IT202000025741A1 - DEVICE FOR THERAPY AND CONTROL OF SKIN DISEASES - Google Patents

DEVICE FOR THERAPY AND CONTROL OF SKIN DISEASES Download PDF

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IT202000025741A1
IT202000025741A1 IT102020000025741A IT202000025741A IT202000025741A1 IT 202000025741 A1 IT202000025741 A1 IT 202000025741A1 IT 102020000025741 A IT102020000025741 A IT 102020000025741A IT 202000025741 A IT202000025741 A IT 202000025741A IT 202000025741 A1 IT202000025741 A1 IT 202000025741A1
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layer
therapy
active ingredient
control
skin diseases
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IT102020000025741A
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Francesca Nesci
Valentina Nesci
Francesco Nesci
Monia Melia
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Valentina Nesci
Francesca Nesci
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Priority to IT102020000025741A priority Critical patent/IT202000025741A1/en
Publication of IT202000025741A1 publication Critical patent/IT202000025741A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • 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
    • 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
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • 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
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • 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
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685Microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • 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
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
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  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Description

DESCRIZIONE DESCRIPTION

del brevetto per invenzione industriale dal titolo: ?Dispositivo per la terapia e controllo di malattie cutanee? of the patent for an industrial invention entitled: ?Device for the therapy and control of skin diseases?

La presente invenzione ? relativa ad un dispositivo per la terapia e controllo di malattie cutanee. The present invention ? relating to a device for the therapy and control of skin diseases.

In particolare, la presente invenzione ? relativa ad un dispositivo per la terapia e controllo di malattie cutanee, come la psoriasi. In particular, the present invention ? relating to a device for the therapy and control of skin diseases, such as psoriasis.

Come ? noto, la psoriasi ? una malattia infiammatoria cronica della pelle solitamente di carattere cronico e recidivante. Nella sua patogenesi intervengono fattori autoimmunitari, genetici e ambientali. La malattia si presenta pi? frequentemente, ma non esclusivamente, sulle superfici estensorie degli arti. La malattia, ad andamento cronico e ricorrente, ? variabile nell'estensione dell'interessamento cutaneo. Si va da soggetti affetti da un numero molto limitato di piccole chiazze fino a soggetti con il corpo quasi completamente coperto da lesioni. Le cause alla base della psoriasi non sono ancora del tutto chiare, ma si ritiene che la componente genetica ed immunologica abbiano un ruolo fondamentale. Diversi fattori ambientali sono in grado di scatenare od aggravare la psoriasi. Fra questi un ruolo importante ? rivestito da traumatismi della pelle, processi infettivi ed alcuni farmaci. How ? know, psoriasis ? a chronic inflammatory skin disease usually of a chronic and relapsing nature. Autoimmune, genetic and environmental factors are involved in its pathogenesis. The disease occurs more frequently, but not exclusively, on the extensor surfaces of the limbs. The disease, with a chronic and recurring course, is variable in the extent of skin involvement. They range from subjects affected by a very limited number of small patches up to subjects with the body almost completely covered by lesions. The underlying causes of psoriasis are not yet fully understood, but it is believed that the genetic and immunological components play a fundamental role. Several environmental factors can trigger or aggravate psoriasis. Among these an important role? covered by skin trauma, infectious processes and some drugs.

Per accertare una diagnosi di psoriasi solitamente ? sufficiente l?osservazione della cute, dato che le manifestazioni sono piuttosto riconoscibili. Tuttavia, a volte una biopsia con esame istologico pu? aiutare a distinguere fra patologie con caratteristiche simili. La diagnosi differenziale, inoltre, serve ad escludere o ad evidenziare la presenza di altre malattie infiammatorie, infettive, allergie e tumori cutanei. To ascertain a diagnosis of psoriasis usually ? observation of the skin is sufficient, given that the manifestations are quite recognizable. However, sometimes a histological biopsy can help distinguish between conditions with similar characteristics. The differential diagnosis also serves to exclude or highlight the presence of other inflammatory, infectious diseases, allergies and skin tumors.

Tuttavia, non esistono dispositivi indossabili in grado di diagnosticare la psoriasi. However, there are no wearable devices that can diagnose psoriasis.

