JPWO2021136820A5

JPWO2021136820A5 -

Info

Publication number: JPWO2021136820A5
Application number: JP2022540851A
Authority: JP
Publication date: 2024-01-04

Claims

A small device for producing reflex lachrymal secretion, the device comprising:
said reflex by chemically stimulating the cornea of the subject's eye by means of spraying said cornea with a controlled jet of a gas mixture having a high _CO2 content, of which at least 80% is _CO2 . lachrymal secretion is produced ,
said chemical stimulation is combined with mechanical and cold stimulation caused by gas injection to result in maximal reflex lachrymal secretion;
small device .

the exit pressure of the gas jet applied towards the surface of the cornea is higher than atmospheric pressure;
Miniaturized device (1,1) according to claim 1, wherein the gas mixture comprises 99% _CO2 .

Small device (1,1) according to claim 1 or 2 , wherein the blowing of gas towards the surface of the cornea is applied at a flow rate of 150 ml/min or more.

4. According to any one of claims 1 to 3 , the blow of gas directed towards the surface of the cornea is a short puff applied over a preset time period of between 2 seconds and 6 seconds. Small device (1,1) .

A small device (1, 1') according to claim 1, comprising :
a gas source (7) in the form of a disposable cartridge containing a pressurized gas whose composition is at least 80% _CO2 ;
a pneumatic circuit connecting the outlet of the gas source (7) to the gas outlet nozzle (3) of the small device (1, 1');
The pneumatic circuit includes a pressure adjustment means (8) and a flow rate (17) adjustment means,
Said pressure regulating means (8) and said flow rate (17) regulating means direct said gas spray through said outlet nozzle (3) at a predetermined pressure of 1 to 1.5 bar (100 to 150 kPa) and at least 150 ml/min, respectively . Suitable for discharging at a predetermined flow rate of
the gas source (7) and the pneumatic circuit are integrated into a housing (2) that can be grasped with one hand or attached to an instrument holding bar of a common eye examination table;
The small device (1, 1') is
a user-operable gas blowing trigger (4);
further comprising a spacer bracket (5);
The spacer bracket (5) is
a proximal end coupled to the housing (2) around the outlet nozzle (3);
ergonomically supported on the target eye socket of the subject and providing a separation distance between the gas outlet nozzle (3) and the corneal surface of the subject during firing by the small device (1, 1'); a small device (1,1') having a distal end with a structured periphery.

The pressure adjustment means (8)
connected to the outlet of the gas source (7);
The pressure of the gas stream at the outlet of the gas source (7) is adjusted to a pre-established set point of 1.2 to 1.6 bar (120 kPa to 160 kPa) to Miniaturized device (1,1') according to claim 5 , configured to provide a predetermined pressure of 1.0 to 1.5 bar (100 kPa to 150 kPa) at the outlet.

said pneumatic circuit further comprising solenoid valve means (13) arranged downstream of said pressure regulating means (8) and configured to control the passage of said gas flow towards said outlet nozzle (3);
Compact device (1, 1') according to claim 5 or 6 , wherein said flow rate (17) regulating means are arranged downstream of said solenoid valve means (13) and connected to said outlet nozzle (3). ).

Claims 5 to 7 , wherein the pneumatic circuit further comprises pressure sensor means (25, 26) configured to measure the pressure (P1, P2) at one or more intermediate points along the gas flow path. The small device (1, 1') according to any one of the above.

The pressure sensor means for the gas flow comprises:
a first pressure sensor (25) designed to measure the intermediate pressure (P1) present at the outlet of said pressure regulating means (8);
Compact device (1, according to claim 8 ), comprising a second pressure sensor (26) designed to measure the intermediate pressure (P2) present at the inlet of said flow rate (17) regulating means. 1').

The pneumatic circuit ensures that the gas flow is discharged when the pressure (P1, P2) detected by the pressure sensor means (25, 26) is higher than a set pressure value at each of the intermediate measurement points. Compact device (1, 1') according to claim 8 or 9 , further comprising configured safety valve means (9, 16).

11. According to any one of claims 5 to 10 , the pneumatic circuit further comprises solid particle filtration means (10, 14) arranged at one or more intermediate points along the gas flow path. A small device (1,1').

