IT202100002924A1 - SCREENING DEVICE TO SUPPORT CLINICAL DIAGNOSIS, PARTICULARLY THE DIAGNOSIS OF CYSTIC FIBROSIS - Google Patents

SCREENING DEVICE TO SUPPORT CLINICAL DIAGNOSIS, PARTICULARLY THE DIAGNOSIS OF CYSTIC FIBROSIS Download PDF

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Publication number
IT202100002924A1
IT202100002924A1 IT102021000002924A IT202100002924A IT202100002924A1 IT 202100002924 A1 IT202100002924 A1 IT 202100002924A1 IT 102021000002924 A IT102021000002924 A IT 102021000002924A IT 202100002924 A IT202100002924 A IT 202100002924A IT 202100002924 A1 IT202100002924 A1 IT 202100002924A1
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IT
Italy
Prior art keywords
sweat
screening device
diagnosis
meq
sensor
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IT102021000002924A
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Italian (it)
Inventor
Valentina Stellato
Original Assignee
Cerebro S R L
Valentina Stellato
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Application filed by Cerebro S R L, Valentina Stellato filed Critical Cerebro S R L
Priority to IT102021000002924A priority Critical patent/IT202100002924A1/en
Priority to PCT/EP2021/061862 priority patent/WO2022171315A1/en
Publication of IT202100002924A1 publication Critical patent/IT202100002924A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/14517Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat
    • A61B5/14521Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat using means for promoting sweat production, e.g. heating the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient ; user input means
    • A61B5/742Details of notification to user or communication with user or patient ; user input means using visual displays

Description

Descrizione dell?Invenzione Industriale avente per titolo: Description of the Industrial Invention entitled:

?Dispositivo di screening per supportare diagnosi cliniche, in particolare la diagnosi della fibrosi cistica? ?Screening device to support clinical diagnoses, especially the diagnosis of cystic fibrosis?

DESCRIZIONE DESCRIPTION

La presente invenzione si riferisce ad un dispositivo di screening per supportare diagnosi cliniche, in particolare la diagnosi della fibrosi cistica. The present invention relates to a screening device for supporting clinical diagnoses, in particular the diagnosis of cystic fibrosis.

Il test di screening della presente invenzione ? uno strumento di piccole/medie dimensioni, trasportabile e pratico, ed ? ideato per prelevare la quantit? di salinit? nel sudore, necessario in pratica clinica per aiutare a supportare alcune diagnosi, soprattutto per la diagnosi della fibrosi cistica. La presente descrizione sar? pertanto incentrata sulla diagnosi della fibrosi cistica, anche se il dispositivo descritto potr? essere utilizzato anche per altre diagnosi cliniche. The screening test of the present invention ? a small / medium-sized tool, transportable and practical, and ? designed to take the amount? of salinity in sweat, which is needed in clinical practice to help support some diagnoses, especially for the diagnosis of cystic fibrosis. This description will be therefore focused on the diagnosis of cystic fibrosis, even if the described device could? also be used for other clinical diagnoses.

La fibrosi cistica ? una malattia genetica autosomica recessiva, causata da una mutazione del gene CF che codifica per una proteina che funge da canale per il cloro, definita CFTR. L?alterazione di questo gene determina la produzione di muco eccessivamente denso, che causa vari problemi, tra cui: infezioni ricorrenti; chiusura dei bronchi; ed inoltre comporta un?anomalia del trasporto di sali e determina la produzione di secrezioni maggiormente disidratate. Cystic fibrosis? an autosomal recessive genetic disorder caused by a mutation in the CF gene that codes for a protein that acts as a chloride channel, called CFTR. The alteration of this gene causes the production of excessively thick mucus, which causes various problems, including: recurring infections; closure of the bronchi; and also involves an anomaly in the transport of salts and determines the production of more dehydrated secretions.

Pertanto, il sudore ? ricco di sodio e cloro, rilasciando e producendo muco pi? denso e vischioso, che tende ad ostruire i dotti nei quali viene a trovarsi. In questa malattia, tra i sintomi riscontrabili si nota: eccessiva salinit? nel sudore del soggetto affetto da tale malattia. Therefore, the sweat ? rich in sodium and chlorine, releasing and producing more mucus? thick and viscous, which tends to obstruct the ducts in which it is found. In this disease, among the symptoms that can be found we note: excessive salinity? in the sweat of the subject affected by this disease.