Scopo della presente invenzione ? fornire un dispositivo per la terapia e controllo della psoriasi che sia indossabile, avente, quindi, caratteristiche tali da superare i limiti degli attuali dispositivi di terapia e controllo noti. Purpose of the present invention? to provide a device for the therapy and control of psoriasis which is wearable, therefore having characteristics such as to overcome the limits of the current known therapy and control devices.

Secondo la presente invenzione viene realizzato un dispositivo per la terapia e controllo di malattie cutanee, come definito nella rivendicazione 1. According to the present invention, a device is provided for the therapy and control of skin diseases, as defined in claim 1.

Per una migliore comprensione della presente invenzione viene ora descritta una forma di realizzazione preferita, a puro titolo di esempio non limitativo, con riferimento ai disegni allegati, nei quali: For a better understanding of the present invention, a preferred embodiment is now described, purely by way of non-limiting example, with reference to the attached drawings, in which:

- la figura 1 mostra una vista tridimensionale del dispositivo per la terapia e controllo di malattie cutanee, secondo l?invenzione. - figure 1 shows a three-dimensional view of the device for the therapy and control of skin diseases, according to the invention.

Con riferimento a tale figura, ? mostrato un dispositivo 100 per la terapia e controllo di malattie cutanee, secondo l?invenzione. In particolare, il dispositivo 100 comprende un primo strato 101 di supporto adesivo comprendente un biosensore 101a, comprendente un elemento sensibile biologicamente attivo e un?unit? elettronica di processamento del segnale ricevuto dall?elemento sensibile, in grado di rilevare la presenza di molecole infiammatorie quali TNF-alfa, IL-17, iNos, NF-KB e IKB responsabili della desquamazione e del prurito, che vengono generate sull?epidermide come risposta immunitaria alla patologia in fase attiva, e una valvola di ricarica 101b; un secondo strato 102 contenente un principio attivo costituito da un estratto vegetale, in particolare ricavato da Gypsophila Arrosti, attaccato al di sotto del primo strato di supporto adesivo 101; e un terzo strato 103 comprendente micro-aghi 103a in grado di penetrare l?epidermide e attaccato al di sotto del secondo strato 102. With reference to this figure, ? shown is a device 100 for the therapy and control of skin diseases, according to the invention. In particular, the device 100 comprises a first layer 101 of adhesive support comprising a biosensor 101a, comprising a biologically active sensitive element and a unit? signal processing electronics received by the sensitive element, capable of detecting the presence of inflammatory molecules such as TNF-alpha, IL-17, iNos, NF-KB and IKB responsible for scaling and itching, which are generated on the epidermis as immune response to active disease, and a refill valve 101b; a second layer 102 containing an active ingredient consisting of a vegetable extract, in particular obtained from Roasted Gypsophila, attached below the first adhesive support layer 101; and a third layer 103 comprising microneedles 103a capable of penetrating the epidermis and attached below the second layer 102.

Vantaggiosamente secondo l?invenzione, il dispositivo 100 ? scalabile e pu? essere utilizzato anche per la cosomministrazione di principi attivi e per il trattamento di altre patologie della pelle, come dermatiti, allergie cutanee, lesioni cutanee bollose etc. Advantageously according to the invention, the device 100 is scalable and can It can also be used for the co-administration of active ingredients and for the treatment of other skin pathologies, such as dermatitis, skin allergies, bullous skin lesions, etc.

Vantaggiosamente secondo l?invenzione, attraverso la valvola di ricarica 101b, il paziente pu? ricaricare il dispositivo 100 di principio attivo utilizzando una semplice siringa. Advantageously according to the invention, through the refill valve 101b, the patient can refill the device 100 with active principle using a simple syringe.

Secondo un aspetto dell?invenzione, il dispositivo 100 comprende un led in grado di illuminarsi di rosso quando il dispositivo 100 e?scarico di principio attivo, indicando al paziente la necessita? di ricarica dall?apposita valvola 101b predisposta sullo strato 101 di supporto adesivo. According to one aspect of the invention, the device 100 comprises a LED capable of lighting up red when the device 100 is empty of active principle, indicating to the patient the need from the appropriate valve 101b arranged on the adhesive support layer 101.

Secondo un aspetto dell?invenzione, i dati raccolti dal dispositivo 100 sono resi disponibili ad essere inviati ad un dispositivo mobile su cui sia attiva un?applicazione dedicata, in modo da poter essere organizzati in database per valutare l?andamento della malattia e il follow-up dei pazienti, contribuendo ad avvalorare le attivit? dei dermatologi e dei servizi di telemedicina. According to one aspect of the invention, the data collected by the device 100 are made available to be sent to a mobile device on which a dedicated application is active, so that they can be organized in databases to evaluate the progress of the disease and the follow-up -up of patients, helping to validate the activities? dermatologists and telemedicine services.

