CN101874755A - Device and method used for wetting eye - Google Patents
Device and method used for wetting eye Download PDFInfo
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- CN101874755A CN101874755A CN2009101378670A CN200910137867A CN101874755A CN 101874755 A CN101874755 A CN 101874755A CN 2009101378670 A CN2009101378670 A CN 2009101378670A CN 200910137867 A CN200910137867 A CN 200910137867A CN 101874755 A CN101874755 A CN 101874755A
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Abstract
The invention discloses a method used for wetting an eye. In the method, a certain amount of water-containing fluid is transported to the eye, wherein a transportation volume is lower than the volume which causes eye overflow and is removed from the surface of the eye by a normal tear film. Preferably, the fluid mainly comprises the water. In other words, the fluid does not contain a therapeutic active ingredient, but can contain non-therapeutic ingredients such as a preservative, a lubricant, a surface active agent and a buffer. When the fluid is conveyed according to the method, the fluid makes the existing tear film rehydrated, rather than replace the tear film. The fluid is conveyed by jetting fluid mist towards the face of a person from a container held by the person.
Description
Technical field
The present invention relates to the field of the nursing and the treatment of ocular surface, comprise sclera, conjunctiva and cornea.More particularly, the present invention relates to apply treatment and other fluid and be used for moistening and treatment ocular surface.
Background technology
Under the normal condition, ocular surface comprises sclera, conjunctiva and cornea, owing to the existence of tear film keeps moistening.This tear film has all been found in the vertebra biology of all lands actually, except Serpentis.
The long-pending about 2cm of adult's ocular surface
2It is covered by the tear film of complexity (tear film), and this tear film has trilaminar structure, and wherein each layer has independent and functions needs.
Near ocular surface be the internal layer of mucus (mucus), the about 10-20 Φ of thickness m.Mucus in this one deck makes the tear film stable, and adhering to of tear film and following cornea and conjunctiva is provided.Mucus has also reduced the surface tension between tear film and the eyes, and thereby allows the tear film to be evenly distributed on the eyes.
The intermediate layer of eyes is water-bearing layer (aqueous layer), and this layer mainly comprises water, electrolyte and range protein.This one deck comprises the aqueous fluid (aqueous fluid) of about 2-5 Φ l, and has formed the major part (bulk) of tear film.In this one deck, PH, osmotic pressure, oxygen tension and electrolyte for example the level of potassium, calcium, chloride, inorganic phosphate and acid for example the level of lactic acid and citric acid remain in the narrow physiological range.The protein that is present in the water-bearing layer of tear film comprises albumin and other protein, for example immunoglobulin, interferon, beta lysin and lysozyme, and they have antibacterial activity.
Apart from ocular surface farthest be oils and fats (lipid) layer, its thickness from monolayer to about 200nm.Usually, the about 100nm of this one deck is thick.This one deck is used to stop the evaporation of tear film.
Thickness reduces rapidly the tear film along with nictation.Under the situation that does not have nictation afterwards, in about 30 seconds, the hole is formed in the tear film beginning, and is called the tear film rupture.The breakup time of tear film that is lower than 10 seconds is considered to unusual.The tear that reduce in the rete malpighii that this can be along with the tear film form or are not enough and take place.Can cause exsiccant other situation of ocular surface to comprise environmental drying, contact lens wearing and tearing and stay up late (upon waking).
Usually, the drying of eyes is to utilize group water solution to treat, and this solution contains electrolyte and antiseptic, and antiseptic keeps the aseptic condition of solution to be used for repeatedly using.The solution that does not have antiseptic is packaged in the container, and this container is used to provide single to use, and wherein container and any rest solution are dropped after single uses.
Solution applies by drop usually, and this provides the fluid of about 20-25 Φ l to ocular surface.The application of eye drop causes the quick humidification of eyes.Yet because the amount of carrying is greater than the volume of tear film, so these eye drop have and make the overflow shortcoming of (flooding) of eyes, and this has washed away the tear film, and has replaced the tear film with the fluid that comprises eye drop.And then, have such a period of time after this overflowing: at this moment, the normal tear film with three-decker and every layer of constituent does not exist on ocular surface.This can cause incomplete eyes moistening, and this can continue several circulations nictation.
