic level required.

  Although several therapies have been proposed to restore these glands to normal function, most physicians recognize that heating is beneficial when treating MGD. Depending on the nature of the occlusion, heating may actually dissolve or loosen the occluding material or the material that binds the solid particles that form the occlusion, allowing the gland to freely initiate the production and excretion of lipids and other fluids. It will be beneficial. Although it has been found that there are many deficiencies in the heat treatment methods described in the background section of this specification, the heat methods described in the above referenced copending applications are effective and beneficial. I know. In general, these devices provide controlled heating of the eyelid (measured on the outer surface of the eyelid) from about 40 to 50 degrees Celsius, more preferably about 44 to 47 degrees Celsius with a target temperature of 45 degrees Celsius. Up to the treatment temperature.

  It has been observed that the outer surface of the human eyelid is about 1 to 2 degrees Celsius cooler than body temperature, although there is some variation. Increasing the temperature to at least 37 degrees can begin to provide therapeutic effects to mild cases of MGD. One convenient range for treatment is from 44 degrees Celsius to 47 degrees Celsius, and a target temperature of 45 degrees Celsius has proven effective and comfortable for the patient. In some embodiments, a mechanical procedure is performed, preferably with a heated instrument, during the period or immediately after the end of the period to further maintain the occluded flow state. Higher temperatures (such as 50 to 55 degrees Celsius) can be used (or applied intermittently over a shorter period of time), especially if the eyelid is under anesthesia, in which case the patient is permanently A much higher temperature treatment over a shorter period of time can be used without damage. In general, higher temperatures can be used for shorter periods of time. Furthermore, the temperature and time used should be individualized depending on the severity of the condition and patient tolerance. Patients with white skin are generally considered less tolerant of heat than patients with dark skin, and patients with dark skin tend to be less prone to inflammation as a result of exposure to heat I know that. Treatment time and / or temperature can be adjusted to accommodate these differences. Each of the above temperatures refers to the temperature measured on the outer surface of the eyelid.

  Also, in some embodiments, the patient feels more comfortable when the treatment starts at a lower temperature and the temperature is raised over time. The temperature should therefore be adjusted, in which case the amount of sustained heating is increased and / or reduced in an automated, controlled and repeatable manner and delivered to the eyelid. It should be interpreted as meaning to obtain. Additional heating can therefore be applied at will. The heating temperature profile can be a constant temperature, may have an increase, decrease, maximum value, minimum value, can be added intermittently, and can be adjusted using various characteristics, etc. Although possible, such a profile should be adjusted to be repeatable. It has also been found that adjusting the temperature can produce an average temperature that is higher than a certain temperature, which is useful in some applications.

  This temperature can be maintained at a treatment temperature for a treatment period of about 10 to 60 minutes (or some patients have been found to be safe and beneficial even beyond this time). The fact (by dissolution of the substance that binds the solids to each other) during or after such treatment with controlled heat, by mechanically squeezing lipids and other fluids from the meibomian glands It has been found that occlusions that dissolve or remain in suspension are removed. The above application separates the movement of fluid from glands containing dissolved or suspended substances that exert a wide squeezing action on the eyelids to exude fluids or suspensions or cause occlusion or closure. An apparatus for mechanical stimulation in the manner described above is disclosed. In some cases, continuous moderate pressure on the eyelids can help exudate fluids and suspensions, and vibration can be used simultaneously with heating or immediately after heating. As used herein, the term “melted” should be interpreted to include the state in which solid particles remain suspended in a liquid fluid.

  Referring now to FIG. 5, the graph shows the inner surface of the eyelid and the outer surface of the eyelid when a constant heat source of about 45 degrees Celsius is applied to the subject patient. The heater is turned on at time 0:00 and turned off at time 8:00 (after 8 minutes). It should be noted that the circulatory system attempts to regulate the temperature of the eyelid and blood flow increases with heating. In this patient, it took about 4 minutes for the outer surface of the eyelid to reach about 45 degrees Celsius, and the inner surface of the eyelid did not reach this temperature at all, probably due to the body's thermal regulation mechanism. Thus, if a 45 degree constant heat source is used, it takes at least about 4 minutes for the eyelid to reach the treatment temperature.

  The graph also shows that when the heat source is removed from the eyelid, the temperature drops rapidly to body temperature. In almost any case, the temperature falls within 2 to 3 minutes, and more commonly it takes about 30 to 90 seconds for the patient's eyelid temperature to drop. In this example, the temperature dropped rapidly over the first 30 seconds after heat removal. During this short period, some or all of the dissolved occlusion can reconsolidate. Therefore, if the hand squeezing method is performed following heating, hand squeezing should be performed immediately or within about 90 seconds, with a shorter interval being preferred, such as within 30 seconds. Thus, from this graph, it will be clear that the conventional technique using a hot compress is substantially less effective if hand squeezing is not performed in a very short time thereafter. In addition, if the heating pad does not maintain heat within its treatment range for at least 4 minutes or cools below therapeutic levels prior to hand squeezing, the heating pad is a minimal source for patients suffering from severe obstruction. It can only bring benefits.

  FIG. 6 is a block diagram showing the treatment of the meibomian glands of the eyelid, particularly the lower eyelid. This treatment (and other treatments and devices described herein) may be utilized or configured for the upper or lower eyelid, or both upper and lower eyelids of the left or right eye or both eyes It can be seen that it can be done. In this embodiment, the power supply 34 provides power to the thermal conditioning circuit 38, and the thermal conditioning circuit 38 can be of any design suitable for achieving thermal regulation. This thermal conditioning circuit 38 is used to generate a regulated temperature within the therapeutic range, eg 45 ° C., heating element 42 (heat generated when current flows through a resistor, ie, flexible generating heat by resistance heating. An electric signal (AC signal, DC signal, pulse signal, program signal or modulation signal) such as a current is applied to a foil heating element or the like. This heating element 42 is used to generate heat that is ultimately transferred to the eyelid for thermal therapy. In the present embodiment, a heat sink 46 is disposed between the heating element 42 and the eyelid 50 of the eyeball 54. The heat sink 46 may be, for example, a flexible silicon member that bends (along with a heating element in some embodiments) to match the shape of the eyelid being treated. In one embodiment, a relatively thermally conductive flexible silicone rubber pad (such as one or two layers 1/16 inch thick) may be used. Alternatively, the heat sink 46 may be a rigid or relatively rigid heat conducting member that is pre-shaped to fit closely to the outer surface of the eyelid 50. In this embodiment, one representative size or multiple sizes are provided to match the outer shape of the eyeball and thereby treat the upper and lower eyelids simultaneously, but one eyelid or piece of one eye It can also be easily configured to explore both eyes or treat one or both eyelids of both eyes.

  The heating element 42 is sandwiched between the heat sink 46 and the heat insulating material 58. The insulation 58 serves to minimize heat loss from the back of the heating element (the side farthest from the eyelid being treated), thereby transferring heat from the heating element 42 through the heat sink to the eyelid 50. help. In some embodiments, as will become apparent later, the backplate 62 is optionally insulated to help attach the assembly to the eyelid or otherwise contact the eyelid 50 and connect to the eyelid. It is applied to the outer surface of the material 58. In some embodiments, the heat sink is stimulated with a slight force as indicated by arrow 66 to more efficiently transfer heat energy to the eyelid while applying force to the meibomian gland to release fluid. Contact with eyelid 50.