Vantaggiosamente secondo l?invenzione, la mascherina esterna del dispositivo pu? essere personalizzata dal paziente a seconda dei gusti e delle sue preferenze, rendendo il dispositivo non un semplice dispositivo indossabile ma un prodotto distintivo, unico, di tendenza. In tal modo il dispositivo 100 permette di controllare il quadro clinico dei pazienti nel tempo, grazie al monitoraggio attivo H24 dello status della malattia. Advantageously according to the invention, the external mask of the device can be personalized by the patient according to his tastes and preferences, making the device not a simple wearable device but a distinctive, unique, trendy product. In this way, the device 100 makes it possible to check the clinical picture of the patients over time, thanks to the 24-hour active monitoring of the disease status.

Vantaggiosamente secondo l?invenzione, il dispositivo 100 consente di ridurre le conseguenze proprie della malattia ma soprattutto di neutralizzare le cause di numerosi effetti collaterali ad essa collegati, eseguendo il monitoraggio costante della malattia che consentira? di organizzare i dati raccolti in database. Advantageously according to the invention, the device 100 allows to reduce the consequences of the disease but above all to neutralize the causes of numerous side effects connected to it, carrying out the constant monitoring of the disease which will allow to organize the data collected in databases.

Durante l?utilizzo, ad esempio, per la terapia e controllo della psoriasi, il biosensore 101a attiva il rilascio del principio attivo direttamente all?interno della placca psoriasica grazie alla tecnologia a micro-aghi. L?elemento biologico del sensore, infatti, interagisce con il substrato da analizzare trasducendo il segnale biochimico in un segnale elettrico. A questo punto, l?unit? di processamento, ad esempio un microcontrollore, in base al valore assunto dall?ingresso del segnale elettrico, attiver? il rilascio della sostanza direttamente all?interno della placca psoriasica grazie ad alla tecnologia a micro-aghi. La valvola 101b consentir? la ricarica del dispositivo 100. Il microcontrollore puo? essere programmato in modo da comunicare con un?applicazione dedicata fornendo un segnale di allerta email, notifica sonora, sms, ecc), in caso di peggioramento o miglioramento della malattia o semplicemente fornendo il servizio di raccolta dati da inviare direttamente al proprio medico. During use, for example, for the therapy and control of psoriasis, the 101a biosensor activates the release of the active ingredient directly inside the psoriatic plaque thanks to micro-needle technology. Indeed, the biological element of the sensor interacts with the substrate to be analyzed by transducing the biochemical signal into an electrical signal. At this point, the unit? of processing, for example a microcontroller, on the basis of the value assumed by the input of the electrical signal, will activate? the release of the substance directly inside the psoriatic plaque thanks to the micro-needle technology. Will valve 101b allow? the recharging of the device 100. The microcontroller can? be programmed to communicate with a dedicated application providing an email alert, sound notification, text message, etc.), in the event of worsening or improvement of the disease or simply providing the data collection service to be sent directly to your doctor.

Il principio attivo ? stato ottenuto mediante il seguente processo di produzione comprendente le fasi di: The active ingredient? been obtained through the following production process including the steps of:

- Sminuzzare 50 g di radici di Gypsophila Arrosti conservate al riparo della luce e inserirle in 200 ml di acqua autoclavata, sotto agitazione in un becker di vetro a riparo dalla luce e a temperatura ambiente per 48 h; - Chop 50 g of Roasted Gypsophila roots stored away from light and put them in 200 ml of autoclaved water, stirring in a glass beaker away from light and at room temperature for 48 hours;

- separare l?acqua dalle radici attraverso la carta da filtro e raccogliere l?acqua cos? filtrata in un altro becker (sempre al riparo dalla luce), costituendo cos? il cosiddetto ?I estratto acquoso?; - separate the water from the roots through the filter paper and collect the water in this way? filtered in another beaker (always away from light), thus constituting? the so-called ?I aqueous extract?;

- addizionare alle radici da cui ? gi? stato ottenuto il I estratto il medesimo volume di acqua autoclavata; - add to the roots from which ? already the same volume of autoclaved water was obtained;

- riporre in agitazione a temperatura ambiente il becker contenente entrambi i becker per altre 48 h; - filtrare l?acqua attraverso la carta da filtro e raccolta in un altro becker (sempre al riparo dalla luce), costituendo cos? il ?II estratto acquoso?. - stir the beaker containing both beakers at room temperature for another 48 hours; - filter the water through the filter paper and collect it in another beaker (always protected from light), thus constituting the ?II aqueous extract?.

