WO2018122710A1 - Tampon oculaire et procédé de chauffage d'une zone péri-oculaire - Google Patents

Tampon oculaire et procédé de chauffage d'une zone péri-oculaire Download PDF

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Publication number
WO2018122710A1
WO2018122710A1 PCT/IB2017/058335 IB2017058335W WO2018122710A1 WO 2018122710 A1 WO2018122710 A1 WO 2018122710A1 IB 2017058335 W IB2017058335 W IB 2017058335W WO 2018122710 A1 WO2018122710 A1 WO 2018122710A1
Authority
WO
WIPO (PCT)
Prior art keywords
pad
ocular
pad according
gel material
anyone
Prior art date
Application number
PCT/IB2017/058335
Other languages
English (en)
Inventor
Daniela ZELASCHI
Shujing YU
Original Assignee
Ntc S.R.L.
Touch Medical Device Jiashan Co. Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ntc S.R.L., Touch Medical Device Jiashan Co. Ltd. filed Critical Ntc S.R.L.
Priority to EP17829039.1A priority Critical patent/EP3562447A1/fr
Publication of WO2018122710A1 publication Critical patent/WO2018122710A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0001—Body part
    • A61F2007/0002—Head or parts thereof
    • A61F2007/0004—Eyes or part of the face surrounding the eyes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0095—Heating or cooling appliances for medical or therapeutic treatment of the human body with a temperature indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/02—Compresses or poultices for effecting heating or cooling
    • A61F2007/0203—Cataplasms, poultices or compresses, characterised by their contents; Bags therefor
    • A61F2007/0215—Cataplasms, poultices or compresses, characterised by their contents; Bags therefor containing liquids other than water
    • A61F2007/0219—Gels