  One reason for using heat to treat the meibomian glands is that by heating the meibomian glands, it has been observed that the substance causing the occlusion and closure is almost dissolved and fluidized. . Thus, heat is beneficial and with a slight pressure, the dissolved material that was causing the occlusion is stimulated and released from one or more meibomian glands. As used herein, the term “melted” should be taken to include the state in which solid particles remain suspended in the liquid fluid.

  According to some embodiments, the heating element 42 is implemented as a flexible foil resistance heating element. Such an element comprises a flexible circuit having a resistive path through which a current is passed to generate resistive heating. Often in such heating elements, the temperature can be monitored by measuring the resistance of the element which changes somewhat as the element heats. Resistance can be measured in a number of ways, including indirectly by measuring the flow of current to the heating element and / or the voltage applied across the heating element. Thus, in the heating element used in this particular embodiment, the main or only form of heat generation is by direct contact between the heating unit and the heat provided by resistance heating, which is potentially harmful. Production of minimal infrared energy is minimal or nonexistent. Other types of resistive heating elements may also be used without departing from embodiments consistent with the present invention.

  The circuit shown in FIG. 6 is essentially basic, and many variations consistent with embodiments of the present invention can be utilized. In one embodiment, a temperature-fixed device is utilized that is factory calibrated such that the thermal conditioning circuit 38 generates the desired constant treatment temperature at the heating element 42, as shown in FIG. This constant treatment temperature may be configured at the factory by measuring the temperature and resistance of the heating element 42 or heat sink 46 such that a safe treatment level of heating is obtained. A selection of heating settings can be provided for use by the clinician or patient. The thermal conditioning circuit also incorporates a timer in which heat is applied for a specified period after the start of the heating cycle and heating is discontinued after a specified treatment period. In addition, the thermal conditioning circuit also triggers an alarm that notifies the user of the end of the treatment period when the specified treatment time has expired. In general, a treatment time of about 15 minutes has been found to be sufficient, but significant variations and optimizations are possible without departing from the invention. In general, depending on the severity of the condition and the temperature, a time in the range of about 10 to 60 minutes is appropriate, but this should not be considered limiting.

  In addition, the heating element can be implemented without limitation as an assembly or arrangement of heating elements. These and other variables will occur to those skilled in the art when considering the teachings of the present invention.

  In this specification, the thermal insulation has adequate thermal insulation to try to act as a barrier to the release of heat from behind the heating element, while the heat sink absorbs heat from the heating element toward the eyelid. It is necessary to have appropriate conductivity so as to try. In an embodiment consistent with the present invention, contact with the human eyelid is required, and it is often desirable that the heat sink or other element placed in contact with the eyelid is soft and comfortable. This may limit the actual unconditional thermal conductivity of the material. However, as long as there is a reasonable tendency for heat to flow through the material, it is considered a heat sink. Similarly, insulation is less likely to resemble an ideal insulation due to similar limitations and sizes, but with sufficient heat loss than an exposed heating element, and is well-oriented to the eye. If it retains the heat that is generated, it is sufficient to be considered a thermal insulator. Therefore, the relative heat conductivity of the heat sink should be greater than the heat conductivity of the insulation, and should preferably be much larger (such as 10 times). That is, the insulation should preferably have a lower thermal conductivity than the heat sink.

  In the prototype, the thermal conductivity of the insulation is lower than that of 92% rubber with a thermal conductivity of about 0.10 W / mK (watts per meter per Kelvin) and the heat conductivity of the heat sink is about Although 1.3 W / mK, these conductivity values should not be considered limiting. In some embodiments, the backplate works sufficiently to provide the insulation function.

  Those skilled in the art will understand that the terms “heat sink” and “insulation” are relative terms that describe the tendency of a material to absorb and transfer heat or to block the flow of heat. Will understand. As used herein, the term “heat sink” indicates that the material in question is a relatively good thermal conductor (compared to thermal insulation). For materials such as thermally conductive silicon rubber, the thermal conductivity is generally better than what is considered a thermal insulator, even if not as much as a metal such as steel or aluminum. However, commercially available materials designed to improve thermal conductivity are available and are made of flexible materials such as silicone rubber. Similarly, most “insulations” essentially transfer a certain amount of heat. This does not exclude that the material is considered a thermal insulator herein. Thermal insulation materials such as thermal insulation foam rubber and plastic are commercially available.

  One example of a thermal insulation material suitable for use in embodiments of the present invention is neoprene rubber about 1/8 to 1/4 inch thick, but these dimensions should not be considered limiting. Thermally conductive silicone rubber materials are available, for example, from Stockwell Elastomerics, Inc., located at 4749 Tarbat Street, Philadelphia, Pennsylvania, USA. Available from several manufacturers, including the product T100.

  Referring now to FIG. 7, an alternative embodiment similar to that of FIG. 6 is shown except that it includes a separate temperature sensor 70 adjacent to the heating element 42. Although this temperature sensor is shown as structurally occupying a separate layer for convenience, this is for illustrative purposes only. The temperature sensor 70 can be placed between the insulation 58 and the heat sink 46 without limitation to read the temperature emitted by the heating element 42 and / or sent to the outer surface of the eyelid. It can be placed in between, between the heating element 42 and the insulation 58, embedded in the heating element 42, embedded in a heat sink, or placed on the surface of the eyelid. If the heatsink and insulation function properly, using any of these points, measure the temperature ultimately delivered to the outer surface of the eyelid with a reasonable degree of accuracy (after the settling period) (Or can be calibrated to represent the final eyelid surface temperature). However, the best place to measure this temperature is on the surface of the eyelid.

  The temperature sensor 70 is implemented as a sensor array in some embodiments. The temperature sensor 70 sends an electrical signal back to the conditioning circuit 38 so that the thermal conditioning circuit 38 can monitor the actual temperature emitted by the heating element 42. Feedback control techniques can then be utilized to ensure that the heating element 42 maintains proper heating within the therapeutic range. The temperature sensor 70 can be any number, including but not limited to thermocouples (such as the miniature thermocouple available from Physitemp Instruments Inc., 07013 Clifton, NJ, Huron Avenue, 154) and conventional small thermistors. Can be implemented in any way.

  Referring now to FIG. 8, there is shown one embodiment of a treatment device consistent with the present invention in which a separate housing is used to house the power source 34 and the thermal conditioning circuit 38. This housing can be attached to the heating unit 80 by wiring 78. Alternatively, the power supply 34 and the thermal conditioning circuit can be incorporated within a protective eyeglass assembly or helmet-like assembly. The heating unit 80 incorporates some or all of the elements shown in FIGS. 6 and / or 7 (and variations described below) along with the outer surface of the heat sink 46 that provides contact to the eyelids. The heating unit 80 should incorporate a heat sink 46, a heating element 42, and in some cases a temperature sensor 70, and a thermal insulator 58 and back plate 62. In the prototype, a 1 or 2 layer thick 1/16 inch silicon rubber heat sink was used with satisfactory results. The back plate 62 of the present embodiment fixes the ball 84 to a mooring socket in the back plate, rotates the heating unit 80 with respect to a holder (such as protective glasses described later), and adjusts it to the eyelid to be treated. Used for proper contact. The ball further allows the user, clinician, nurse, doctor or technician to screw the shaft and adjust contact with the eyelid, thereby adjusting the initial pressure applied from the heating unit to the eyelid, It is connected to a threaded shaft 88 with a wing nut, wing screw, or other operational convenient end 92. In this embodiment, the shaft is screwed through a lens piece 94 that forms part of protective eyewear 98 that the user places on the patient's head using a strap 102 that can be adjusted in any conventional manner. It is.