Other the method that inserts the liquid on the ocular surface comprises that eyecup, aerosol apparatus and pump spray and sprayer unit.Eyecup is used for ocular surface in the fluid bathing, and this causes overflowing and causes the tear film on the ocular surface to be washed off.Can be used for the drop bundle is transported to aerosol apparatus on the eyes at U.S. Patent No. 5,346,132 and the No.5 of Haha, describe in 893,515, these patents are drawn at this and are reference.In these patents, Hahn discloses by drop and has transported fluid into a plurality of shortcomings in the eyes, comprises being difficult to locate dropper, and causes incomplete drug conveying owing to do not aim at eyes, and splash on the face.Hahn does not solve the problem of the Fluid Volume of introducing eyes, does not have to solve the problem that causes the tear film to be washed out owing to overflowing yet.The aerosol apparatus of Hahan has been carried can measure the fluid of dosage, and can be used for family or medical application, perhaps is used for wetting eye or skin.
Another kind of aerosol apparatus is described in the U.S. Patent No. 5,588,564 of Hutson, draws at this to be reference.Similar with the aerosol apparatus of Hahn, but the aerosol apparatus of Hutson can be used for carrying the fluid of adjustable and repeated doses on ocular surface.Hutson does not solve the problem of the fluidic amount of introducing eyes, the problem that the tear film that does not also have solution to cause owing to overflowing is washed out.
Need a kind of method to come the wetting eye surface, the while can not make eyes overflow or destroy the integrity of natural tear film.
Summary of the invention
Find unexpectedly, a certain amount of fluid is sent to the improvement that ocular surface causes the eyes moistening of relative art methods, be higher than this level and then cause overflow and tear film to be washed off with certain level.
Among the embodiment, the present invention is a kind of method that is used for wetting eye.The method according to this invention comprises: obtain giver, its can be controllably with aqueous fluid with a certain amount of ocular surface that is transported to, this amount is lower than the amount that will cause eyes to overflow.Like this, method of the present invention is used for the water-bearing layer of rehydrated tear film, and it is unaffected to keep normal three layers of tear film.The method according to this invention is distributed to the about twice of the fluidic amount of ocular surface less than the volume in the normal water-bearing layer of tear film, just less than about 10 Φ l.Preferably, send between about 0.5-6 Φ l, and most preferred, send between the 2-5 Φ l.According to the present invention, fluid can singly be rolled into a ball (bolus) and send into ocular surface, perhaps can be along with the time is sent into, and in 10 seconds or shorter time, preferred 5 seconds or shorter.
Fluid can be used as drop and is transferred, but most preferably is transferred as mist.The aqueous fluid that has been found that the mist form be adapted such that most the tear film to contain water section rehydrated, can not clean the tears falling film simultaneously.
Among another embodiment, the present invention is an external member, is used to carry drug component to be used for the treatment of eyes, for example wetting eye.According to the present invention, this external member contains the aqueous fluid ingredient, the container that contains ingredient, and giver, when activateding, this giver controllably is sent to the ingredient between about 0.5-50 Φ l on the surface of about 2cm2, in 10 seconds or shorter time, and 5 seconds or shorter preferably approximately.Preferably,, this external member utilize external member controllably ingredient to be applied on the ocular surface thereby comprising command device,
Description of drawings
Fig. 1 shows an embodiment of complexes of the present invention, is used for the method according to this invention wetting eye.
The specific embodiment
Have been found that on the contrary with fluidic splash, as utilize present obtainable dropper and aerosol apparatus to carry out, the unexpected increase of the humidity of tear film can increase the water content of tear film, simultaneously seldom or can not cause the replacement of tear film fully.
Find in addition, thereby this unexpected increase of tear film humidity is best is that the hand-held containers of holding from staff is sent into (administer) in people's eyes by the vaporific beam that sprays aqueous fluid, this aqueous fluid preferably mainly comprise water, between 12 inches (30 centimetres) to 24 inches (60 centimetres), the time period that continues is enough to wetting eye to this container apart from the distance of face.