Per questo motivo, nel 1959 ? stato coniato il test del sudore, da Gibson e Cooke. Il test dell?arte nota, prevede due fasi: For this reason, in 1959 ? The sweat test was coined by Gibson and Cooke. The prior art test involves two phases:

1. La prima fase ? composta dalla stimolazione del sudore, attraverso l?applicazione, sulle gambe o sugli avambracci, di due elettrodi su cui sono posti due gel aventi pilocarpina. La corrente elettrica a basso voltaggio, che proviene da un generatore a batteria, favorisce il trasporto di pilocarpina su strati superficiali della pelle, stimolando la produzione del sudore. 1. The first phase ? composed of the stimulation of sweat, through the application, on the legs or forearms, of two electrodes on which two gels containing pilocarpine are placed. The low voltage electric current, which comes from a battery generator, favors the transport of pilocarpine on the superficial layers of the skin, stimulating the production of sweat.

2. La seconda fase, invece, prevede l?analisi del sudore del paziente. 2. The second phase, on the other hand, involves the analysis of the patient's sweat.

L?arte nota, ha i seguenti svantaggi: The prior art has the following disadvantages:

- il test pu? essere eseguito solo ed esclusivamente da personale esperto e in strutture specializzate - the test can? be performed only and exclusively by expert personnel and in specialized structures

- pu? provocare dolore od avvertire una sensazione di prurito con comparsa di eczema nella zona dove ? stato stimolato il sudore - can? cause pain or feel an itchy sensation with the appearance of eczema in the area where ? sweat was stimulated

- per la fase in cui deve essere applicata la carta assorbente, affinch? si esegua il test correttamente, il tempo necessario ? all?incirca di 30 minuti - for the phase in which the absorbent paper must be applied, so that? the test is performed correctly, how long does it take? approximately 30 minutes

- rischio di ustioni, anche se in rari casi (nell?ordine di un caso su 50.000) ed aumenta in caso di scarsa esperienza dell?operatore o di apparecchiature obsolete/antiquate - risk of burns, even if in rare cases (in the order of one case in 50,000) and increases in the case of lack of experience of the operator or obsolete/old-fashioned equipment

- per l?analisi del sudore, il dispositivo deve essere inviato ad un laboratorio specializzato, dove il tempo di refertazione pu? essere di 1 o 2 giorni lavorativi. Inoltre un singolo risultato di laboratorio non ? sufficiente a confermare od a escludere la diagnosi di FC. - for sweat analysis, the device must be sent to a specialized laboratory, where the reporting time can be 1 or 2 business days. Furthermore, a single laboratory result is not ? sufficient to confirm or exclude the diagnosis of CF.

Scopo della presente invenzione ? risolvere i suddetti problemi della tecnica anteriore, prevedendo un dispositivo di screening per supportare diagnosi cliniche, in particolare la diagnosi della fibrosi cistica, che sostituisca la tecnica sopra indicata, che necessita di un personale sanitario per essere effettuata e strumenti adatti. Purpose of the present invention? solve the aforementioned problems of the prior art, providing a screening device to support clinical diagnoses, in particular the diagnosis of cystic fibrosis, which replaces the above indicated technique, which requires a healthcare personnel to be performed and suitable tools.

I suddetti ed altri scopi e vantaggi dell?invenzione, quali risulteranno dal seguito della descrizione, vengono raggiunti con un dispositivo di screening per supportare diagnosi cliniche, in particolare la diagnosi della fibrosi cistica, come quello descritto nella rivendicazione 1. Forme di realizzazione preferite e varianti non banali della presente invenzione formano l?oggetto delle rivendicazioni dipendenti. The above and other objects and advantages of the invention, as will appear from the following description, are achieved with a screening device for supporting clinical diagnoses, in particular the diagnosis of cystic fibrosis, such as the one described in claim 1. Preferred embodiments and non-trivial variants of the present invention form the object of the dependent claims.

Resta inteso che tutte le rivendicazioni allegate formano parte integrante della presente descrizione. It is understood that all the attached claims form an integral part of the present description.

La presente invenzione verr? meglio descritta da alcune forme preferite di realizzazione, fornite a titolo esemplificativo e non limitativo, con riferimento ai disegni allegati, nei quali l?unica Figura 1 ? una vista schematica di una realizzazione preferita del dispositivo secondo la presente invenzione. This invention will come better described by some preferred embodiments, provided by way of non-limiting example, with reference to the attached drawings, in which the only Figure 1 is a schematic view of a preferred embodiment of the device according to the present invention.