  In some embodiments, the heatsink or the entire heating unit 80 or part of the heating unit 80 so that the regulator and other parts are reused by multiple patients and the remaining part remains clean. It is made disposable.

  Although protective glasses are used herein as an exemplary embodiment of a holder or connection mechanism that holds the heating unit 80 in place, other mechanisms are possible. Thus, a description using the term “protective glasses” may be attached to the patient's head in any manner to hold a heating unit, such as 80, that contacts the patient's eyelid during the treatment described herein. Any type of protective eyeglasses, frame, headgear, protective eyeglass-like headgear, helmet, strap or other device that can be used for. The protective eyeglass lens piece discussed is defined as an element of protective eyeglasses or other device that is generally located where the lens is normally located in front of the eye and does not necessarily imply that an actual optical lens is present. Absent.

  In this embodiment, protective eyeglasses similar to those used for swimming are equipped with a heating unit 80 and configured to hold the heating unit 80 close to the eyelid being treated for a specified treatment time. Can do. The protective glasses 98 shown in FIG. 8 are more or less normal protective glasses such as those used to cover the eyes when swimming, but with adhesives, tapes, straps, helmets, clamps, or any other suitable means Any other mechanism suitable for holding the heating unit 80 in place in one or both of the eyelids to be treated can be utilized. Each such mechanism may be considered a suitable connection mechanism for this specification.

  Accordingly, an apparatus for supplying regulated heat to at least one of a patient's eyelids in a manner consistent with another embodiment includes a first surface and a second surface that generate heat when an electrical signal is applied. A heating element comprising: a heat sink coupled to the first surface of the heating element for transferring heat from the heating element to the eyelid; and a second surface of the heating element for reducing heat loss from the second surface And a heating unit including a heat insulating material coupled to the heat insulating material and a back plate coupled to the heat insulating material. A temperature regulator applies an electrical signal to the heating element to achieve heating of the heating element to a specified temperature range. Protective eyeglasses suitable for being attached to a patient's head and covering the patient's eyelid with a lens piece comprise a lens piece with a threaded hole. The heating unit at the back plate passes through the threaded lens piece so that the heating unit can be moved into contact with the eyelid by screwing the shaft into the hole until contact with the eyelid is achieved. Is bound to.

  In some embodiments, an apparatus for providing regulated heat to at least one of a patient's eyelids comprises a heating unit comprising a heating element that generates heat that is transferred to the patient's eyelids when an electrical signal is applied. A temperature regulator applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element.

  Referring now to FIG. 9, a more detailed view of the connection of the heating unit 80 to the lens piece 94 is shown. In this figure, each layer of the heating unit 80 is shown in an exaggerated form for clarity. There is a heat sink 46 in contact with the heating element 42 on the outermost surface, and the heating element 42 can be, for example, a flexible resistance foil heater manufactured and sold by Minco Corporation. Foil heaters are readily available commercially, and some have a size and thermal characteristics suitable for use with the heating unit 80 of the present invention. The next layer is a thermal insulation layer 58 that serves to prevent heat from dissipating from behind the heating unit 80 so that heat is maintained where needed in contact with the eyelid. Finally, a back plate 62 is secured to the back of the insulation 58 for interconnection with the structure that holds the heating unit 80 in proper contact with the eyelid. In some embodiments, the backplate described below is made of a material that has suitable thermal insulation properties that are considered to be both the backplate and the insulation itself.

  This back plate 62 embodiment includes a socket 110 that receives a ball 84 that freely rotates a threaded shaft 88 to pivot the heating unit 80 into proper contact with the eyelid to be treated. The threaded shaft 88 passes through the lens piece 94 and in this example is fitted with a knurled knob 114 by which the user, patient, doctor, clinician, nurse, or technician can The amount of pressure applied to the eyelid can be adjusted to ensure proper contact, patient comfort, and heating for proper treatment, preferably with little pressure anyway.

  Devices or mechanisms that sense micro forces can be added to consistently set the pressure. A simple such device is shown in the partially cutaway view of FIG. In this exemplary embodiment, a spring or material 104 having spring properties is inserted between a ball 84 used in a ball joint and a threaded shaft 88. The ball 84 fits into the eyepiece socket 110 of FIG. 9, but the ball 84 is now attached to the hollow tube 106 rather than directly to the threaded shaft 88. The hollow tube 106 includes a spring 104 inserted into the tube 106, with a threaded shaft 88 pushing the spring 104, which further pushes the ball joint, pushing the eyepiece against the eyelid. The force is indicated by the amount of displacement between the hollow tube 106 and the threaded shaft 88. The hollow tube 106 may include markings that appear as the pressure decreases and disappear as the pressure increases. In the embodiment shown in FIG. 10, the hollow tube 106 is shown in the hollow end of the shaft 88, but the shaft 88 can be disposed in the hollow tube 106 as well. In such embodiments, the end of the threaded shaft 88 is not threaded to place an indicia that provides a pressure indication. Also, other pressure indicators can be devised without departing from embodiments consistent with the present invention. Tabs can be used to take the tube into the shaft and vice versa as shown.

  The force can also be measured without using a spring, simply by installing the force gauge in an appropriate position, for example, on the threaded shaft 88 between the eyeglasses and the eyepiece, or within the eyepiece 80 itself. You can also This is illustrated in the exemplary embodiment shown as FIG. The force gauge 116 is disposed along a path to which a force is directed, such as a portion of the shaft 88, as shown. In that case, the output signal from the force gauge 116 is electronically processed (for example, using a control processor or other processing device), and a visible image (numerical or graphic display) representing the amount of force is displayed on the display device 118. Can be displayed.

  FIG. 12 shows another mechanism for measuring force using thin film (or other) technology that changes color in response to force. For example, the back plate 62 is made of a transparent material (complete transparency is unnecessary as long as the color change can be identified), and the thin film pressure-sensitive film 122 is disposed adjacent to the back plate 62. Can be implemented. The thin film 122 changes color according to pressure. Standard or other known pressures can be achieved by adjusting the device to provide a specific color.

  FIG. 13 shows a similar configuration. However, a temperature sensor is generally shown as a layer 70 between the thermal insulator 58 and the heating element 42 for ease of illustration. The temperature sensor 70 can be, for example, a thermistor or a thermal resistor that can measure its resistance as an indication of the temperature emitted by the heating element 42. The wire bundle 78 may include a pair of wires leading to the heating element 42 and a pair of wires leading to the temperature sensor 70, and one common wire for connecting the unit 76 using the three-wire wire bundle 78. May be used for both the heater 42 and the temperature sensor 70. In practice, such temperature sensors may be attached directly to the foil heater, insulation 58 or heat sink 46, and may be incorporated within the heat sink 46 or on the surface of the eye. Further, a greater degree of control freedom may be realized using a plurality of sensors 70 or heating elements 42.

