ITUB201644507U1 - Catheter for administration of a pulmonary surfactant - Google Patents

Catheter for administration of a pulmonary surfactant

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Publication number
ITUB201644507U1
ITUB201644507U1 ITUB2016U044507U ITUB201644507U ITUB201644507U1 IT UB201644507 U1 ITUB201644507 U1 IT UB201644507U1 IT UB2016U044507 U ITUB2016U044507 U IT UB2016U044507U IT UB201644507 U ITUB201644507 U IT UB201644507U IT UB201644507 U1 ITUB201644507 U1 IT UB201644507U1
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IT
Italy
Prior art keywords
tube
catheter
catheter according
notch
pulmonary surfactant
Prior art date
Application number
ITUB2016U044507U
Other languages
Italian (it)
Inventor
Mats Blennow
Kajsa Bohlin
Dargaville Peter Anderson
Linda Storari
Valentina Comito
Original Assignee
Chiesi Farm Spa
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 Chiesi Farm Spa filed Critical Chiesi Farm Spa
Publication of ITUB201644507U1 publication Critical patent/ITUB201644507U1/en

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Classifications

    • 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
    • A61M25/00Catheters; Hollow probes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Materials For Medical Uses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Description

DESCRIZIONE DEL MODELLO DI UTILITA’ dal titolo “Catetere per la somministrazionediunsurfattantepolmonare” DESCRIPTION OF THE UTILITY MODEL entitled "Catheter for the administration of a pulmonary surfactant"

Il presente trovato riguarda un catetere per la somministrazione di un surfattantepolmonare inneonatipreterminesofferentie/oa rischiodisindrome dadistress respiratorio. The present invention relates to a catheter for administering a pulmonary surfactant in preterms suffering and / or at risk of respiratory distress syndrome.

Piùspecificamente,ilpresentetrovatoriguardauncatetereperl’instillazionedi unsurfattantepolmonareinneonaticherespirinospontaneamenteemantenutiin pressione respiratoria positiva continua nasale (CPAP – continuous positive airwayspressure). More specifically, the present retrovator concerns a catheter for the instillation of a pulmonary surfactant in neonates with spontaneous breaths and maintained in continuous positive airways pressure (CPAP).

Neiduedecenni scorsi la terapiadi somministrazionedi surfattantipolmonari esogenièstatafondamentaleneltrattamentodineonatipretermine ocometerapia disoccorsoinneonatiaffettidadisturbidellamembranaialina,comeperesempio la sindromeda distress respiratorio. Con l’evoluzionee ilmiglioramentodimolti altriaspettidicuradeineonatipretermineècambiatoanchel’utilizzodellaterapia deisurfattantipolmonari. Over the past two decades, the administration of exogenous pulmonary surfactants has been fundamental in the treatment of newborn preterm or rescue comotherapy in infants affected by membrane disturbances, such as respiratory distress syndrome. With the evolution and improvement of many other safety aspects of these new terms, the use of lung surfactant therapy has also changed.

In particolare, nell’ultimo decennio si è verificato un significativo aumento dell’impiego dellapressionerespiratoriapositivacontinuanasalecomestrumento principale di supporto respiratorio, così da evitare in molti casi l’intubazione endotracheale. In particular, in the last decade there has been a significant increase in the use of continuous positive respiratory pressure in the body as the main respiratory support tool, so as to avoid endotracheal intubation in many cases.

Tuttavia, riconoscendo i meriti dei surfattanti polmonari, in particolarequando somministratiprecocemente,inalcunicasisipuòdeciderediintubareineonatiper consentire la somministrazione di surfattanti polmonari e successivamente immediatamente estubarli al fine di procedere con l’applicazione della pressione respiratoria positiva continua nasale. Questo approccio riduce il rischio di una successivaventilazionemeccanicae ilrischioassociatodipneumotorace. However, recognizing the merits of pulmonary surfactants, particularly when administered early, in some cases it can be decided to intubate infants to allow the administration of pulmonary surfactants and subsequently immediately extubate them in order to proceed with the application of continuous nasal positive respiratory pressure. This approach reduces the risk of subsequent mechanical ventilation and the associated risk of pneumothorax.

