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RS20100468A2 - CARDIO-CIRCULATORY DEVICE DEVICE - Google Patents

CARDIO-CIRCULATORY DEVICE DEVICE

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Publication number
RS20100468A2
RS20100468A2 RS20100468A RSP20100468A RS20100468A2 RS 20100468 A2 RS20100468 A2 RS 20100468A2 RS 20100468 A RS20100468 A RS 20100468A RS P20100468 A RSP20100468 A RS P20100468A RS 20100468 A2 RS20100468 A2 RS 20100468A2
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Serbia
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syringe
cannula
heart
blood
left ventricle
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RS20100468A
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Serbian (sr)
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Uroš BABIĆ
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Uroš BABIĆ
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Priority to RS20100468A priority Critical patent/RS20100468A2/en
Publication of RS20100468A2 publication Critical patent/RS20100468A2/en

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Abstract

Invention herewith described refers to the device for invasive cardio-circulatory resuscitation. A large-volume syringe with a mechanism for the electric motor cyclic drive (128) is connected to the access cannula (200) with a large inner lumen placed into the left ventricular cavity of the circulatory arrest victim. A rearward movement of the motor actuated lever (112) enables aspiration of a large volume of the oxygenated blood out of the left ventricle and of the left atrium into the big syringe (128). By forward movement of the lever, the blood is injected back into the left ventricle through the same access cannula. The left ventricular unidirectional inflow check valve i.e. mitral valve closes during the injection due to increased left ventricular pressure. Since the volume of the injected blood exceeds the volume capacity of the non-contracting left ventricle, the surplus of injected blood is through the aortic valvula transported into the aorta. Repeating this manoeuvre as long as necessary provides vascularisation of the vital organs during arrest of the spontaneous circulation. In the process, the right heart functions as a passive pathway based on the pressure difference between aorta and the right and left atrium, additionally aided by dynamics of mechanical ventilation.

Description

Naprava za kardio-cirkulatorno oživljavanje Device for cardio-circulatory resuscitation

Ova prijava patenta je nastavak prijave patenta P-2010/0326 od istog pronalazača. This patent application is a continuation of patent application P-2010/0326 by the same inventor.

Oblast na koju se pronalazak odnosi Field to which the invention relates

Pronalazak pripada široj oblasti urgentne i intensivne medicine i odnosi se na sistem za hitno uspostavljanje veštacke mehaničke circulacije pri kardiocirculatornom arestu. Po međunarodnoj klasifikaciji patenata (MKP- IPC) oznaka je A61M1/10 . The invention belongs to the wider field of emergency and intensive medicine and refers to a system for the emergency establishment of artificial mechanical circulation in case of cardiocirculatory arrest. According to the international classification of patents (MKP-IPC), the designation is A61M1/10.

Tehnički problem Technical problem

Pronalazak rešava problem hitne uspostave efikasnog prokrvljavanja (perfuzije) vitalnih struktura organizma za vreme zastoja srca i cirkulacije u svim uslovima (u medicinskim ustanovama kao i na terenu). Dosadašnje metode oživljavanja srca i cirkulacije ili nisu dovoljno efikasne kao sto je spoljna masaža srca, ili su komplexne i rezervisane za primenu u specijalizovanim medicinskim ustanovama. The invention solves the problem of emergency establishment of effective blood supply (perfusion) of the vital structures of the body during cardiac arrest and circulation in all conditions (in medical institutions as well as in the field). The existing methods of reviving the heart and circulation are either not effective enough, such as external heart massage, or are complex and reserved for use in specialized medical institutions.

Stanje tehnike State of the art

Akutno otkazivanje srčane funkcije i prestanak cirkulacije su najčešći uzroci nagle smrti. Hitne medicinske mere sastoje se od veštackog disanja i spoljne masaže srca. Acute heart failure and cessation of circulation are the most common causes of sudden death. Emergency medical measures consist of artificial respiration and external cardiac massage.