  According to some embodiments, it may be desirable for the foil heater or other heating element 42 to provide uniform heat across the surface of the thermally conductive heat sink. Some off-the-shelf heating elements have irregular eyelid shapes compared to many commercially available heating elements that are circular, square, rectangular, or oval, so that the entire surface of the element or the eyelid being treated Some do not provide uniform heating across the entire surface. However, it is also possible to provide a custom designed heating element that solves this problem by changing the position at which the heating element is electrically connected to the foil and mechanically placing the heating element appropriately. By supplying power to a tab that is not part of the heating element and shaping the heating element so that it approaches the outline of the eyelid, the temperature gradient across the heating unit 80 at the eye contact portion can be minimized. Preferably, the heating element is shaped to be suitable for supplying uniform heat throughout the eyelid with no hot or cold spots. Also, the use of a suitable heat conductive heat sink helps to flatten the temperature gradient across the heating unit 80 at the contact of the heating unit 80 to the eyelid. However, in some embodiments, using a properly designed heating element eliminates the need for a heat sink.

  The prototype heating unit utilized a commercially available Heaterstat (TM) model CT198-1001R8.00L1 temperature controller from Minco. This device has the advantage that only two wires are needed to connect to a Minco foil heating element, which provides the heating current and temperature regulation of the foil heater. This can be achieved by the Minco foil heater used in the prototype (Minco HK5207R6.5L12A, see Minco “Thermofoil Heaters” PR HS-202, incorporated herein by reference), This is because it functions as both a heating element and a sensor. The foil heater measured 0.3 "x 1.5" and covered only the upper part of the tested lower eyelid. Improved heating elements are discussed below.

  In the prototype, the heater was operated at about 3.0 volts with a 50% duty cycle. A higher voltage results in a lower duty cycle to achieve the same heating. As the temperature increases, the resistance of the heating element also increases. Thus, the regulator can control the temperature of the heating element by targeting a specific resistance value, increasing the current when the temperature is too low, and turning off the power when the temperature is too high. In this commercially available Heaterstat (TM) regulator, the temperature is applied to the foil heater, similar to that used by most heater thermostats, and then waits for the temperature to drop, It is adjusted by applying power again. This device thus supplies a temperature that varies within a narrow temperature range. When utilizing the device, this temperature is within about 1 ° C., so that the device is very suitable for use in this application.

  However, it has been observed that applying the heating unit to the eyelid results in a short-term drop in surface temperature (shown in FIG. 4 as the left-most rising curve as the heating unit regains thermal initial loss). The Heaterstat (TM) temperature controller used in the prototype took time to compensate for the extra heat dissipation initially caused by contact with the eyelid. This is because the temperature drop at the eyelid is not detected initially, but is detected after the temperature transfer from the heat sink reaches the heating element. This problem is addressed in the improved heating element described below by increasing the heater area and total heat output.

  The power source can be an AC signal, a DC signal, a pulse signal, a program signal, or a modulation signal, and in the experimental prototype, three series-connected AA size commercially available alkaline batteries were used. This provides a DC voltage of about 3.6 volts. Since the designated treatment time used in the prototype experiment was about 15 minutes, a battery life of about 1 hour is sufficient to perform 3 to 4 treatments without problems. However, alternative embodiments may be utilized to optimize battery life or provide a solution that utilizes modulation signals, pulse signals or program signals other than AC power, rechargeable batteries and / or DC.

  Referring now to FIG. 14, a heating unit 80 consistent with some embodiments is shown, again with the insulation 58 as the last layer, the heating element 42 as the center layer, A laminated sandwich type assembly is shown which forms the front layer where the heat sink 46 is placed in contact with the eyelid. In this embodiment, an adhesive 120 is attached to the outer surface of the heat sink in order to fix the heating unit to the eyelid. In this example, the adhesive 120 is in the form of a double-sided adhesive tape that includes a cover to peel off and expose the adhesive for the purpose of attaching the heating unit 80 to the eyelid. In the illustrated example, the heat sink 46 is flexible or pliable so that when pressed in place, it conforms to the shape of the eyelid and provides intimate contact between the heat sink 46 and the eyelid. It is. However, in another embodiment, the surface to which the adhesive 120 is applied may be shaped to match the curvature of the top and bottom of the eyelid to be treated, and the upper left and upper right. In this example, the heat sink 46 may be rigid rather than easily bent. It is depicted in a semi-moon shape for ease of illustration, but the shape is preferably closely matched to the eyelid or pair or eyelid. In particular, since a problem is likely to occur in the lower eyelid in general, a shape suitable for the lower eyelid is desirable.

  When the heating unit 80 is attached using an arbitrary bonding mechanism, it is desirable to clean and dry the surface to which the adhesive is applied in order to remove body oil and the like so as to ensure that the adhesive adheres correctly. If this is neglected, the heating unit will not fit the eye and will peel off near the ends.

  A similar embodiment is shown in FIG. In this embodiment, the temperature sensor 70 is incorporated in front of the thermal heat sink 46 or in a layer that forms part of the thermal heat sink 46. Although depicted as layer 70, the temperature sensor can be a single element temperature sensor or an array of temperature sensors that detect temperature across various sections or regions of the heating element. . In addition, although a single foil heating element is discussed above, the heating element may be implemented as an array of heating elements that can be individually controlled to provide uniform heating across the surface of the eyelid.

  FIG. 16 illustrates the bonding of a heating unit 80, such as any of the heating units described above, such as a single-sided adhesive medical adhesive tape 130, to keep the heating unit 80 in contact with the upper or lower eyelid for treatment. Fig. 4 illustrates another embodiment consistent with the present invention that can be attached to the lower eyelid using a strip of tape. Again, the heating unit 80 is illustrated as having a relatively flat but flexible contact surface that conforms to the shape of the eyelid being treated in the illustrative example. However, shapes that fit the eyelid using a more rigid heat sink 46 may be utilized without departing from embodiments consistent with the present invention.

  Referring now to FIG. 17, another embodiment is shown in which an example vibrating element 136 is incorporated within the device. Heating and moderate pressure can facilitate the discharge of dissolved substances that cause meibomian gland closure or occlusion, but the application of moderate vibrations (for example, during the entire treatment period, some treatment periods near the end of the specified treatment time , Or immediately after) may further induce the elimination of dissolved occlusive material. In this embodiment, a general vibrator 136 is shown as being embedded in the eyepiece. Such a vibrating element 136 can be of any suitable design. There are several mechanisms that can be utilized to provide vibration energy to the heated eyepiece. Although not to be considered limiting, for example:

  An offset motor can be used and attached to the outer surface of eyepiece heater 80 or shaft 88. Some offset motors operate by having an eccentric weight attached to a shaft that generates vibration when the motor is powered on. Offset motors are used to alert users in cell phones and electronic buzzers. Offset motors are readily available in various commercial sizes and can operate to generate vibrations of a variety of different frequencies and amplitudes. Appropriate frequencies and amplitudes can be determined by experimentation taking into account the present teachings.

  A button-type vibration motor can be embedded in the eyepiece or otherwise attached to operate to induce vibration.

  A small motor can be placed on the screw mechanism connected to the mask and the heater. In that case, the screw of FIG. 8 can be rotated using a motor, and the screw can be inserted and removed. The amount of displacement in this case is fixed, but the speed (frequency) can be controlled by the microprocessor unit.