- Sterilizzare gli estratti sulle colture cellulari facendoli passare attraverso una membrana di nylon da 0.22 ?m sotto cappa a flusso laminale; - Sterilize the extracts on the cell cultures by passing them through a 0.22 µm nylon membrane under a laminal flow hood;

- Aliquotare gli estratti e conservarli al buio a -20?C. - Aliquot the extracts and store them in the dark at -20?C.

La Richiedente ha eseguito esperimenti utilizzando cellule HaCaT, una linea cellulare immortalizzata di cheratinociti umani (cellule della pelle), ampiamente utilizzata negli studi in vitro per la loro grande capacita? di differenziazione e proliferazione. Le cellule HaCaT sono simili ai normali cheratinociti in termini di produzione di citochine, suggerendo che le HaCaT possono essere un modello utile per studiare interventi e terapie antinfiammatorie sulle malattie della pelle. Sono stati utilizzati quattro gruppi cellulari: un gruppo controllo il quale non ha ricevuto nessun tipo di trattamento (CTR, in bianco); un gruppo stimolato con Oncostatina M (citochina infiammatoria utilizzata per stimolare la crescita cellulare e presente abbondantemente nelle placche psoriasiche; un gruppo trattato con Oncostatina M e I estratto acquoso; un gruppo trattato con Oncostatina M e II estratto acquoso. I due estratti contengono il principio attivo innovativo e sono stati ottenuti dalla stessa specie vegetale, alla stessa concentrazione ma con due metodiche differenti. In particolare, si e? valutata la vitalit? cellulare dei 4 gruppi. Il gruppo trattato con OSM mostra una vitalit? cellulare significativamente ridotta, rispetto al gruppo CTR, mettendo in evidenza come le cellule stimolate con questo agente pro-infiammatorio inizino a morire creando formazioni multistrato come nella psoriasi. Il gruppo trattato con OSM e I estratto acquoso posti insieme a contatto con le cellule ha invece ridotto la mortalit? cellulare, dimostrando significativi effetti protettivi (rispetto al gruppo OSM). Infine, il gruppo trattato con OSM e II estratto acquoso posti insieme, ha ridotto in maniera meno significativa (rispetto al gruppo OSM+I estr. acqu.) la mortalita?cellulare. E? stato inoltre dimostrato che sia il I estratto che il II estratto vegetale posti a contatto con le cellule 1h prima della stimolazione con OSM, hanno mostrato una significativa riduzione della mortalit? cellulare, esibendo effetti protettivi rispetto al gruppo trattato con la sola OSM e rispetto al trattamento insieme. In conclusione, il trattamento con entrambi gli estratti contenti il principio attivo innovativo si e? dimostrato efficace nello stato infiammatorio in un modello cellulare di psoriasi. Tale principio attivo e? capace di ridurre il pattern infiammatorio che coinvolge le principali citochine espresse nella malattia. Le citochine ?coordinano? la comunicazione tra le cellule immunitarie quando e? in atto un processo infiammatorio come l?interleuchina IL-17 A che e?la citochina chiamata in causa nel processo infiammatorio scatenato dalla psoriasi. L?inibizione diretta dell?attivita? di questa interleuchina rappresenta il target terapeutico ideale. Pertanto, l?utilizzo della nostra sostanza da sola o a supporto di una terapia sistemica potrebbe delineare un valido aiuto nel trattamento della psoriasi lieve e moderata. Has the Applicant performed experiments using HaCaT cells, an immortalized cell line of human keratinocytes (skin cells), widely used in in vitro studies due to their large capacity? of differentiation and proliferation. HaCaT cells are similar to normal keratinocytes in terms of cytokine production, suggesting that HaCaTs may be a useful model for studying anti-inflammatory interventions and therapies for skin diseases. Four cell groups were used: a control group which did not receive any type of treatment (CTR, blank); a group stimulated with Oncostatin M (inflammatory cytokine used to stimulate cell growth and abundantly present in psoriatic plaques; a group treated with Oncostatin M and I aqueous extract; a group treated with Oncostatin M and II aqueous extract. The two extracts contain the innovative active ingredient and were obtained from the same plant species, at the same concentration but with two different methods. In particular, the cellular vitality of the 4 groups was evaluated. The group treated with OSM shows a significantly reduced cellular vitality, compared to the CTR group, highlighting how the cells stimulated with this pro-inflammatory agent begin to die creating multilayered formations as in psoriasis.The group treated with OSM and I aqueous extract placed together in contact with the cells instead reduced cell mortality, demonstrating significant protective effects (compared to the OSM group).Finally, the t treated with OSM and II aqueous extract placed together, reduced significantly (compared to the OSM+I extr. acqu.) cellular mortality. AND? It has also been demonstrated that both the I extract and the II plant extract placed in contact with the cells 1h before stimulation with OSM, have shown a significant reduction in mortality. cell, exhibiting protective effects compared to the group treated with OSM alone and compared to treatment together. In conclusion, the treatment with both extracts containing the innovative active ingredient is? demonstrated efficacy in the inflammatory state in a cellular model of psoriasis. This active ingredient is? capable of reducing the inflammatory pattern involving the main cytokines expressed in the disease. Cytokines ?coordinate? communication between immune cells when and? an inflammatory process such as interleukin IL-17 A which is the cytokine involved in the inflammatory process triggered by psoriasis. The direct inhibition of the activity? of this interleukin represents the ideal therapeutic target. Therefore, the use of our substance alone or in support of systemic therapy could outline a valid aid in the treatment of mild and moderate psoriasis.