Tretman kardiocirkulatornog zastoja nije se menjao vec 50 godina. Električna nestabilnost srca se danas jednostavno i efikasno tretira defibrilatorima, zastoj disanja se u potpunosti moze nadoknaditi mehaničkom ventilaciom posle ubacivanja tubusa u disajne puteve. Za održavanje cirkulacije i prokrvljenosti vitalnih struktura organizma (mozak i srčani misic) praktikuje se mehaničko pritiskivanje grudnog kosa. Mala stopa uspesnosti oživljavanja žrtava od srčanog i cirkulatornog zastoja posledica je ne-efikasnosti mehaničkog pritiskivanja na grudni kos da se održi i minimalana prokrvljenost vitalnih organa. Razlika pritisaka izmedju aorte i desne pretkomore kao najvažniji determinant postojanja efektivne cirkulacije je zanemarljiva tokom reanimacije mehaničkim pritiskivanjem grudnog kosa. The treatment of cardiocirculatory arrest has not changed for 50 years. Today, electrical instability of the heart is simply and effectively treated with defibrillators, respiratory arrest can be completely compensated by mechanical ventilation after inserting a tube into the airways. To maintain circulation and blood supply to the vital structures of the body (brain and heart muscle), mechanical compression of the chest is practiced. The low rate of success in reviving victims of cardiac and circulatory arrest is a consequence of the ineffectiveness of mechanical pressure on the chest to maintain minimal blood flow to the vital organs. The pressure difference between the aorta and the right atrium, as the most important determinant of effective circulation, is negligible during resuscitation with mechanical chest compressions.

Postoje mnogobrojne verzije aparata za mehaničku kompresiju srca: US patent No.7,131.953 od Shermana (2006) opisuje aparat za oživljavanje sa automatskom kompresiom grudnog kosa sa pojasem koji je pričvršćen na podlogu na kojoj žrtva lezi; US patent No.5,399.148 od VVaide (1995) opisuje napravu za spoljnu masagu srca koja se sastoji od izvora za pritiskivanje ( kompresiju) i aktivnu dekompresiju prilagodjenu grudnom kosu žrtve. Takodje mnogobrojnie su verzije naprava za unutrašnju masažu srca: W.O.patent No. 94/03228 od Zadinija (1994) opisuje aparat koji se stavlja ispod grudne kosti hiruskim putem , aparat ima deo koji se naduvava i izduvava cime se srce ponavljano pritiska i opušta izmedju aparata napred i kičme pozadi; W.O patent No. 98/05289 od Fogarthv (1998) opisuje drugu varijantu naprave za naduvavanje i izduvavanje koja se placira kroz medjurebarni prostor izmedju grudne kosti i srca. There are many versions of mechanical cardiac compression apparatus: US Patent No. 7,131,953 to Sherman (2006) describes an automatic chest compression resuscitator with a belt that is attached to a bed on which the victim lies; US Patent No. 5,399,148 by Waide (1995) describes a device for external cardiac massage consisting of a source for pressing (compression) and active decompression adapted to the chest hair of the victim. There are also numerous versions of devices for internal heart massage: W.O.patent No. 94/03228 by Zadini (1994) describes an apparatus that is placed under the sternum surgically, the apparatus has a part that inflates and deflates, whereby the heart repeatedly presses and relaxes between the apparatus at the front and the spine at the back; W.O. patent No. 98/05289 to Fogarth (1998) describes another variant of an inflation and deflation device which is placed through the intercostal space between the sternum and the heart.

Ni jedan od ovih sistema nije suštinski doprineo većoj efikasnosti reanimacije. None of these systems significantly contributed to greater resuscitation efficiency.