  A small piezoelectric motor can be used to move the screw mechanism connected to the mask and the heater. The amount of displacement and the operating frequency can be controlled by the microprocessor unit.

  It is also possible to remove the screw connection mechanism between the protective glasses and the eyelid heater and replace it with a diaphragm. The diaphragm can be placed between the protective glasses and the eyelid heater and attached to both. A simple pulsating air pump (or fluid pump) can be used to expand and contract the diaphragm to provide mechanical motion to the eyelid heater. Air volume and pulsation frequency can be controlled by the microprocessor unit.

  In view of the teachings of the present invention, mechanical energy can be used using any suitable mechanism (meibomian gland to help push the blockage or occlusion out of the gland while the occlusion is softening by heat. Other embodiments can be devised in which energy is applied (defined as any form of mechanical pressure applied to the gland to apply pressure to the gland). After the heating element has worked to dissolve one or more meibomian gland occlusions, mechanical fluid effects such as pulsation, vibrational energy, squeezing, etc. are applied to the eyelids and are now fluid Excretion of lipids with substances having is stimulated.

  Referring now to FIG. 18, one mechanism for adjusting the temperature emitted by the heating element 42 is shown. In this embodiment, a control processor 160 is used to control the switch 164 that receives feedback information from the temperature sensor 70 and applies power to the heating element 42 to adjust the temperature of the heating element 42. A thermal conditioning circuit 38 is implemented. In this embodiment, the heating element 42 and the temperature sensor 70 are depicted as being two separate devices, but as described above, for the purpose of sensing the operating temperature of the heating element (s), The resistance of the heating element or other characteristics of the heating element 42 can also be utilized. The control processor 160 may have an internal or external clock (not shown) to allow control of the amount of time to alert if the heating element 42 is activated and a malfunction occurs or the designated treatment period is over. Works with. Also, other functions may be performed using the control processor 160 without departing from the invention.

  FIG. 19 shows another embodiment of a mechanism for adjusting the temperature of the heating element 42. In this embodiment, the control processor similarly controls the operation of the heating element 42 based on the temperature sensed by a separate temperature sensor 70 or by the heating element 42 itself. This information is used to control the pulse width modulator 168. By increasing the width of the pulses generated by pulse width modulator 168 (ie, increasing the duty cycle), heating element 42 generates more heat and reduces the width of the pulses generated by pulse width modulator 168. As a result, the temperature of the heat generated by the heating element 42 decreases. Also, without departing from the present invention, the heating of the heating element 42 may be adjusted using other modulation schemes, including but not limited to variable voltage and / or variable current sources. Again, the control processor 160 may control other functions as described below.

  Referring now to FIG. 20, the heating unit 80 incorporates a heating element 42 (in addition to a thermal heat sink, insulation, backplate, etc.) with a separate or integrated temperature sensor 70 and vibration element 136. , All of which form part of a heating unit 80 that is placed in contact with the eyelid. In this embodiment, the control processor 160 uses the temperature adjustment circuit 172 (as described above or of another design) to configure the heat adjustment circuit 38. A power supply 34 supplies power to both the heating element and the control processor 160 and also to the alarm 176 and the vibrator 136. In this embodiment, a user interface 180 (such as one that incorporates display 118) is provided for a user to interact with control processor 160 to control various aspects of the operation of the device. In one embodiment, for example, a user interface is utilized to adjust the treatment time. The elements of the other embodiments described above may be freely interchanged without departing from the invention.

  It is useful herein to define vibration energy as mechanical motion having a frequency component and an amplitude component. Currently, the frequency component is from about 0.1 Hz to 300 Hz including random vibration, the amplitude component defined as the displacement is preferably up to about 3 mm, and the currently preferred excursion is about 0. .5 mm is considered most preferred. However, this should not be considered a limitation. This is because the optimization of these parameters and the definition of an appropriate profile can be optimized by experiment. In one embodiment, for example, the temperature profile is an application of vibration energy that increases linearly from 0.1 Hz to 300 Hz over the last 5 minutes, and the amplitude of vibration energy that decreases linearly from 3 mm to 0 mm over the last 5 minutes. A constant temperature of 45 degrees Celsius over 15 minutes may be set. The actual profile used can be optimized experimentally after considering the teachings presented herein.

  As mentioned above, the heating profile of the heating element used in the prototype produced a temperature gradient of several degrees Celsius across the entire eyelid. In the prototype, a Minco thermofoil heater HK5207R6.5L12A was used. Although this heating element is very practical, it does not produce an ideal temperature profile and thus only a part of the eyelid was heated.

  FIG. 21 shows an example of a heating element design customized to heat the eyelid. Such heating element designs can be easily custom made by foil heater companies such as Minco, Commerce Lane, 7300, Minneapolis, Minnesota, USA. In this embodiment, the outline of the heating element is designed to match the contour of the lower eyelid, but other designs for treating the upper eyelid or simultaneously both eyelids can be devised. One typical practical dimension of such a heater design is that dimension 204 is about 1.8 inches, dimension 208 is about 1.015 inches, and dimensions 214 and 216 of tab 212 are about 0.375 inches. . Of course, these dimensions should not be considered limiting and are considered suitable for an average size human eyelid. In this design, a tab 212 is provided that is bent about 90 degrees away from the eyelid and allows the connection of the wires. In addition, the shape of the tab 212 and foil heater also reduces the heating unevenness across the eyelids observed in standard commercial foil heaters tested.

  According to some embodiments, the heating unit 80 as shown in FIG. 20 is removable so that the heating unit 80 can be removed for cleaning or to discard part (such as a heat sink) or the entire heating unit 80. In addition, it is connected to the regulator using an electric wire and a plug connection. In this way, while maintaining hygiene, a portion of the device can be reused to improve treatment speed.

  Heating is resistance heating caused by the resistance of the conductive path between the conductors terminating in the tab 212. In this embodiment, the heating path meanders from left to right and from right to left so as to realize a resistance path that generates heat. In another embodiment, the resistance path may meander from top to bottom and from bottom to top to create a resistance path as shown in FIG. Many other patterns can be used. The path dimensions and exact layout make use of the normal design principles of foil heaters or other resistance heater designs, the distance between conductors suitable to generate the necessary heat with a uniform heating profile, Designed to maintain line width and resistance. Furthermore, heating techniques other than resistance heating can be used other than foil heaters without departing from the present invention.

  Those skilled in the art will appreciate from the teachings of the present invention that many variations in the illustrated embodiments are possible without departing from the invention. For example, the heating element should preferably provide uniform heat throughout the eyelid, which is achieved using an array of heating elements rather than a single heating element. The heating element is preferably a flexible heating element, such as a foil heating element, which helps to adapt to the shape of the eyelid. However, the heating element may be rigid and provided as an average or pre-shaped shape to fit various eyelid shapes and sizes. Alternatively, the rigid heating element may be accompanied by a soft heat sink that fits the eyelid. As mentioned above, this heat sink can be a thermally conductive rubber, fluid, gel or air filled diaphragm, a damp cloth, or any number of materials that are thermally conductive and can be easily adapted. Can be created.