Compact device (1, 1') according to any one of claims 5 to 11 , comprising power supply means (14).

Small device (1, 1') according to claim 12 , wherein the power supply means are constituted by a battery (24) rechargeable using an external charger (31) connected to a power supply network. ).

It further comprises lights (21, 22, 23) and/or acoustic indicator means, said lights (21, 22, 23) and/or said acoustic indicator means indicating whether said small device (1, 11') is on or off. Compact device according to any one of claims 5 to 13 , associated with different states and alarm situations, such as off-state, activation of a trigger phase, pressure status alarm, load level of the power supply means. (1,1').

comprising control means managed by a microprocessor (27) with appropriate software;
said control means are configured to process signals detected by said pressure sensors (25, 26) and signals about the state of charge of said power supply means (24) during the activation of a trigger phase; This sends an actuation signal to said solenoid valve means (13) to direct the subject's cornea through said nozzle (3) for a predetermined period of time under controlled, i.e. pre-established conditions of outlet pressure and flow rate. Small device (1, 1') according to any one of claims 12 to 14 , intended for emitting a puff of gas applied in the direction of.

The microprocessor (27) comprises a personal area communication (PAN), which allows the microprocessor (27) to perform read/write actions through an interface/application. Small device (1, 1') according to claim 15 , making it possible to connect with an external device to obtain information related to the identification of the cartridge using NFC technology.

The spacer bracket (5) is
It is asymmetrical;
Device (1) according to any one of claims 5 to 16 , which is rotatable around the outlet nozzle (3) and can be used interchangeably in one or the other eye of the subject. ,1').

The periphery of the spacer bracket (5) intended to be in contact with the eye socket is made of biocompatible material, such as silicone, with antibacterial and hypoallergenic properties, so as to be more hygienic and comfortable. Small device (1, 1') according to any one of claims 5 to 17 , covered with a fabricated protective element (6).

the protective element (6) is provided with removable fixing means, such as adhesive, on the contact surface with the spacer bracket (5) to facilitate the placement and removal of the protective element (6); 19. Small device ( 1 , 1') according to claim 18, wherein the protective element (6) is disposable and for single use per subject.

the small device has a pistol- like shape and is portable and has dimensions that can be held in one hand;
Said housing (2) comprises a handle-like part (2a) and a body (2b), in the front end of said body (2b) there is said outlet nozzle (3) for spraying CO ₂ and said trigger Compact device (1, 1') according to any one of claims 5 to 19 , characterized in that (4) is integrated in the area of the housing (2).

said trigger comprises a trigger (4) arranged at an ergonomic distance from said handle (2a) and actuable with at least one finger of the same hand holding said grip part (2a); Small-sized device (1) according to claim 20 .

The housing (2) comprises a removable part arranged in the area of the handle (2a) and provided with an internal cavity for placing a CO ₂ cartridge (7). 22. Small-sized device (1) according to claim 20 or 21 , comprising:

the small device is configured to be coupled to an instrument holding bar of a typical eye examination table;
Compact device (1') according to any one of claims 5 to 22 , wherein the trigger comprises remote actuation means separate from the housing (2).

A kit for measuring and analyzing the magnitude of tear flow, the kit comprising:
A small device (1, 1') according to any one of claims 5 to 23 ,
a set of measuring strips (40) for carrying out a Schirmer test for the purpose of diagnosing ophthalmological diseases, in particular dry eye diseases;
said measuring strip (40) is particularly suitable for being used to measure the magnitude of the maximum reflective tear secretion produced by said miniature device (1, 1');
The measuring strip is composed of a millimeter filter paper strip (40) with a length of more than 30 mm, and the proximal end of the filter paper strip (40) has rounded edges to avoid irritation by eliminating sharp corners. intended to be inserted into the space between the bulbar conjunctiva and the eyelid as a tab (41) having a section;
Kit, wherein said filter paper strip (40) is sterile and said tab (41) contains a dry solution of ophthalmic anesthetic.

Kit according to claim 24 , wherein the filter paper strip (40) has a width of 5 to 10 mm and a total length of 50 mm.