L’intubazione della trachea per il solo scopo della somministrazione di surfattanti polmonari nonè tuttaviaprivadi pericoliperchépuòesserecomplicata da numerosi tentativi richiesti e da un rischio di ipossia durante la procedura. Inoltre, l’intubazione viene quasi sempre eseguita con una pre-medicazione con narcoticie rilassanti deimuscoli,equestoporta a unritardo nell’estubazione dopo cheilsurfattantepolmonare èstatosomministrato. However, intubation of the trachea for the sole purpose of administering pulmonary surfactants is not without danger because it can be complicated by numerous attempts required and by a risk of hypoxia during the procedure. In addition, intubation is almost always performed with a pre-medication with narcotic and relaxing muscles, leading to a delay in extubation after the pulmonary surfactant has been administered.

Alla luce delle difficoltà associate con l’intubazione legata unicamente alla somministrazione di surfattanti polmonari, sonostati ideati metodi alternativi per lalorosomministrazione notiinletteraturecometerapiasurfattante minimamente invasiva (MIST – minimally invasive surfactant therapy) o eliminazione della ventilazionemeccanica(AMV– avoidmechanicalventilation). In light of the difficulties associated with intubation linked solely to the administration of pulmonary surfactants, alternative methods have been devised for their administration of well-known literature therapy and minimally invasive surfactant therapy (MIST - minimally invasive surfactant therapy) or elimination of mechanical ventilation (AMV - avoid mechanical ventilation).

Tali metodi prevedono una tecnica di intubazione tracheale meno invasiva utilizzando cateteri più piccoli oppure tubi (naso)-gastrici. L’uso del tubo di alimentazione altamente flessibile che deve però essere spinto nella trachea tramitelapinzadiMagillnonèconsigliabile perun’applicazionesulargascala. Scopodelpresentetrovato èdunquequellodiproporreunnuovocatetereperla somministrazione di un surfattante polmonare che possa essere facilmente utilizzatosulargascalaechesiamigliorativoperlacompliance dei neonati. These methods involve a less invasive tracheal intubation technique using smaller catheters or (nose) -gastric tubes. The use of the highly flexible feeding tube, which must however be pushed into the trachea by the Magill forceps, is not recommended for an application on a scale. The aim of the present finding is therefore to propose a new catheter for the administration of a pulmonary surfactant that can be easily used in the lungs and is better for compliance with infants.

Questo e altriscopivengonoraggiunticonun cateterelecuicaratteristiche sonodefinitenellarivendicazione1. This and other purposes are added with a catheter and the features are defined in the claim1.

Modi particolari di realizzazione formano oggetto delle rivendicazioni dipendenti, il cui contenuto è da intendersi come parte integrante della presente descrizione. Particular embodiments form the subject of the dependent claims, the content of which is to be understood as an integral part of the present description.

Ulteriori caratteristiche e vantaggi del trovato appariranno dalla descrizione dettagliata che segue, effettuata a puro titolo di esempio non limitativo, con riferimentoaidisegniallegati,neiquali: Further characteristics and advantages of the invention will appear from the following detailed description, carried out purely by way of non-limiting example, with reference to the accompanying drawings, in which:

- lafigura1èunavista prospetticadiuncateteresecondoilpresentetrovato;e - lafigura2èunavistafrontaledelcateteredifigura1. - figure1 is a perspective view of a catethers according to the present found; and - figure2 is a frontal view of the catheter in figure1.

In figura 1 è illustrato un catetere 1 secondo il presente trovato. Il catetere 1 comprende un tubo 2 di materiale flessibile, preferibimente un polimero di propileneetilenefluorinato,aventesiaunarigidezzasufficienteperpermetternela guidaversoe oltre lecordevocali siaunaelasticitàeunamorbidezzasufficientida evitaredanniallecordevocalioaltrestrutturevitalidurantel’intubazione. Figure 1 illustrates a catheter 1 according to the present invention. The catheter 1 comprises a tube 2 of flexible material, preferably a propylene-ethylene-fluorinated polymer, having sufficient stiffness to allow it to be guided through and beyond the evocative cords, both an elasticity and a softness sufficient to avoid damage to the cords and other vital structures during intubation.

Il tubo 2 può essere spinto sotto diretto controllo visivo utilizzando un laringoscopio e il surfattante polmonare viene somministrato preferibilmente in unoodueboli. The tube 2 can be pushed under direct visual control using a laryngoscope and the pulmonary surfactant is preferably administered in an oooduebole.

Il tubo è preferibilmente di colore blu. Può avere una lunghezza compresa tra 100 e 300 mm, preferibilmente 300 mm oppure 135 mm o ancora più preferibilmente 130 mm, e ha un diametro esterno compreso tra 5 French (1,65 mm)e3,5French (1,155mm),preferibilmenteparia 5French. The tube is preferably blue in color. It can have a length comprised between 100 and 300 mm, preferably 300 mm or 135 mm or even more preferably 130 mm, and has an external diameter comprised between 5 French (1.65 mm) and 3.5French (1.155mm), preferably several 5French.