  The heat sink may be made of thermally conductive rubber or silicon, and may be an encapsulated fluid or gelatin. In another embodiment, the heat sink may be a solid thermally conductive material that is appropriately shaped to conform to the eyelid geometry (appropriate to a surface that is generally part of a spheroid). . The thermal insulation element 58 can be made from non-conductive rubber or foam material (non-conductive means low thermal conductivity) or it can be made from a low thermal conductivity solid material. The heating element may be used in conjunction with a thermally conductive gel, liquid, or cream to fill the gap between the heat sink and the eyelid so as to create a more uniform conductive boundary between the eyelid and the heating unit. Alternatively, sweat generated by heating the eyelids naturally promotes heat transfer and is a byproduct of using a non-absorbing heat sink such as thermally conductive silicone rubber. The illustrated layers can be integrated together in any suitable manner and can take any other form suitable for the purpose of providing relatively uniform and controlled heating to the eyelid.

  The adjustment element for adjusting the temperature of the heating element 42 and the vibration element 136, if any, may operate under computer control and can be adjusted by the user, including temperature setpoint and vibration including amplitude and frequency. It may have a set value. If desired, various temperature profiles and / or mechanical energy profiles can also be implemented under computer control, in which case the temperature and vibrational energy is time-dependent if it is considered a desired control function. It can also increase and / or decrease over time. The temperature regulator and / or mechanical energy element can also operate based on a timer to provide a time limit for treatment. While pulse width modulation and / or simple on / off switching to adjust the temperature of the heating element has been disclosed, other embodiments will occur to those skilled in the art when considering the teachings of the present invention. I will. According to some embodiments, this thermal regulation and / or mechanical energy regulation is controlled by a computer program stored as instructions on an electronic computer readable storage medium such as a read only memory (ROM) or other suitable storage medium. It may be executed under the control of a computer, such as a microprocessor operating underneath.

  The power source 34 may be a replaceable or rechargeable battery and may utilize AC power that is converted to DC as needed when implementing the device.

  Any mechanism suitable for attaching the heating unit to the eyelid can be utilized. As described above, this can be done using a double-sided adhesive medical tape to hold the heating unit in place, or using a headpiece such as protective glasses. In another embodiment, the heating unit may be strapped in place, may be held in place by a nose bridge, may be rotated into place and may be pre-determined by a protective eyeglass mechanism. It may be screwed into position, may be latched in place, and may utilize any other suitable adjustment mechanism from protective glasses or other headgear. Such a mechanism serves to adjust the amount of force applied to the eyelid from the heating unit. In another embodiment, a mechanism may be devised that automatically adjusts the force applied to the eyelid, which may be included within the heating unit 80 to transmit mechanical energy to the heating unit 80 ( It may be coupled in another way to the heating unit 80 (for example in protective glasses).

  Thus, according to some embodiments, the apparatus is adjusted to at least one of the patient's eyelids using a heating unit that includes a heating element that generates heat that is transferred to the patient's eyelid when an electrical signal is applied. Provide heat. A temperature regulator applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element.

  With reference to FIG. 23, any number of therapies that can be performed using the various disclosed embodiments can be envisioned. This flow diagram shows the general process that begins when performing a therapy according to some embodiments, starting at 250. At 254, the heating unit is attached to the patient (using the protective eyeglass device, adhesive device, etc. shown). In embodiments in which pressure can be applied, the pressure is adjusted to hold the heating unit in contact with one or more eyelids to be treated with a moderately selected force. The heating unit can then be turned on and a treatment cycle begins at 258 according to a manual or automatic process.

  After the heating unit reaches an appropriate treatment temperature (such as 45 degrees Celsius), at 262, heat is maintained at a constant level using feedback control, or a desired heat treatment profile is achieved. Similarly, mechanical energy may be applied at 266 (if the heating unit embodiment is so equipped) at the desired timing of the treatment profile. Currently, optimal results are likely to be achieved when mechanical energy is applied when the treatment temperature is reached and interrupted immediately after the thermal therapy is complete. This process proceeds according to the selected treatment profile (whether selected by the operator or pre-programmed) at 270 until the treatment profile is complete. The treatment is then terminated at 274, or subsequently proceeds to the next treatment modality (such as hand squeezing).

  Thus, a method of treating at least one of a patient's eyelids using heat adjusted in a manner consistent with some embodiments comprises placing a heating unit comprising a heating element in contact with the patient's eyelid, and heating This involves applying a control signal to the element to generate heat in the heating element and transferring the generated heat to the eyelid over a specified period of time.

  Returning to FIG. 8, in use, the patient wears protective goggles 98 in the same manner as wearing normal swimming protective goggles, and then push screws (threaded) until the heating unit contacts the eyelids with a comfortable force. It is only necessary to adjust the shaft. At this point, the device is ready for operation and treatment can be started by simply turning it on. In prototypes and preferred implementations, the adjustment mechanism threaded shaft, backplate, bumpy knob, and other mechanisms are made of nylon, allowing the patient, technician, doctor, or nurse to use the appropriate amount for the eyelid. It can be easily adjusted to apply a pressure of. By applying a small amount of static pressure to the eyelid during treatment, secretion from the meibomian gland is promoted when the occlusion dissolves by heat. In the experiment, the amount of pressure used in the device described in the above-referenced and incorporated patent application utilizes pulsating pressures up to about 30 pounds per square inch, and more The general range was about 2 to 10 pounds per square inch. The pulsating pressure is generally more effective and can withstand more with an average pressure higher than the equivalent static pressure. Thus, pressures in the range of up to 2 pounds per square inch are suitable for use as static pressures, and more in combination with other forms of mechanical energy such as vibration, pulsation and / or squeezing action as described above. Large pressures are expected to be available (for reference, when the meibomian glands are squeezed by hand, for example, between the instrument and a human finger, the pressure is several hundred per square inch. Can reach pounds).

  Thus, with the disclosed device, only localized heating of the eyelid can be obtained so as not to dilate the blood vessels in the surrounding facial tissue. When heat is transferred to the eyelid using a silicon rubber heat sink, a thin layer of sweat is formed, which appears to improve heat transfer. The treatment is simple and easy to carry out, and the patient himself provides home treatment to supplement the treatment given by the health care professional and help keep the free flow of lipids produced in the meibomian glands. You can even use it to do it. The heat generated is constant or can be adjusted to a specified profile, thus improving problems associated with the use of dry heat, bean bags, or hot packs. In addition, the device is easily transported, can be battery operated as needed, and can be programmed to provide an appropriate amount of heat for an appropriate amount of time.

  In addition, the filth associated with the heating pad, the inconsistent temperature profile associated with the heating pad, and the IR heating method provided by it with the risk of overheating are minimized. Because the heating unit 80 is small and lightweight, it can be attached to the eyelid using any of several methods depending on the individual patient and other factors. When attached to the lower eyelid, the device can be used with the eyes open. This allows the patient to do some simple work (such as reading or watching TV) to kill time while receiving treatment. In addition, the constant pressure applied to the eyelids facilitates the drainage of meibomian gland lipids and other fluids as the occlusion dissolves. In embodiments utilizing mechanical energy devices, vibration, pulsation and / or squeezing action further assists in removing the occlusion.