Facendo riferimento alla Figura, ? illustrata e descritta una forma di realizzazione preferita del dispositivo della presente invenzione. Risulter? immediatamente ovvio che si potranno apportare a quanto descritto innumerevoli varianti e modifiche (per esempio relative a forma, dimensioni, disposizioni e parti con funzionalit? equivalenti) senza discostarsi dal campo di protezione dell'invenzione come appare dalle rivendicazioni allegate. Referring to the Figure, ? illustrated and described a preferred embodiment of the device of the present invention. will result? it is immediately obvious that innumerable variations and modifications may be made to what has been described (for example relating to shape, dimensions, arrangements and parts with equivalent functions) without departing from the scope of protection of the invention as appears from the attached claims.

Con riferimento alla Figura 1, il dispositivo di test della presente invenzione comprende: With reference to Figure 1, the test device of the present invention comprises:

- almeno un tampone 1 assorbente la quantit? di sudore necessario ai fini di un test diagnostico; - at least one absorbent pad 1 the quantity? of sweat needed for a diagnostic test;

- almeno un rilevatore di salinit? 2 collegato al tampone 1 ed atto a misurare la quantit? di sali presenti sul tessuto da analizzare; - at least one salinity detector? 2 connected to buffer 1 and suitable for measuring the quantity? of salts present on the tissue to be analysed;

- almeno un sensore/attuatore 3 collegato al rilevatore di salinit? 2, il quale sensore/attuatore 3, a seconda delle concentrazioni, segnala i valori che possono essere riscontrati per una probabile diagnosi. - at least one sensor/actuator 3 connected to the salinity detector? 2, which sensor/actuator 3, depending on the concentrations, signals the values which can be found for a probable diagnosis.

Nel momento di secrezione del sudore, il soggetto pu? mettere il dispositivo sotto le ascelle per qualche minuto (preferibilmente, all?incirca 5 minuti), che ? il tempo necessario in cui il tampone 1 possa assorbire il sudore. In the moment of sweat secretion, the subject can? put the device under the armpits for a few minutes (preferably, around 5 minutes), what is it? the time required for pad 1 to absorb sweat.

Le quantit? di sudore che il tampone 1 deve raccogliere deve essere: The quantities? of sweat that pad 1 must collect must be:

- superiore a 75 mg - greater than 75 mg

- inferiore a 400/500 mg - less than 400/500 mg

affinch? tali quantit? risultino essere sufficienti per eseguire correttamente il test, come gi? noto ad un tecnico del ramo. so that such quantities? turn out to be sufficient to correctly run the test, as already? known to a person skilled in the art.

Inoltre, le concentrazioni su cui dovr? basarsi il rilevatore 2, sono le seguenti: Furthermore, the concentrations on which it will have to? be based on detector 2, are as follows:

- una concentrazione di cloro nel sudore: < 40 mEq/L corrisponde ad una situazione normale - a concentration of chlorine in sweat: < 40 mEq/L corresponds to a normal situation

- una concentrazione di cloro nel sudore di livello intermedia, tra 40 e 60 mEq/L ? un valore suggestivo, ma non sufficiente per una diagnosi di FC: potrebbe essere segnalata dal sensore 3, ad esempio, con il colore giallo - an intermediate level of chlorine concentration in sweat, between 40 and 60 mEq/L ? a suggestive value, but not sufficient for a diagnosis of HR: it could be signaled by sensor 3, for example, with the color yellow

- una concentrazione di cloro nel sudore uguale o maggiore di 60 mEq/L supporta, invece, la diagnosi di fibrosi cistica. - a concentration of chloride in sweat equal to or greater than 60 mEq/L supports the diagnosis of cystic fibrosis.

Fino ai 6 mesi d?et? la normale concentrazione di cloro nel sudore scende a 30 mEq/L. Up to 6 months d?et? normal sweat chloride concentration drops to 30 mEq/L.

Il sensore 3 pu? essere collegato ad almeno un display (non mostrato) per mostrare all?utente il risultato calcolato dal sensore 3 mediante il rilevatore 4. The sensor 3 can? be connected to at least one display (not shown) to show the user the result calculated by sensor 3 using detector 4.

Ad esempio, se la concentrazione di cloro nel sudore: < 40 mEq/L per gli adulti o 30 mEq/L per i bambini, allora si potrebbe accendere una spia di colore verde. For example, if the chlorine concentration in sweat: < 40 mEq/L for adults or 30 mEq/L for children, then a green light may turn on.