U specijalizovanim bolničkim centrima sporadično se primenjuju sistemi za veštačku cirkulaciju koji se sastoje od pristupa rezervoaru krvi (šupljine srca) ispumpavanja te krvi ka mehaničkoj pumpi i ponovnog upumpavanja u arteriski sistem. US Pat. No. US5190528 opisuje sistem kanula (plastična medicinska cev) za pristup levoj pretkomori takozvanim transseptalnim putem: Pod Roentgen kontrolom uvodi se kanula iz desne preponske vene kroz atrialni septum do leve pretkomore odakle se krv bogata kiseonikom ispumpava i roler pompom vraća nazad u kanulu smeštenu preko preponske arterije u arteriski sistem. Instalacija ovog sistema zahteva visokospecijalizovan tim ,uslove katereske laboratorije a kanule uvedene preko preponskih krvnih sudova su velikog promera i mogu ugroziti cirkulaciju nogu. Takođe vreme da se instalira opisana procedura je dugo da bi se mogla primenjivati u akutnim stanjima koja se dešavaju izvan kateterizacione laboratorije. Sličan sistem je opisan i u US Pat.No. US4790825 od Bernard A. 1988. Pristup reservoaru krvi levog srca bez operacije opisan je nadalje u Japanskom patentu JP7275350 Hirobumi 1995 godine: Kanula se preko preponske arterije uvodi retrogradno kroz aortnu valvulu u levu komoru te se krv drenira i upumpava preko pumpe u sistemsku cirkulaciju. I ova metoda ima slične manjkavosti: zahteva dugo vremena za instaliranje i ugrožava cirkulaciju nogu. Figulla HR i Scholz iz Goettingena Nemacka opisuju u objavljenoj knjizi" Circulatorv Support Devices in Interventional Cardiologv" (S.Karger Medical and Scientific Publishers, 1994, ISBN 3-8055-5977-1) i u " Cardiology 1994;84:3".danas najčešće upotrebljavane sisteme za nehirušku mehaničku vestacku cirkulaciju: Intraaortalna balloon pumpa služi samo za pomaganje (support) slabog srca i nije upotrebljiva pri arrestu; Hemopump TM turbine pumpa koja se nalazi na vrhu catheter svstema koji se uvodi iz preponske arterije retrogradno kroz aortnu valvulu do leve komore odakle pumpa krv velikom brzinom nazad u aortu. Potrebno je hiruški otvoriti veliku preponsku ili čak slabinsku arteriju da se pumpa uvede u krvni sud a potom pod Roentgenskom kontrolom manevriše preko aortne valvule do leve komore. Pumpa je predviđena za potporu slabe leve komore, a sporadično je upotrebljavana i za totalnu zamenu zastoja srca u kom slučaju dostigne pumpni kapacitet do 2 Litre/minutu i pritisak u aorti srednji od 50 mmHg. Nedostatak ove pumpe je teško uvodjenje u arteriju, i mali kapacitet pumpanja kao i potreba da se arterija najčešćce hiruški otvori iako postoji verzija za percutano uvodjenje; cardiopulmonalni support sistem se sastoji od debljih kanula koje se od preponske vene uvode do desne pretkomore odakle se krv drenira ka konsoli sa membranskim oksigenatorom (koji zamenjuje pluća) i potom se pumpa nazad preko veće kanule u arterijski sistem kroz preponsku arteriju. Ovaj sistem je korišten čak i kao premoštenje vremena do transplantacije srca kod dece (Barclav L. LANCET 2003;362:1948-1949). Deca sa akutnim otkazivanjem srca su potpomognuta ovim sistemom preživela nekoliko dana dok je donor srca za transplantaciju nađen. In specialized hospital centers, systems for artificial circulation are sporadically applied, which consist of accessing the blood reservoir (cavity of the heart), pumping that blood to a mechanical pump and re-pumping it into the arterial system. US Pat. No. US5190528 describes a cannula system (plastic medical tube) for access to the left atrium by the so-called transseptal route: Under Roentgen control, a cannula is introduced from the right inguinal vein through the atrial septum to the left atrium, from where the oxygen-rich blood is pumped out and returned by a roller pump to the cannula placed over the inguinal artery into the arterial system. The installation of this system requires a highly specialized team, the conditions of a catheterization laboratory, and the cannulas introduced through the groin blood vessels are of large diameter and can endanger the circulation of the legs. Also, the time to install the described procedure is long enough to be applied in acute conditions that occur outside the catheterization laboratory. A similar system is described in US Pat. No. US4790825 by Bernard A. 1988. Access to the blood reservoir of the left heart without surgery is further described in Japanese patent JP7275350 Hirobumi in 1995: A cannula is introduced retrograde through the inguinal artery through the aortic valve into the left ventricle and the blood is drained and pumped into the systemic circulation via a pump. And this method has similar drawbacks: it requires a long time to install and threatens the circulation of the legs. Figulla HR and Scholz from Goettingen, Germany describe in the published book "Circulatorv Support Devices in Interventional Cardiology" (S.Karger Medical and Scientific Publishers, 1994, ISBN 3-8055-5977-1) and in "Cardiology 1994;84:3". it is not usable during arrest; The Hemopump TM turbine pump is located on top of a catheter system that is introduced from the inguinal artery retrograde through the aortic valve to the left ventricle from where it pumps blood at high speed back into the aorta. It is necessary to surgically open a large inguinal or even lumbar artery to introduce the pump into the blood vessel and then maneuver it under Roentgen control over the aortic valve to the left ventricle. The pump is designed to support a weak left ventricle, and it has been used sporadically for total heart failure replacement, in which case it reaches a pumping capacity of up to 2 liters/minute and an average pressure in the aorta of 50 mmHg. The disadvantage of this pump is the difficult introduction into the artery, and the low pumping capacity, as well as the need to open the artery most often surgically, although there is a version for percutaneous introduction; the cardiopulmonary support system consists of thicker cannulas that are introduced from the inguinal vein to the right atrium, from where the blood is drained to the console with the membrane oxygenator (which replaces the lungs) and then pumped back through the larger cannula into the arterial system through the inguinal artery. This system was even used to bridge the time until heart transplantation in children (Barclav L. LANCET 2003;362:1948-1949). Children with acute heart failure were helped by this system to survive for several days while a donor heart for transplantation was found.