According to the present invention, the volume of ocular surface tear film increases by applying a certain amount of fluid, and this amount is not more than the volume that contains water section about 100% to 200% of tear film, and it has the volume of 2-5 Φ l usually.Therefore, according to the present invention, about 10 Φ l or still less be applied to ocular surface.Preferably, 0.5-6 Φ l is applied in, and most preferably 1-2 Φ l is applied in, particularly when because when the existence of xerophthalmia and wetting eye, wherein, total tear volume is usually between 1-2 Φ l.According to the present invention, fluidic volume is used for the water section that contains of rehydrated tear film, and the integrity of oils and fats above keeping and following rete malpighii.
Opposite with prior art, wherein, the fluid of 20-50 Φ l is applied to eyes by dropper or injection, and the method according to this invention has rebulid normal state in the human body of sears optical.This method has only been washed existing tear film off, and utilizes aqueous solution to replace tear film or middle at least water-bearing layer.These solution lack the structure of intact tear film, and are different from the normal water-bearing layer of tear film equally.
The fluid of the above-mentioned amount that usually, applies according to the present invention is applied in the circulation nictation between nictation (blink).Yet fluid can be applied in the time period that once or repeatedly carry out nictation.Preferably, fluid was applied in 5-10 second or shorter time period.
Though fluid can be admitted to (administered) in any form, comprise dispersive drop (mist) or steam in drop, the air, but preferably, fluid is admitted to the mist form of dispersant liquid drop, wherein, the average-size of fluid drop is between the diameter of about 5-150 micron.Have been found that mist that the drop by this size range constitutes provides the hydration of optimum of tear film and the moistening of ocular surface, in each drop of this gravel size decision between the about 0.1%-1% of tear volume.Preferably, the average-size of fluid drop is less than 100 microns, and most preferred, less than 75 microns.Most preferred, liquid-drop diameter is between the 10-50 micron, and the most preferred range of diameter is between the 10-30 micron.Diameter surpasses the evaporation by halves easily of about 100 microns drop, and will fall the outside, and the face of getting wet inadequately, and horizontal surface.Diameter is considered to suck less than about 20 microns drop usually, and can be inhaled into lower respiratory tract.
When for example water was transported to eyes surperficial the material that does not have a potential hazard for respiratory system, this was acceptable.Yet when part or opthalmological were bonded in the solution that will be admitted in the eyes, this was unaccommodated, at this moment, can be irritating or deleterious if this medicine is inhaled into.
The fluid that is transported to ocular surface according to the present invention is a water-based fluid.For wetting eye, fluid is aqueous fluid preferably, has neutral PH to little acid, for example between about 7 to about 6.5.Preferably, fluid has the solute of low concentration, is lower than common tear film.According to the preferred embodiment of the present invention, fluidic osmotic pressure is less than 350mOsm, and most preferredly is lower than 311mOsm.
Preferably water is that low strain is former or do not have antiseptic and other chemical mixture substantially in addition, and they may stimulate ocular surface.
In the preferred embodiment, the aqueous fluid that is transported to ocular surface mainly comprises water.In this preferred embodiment, water can contain the mineral of trace.Water also can comprise such composition, and it can not stimulate eyes, and can not provide therapeutic effect to eyes.This composition that is suitable for the aqueous fluid of this preferred embodiment according to the present invention comprises: lubricant, antiseptic, buffer agent and surfactant.Yet most preferably the amount of mineral is the least possible in the fluid, and water base do not have this composition, for example lubricant, antiseptic, buffer agent and surfactant.
Method of the present invention can be used for medicine is transported to ocular surface.Medicine is sent into this method of eyes and used big relatively drip (drop), about 20 Φ l or bigger, thus carry medicine.This causes overflowing of margo palpebrae (eyelid margin), and a part of drug flow is gone on the face.
The method according to this invention, the medicine in the aqueous solution is applied on the ocular surface, and wherein the volume of solution is less than about 10 Φ l.Preferably, the volume of the solution of sending into according to the present invention that contains medicine is between 0.5-6 Φ l, and most preferably between 2 and 5 Φ l.The solution that contains medicine is preferably sent in second at 5-10, and most preferably sends in the circulation a nictation, but sending into of solution can be in the time course of blinking several times.