  In view of the above teachings, those skilled in the art will appreciate that some of the above exemplary embodiments are based on the use of a programmed processor. However, the present invention is not limited to only such exemplary embodiments. This is because other embodiments may be implemented using equivalent hardware components such as dedicated hardware and / or dedicated processors. Similarly, alternative equivalent embodiments may be constructed using general purpose computers, microprocessor based computers, microcontrollers, optical computers, analog computers, dedicated processors, application specific circuits and / or dedicated wiring logic. Good. Those skilled in the art will also recognize that some embodiments require conversion from the digital domain to the analog domain and vice versa. Such conversion may be performed using a conversion device such as a D / A converter or A / D converter, if necessary, but such a device is omitted from the drawing for clarity. .

  Some embodiments of the methods described herein can be stored on any suitable electronic or computer readable storage medium, generally described above as a flow chart or description, and / or any suitable It can be or can be implemented using a program processor that executes programming instructions that can be transmitted over an electronic communication medium. However, given the teachings of the present invention, one of ordinary skill in the art will recognize that each of the processes described above may be implemented in any number of suitable programming languages as any number of variations without departing from embodiments of the present invention. Will understand. For example, the order of some operations performed can often be changed, additional operations can be added, and operations can be deleted without departing from some embodiments of the present invention. it can. Error traps can be added and / or improved, and user interface and information presentation variations can be made without departing from some embodiments of the present invention.

  The software and / or firmware embodiments may in some embodiments be any suitable electronic or computer readable storage medium (eg, disk storage, read only memory (ROM) device, random access memory (RAM) device, Network memory device, optical storage element, magnetic storage element, magneto-optical storage element, flash memory, core memory and / or other equivalent volatile and non-volatile storage technology, etc.) and / or optional Can be implemented using a program processor that executes the programming instructions generally described above as a flow chart that can be transmitted over any suitable electronic communication medium. However, given the teachings of the present invention, one of ordinary skill in the art will recognize that each of the processes described above may be implemented in any number of suitable programming languages as any number of variations without departing from embodiments of the present invention. Will understand. For example, the order of some operations performed can be changed in most cases, additional operations can be added, and operations can be deleted without departing from some embodiments of the present invention. You can also. Error traps can be added and / or improved, and user interface and information presentation variations can be made without departing from some embodiments of the present invention. Such variations are contemplated and are considered equivalent.

  While several embodiments have been described above, many alternatives, modifications, substitutions and variations will become apparent to those skilled in the art in light of the above description.

Claims (90)