Prednost ovog sistema je veliki pumpni kapacitet i do 6 Litara/minut; nedostatak sistema je što circulacija zaobilazi levo srce koje se ovim sistemom ne dekomprimira t.j krv ostaje u plućima i levom srcu , takođe veliki promer kanula često ozleđuje preponske sudove i nerve, dodatno često je potrebna transfusija krvi a za instaliranje sistema potrebno je imati obučen personal i dovoljno vremena koje je u uslovima hitnosti kratko.Nadalje zbog visoke cene i komplexnosti upotreba ovog sistema je ograničena na visokospecijalizovane centre u ekonomski dobro stojećim sredinama. Svi opisani sistemi za mehaničku circulaciju percutanim putem predviđaju pristup preko vena i/ili arterija. U hitnim slučajevima međutim kod akutnog arresta teško je punktirati arteriju i/ili venu u odsustvu pulsa. Višemesečna asistencija circulacije se praktikuje takozvanim LVAD (left ventricularnim assist devices) sistemima koji se hiruški implantiraju u srce kao n.p.Jarvik 2000 koji se sastoji od drenazne kanule hiruški smestene u vrh leve komore i povratne aortne kanule plasirane u torakalnu aortu i pumpe koja je ugradjena u sistem kanula a koja se pokreće akumulator-bateriskom energiom (Frazier OH isaradnici. Circulation105(24):2855-2860, 2002) Srčana pumpa ispunjena krvlju je puno većih dimenzije od preponske arterije i/ili vene i može se lakše punktirati i pri zastoju. Percutana transtoracalna punkcija leve komore vršena je za dijagnostičke svrhe ( dijagnostička kateterizacija) kod pacijenata sa ugrađenom mehaničkom mitralnom i aortnnom veštačkom valvulom. Stopa ozbiljnih komplikacija bila je prihvatljiva ( VValters DL i saradnici Catheter Cardiovasc Interv 2003 Apr 58:539-44 : Transthoracic left ventricular puncture for the assessment of patients with aortic and mitral valve prostheses: the Massachusetts General Hospital experience, 1989-2000). Transapicalni pristup ka aorti korišćen je i u hirurgiji kod pacijenata sa akutnom dissectiom aortae da se postavi aortna kanula pri hiruškoj ekstrakorporalnoj circulaciji ( Terada Y. J i sradnici Thorac Cardiovasc Surg 2003 Mar 125:739-40.). Pristup unutrašnjosti srca toracoskopskim metodama opisan je u US patenu US2002100485 za takozvane minimal invasivne hiruške intervencije. Rigidna cev se plasira u šupljine srca a mesto ulaska kroz mvocard se osigura protiv krvarenja ili šavom oko cevi (purse string suture) ili balonom. Pristupna cev sluši za uvođenje minimal invazivnih instrumenata u unutrašnjost srca. US patent 6,406,422 BI od Landsberga (2002) opisuje svstem za potporu oslabljene srčane pumpe (assist device) koji koristi jednu kanilu i za izpumpavanje i za upumpavanje krvi iz oslabljene komore (single cannula ventricular assit apparatus). Ovaj svstem je namenjen za potporu slabe komore (obično leve komore) tako sto se kompjuterski odredjuje vreme i moment usisavanja krvi iz komore za vreme srčanog opustanja (diastole) kada se komora i normalno puni a upumpavanje krvi u istu komoru kroz istu kanilu se kompjuterski usaglasava sa komorskom svstolom - kontrakciom. Ovom metodom se praktično dodaje snaga komori za vreme kontrakcije. Volumen dodatne količine krvi koja se moze dodati oslabljenoj komori za vreme njene vlastite kontrakcije je mali i iznosi oko 30 ml. Ovaj svstem nije