Water-soluble any medicine is applicable to method of the present invention.The medicine that does not preferably have the zest effect, but think for eyes, in some cases, be fit to be or necessary be that medicine is flowed to ocular surface, even medicine has caused stimulation.Be applicable to the example of the suitable medicine of the inventive method, comprise antibiotics, sympathetic nerve and parasympathetic nervous agent, anti-glaucoma agent and antiinflammatory be steroid for example, and described antibiotics comprises antibacterial, antifungal and antiviral agent.
Among another embodiment, the present invention is a kind of external member (kit), is used for 0.5 and is sent to ocular surface less than the aqueous fluid of the controlled dose between the 20 Φ l.Preferably, controlled dose is less than 10 Φ l, and most preferably less than 5 Φ l.In the most preferred embodiment, controlled metering is the fluid between the 1 and 2 Φ l.According to the present invention, this external member comprises: container, and aqueous fluid is positioned at container; And actuator, this actuator is with the beam or the mist of above-mentioned dosage conveyance fluid.Preferably mist comprises dispersive drop, the average-size of drop is the about 5-150 micron of diameter, most preferably less than 100 microns, even is more preferably less than 75 microns, most preferably be that most preferred scope is that diameter is between the 15-30 micron less than between 10 and 50 microns.External member also can comprise command device (instruction), thereby the aqueous fluid of controlled dose is applied to ocular surface.Preferably, the container of external member is sealed, thereby it can be used for repeatedly applying aqueous fluid in a couple of days and even several months, and need not comprise antiseptic in fluid.
In a particularly preferred embodiment, container is a tube jar (canister), for example metal or plastics, holding aqueous fluid.Tube jar remains in the staff, and hands is squeezed on the actuator, and when holding tube jar, with the mist of aqueous fluid towards the guiding of people's face, thereby to the mist of eyes injection aqueous fluid.
The preferred embodiment of external member of the present invention schematically shows in Fig. 1.Fig. 1 shows for example case 101 of housing (package), is used to hold the sealed container 102 of inflexible preferable alloy, and its inside is the flexible bag 103 of inner sealing, and sack 103 is holding fluid to be allocated.Have the hypertensor (pressurization agent) between sealed container 102 and flexible bag 103, for example compressed air or nitrogen 104, and have actuator 105, the fluid that allows to be fit to dosage in the sack 103 flows out when being extruded.External member also comprises the command device (not shown), is used for FLUID TRANSPORTATION with predetermined close to eyes.
In limiting examples, further describe the present invention below.
Example 1
Tear membrane volume on three adult subjects' the eyes is measured and be defined as meansigma methods 2.26 Φ l.The subject is treated by following mode then: send into the mist of average droplet size between 50 and 100 microns to their ocular surface, wherein cumulative volume is 2-5 Φ l in each 10 time in second of eyes.After sending into, the tear volume is measured once more, and is defined as average 2.96 Φ l.
Example 2
Obtained the sample of tear film, thereby and they have been carried out the baseline values that the HPLC chromatography is determined protein and other composition in the tear film from three adult subjects.Each subject's eyes are wetted by the standard drop of sending into the artificial tears between the 25 and 50 Φ l then.Obtained then from three samples, and carried out the HPLC chromatography through the tear film of the eyes of treatment.After having obtained second group of sample, each subject's opposite eyes are wetted by sending into the same artificial tear then, but the mist of being made up of drop, the size of this drop between 50 and 100 microns, the about 5 Φ l of cumulative volume.Sample from the tear film of the eyes of mist treatment has obtained then, and carries out the HPLC chromatography.The artificial tears carries out the HPLC chromatography equally.
The HPLC chromatography of beginning provides the profile of the composition of finding in normal tear film.Discovery contains various oils and fatss, mucus, protein and electrolyte.
The HPLC chromatography of carrying out after the moistening of being undertaken by single big drop discloses: whole or most of oils and fatss and mucus are retained in the tear film.The protein and the electrolyte that exist in the common tear film no longer exist, and the tear film has and the similar chromatographic analysis profile of artificial tears (profile), have removed oils and fats and mucus.