Se la concentrazione di cloro nel sudore ? intermedia, tra 40 e 60 mEq/L, allora si potrebbe accendere una spia di colore giallo. If the concentration of chlorine in the sweat ? intermediate, between 40 and 60 mEq/L, then a yellow light could come on.

Se la concentrazione di cloro nel sudore ? uguale o maggiore di 60 mEq/L, allora si potrebbe accendere una spia di colore rosso. If the concentration of chlorine in the sweat ? equal to or greater than 60 mEq/L, then a red light may turn on.

I vantaggi offerti da tale test, a differenza dell?arte nota, sono: The advantages offered by this test, unlike the prior art, are:

- esso non necessita dell?assistenza di personale esperto o specializzato - it does not require the assistance of expert or specialized personnel

- fornisce risultati in pochi minuti - provides results in minutes

- pu? essere eseguito ovunque si voglia, date le dimensioni del dispositivo - can? run wherever you want, given the size of the device

- non causa irritazioni od altre conseguenze al soggetto in esame - does not cause irritation or other consequences to the subject in question

- evita la fase di invio ad un laboratorio per poter analizzare il campione, che ? sostituito nell?innovativo dispositivo, dal componente 3, che riesce ad esaminare in tempi rapidi il valore necessario ai fini del test. - avoids the phase of sending to a laboratory to be able to analyze the sample, which ? replaced in the innovative device by component 3, which is able to rapidly examine the value necessary for the purposes of the test.

Ad una parte terminale del dispositivo inventivo ? possibile associare almeno un cerotto 4, collegato al rilevatore di salinit? 3, tale cerotto 4 operando come elemento di rilascio transdermico contenente pilocarpina. To an end part of the inventive device ? Is it possible to associate at least one patch 4, connected to the salinity detector? 3 , this patch 4 acting as a pilocarpine-containing transdermal delivery element.

Preferibilmente, si possono utilizzare un alimentatore esterno (non mostrato) o una batteria interna (non mostrata) per velocizzare il processo/azione della pilocarpina a far rilasciare il sudore, attraverso il cerotto 4. Da solo un cerotto 4, secondo l?arte, nota pu? impiegare dalle 48 alle 72 ore per rilasciare la sostanza, ed avere effetti desiderati, mentre lo scopo della batteria o dell?alimentatore ? quello di ridurre i tempi di rilascio della sostanza per permettere la secrezione di sudore. Preferably, an external power supply (not shown) or an internal battery (not shown) can be used to speed up the process/action of the pilocarpine to release sweat, through the patch 4. A patch 4 alone, according to the art, note can? take from 48 to 72 hours to release the substance, and have the desired effects, while the purpose of the battery or power supply? that of reducing the time of release of the substance to allow the secretion of perspiration.

Sono state illustrate e descritte in precedenza alcune forme di realizzazione preferite della presente invenzione: ovviamente, agli esperti nel ramo risulteranno immediatamente evidenti numerose varianti e modifiche, funzionalmente equivalenti alle precedenti, che ricadono nel campo di protezione dell'invenzione come evidenziato nelle rivendicazioni allegate. Some preferred embodiments of the present invention have been illustrated and described above: obviously, numerous variants and modifications, functionally equivalent to the previous ones, which fall within the scope of protection of the invention as highlighted in the attached claims, will obviously be immediately apparent to those skilled in the art.

Claims (6)