A device for supplying regulated heat for the treatment of mammalian eyelids,
A heating unit comprising a heating element that generates heat when an electrical signal is applied;
A temperature regulator that applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element;
An eyelid contact mechanism that couples the heating unit in contact with the eyelid to achieve controlled heating of the eyelid within a specified temperature range.   The apparatus of claim 1, further comprising a sensor that senses temperature and provides temperature information to a temperature regulator.   The apparatus of claim 1, wherein the eyelid contact mechanism comprises protective eyeglasses adjustably coupled to the heating unit to move the heating unit to achieve contact with the eyelid.   4. The apparatus of claim 3, wherein the protective glasses are adjustably coupled to the heating unit by a screw connection so that the position of the heating unit can be adjusted by a screwing operation.   The apparatus of claim 1, wherein the heating unit further comprises a thermal heat sink coupled to the surface of the heating element to conduct heat from the heating element to the eyelid.   6. The apparatus of claim 5, wherein the thermal heat sink is selected from the group consisting of a thermally conductive rubber member, a thermally conductive silicon member, an encapsulated fluid containing member, and a solid conductive member.   6. The apparatus of claim 5, wherein one of a heat conductive gel, cream or liquid is disposed between the heat sink and the eyelid to improve heat transfer from the heat sink to the eyelid.   The apparatus of claim 1, wherein the heating unit further comprises a thermal insulator coupled to the surface of the heating element to reduce heat loss from the heating unit in a direction other than toward the eyelid.   The apparatus of claim 8, wherein the thermal insulation is selected from the group consisting of a non-thermally conductive foam element, a non-thermally conductive rubber element, and a non-thermally conductive solid element.   The apparatus of claim 1, wherein the temperature regulator applies a pulse width modulated electrical signal to the heating element to regulate the heat generated by the heating element.   The apparatus of claim 10, further comprising a control processor, wherein the pulse width modulated electrical signal is generated under control of the control processor.   The apparatus of claim 1, wherein the temperature regulator comprises a switch that selectively applies an electrical signal to the heating element to regulate the heat generated by the heating element.   The apparatus of claim 1, further comprising a control processor, wherein the electrical signal comprises at least one of a current and a voltage that is selectively applied to the heating element under the control of the control processor.   The apparatus of claim 1, wherein the temperature regulator provides a constant continuous power to the heating element.   The apparatus of claim 1, wherein the heating unit comprises a flexible portion that contacts the eyelid to conform to the eyelid.   The apparatus of claim 1, wherein the heating unit comprises a rigid portion that contacts the eyelid, the rigid portion being shaped to conform to the shape of the eyelid.   The apparatus of claim 1, wherein the heating unit further comprises an adhesive for attaching the heating unit directly to the eyelid.   The apparatus of claim 1, wherein the heating unit is attached to the eyelid by use of an adhesive tape.   The apparatus of claim 1, further comprising a user interface that allows a user to set at least one of time and temperature for treatment.   The mechanical energy generator for generating a force on the eyelid to stimulate secretion from the meibomian gland, further comprising the generator for providing the eyelid with mechanical energy having both amplitude and frequency. The device described.   The apparatus of claim 1 wherein the specified temperature range is greater than 37 ° C.   The apparatus of claim 1, wherein the specified temperature range is from 44C to 47C.   The apparatus of claim 1, wherein the specified temperature range comprises a temperature range around 45 ° C.   The apparatus of claim 1, further comprising a timer that shuts off a signal to the heating element after a specified treatment time.   25. The device of claim 24, wherein the specified treatment time is about 10 to 60 minutes.   25. The device of claim 24, wherein the specified treatment time is greater than 10 minutes.   The apparatus of claim 1, further comprising a pressure sensor that measures pressure when the heating unit is applied to the eyelid.   The apparatus of claim 1, wherein a portion of the eyelid contact mechanism is disposable.   The apparatus of claim 1, further comprising adjusting means for setting the amount of pressure that the heater applies to the eyelid. A device for supplying regulated heat to at least one of the patient's eyelids,
A heating element comprising a first surface and a second surface that generate heat when an electrical signal is applied;
A heat sink coupled to the first surface of the heating element to conduct heat from the heating element to the eyelid;
A heating unit having a heat insulating material coupled to the second surface of the heating element to reduce heat loss from the second surface, and a back plate coupled to the heat insulating material;
A temperature regulator that applies an electrical signal to the heating element to achieve heating to a specified temperature range of the heating element;
Protective eyeglasses suitable for being attached to the patient's head and covering the patient's eyelid with a threaded lens piece;
Through the threaded lens piece, coupled to the heating unit at the back plate so that the heating unit can be moved into contact with the eyelid by screwing the shaft into the hole until contact with the eyelid is achieved A device comprising: a threaded shaft.   32. The apparatus of claim 30, further comprising a sensor that senses temperature and provides temperature information to a temperature regulator.   31. The apparatus of claim 30, further comprising a pressure sensor that measures pressure when the heating unit contacts the eyelid.   31. The apparatus of claim 30, wherein the thermal heat sink is selected from the group consisting of a thermally conductive rubber member, a thermally conductive silicon member, an encapsulated fluid containing member, and a solid conductive member.   32. The device of claim 31, wherein one of a heat transfer gel, cream or liquid is used to improve heat transfer from the heat sink to the eyelid.   32. The apparatus of claim 30, wherein the thermal insulation is selected from the group consisting of a non-thermally conductive foam element, a non-thermally conductive rubber element, and a non-thermally conductive solid element.   32. The apparatus of claim 30, wherein the temperature regulator applies a pulse width modulation signal to the heating element to regulate the heat generated by the heating element.   40. The apparatus of claim 36, further comprising a control processor, wherein the pulse width modulated signal is generated under control of the control processor.   32. The apparatus of claim 30, wherein the temperature regulator comprises a switch that selectively applies an electrical signal to the heating element to regulate the heat generated by the heating element.   32. The apparatus of claim 30, comprising a control processor, wherein at least one of current and voltage is applied to the heating element under control of the control processor.   32. The apparatus of claim 30, wherein the temperature regulator provides a constant continuous power to the heating element.   32. The apparatus of claim 30, wherein the heating unit comprises a flexible portion that contacts the eyelid to conform to the eyelid.   32. The apparatus of claim 30, wherein the heating unit comprises a rigid portion that contacts the eyelid, and the rigid portion is shaped to conform to the shape of the eyelid.   32. The apparatus of claim 30, further comprising a user interface that allows a user to set at least one of a time and a temperature for treatment.   32. The apparatus of claim 30, further comprising a vibration generator for generating eyelid vibrations to stimulate secretion from the meibomian glands.   The apparatus of claim 30, wherein the specified temperature range is greater than 37 ° C.   32. The apparatus of claim 30, wherein the specified temperature range includes a temperature range around about 45 degrees Celsius.   32. The apparatus of claim 30, further comprising a timer that blocks a signal to the heating element after a specified treatment time.   32. The device of claim 30, wherein the specified treatment time is about 10 to 60 minutes.   32. The apparatus of claim 30, wherein the heating element is a resistance heating element.   32. The device of claim 30, wherein a portion of the eyelid contact mechanism is disposable.   32. The apparatus of claim 30, further comprising adjustment means for setting the amount of pressure that the heater applies to the eyelid meibomian glands. A device for supplying regulated heat to at least one of the patient's eyelids,
A heating unit having a resistance heating element that generates heat that is transferred to the patient's eyelid when an electrical signal is applied;
A temperature regulator that applies an electrical signal to the heating element to achieve heating of the heating element to a specified temperature range.   53. The apparatus of claim 52, further comprising a thermal heat sink coupled to the surface of the resistance heating element to conduct heat from the resistance heating element to the eyelid.   53. The apparatus of claim 52, further comprising a thermal insulator coupled to the surface of the resistive heating element to reduce heat loss from the surface.   53. The apparatus of claim 52, further comprising protective eyeglasses adjustably coupled to the heating unit to move the heating unit to achieve contact with the eyelid.   53. The apparatus of claim 52, further comprising a thermal heat sink coupled to the surface of the resistive heating element to conduct heat from the heating element to the eyelid.   53. The apparatus of claim 52, further comprising a thermal insulator coupled to the surface of the resistance heating element to reduce heat loss from the surface of the heating element.   53. The apparatus of claim 52, wherein the temperature regulator applies a pulse width modulated electrical signal to the resistive heating element to regulate the heat generated by the heating element.   53. The apparatus of claim 52, wherein the temperature regulator comprises a switch that selectively applies at least one of current and voltage to the resistive heating element to regulate the heat generated by the heating element.   53. The apparatus of claim 52, comprising a control processor, wherein the electrical signal is applied under the control of the control processor.   53. The apparatus of claim 52, wherein the heating unit comprises a flexible portion that contacts the eyelid to conform to the eyelid.   53. The apparatus of claim 52, wherein the heating unit comprises a rigid portion that contacts the eyelid, the rigid portion being shaped to conform to the shape of the eyelid.   53. The apparatus of claim 52, further comprising an adhesive for attaching the heating unit directly to the eyelid.   53. The apparatus of claim 52, wherein the heating unit is attached to the eyelid by use of an adhesive tape.   53. The apparatus of claim 52, further comprising a user interface that allows a user to set at least one of a time and a temperature for treatment.   53. The apparatus of claim 52, further comprising a vibration generator for generating eyelid vibrations to stimulate secretion from the meibomian glands.   53. The apparatus according to claim 52, further comprising protective eyeglasses attached to the patient's head and suitable for covering the patient's eyelid with the lens piece, wherein the heating unit is movably attached to the lens piece.   53. The apparatus of claim 52, wherein the specified temperature range is greater than 37 ° C.   53. The apparatus of claim 52, wherein the specified temperature range includes about 44 ° C to 47 ° C.   54. The apparatus of claim 53, further comprising a timer that shuts off current to the heating element after a specified treatment time.   72. The apparatus of claim 70, wherein the specified treatment time is about 10 to 60 minutes.   71. The device of claim 70, wherein the specified treatment time is about 15 minutes.   53. The apparatus of claim 52, further comprising a pressure sensor that measures the pressure at which the heating unit contacts the eyelid. A method of treating at least one of a patient's eyelids with controlled heat comprising:
Disposing a heating unit comprising a heating element in contact with the patient's eyelid; and applying a control signal to the heating element to generate heat in the heating element and transferring the generated heat to the eyelid for a specified period of time. Method.   75. The method of claim 74, further comprising removing the control signal after expiration of a specified period. Can be placed
75. The method of claim 74, comprising: attaching protective eyeglasses with adjustable eye contact that includes a heating element to the patient; and adjusting the eye contact to achieve contact with the eyelid.   75. The method of claim 74, wherein positioning includes tapering the eyepiece to the patient's eyelid using a strip of adhesive tape.   75. The method of claim 74, wherein positioning comprises attaching an eyepiece to a patient's eyelid using a medical double-sided adhesive tape.   75. The method of claim 74, wherein attaching includes attaching an eyepiece to the eyelid using an adhesive attachment.   75. The method of claim 74, wherein the heat is emitted until greater than 37 degrees Celsius.   75. The method of claim 74, further comprising applying vibrations to the patient's eyelid.   75. The method of claim 74, wherein the specified period is about 10 minutes to 60 minutes.   75. The method of claim 74, applied to both the upper and lower eyelids of a patient.   75. The method of claim 74, applied to at least one eyelid of both eyes of the patient.   75. The method of claim 74, further comprising measuring the pressure at which the heating unit contacts the eyelid.   75. The method of claim 74, wherein the heating element is a resistance heating element.   75. A computer readable storage medium storing instructions that, when executed on a program processor, perform the method of claim 74.   A method of treating a mammalian eyelid comprising heating the eyelid and maintaining a defined temperature for at least 4 minutes and less than 60 minutes while simultaneously applying mechanical energy and pressure to the eyelid.   Applying sustained controlled heat to at least one mammalian eyelid over a period of less than 60 minutes and applying force to the eyelid during heating or within 3 minutes after heating to remove meibomian gland obstruction A method of treating at least one mammalian eyelid. An apparatus for supplying controlled heating to a mammalian eyelid,
A heating unit having means for generating heat within a specified temperature range;
An eyelid contact mechanism for coupling the heating unit to contact the eyelid;
Means for adjusting the contact of the heating unit with the eyelid.

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