The moistening HPLC chromatography afterwards of being undertaken by mist discloses: oils and fats and mucus are retained in the tear film.Protein that exists in the normal tear film and electrolyte are proved in the tear film that is retained in after the moistening that mist carries out by chromatography.
Described further modification of the present invention, purposes and application are conspicuous for those skilled in the art.This distortion drops in the following claim scope.
Claims (53)
1. one kind is used for wetting eye and can wash out simultaneously the method in the water-bearing layer of eyes tear film, comprise the aqueous fluid between the 0.5 and 10 Φ l is sent to described ocular surface, described aqueous fluid mainly comprises water, wherein said fluid is the form of mist, and described mist comprises the drop of average-size between 5 and 150 microns.
2. the method for claim 1 is characterized in that, described fluid comprises one or more in antiseptic, lubricant, buffer agent and the surfactant.
3. the method for claim 1 is characterized in that, described fluid does not have antiseptic substantially.
4. method as claimed in claim 3 is characterized in that, described fluid does not have lubricant and surfactant substantially.
5. method as claimed in claim 4 is characterized in that, described fluid does not have buffer agent substantially.
6. the method for claim 1 is characterized in that, the average-size of described drop is between diameter 10 and 50 microns.
7. method as claimed in claim 6 is characterized in that, the average-size of described drop is between diameter 15 and 30 microns.
8. the method for claim 1 is characterized in that, the fluid between the about 0.5 and 6 Φ l is admitted to.
9. method as claimed in claim 8 is characterized in that, the fluid between the about 2 and 5 Φ l is admitted to.
10. the method for claim 1 is characterized in that, described fluidic osmolarity is lower than the osmolarity in the normal water-bearing layer of tear film.
11. method as claimed in claim 10 is characterized in that, described osmolarity is lower than 311mOsm.
12. the method for claim 1 is characterized in that, fluidic PH is lower than 7.
13. method as claimed in claim 12 is characterized in that, described Ph about 6.5.
14. an external member that is used for wetting eye comprises: container comprises that mainly the fluid of water is positioned at this container; Actuator is carried a certain amount of fluid, and fluidic amount is enough to the water-bearing layer of the tear film on wetting eye surface, and washes out the amount in described water-bearing layer less than meeting; And command device, be used to carry the fluid of described dosage to ocular surface.
15. external member as claimed in claim 14 is characterized in that, the amount that actuator is carried is between 0.5 and 20 Φ l.
16. external member as claimed in claim 15 is characterized in that, described fluid comprises one or more in antiseptic, lubricant, buffer agent and the surfactant.
17. external member as claimed in claim 14 is characterized in that, described fluid does not have antiseptic substantially.
18. external member as claimed in claim 17 is characterized in that, described fluid does not have lubricant and surfactant substantially.
19. external member as claimed in claim 18 is characterized in that, described fluid does not have buffer agent substantially.
20. external member as claimed in claim 14 is characterized in that actuator is carried fluid as mist, this mist has the average droplet size of diameter between 5 and 150 microns.
21. external member as claimed in claim 20 is characterized in that, described average droplet size is between diameter 10 and 50 microns.
22. external member as claimed in claim 21 is characterized in that, described average droplet size is between about 15 and 30 microns of diameter.
23. method that is used for wetting eye, comprise that the aqueous fluid with the mist form is sent on the ocular surface, the fluidic amount that wherein is fed to eyes be enough to volume with the water-bearing layer of tear film increase common water-bearing layer volume at least 5%, and described amount is washed out the tear film less than meeting from eyes amount, and the water-bearing layer of permission fluid wets tear film.
24. the method shown in claim 23 is characterized in that, described aqueous fluid mainly comprises water.
25. the method shown in claim 23 is characterized in that, the volume of aqueous fluid that is sent to eyes is less than 3 microlitres.
26. the method shown in claim 25 is characterized in that, the volume of aqueous fluid that is sent to eyes is less than about 2 microlitres.
27. the method shown in claim 26 is characterized in that, the volume that is sent to the aqueous fluid of eyes is the 1-2 microlitre.
28. the method shown in claim 23 is characterized in that, the average-size of drop is that diameter is less than 20 microns in the mist.
29. the method shown in claim 28 is characterized in that, the average-size of drop be diameter 10 and less than 20 microns between.