Il catetere 1 comprende inoltre un corpo di supporto 4 fissato a un’estremità prossimale 2a al tubo 2 e predisposto per essere accoppiato, a un’altra sua estremità 6, a una siringa non mostrata in figura e contenente il surfattante polmonare dasomministrare. The catheter 1 also comprises a support body 4 fixed at a proximal end 2a to the tube 2 and designed to be coupled, at its other end 6, to a syringe not shown in the figure and containing the pulmonary surfactant to be administered.

Il tubo2èprovvistodiunapluralitàdi tacche8,prefebilmentebianche,attea segnalareuna lunghezzaprogressivadel tubo2 rispetto aun’estremitàdistale2b deltubo2. L’estremitàdistale2brappresentalapuntadelcatetereed èarrotondata eliscia. Pipe2 is provided with a plurality of notches8, preferably white, to indicate a progressive length of pipe2 with respect to a distal end2b of pipe2. The distal end 2 is at the tip of the catheter and is rounded and smooth.

Inunaparticolare formadirealizzazione,unaprimatacca8aèrappresentatadal numero romano uno, cioè I, una seconda tacca 8b è rappresentata dal numero romanodue,cioèII,unaterzatacca8cèrappresentatadalnumeroromanotre,cioè III. La peculiarità dei numeri romani uno, due e tre è che corrispondono rispettivamenteaunataccalinearesingola(ilnumerounocheinnumeriromaniè scritto“I”),aunataccalinearedoppia(ilnumeroduecheinnumeriromanièscritto “II”)eaunataccalinearetripla(ilnumerotrecheinnumeriromanièscritto“III”). In una forma di realizzazione più generale, la prima, seconda e terza tacca, non devono necessariamente rappresentare numeri romani, ma possono semplicementeincludereunasingola,doppiaotriplataccalineare:soloperfareun esempio, il sistema di tacche progressive può essere realizzato mediante linee continuechiusea formareanelli intornoal tubo.Talecaratteristica fondamentale del presente modello di utilità offre il vantaggio di essere immediatamente e facilmente“leggibile”ancheincondizioniavversedivisibilità,comeperesempiole condizionioperative descritte sopra. L’utente (peresempiounMedico)nondeve necessariamente “leggere” il numero,mapuò ricevereunapercezione immediata dalla taccasingola,doppiaotripla.E’unapercezioneintuitivadelsistemaditacche progressivechepuòaiutarequandosioperainsituazioniambientalidifficili. In a particular form of realization, a first notch 8a is represented by the Roman number one, i.e. I, a second notch 8b is represented by the Roman number two, i.e. II, a third notch8c is represented by the Roman number three, i.e. III. The peculiarity of the Roman numerals one, two and three is that they correspond respectively to a single block (the number one, which number of Romans is written "I"), to a double line (the number of two numbers in the Romans is written "II") and to a triple line (the number three in number of Romans is written "III"). In a more general embodiment, the first, second, and third notches do not necessarily have to represent Roman numerals, but can simply include a single, double or triple linear line: for example only, the system of progressive notches can be made by continuous lines which can form rings around the tube. this utility model offers the advantage of being immediately and easily "readable" even in conditions of adverse visibility, as for example the operating conditions described above. The user (for example a doctor) does not necessarily have to "read" the number, but can receive an immediate perception from the single, double or triple notebook.

Ogni tacca è posta a una distanza predeterminata D, preferibilmente 1cm, da quellaprecedente. Each notch is placed at a predetermined distance D, preferably 1cm, from the previous one.

Iltubo2comprendeinoltreunaquartatacca8d,postaaunadistanzadoppia2D dalla terzatacca8c erappresentatadauntrattodi linea simileal numeroromano uno accompagnatadalnumeroarabocinque. Pipe2 also includes a fourth notch8d, located at a double distance2D from the third notch8c, was represented by a section of line similar to the Roman number one accompanied by the number five.