RIVENDICAZIONI 1. Dispositivo di screening per supportare diagnosi cliniche, in particolare la diagnosi della fibrosi cistica, detto dispositivo comprendendo:A screening device for supporting clinical diagnoses, in particular the diagnosis of cystic fibrosis, said device comprising: - almeno un tampone (1) assorbente la quantit? di sudore necessario ai fini di un test diagnostico;- at least one pad (1) absorbing the quantity? of sweat needed for a diagnostic test; - almeno un rilevatore di salinit? (2) collegato al tampone (1) ed atto a misurare la quantit? di sali presenti su un tessuto da analizzare;- at least one salinity detector? (2) connected to the pad (1) and able to measure the quantity? of salts present on a tissue to be analysed; - almeno un sensore/attuatore (3) collegato al rilevatore di salinit? (2), detto sensore/attuatore (3) essendo progettato, a seconda delle concentrazioni, per segnalare i valori che si riscontrano per una diagnosi.- at least one sensor/actuator (3) connected to the salinity detector? (2), said sensor/actuator (3) being designed, depending on the concentrations, to signal the values found for a diagnosis. 2. Dispositivo di screening secondo la rivendicazione 1, caratterizzato dal fatto di comprendere inoltre almeno un display, collegato al sensore (3) e progettato per mostrare ad un utente il risultato calcolato dal sensore (3) mediante il rilevatore (4).2. Screening device according to claim 1, characterized in that it further comprises at least one display, connected to the sensor (3) and designed to show a user the result calculated by the sensor (3) by means of the detector (4). 3. Dispositivo di screening secondo la rivendicazione 2, caratterizzato dal fatto che:3. Screening device according to claim 2, characterized in that: se la concentrazione di cloro nel sudore: < 40 mEq/L per gli adulti o 30 mEq/L per i bambini, sul display si accende una spia di colore verde;if the concentration of chlorine in sweat: < 40 mEq/L for adults or 30 mEq/L for children, a green light will turn on on the display; se la concentrazione di cloro nel sudore ? intermedia, tra 40 e 60 mEq/L, sul display si accende una spia di colore giallo;if the concentration of chlorine in the sweat ? intermediate, between 40 and 60 mEq/L, a yellow light comes on on the display; se la concentrazione di cloro nel sudore ? uguale o maggiore di 60 mEq/L, sul display si accende una spia di colore rosso.if the concentration of chlorine in the sweat ? equal to or greater than 60 mEq/L, a red light comes on on the display. 4. Dispositivo di screening secondo la rivendicazione 1, 2 o 3, caratterizzato dal fatto di comprendere inoltre un cerotto (4), collegato al rilevatore di salinit? (3), tale cerotto (4) operando come elemento di rilascio trans-dermico contenente pilocarpina.4. Screening device according to claim 1, 2 or 3, characterized in that it also comprises a plaster (4), connected to the salinity detector? (3), this patch (4) acting as a pilocarpine-containing transdermal delivery element. 5. Dispositivo di screening secondo la rivendicazione 4, caratterizzato dal fatto di comprendere inoltre un alimentatore esterno per velocizzare il processo/azione della pilocarpina a far rilasciare il sudore, attraverso il cerotto (4).5. Screening device according to claim 4, characterized in that it also comprises an external power supply to speed up the process/action of the pilocarpine to release sweat through the plaster (4). 6. Dispositivo di screening secondo la rivendicazione 4, caratterizzato dal fatto di comprendere inoltre una batteria interna per velocizzare il processo/azione della pilocarpina a far rilasciare il sudore, attraverso il cerotto (4). 6. Screening device according to claim 4, characterized in that it also comprises an internal battery to speed up the process/action of the pilocarpine to release sweat through the plaster (4).
IT102021000002924A 2021-02-11 2021-02-11 SCREENING DEVICE TO SUPPORT CLINICAL DIAGNOSIS, PARTICULARLY THE DIAGNOSIS OF CYSTIC FIBROSIS IT202100002924A1 (en)

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IT102021000002924A IT202100002924A1 (en) 2021-02-11 2021-02-11 SCREENING DEVICE TO SUPPORT CLINICAL DIAGNOSIS, PARTICULARLY THE DIAGNOSIS OF CYSTIC FIBROSIS
PCT/EP2021/061862 WO2022171315A1 (en) 2021-02-11 2021-05-05 Screening device to support a clinical diagnosis, in particular a diagnosis of cystic fibrosis

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150112165A1 (en) * 2013-10-18 2015-04-23 University Of Cincinnati Sweat sensing with chronological assurance
WO2020061460A1 (en) * 2018-09-21 2020-03-26 University Of Cincinnati Devices for integrated, repeated, prolonged, and/or reliable sweat stimulation and biosensing and for removing excess water during sweat stimulation
EP3643236A1 (en) * 2018-10-24 2020-04-29 Nokia Technologies Oy An apparatus for sensing biometric parameters

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150112165A1 (en) * 2013-10-18 2015-04-23 University Of Cincinnati Sweat sensing with chronological assurance
WO2020061460A1 (en) * 2018-09-21 2020-03-26 University Of Cincinnati Devices for integrated, repeated, prolonged, and/or reliable sweat stimulation and biosensing and for removing excess water during sweat stimulation
EP3643236A1 (en) * 2018-10-24 2020-04-29 Nokia Technologies Oy An apparatus for sensing biometric parameters

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SAMUEL M MOSKOWITZ ET AL: "Clinical practice and genetic counseling for cystic fibrosis and CFTR-related disorders", GENETICS IN MEDICINE, vol. 10, no. 12, 1 December 2008 (2008-12-01), US, pages 851 - 868, XP055413096, ISSN: 1098-3600, DOI: 10.1097/GIM.0b013e31818e55a2 *

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