30. a method that is used for wetting eye comprises aqueous fluid is sent to ocular surface, the fluid volume that wherein is sent to eyes is less than 3 microlitres, and the water-bearing layer of permission fluid wets tear film.
31. the method shown in claim 30 is characterized in that, sends into fluid volume to eyes less than about 2 microlitres.
32. the method shown in claim 31 is characterized in that, the fluid volume of sending into to eyes is the 1-2 microlitre.
33. the method shown in claim 30 is characterized in that, the fluid of sending into to eyes is the form of mist.
34. the method shown in claim 33 is characterized in that, the average-size of drop is that diameter is less than 20 microns in the mist.
35. the method shown in claim 34 is characterized in that, the average-size of drop be diameter 10 and less than 20 microns between.
36. the method shown in claim 30 is characterized in that, fluid mainly comprises water.
37. method that is used for wetting eye, comprise aqueous fluid is sent to ocular surface, this aqueous fluid is the form of many drops, the average diameter of drop is less than 20 microns, the fluidic amount to eyes wherein sent into be enough to volume with the water-bearing layer of tear film increase normal water-bearing layer volume 5%, and the amount that this amount causes the tear film to wash out from eyes less than meeting, and the water-bearing layer of permission fluid wets tear film.
38. the method shown in claim 37 is characterized in that, the average diameter of drop 10 and less than 20 microns between.
39. the method shown in claim 37 is characterized in that, sends into fluidic volume to eyes less than 3 microlitres.
40. the method shown in claim 39 is characterized in that, sends into fluidic volume to eyes less than about 2 microlitres.
41. the method shown in claim 40 is characterized in that, the fluidic volume of sending into to eyes is the 1-2 microlitre.
42. the method shown in claim 37 is characterized in that, the drop of sending into is sent into the form of mist.
43. the method shown in claim 37 is characterized in that, aqueous fluid mainly comprises water.
44. method that is used for wetting eye, comprise aqueous fluid is sent to ocular surface, this aqueous fluid mainly comprises water, the amount of aqueous fluid be enough to volume with the water-bearing layer of tear film increase normal water-bearing layer volume at least 5%, and this amount is less than the amount that can make that the tear film washes out from eyes, and allows the water-bearing layer of fluid wets tear film.
45. the method shown in claim 44 is characterized in that, aqueous fluid is the form of the mist of drop, and the average diameter of this drop is less than 20 microns.
46. the method shown in claim 45 is characterized in that, the average diameter of drop is 10 to less than 20 microns.
47. the method shown in claim 44 is characterized in that, the fluidic amount to eyes sent into is less than 3 microlitres.
48. the method shown in claim 47 is characterized in that, the fluidic amount of sending into is less than about 2 microlitres.
49. the method shown in claim 48 is characterized in that, the fluidic amount of sending into to eyes is the 1-2 microlitre.
50. method that is used for wetting eye, comprise that the aqueous fluid that will mainly comprise water sends into to ocular surface, described aqueous fluid is the form of the mist of drop, the average-size of drop is that diameter is less than 20 microns, wherein send into to the fluidic amount of eyes 1 and less than 3 microlitres between, and allow the water-bearing layer of fluid wets tear film.
51. the method shown in claim 50 is characterized in that, the average-size of drop 10 and less than 20 microns between.
52. the method shown in claim 50 is characterized in that, the fluidic amount of sending into is less than about 2 microlitres.
53. the method shown in claim 52 is characterized in that, the fluidic amount of sending into is the 1-2 microlitre.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101378670A CN101874755A (en) | 2009-04-29 | 2009-04-29 | Device and method used for wetting eye |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009101378670A CN101874755A (en) | 2009-04-29 | 2009-04-29 | Device and method used for wetting eye |
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| Publication Number | Publication Date |
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| CN101874755A true CN101874755A (en) | 2010-11-03 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009101378670A Pending CN101874755A (en) | 2009-04-29 | 2009-04-29 | Device and method used for wetting eye |
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|---|---|
| CN (1) | CN101874755A (en) |
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2009
- 2009-04-29 CN CN2009101378670A patent/CN101874755A/en active Pending
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Application publication date: 20101103 |