Sono poi presenti sul tubo 2 altre tacche 8e, ciascuna posta alla distanza D rispetto alla tacca precedente e essendo rappresentate da un tratto di linea accompagnato danumeriarabiprogressivi,preferibilmentedasei (6) anove (9). In unaformadirealizzazione preferita, numeri romani sono presentisudue lati opposti del tubo 2 (fronte e retro), a 180° di distanza, in modo da consentire agevolmentelaletturainqualsiasiposizionesitroviiltubo2rispettoall’operatore. Le prime tre tacche 8a, 8b e 8c non hanno i numeri arabi perché essi non sarebbero facilmente visibili durante le fase iniziali dell’intubazione, a causa della posizionedellaboccadelneonato. There are then 2 other notches 8e on the tube, each placed at the distance D with respect to the previous notch and being represented by a line section accompanied by progressive numbers, preferably six (6) anove (9). In a preferred form of embodiment, Roman numerals are present on two opposite sides of the tube 2 (front and back), at a distance of 180 °, in order to allow easy reading in any position within the tube 2 with respect to the operator. The first three notches 8a, 8b and 8c do not have Arabic numbers because they would not be easily visible during the initial phase of intubation, due to the position of the baby's mouth.

In figura 2 è mostrato frontalmente il catetere di figura 1 in modo da poter vedereinmanierapiùchiaraletaccheprogressive8. Figure 2 shows the catheter of figure 1 from the front so as to be able to see more clearly of the progressive patches8.

Il catetere della presente invenzione può essere utilizzato per esempio per la somministrazione di qualsiasi tipo di surfattante polmonare che appartenga alle classidisurfattantipolmonari naturalimodificatiestrattidaipolmonidimammiferi oppuresurfattantipolmonarisinteticioricostituiti. The catheter of the present invention can be used, for example, for the administration of any type of pulmonary surfactant belonging to the classes of natural modified pulmonary pulmonary surfactants extracted from pulmonary mammals or reconstituted pulmonary surfactants.

Naturalmente, fermorestando ilprincipio del trovato,le formedi attuazioneei particolaridirealizzazionepotrannoessereampiamentevariatirispettoaquantoè statodescrittoeillustratoapurotitolodiesempiononlimitativo,senzaperquesto uscire dall'ambito di protezione della presente invenzione definito dalle rivendicazioniallegate. Naturally, without prejudice to the principle of the invention, the forms of implementation and the particular implementation forms may vary widely with respect to what has been described and illustrated as well as the non-limiting example, without thereby departing from the scope of protection of the present invention defined by the attached claims.

Claims (9)

<RIVENDICAZIONI> 1.Catetere(1)perlasomministrazionediunsurfattantepolmonare comprendente untubo(2)dimaterialeflessibilee uncorpodisupporto(4) fissato a un’estremità prossimale (2a) del tubo (2) e predisposto peressere accoppiato, a un’altra sua estremità(6), a unasiringa contenenteilsurfattantepolmonare,il tubo(2) essendo provvisto di una pluralità di tacche (8) poste a una distanza reciproca predeterminataeatteasegnalareuna lunghezzaprogressivadeltubo(2)rispetto un’estremitàdistale(2b) deltubo(2),incuiunaprimatacca(8a)comprendeuna lineasingola,unasecondatacca(8b)comprendeunadoppialineaeunaterzatacca (8c)comprendeunalineatripla. <CLAIMS> 1.Catheter (1) for the administration of a pulmonary surfactant comprising a tube (2) of flexible material and a support body (4) fixed to a proximal end (2a) of the tube (2) and arranged to be coupled, at another end (6), to a syringe containing the pulmonary surfactant, the tube (2) being provided with a plurality of notches (8) placed at a predetermined distance from each other to indicate a progressive length of the tube (2) with respect to a distal end (2b) of the tube (2), in which a backplate (8a) includes a liner, a second backplate (8b line) 8c) includes a triple line. 2. Catetere secondo la rivendicazione1, in cui la prima tacca (8a) rappresenta il numeroromanouno,la secondatacca(8b) rappresentail numeroromanoduee la terzatacca(8c) rappresentail numeroromanotre. Catheter according to claim 1, wherein the first notch (8a) represents the roman number one, the second notch (8b) represents the hand number two and the third notch (8c) represents the man number. 3.Catetere secondo la rivendicazione2, in cui il tubo (2) comprende inoltreuna quartatacca(8d)posta aunadistanzadoppiarispettoalladistanzapredeterminata dalla terza tacca (8c) e rappresentata da un tratto di linea accompagnato dal numeroarabocinque. 3. A catheter according to claim 2, wherein the tube (2) further comprises a quartatack (8d) placed at a double distance with respect to the distance predetermined by the third notch (8c) and represented by a line segment accompanied by the numberarabocfive. 4.Cateteresecondola rivendicazione3, incui iltubo(2)comprende inoltrealtre tacche (8e) ciascuna posta alla distanza predeterminata rispetto alla tacca precedente e rappresentate da un tratto di linea accompagnato da numeri arabi progressivi. 4. Cateter according to claim 3, in which the tube (2) also comprises other notches (8e) each set at a predetermined distance with respect to the previous notch and represented by a line segment accompanied by progressive Arabic numerals. 5. Catetere secondo la rivendicazione 4, in cui i numeri arabi progressivi sono compresitra6e9. 5. Catheter according to claim 4, wherein the progressive Arabic numerals are comprised between 6 and 9. 6.Cateteresecondounaqualsiasidellerivendicazioniprecedenti,incuiladistanza predeterminataèparia1cm. 6.Catheter according to any one of the previous claims, with predetermined distance is 1cm. 7.Catetere secondouna qualsiasidelle rivendicazioni precedenti, in cui il tubo è lungo130mm. 7. Catheter according to any of the preceding claims, wherein the tube is 130mm long. 8.Cateteresecondounaqualsiasidellerivendicazioniprecedenti,incuiildiametro esternoèparia5French. 8.Catheter according to any one of the previous claims, where the outer diameter is equal to 5French. 9.Cateteresecondounaqualsiasidellerivendicazioniprecedenti,incuiiltubo(2)è blueletacche(8)sonobianche9.Catheter according to any of the preceding claims, including the tube (2) is blue and the pins (8) are white
ITUB2016U044507U 2015-02-13 2016-02-10 Catheter for administration of a pulmonary surfactant ITUB201644507U1 (en)