Definitions

  • the present invention relates to an ocular pad comprising a pocket containing a gel material which reversibly changes color when heated above a threshold temperature. Said pad is particularly suitable for warming a periocular area.
  • MGD Meibomian Gland Dysfunction
  • DE dry eye
  • MGD meibomian Gland Dysfunction
  • the MGD is a chronic abnormality of the meibomian glands (MGs) . It may cause eye discomfort and affect tear film stability which leads to poorer visual function, faster tear evaporation and ocular surface damage. MGD is thought to be a major cause of dry eye that affects 46.2-69.3% Asians and 3.5-19.9% Caucasians .
  • Meibomian glands are large sebaceous glands that are located as separate gland strands in parallel arrangement within the tarsal plates of the eyelids. Their oily product, meibum, is secreted via a holocrine mechanism during which meibocytes are transformed into the meibum. Following production in the gland acini, meibum is transported through the ductal system via the connecting duct and the central duct towards the orifice at the free eyelid margin close to the inner eyelid border. Meibum is a complex mixture of various lipids and minor protein components as well as other components of the meibocytes, which form a clear liquid at body temperature.
  • meibum moves from the posterior eyelid margin reservoir onto the tear meniscus and is pulled as a thin layer onto the pre-ocular tear film every time the eyelid opens. During closure of the eyelid, it is compressed and a small part is continuously renewed. Meibum also has a barrier function against the spillage of tears over the inner border of the eyelid and against the entry of skin lipids (sebum) from the free eyelid margin.
  • obstructive meibomian gland dysfunction is a common source of complaint among patients with dry eye syndrome and its prevalence increases with age.
  • the main clinical consequence of obstructive MGD is evaporative DE syndrome.
  • chronic obstruction of the meibomian glands may also result in degeneration of the secretory gland tissue that can lead to a secondary hypo-secretion even if the primary obstruction is later resolved by therapeutic approaches.
  • Risk factors in the pathogenesis of obstructive MGD include age, hormonal disturbances and environmental influences (e.g., contact lenses) .
  • qualitative alterations in the composition of the meibum may lead to hyper-keratinization of the ductal epithelium and increased viscosity of the meibum.
  • the eyelid warming is regarded as the mainstay of the clinical treatment of ocular conditions [see Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, et al . ; "The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction", Invest. Ophthalmol. Vis. Sci. 2011; 52 ( 4 ) : 2050-2064 ] .
  • the eyelid warming is reached by different methods, such as: warmed towel or cotton, eyelid warming masks, and other improvised methods of heating, like warmed seeds or even hard boiled eggs.
  • heating means known in the art require to be heated before the application on the eyelid.
  • the absence of a system which allows to control the temperature may cause failure of the treatment, since the patient can apply on the eyelid a vehicle that he/she subjectively judges warm, but that has not reached the right temperature for efficacy, making the treatment, often cumbersome, totally ineffective.
  • Medium term consequence will be that the patient will no longer comply with the warming treatment, having had proof of inefficacy.
  • the Applicant has faced the problem to find a heating device suitable for warming a periocular area, allowing the user to know when the device has reached the therapeutic temperature and is consequently ready to be applied on said area in order to alleviate or treat ocular conditions.
  • an ocular pad which can be applied on the periocular area and comprises a pocket containing a gel material which reversibly changes color when heated above a threshold temperature. Particularly, when the pad reaches a temperature suitable for the application to the periocular area, particularly a therapeutically effective temperature, reversible color change in the gel material is observed.
  • the present invention relates to an ocular pad comprising a pocket containing a gel material which comprises a thermochromic dye which reversibly changes color when heated above a threshold temperature ranging from 40°C to 45°C.
  • the pad of the invention when the pad of the invention reaches the suitable temperature under heating, it changes color noticeably, thus allowing the user to have an immediate visual confirmation that the device is ready to be applied, since it has reached a therapeutically effective warm temperature.
  • the control of the temperature for example by a thermometer, is not necessary, having as a result a more convenient, quick and user friendly procedure.
  • the pad of the present invention allows to standardize the application on the periocular area. Furthermore, the use of the pad is very easy, so that it is suitable for the domestic use. Moreover, the small size of the pad makes it portable.
  • Figure 1 shows a schematic view of the pad according to the invention.
  • a pad (1) is shown having a pocket (2) made of polymeric material, which contains the gel material.
  • the pocket (2) is closed by a rim (3) obtained by hot welding the plastic edges.
  • the pad (1) preferably has a flap (4) which is conveniently shaped to allow an easy handling of the pad (1) during heating and during application on the periocular area.
  • peripheral area means the whole periocular area or a partial area thereof, such as, for example, the eyelids (upper and/or lower) .
  • the thermochromic dye is a thermochromic leuco-dye. More preferably, the thermochromic dye comprises a fluoran-based dye and a developer. Preferably, the weight ratio between the fluoran-based dye and the developer ranges from 30:70 to 70:30, more preferably from 40:60 to 60:40.