Pertanto, il dispositivo per la terapia e controllo di malattie cutanee secondo l?invenzione consente di migliorare la qualit? di vita del paziente, grazie alla modalit? di somministrazione della terapia in qualsiasi luogo il paziente si trovi, a lavoro, al parco, in palestra, in piscina, per strada, permettendo cio? al paziente di svolgere le normali attivit? quotidiane, senza sentirsi stigmatizzato dalla societ? a causa del proprio aspetto. Therefore, the device for the therapy and control of skin diseases according to the invention allows to improve the quality of the skin. of life of the patient, thanks to the modality? of administering the therapy in any place the patient is, at work, in the park, in the gym, in the swimming pool, on the street, allowing this? the patient to carry out normal activities daily, without feeling stigmatized by society? because of your appearance.

Inoltre, il dispositivo per la terapia e controllo di malattie cutanee secondo l?invenzione ? comodo da indossare, perche? non e?pesante ed e?ergonomico adattandosi a tutte le parti del corpo colpite dalla malattia (gomiti, ginocchia, schiena, mani etc). Furthermore, the device for the therapy and control of skin diseases according to the invention is comfortable to wear, why? it is not heavy and it is ergonomic, adapting to all parts of the body affected by the disease (elbows, knees, back, hands, etc).

Inoltre, il dispositivo per la terapia e controllo di malattie cutanee secondo l?invenzione ? pratico perch? e? facile da utilizzare e da posizionare sulla placca psoriasica, applicandosi come un semplice cerotto. Furthermore, the device for the therapy and control of skin diseases according to the invention is practical why? And? easy to use and to place on the psoriatic plaque, applying as a simple patch.

Inoltre, il dispositivo per la terapia e controllo di malattie cutanee secondo l?invenzione ? funzionale perch? consente la massima aderenza alla terapia. E?, infatti, il dispositivo a definire i tempi e la quantit? di sostanza da somministrare direttamente nella placca psoriasica. Furthermore, the device for the therapy and control of skin diseases according to the invention is functional why? allows maximum adherence to therapy. And?, in fact, the device to define the times and the quantity? of substance to be administered directly into the psoriatic plaque.

Infine, il dispositivo per la terapia e controllo di malattie cutanee secondo l?invenzione ? autonomo perch? capace di rilevare lo stato di attivit? della malattia e rilasciare direttamente il principio attivo scoperto. Finally, the device for the therapy and control of skin diseases according to the invention ? autonomous why? capable of detecting the state of activity? of the disease and directly release the discovered active principle.