Applications Claiming Priority (1)

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ITMI2015U000033U ITMI20150033U1 (en) 2015-02-13 2015-02-13 CATHETER FOR THE ADMINISTRATION OF A PULMONARY SURFACTANT

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ITMI2015U000033U ITMI20150033U1 (en) 2015-02-13 2015-02-13 CATHETER FOR THE ADMINISTRATION OF A PULMONARY SURFACTANT
ITUB2016U044507U ITUB201644507U1 (en) 2015-02-13 2016-02-10 Catheter for administration of a pulmonary surfactant

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KR (1) KR200494269Y1 (en)
CN (1) CN205729935U (en)
BR (1) BR202016002765U2 (en)
IT (2) ITMI20150033U1 (en)
RU (1) RU169651U1 (en)
TR (1) TR201601076U (en)

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Publication number Priority date Publication date Assignee Title
WO2018077623A1 (en) * 2016-10-26 2018-05-03 Chiesi Farmaceutici S.P.A. Device for facilitating the administration of a medicament to the lung by a catheter
CN107469226A (en) * 2017-09-14 2017-12-15 华润双鹤药业股份有限公司 Pulmonary surfactant doser
EP4297834A1 (en) * 2021-02-28 2024-01-03 RADICIONI, Maurizio Assembly for tracheal instillation of fluid medicaments in infants supported by non-invasive ventilation

Family Cites Families (8)

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Publication number Priority date Publication date Assignee Title
JPH0548953U (en) * 1991-12-05 1993-06-29 アロカ株式会社 Medical catheter
FR2691069B1 (en) * 1992-05-14 1999-08-20 Vygon SURGICAL INSTRUMENT FOR PERIDURAL ANESTHESIA OPERATION.
IL114154A0 (en) * 1994-06-17 1995-10-31 Trudell Medical Ltd Nebulizing catheter system and methods of use and manufacture
CA2414258C (en) * 2000-07-13 2006-10-17 Wilson Cook Medical, Inc. System of indicia for a medical device
RU33699U1 (en) * 2003-06-02 2003-11-10 ГОУВПО Омская государственная медицинская академия NASOBRONCHIAL BLOCKING CATHETER
US8048043B2 (en) * 2007-06-08 2011-11-01 Chiesi Farmaceutici S. P. A. Method of administration of a pulmonary surfactant
EP2566560A4 (en) * 2010-05-07 2017-08-16 Care Fusion 2200, Inc. Catheter allowing variable dosing of an active agent
RU128998U1 (en) * 2012-06-22 2013-06-20 Государственное бюджетное образовательное учреждение высшего профессионального образования "Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения и социального развития Российской Федерации TRANSPARAHE SINGLE-LIGHT CATHETER FOR JET BLOW VENTILATION

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TR201601076U (en) 2018-08-27
KR200494269Y1 (en) 2021-09-07
RU169651U1 (en) 2017-03-28
ITMI20150033U1 (en) 2016-08-13
CN205729935U (en) 2016-11-30
KR20160002937U (en) 2016-08-23
BR202016002765U2 (en) 2016-08-16

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