  • the fluoran-based dye is preferably selected from: 3-diethylamino- 6-methyl- 7,2, 4-xylidinofluoran, 3-dimethylamino-7- methoxyfluoran, 3-diethylamino- 6-methoxyfluoran, 3- diethy1amino-7-methoxyfluoran, 3-diethylamino-7- chlorofluoran, 3-diethylamino- 6-methyl-7-chlorofluoran, 3-diethylamino-6, 7-dimethylfluoran, 3- (N-ethyl-p- toluidino) -7-methylfluoran, 3-diethylamino-7-N-acetyl- N-methylamino ) fluoran, 3-diethylamino-7-N- methylaminofluoran, 3-diethylamino-7- dibenzylaminofluoran, 3-diethylamino-7- (N-methyl-N- benzylaminofluoran,
  • the developer is a phenolic compound preferably selected from: isopropylidenediphenol (bisphenol A) , p-octylphenol , p- tert-butylphenol , p-phenylphenol , p- hydroxyacetophenone, alpha-naphthol , beta-naphthol , p- tert-octylcatechol, 2 , 2 ' -dihydroxybiphenyl , l,l-bis(p- hydroxyphenyl ) butane, 2 , 2-bis ( 4-hydroxyphenyl ) heptane, 2 , 2-bis ( 3-methyl-4-hydroxyphenyl ) propane, 2,2- bis (3,5- dimethyl-4-hydroxyphenyl ) propane, 2, 2-bis (3, 5-dichloro- 4-hydroxyphenyl ) propane, bis ( 4-hydroxyphenyl ) sulfone, bis ( 3 , 4-dihydroxypheny
  • the color change is reversible.
  • the qualitative color change depends on the thermochromic dye used. For example, when the threshold temperature is exceeded, the color of the gel material can change from orange or green to yellow.
  • thermochromic dye is in the form of droplets microencapsulated in a protective coating.
  • the droplets have preferably an average size from 1 ⁇ to 10 ⁇ .
  • Microencapsulation of the thermochromic dye can be obtained according to well known techniques (see e.g. the handbook by A. Kondo and J. Wade van Valkenburg, Eds., Microcapsule Processing and Technology', Marcel Dekker (1979) ) .
  • the threshold temperature ranges from
  • the pad can be effectively used many times, to make the system economically sustainable.
  • the ocular pad is made of a polymeric material, which is flexible and soft so as to improve comfort during use.
  • a polymeric material may be selected from a large number of materials, such as polyvinylchloride (PVC) , polyethylene, polypropylene, polyesters, polyamides, and the like.
  • PVC polyvinylchloride
  • the pocket in the pad may be obtained for instance by peripheral hot welding of two superimposed polymer sheets. The pocket is then filled with the gel material according to well known techniques .
  • the gel material preferably comprises a gelling agent, which is preferably selected from carboxymethyl cellulose or a salt thereof, particularly sodium carboxymethyl cellulose, agar powder, sodium polyacrylate, and the like.
  • a gelling agent which is preferably selected from carboxymethyl cellulose or a salt thereof, particularly sodium carboxymethyl cellulose, agar powder, sodium polyacrylate, and the like.
  • the gel material preferably comprises water. Moreover, it preferably comprises a polyol, more preferably glycerin.
  • the gel material preferably may contain further ingredients such as: solvents, fillers, preservatives, UV stabilizers, antioxidants, and the like.
  • the present invention relates to a method for warming a periocular area, comprising the following steps:
  • the above method is particularly suitable to treat various ocular conditions, such as Meibomian Gland Dysfunction (MGD) , dry eye, chalazion, sore eyes and blepharitis .
  • MMD Meibomian Gland Dysfunction
  • the pad can be heated by dipping the same into hot water or putting the pad under hot running water.
  • the pad can be heated by microwave, preferably for a time ranging from 10 to 15 sec.
  • the heating by microwave is carried out at 400-500 watt.
  • the pad can be of different shapes, such that allowing a suitable and convenient coverage of the periocular area. Moreover, in order to aid the user during the heating step, the pad is equipped with a flap enabling the patient to hold the pad during heating .
  • the pad in order to reach a suitable temperature, is heated for at least 3 minutes with hot water.
  • the pad can be of any suitable shape for application on the periocular area, such as substantially circular, oval, squared or lobated shape.
  • the dimensions are of course suitable to the intended use.
  • the diameter is preferably from 3 to 8 cm, preferably from 4 to 6 cm.
  • the pad has a thickness from 0.3 cm to 3 cm, more preferably from 0,5 cm cm to 1,5 cm.
  • Example 1 The present invention will now be further illustrated by means of the following examples, which are illustrative only and are not intended to limit in any sense the scope of the invention.
  • Example 1 The present invention will now be further illustrated by means of the following examples, which are illustrative only and are not intended to limit in any sense the scope of the invention.
  • a pad was made by hot welding two layers of flexible PVC (free from phthalates) so as to form a pocket which was filled with a gel material having the following composition:
  • the above leuco-dye was in the form of microcapsules by using melamine formaldehyde resin as protective coating.
  • the pad as above was dipped into hot water until a change from green to yellow was observed.
  • the pad was cooled to room temperature, thus observing a color change from yellow to green, and then repeatedly heated with hot water and cooled to room temperature for 28 times.
  • the pad maintained substantially unaltered the ability to change its color from green to yellow and vice versa.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un tampon oculaire comprenant une poche contenant un matériau de gel qui change de couleur de façon réversible lorsqu'il est chauffé au-dessus d'une température seuil. Ledit tampon est particulièrement adapté pour chauffer une zone péri-oculaire.
PCT/IB2017/058335 2016-12-28 2017-12-22 Tampon oculaire et procédé de chauffage d'une zone péri-oculaire WO2018122710A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP17829039.1A EP3562447A1 (fr) 2016-12-28 2017-12-22 Tampon oculaire et procédé de chauffage d'une zone péri-oculaire