Risulta, infine, chiaro che al dispositivo per la terapia e controllo di malattie cutanee qui descritto e illustrato possono essere apportate modifiche e varianti senza per questo uscire dall?ambito protettivo della presente invenzione, come definito nelle rivendicazioni allegate. Finally, it is clear that modifications and variations may be made to the device for the therapy and control of skin diseases described and illustrated herein without thereby departing from the protective scope of the present invention, as defined in the attached claims.

Claims (6)

RIVENDICAZIONI 1.Dispositivo per la terapia e controllo di malattie cutanee comprendente:1. Device for the therapy and control of skin diseases including: - un primo strato (101) di supporto adesivo comprendente un biosensore (101a) comprendente un elemento sensibile biologicamente attivo in grado di sentire un segnale biochimico correlato alla presenza di molecole infiammatorie responsabili della desquamazione e del prurito cutaneo, un?unit? elettronica di processamento del segnale ricevuto dall?elemento sensibile, e una valvola di ricarica (101b) per la ricarica di un principio attivo;- a first layer (101) of adhesive support comprising a biosensor (101a) comprising a biologically active sensing element capable of sensing a biochemical signal correlated to the presence of inflammatory molecules responsible for skin flaking and itching, a unit? electronics for processing the signal received by the sensitive element, and a refill valve (101b) for refilling an active principle; - un secondo strato (102), contenente il principio attivo costituito da un estratto vegetale, depositato al di sotto del primo strato di supporto adesivo (101); e- a second layer (102), containing the active ingredient consisting of a vegetable extract, deposited under the first layer of adhesive support (101); And - un terzo strato (103) comprendente micro-aghi (103a) in grado di penetrare l?epidermide e attaccato al di sotto del secondo strato (102) atti al dosaggio del principio attivo su segnale dell?unit? elettronica di processamento.- a third layer (103) comprising micro-needles (103a) capable of penetrating the epidermis and attached below the second layer (102) capable of dosing the active ingredient on signal from the unit? processing electronics. 2. Dispositivo (100) secondo la rivendicazione 1, caratterizzato dal fatto che detto estratto vegetale ? un estratto acquoso di radici di Gypsophila Arrosti.2. Device (100) according to claim 1, characterized in that said vegetable extract is an aqueous extract of Roasted Gypsophila roots. 3. Dispositivo (100) secondo la rivendicazione 1, caratterizzato dal fatto di essere scalabile.3. Device (100) according to claim 1, characterized in that it is scalable. 4. Dispositivo (100) secondo la rivendicazione 1, caratterizzato dal fatto di comprendere un led in grado di illuminarsi di rosso quando il dispositivo (100) e? scarico di principio attivo, indicando al paziente la necessita? di ricarica dall?apposita valvola (101b) predisposta sullo strato (101) di supporto adesivo.4. Device (100) according to claim 1, characterized in that it comprises a led able to light up red when the device (100) is? discharge of active ingredient, indicating the need to the patient? from the special valve (101b) arranged on the layer (101) of adhesive support. 5. Dispositivo (100) secondo la rivendicazione 1, caratterizzato dal fatto che i dati raccolti dal dispositivo (100) sono resi disponibili ad essere inviati ad un dispositivo mobile su cui sia attiva un?applicazione dedicata, in modo da poter essere organizzati in un database.5. Device (100) according to claim 1, characterized in that the data collected by the device (100) are made available to be sent to a mobile device on which a dedicated application is active, so that they can be organized in a database. 6. Uso di un principio attivo costituito da un estratto acquoso di radici di Gypsophila Arrosti per la terapia e controllo di malattie cutanee. 6. Use of an active ingredient consisting of an aqueous extract of Roasted Gypsophila roots for the therapy and control of skin diseases.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1662987B1 (en) * 2003-09-11 2011-11-09 Theranos, Inc. Medical device for analyte monitoring and drug delivery
WO2019009854A2 (en) * 2017-03-08 2019-01-10 Ozayman Nuri Murat Antimicrobial compositions
US20190223795A1 (en) * 2016-08-22 2019-07-25 Ramot At Tel-Aviv University Ltd. Method and system for subcutaneous sensing

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1662987B1 (en) * 2003-09-11 2011-11-09 Theranos, Inc. Medical device for analyte monitoring and drug delivery
US20190223795A1 (en) * 2016-08-22 2019-07-25 Ramot At Tel-Aviv University Ltd. Method and system for subcutaneous sensing
WO2019009854A2 (en) * 2017-03-08 2019-01-10 Ozayman Nuri Murat Antimicrobial compositions

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