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000131691 2016-12-28
IT102016000131691A IT201600131691A1 (it) 2016-12-28 2016-12-28 Compressa oculare e metodo per scaldare una regione perioculare.

Publications (1)

Publication Number Publication Date
WO2018122710A1 true WO2018122710A1 (fr) 2018-07-05

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Application Number Title Priority Date Filing Date
PCT/IB2017/058335 WO2018122710A1 (fr) 2016-12-28 2017-12-22 Tampon oculaire et procédé de chauffage d'une zone péri-oculaire

Country Status (4)

Country Link
EP (1) EP3562447A1 (fr)
IT (1) IT201600131691A1 (fr)
MA (1) MA47161A (fr)
WO (1) WO2018122710A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022512653A (ja) * 2018-10-11 2022-02-07 インヒブリックス， インコーポレイテッド Ｐｄ－１単一ドメイン抗体およびその治療用組成物
WO2022248543A1 (fr) 2021-05-25 2022-12-01 Aurox Gmbh Dispositif de régulation de température pour patchs pour le visage
DE202022104070U1 (de) 2022-07-19 2023-10-20 Aurox Gmbh Temperiervorrichtung zur dermalen Applikation und thermoelektrische Module
WO2023213950A1 (fr) 2022-05-04 2023-11-09 Aurox Gmbh Dispositif de régulation de température pour coussinets pour le visage

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090149925A1 (en) * 2007-12-05 2009-06-11 Kimberly-Clark Worldwide, Inc. Temperature Indicator for Warming Products
US20110077527A1 (en) * 2009-09-30 2011-03-31 Yang Seungrim Self-cooling gel substrate for temperature differentiated imaging
US20130172829A1 (en) * 2012-01-04 2013-07-04 Sight Sciences, Inc. Dry eye treatment systems

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090149925A1 (en) * 2007-12-05 2009-06-11 Kimberly-Clark Worldwide, Inc. Temperature Indicator for Warming Products
US20110077527A1 (en) * 2009-09-30 2011-03-31 Yang Seungrim Self-cooling gel substrate for temperature differentiated imaging
US20130172829A1 (en) * 2012-01-04 2013-07-04 Sight Sciences, Inc. Dry eye treatment systems

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
"Microcapsule Processing and Technology", 1979, MARCEL DEKKER
GEERLING G; TAUBER J; BAUDOUIN C; GOTO E; MATSUMOTO Y; O'BRIEN T ET AL.: "The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction", INVEST. OPHTHALMOL. VIS. SCI., vol. 52, no. 4, 2011, pages 2050 - 2064
OLSON M C ET AL: "Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction", EYE AND CONTACT, LIPPINCOTT WILLIAMS & WILKINS, US, vol. 29, no. 2, 1 April 2003 (2003-04-01), pages 96 - 99, XP008173754, ISSN: 1542-2321, DOI: 10.1097/01.ICL.0000060998.20142.8D *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022512653A (ja) * 2018-10-11 2022-02-07 インヒブリックス， インコーポレイテッド Ｐｄ－１単一ドメイン抗体およびその治療用組成物
WO2022248543A1 (fr) 2021-05-25 2022-12-01 Aurox Gmbh Dispositif de régulation de température pour patchs pour le visage
WO2023213950A1 (fr) 2022-05-04 2023-11-09 Aurox Gmbh Dispositif de régulation de température pour coussinets pour le visage
DE202022104070U1 (de) 2022-07-19 2023-10-20 Aurox Gmbh Temperiervorrichtung zur dermalen Applikation und thermoelektrische Module
EP4309634A2 (fr) 2022-07-19 2024-01-24 AUROX GmbH Dispositif de régulation de température pour application dermique et modules thermoélectriques

Also Published As

Publication number Publication date
EP3562447A1 (fr) 2019-11-06
IT201600131691A1 (it) 2018-06-28
MA47161A (fr) 2019-11-06

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