namenjen za tretman kardiocirkulatornog zastoja nego samo kao potpora oslabljenom srcu. The advantage of this system is a large pumping capacity of up to 6 Liters/minute; the disadvantage of the system is that the circulation bypasses the left heart, which is not decompressed by this system, i.e. the blood remains in the lungs and the left heart, also the large diameter of the cannula often injures the groin vessels and nerves, additional blood transfusion is often required, and to install the system it is necessary to have trained personnel and enough time, which in emergency conditions is short. Furthermore, due to the high price and complexity, the use of this system is limited to highly specialized centers in economically well-off areas. All described systems for percutaneous mechanical circulation foresee access via veins and/or arteries. In emergency cases, however, in acute arrest, it is difficult to puncture an artery and/or vein in the absence of a pulse. Circulation assistance for several months is practiced with so-called LVAD (left ventricular assist devices) systems that are surgically implanted in the heart, such as the Jarvik 2000, which consists of a drainage cannula surgically placed in the apex of the left ventricle and a return aortic cannula placed in the thoracic aorta and a pump that is built into the cannula system and is powered by accumulator-battery energy (Frazier OH colleagues. Circulation105(24):2855-2860, 2002) The heart pump filled with blood is much larger in dimensions than the inguinal artery and/or vein and can be punctured more easily even during arrest. Percutaneous transthoracic puncture of the left ventricle was performed for diagnostic purposes (diagnostic catheterization) in patients with implanted mechanical mitral and aortic artificial valves. The rate of serious complications was acceptable (Walters DL et al. Catheter Cardiovasc Interv 2003 Apr 58:539-44 : Transthoracic left ventricular puncture for the assessment of patients with aortic and mitral valve prostheses: the Massachusetts General Hospital experience, 1989-2000). A transapical approach to the aorta has also been used in surgery in patients with acute aortic dissection to place an aortic cannula during surgical extracorporeal circulation ( Terada Y. J et al. Thorac Cardiovasc Surg 2003 Mar 125:739-40.). Access to the interior of the heart using thoracoscopic methods is described in US patent US2002100485 for so-called minimally invasive surgical interventions. A rigid tube is placed in the cavities of the heart and the point of entry through the mvocard is secured against bleeding either with a purse string suture or a balloon. The access tube is used to introduce minimally invasive instruments into the interior of the heart. US patent 6,406,422 BI by Landsberg (2002) describes an assist device that uses a single cannula to pump and pump blood from a weakened ventricle (single cannula ventricular assist apparatus). This system is intended to support a weak ventricle (usually the left ventricle) by computer-determining the time and moment of blood suction from the ventricle during cardiac relaxation (diastole), when the ventricle is filling normally, and the pumping of blood into the same ventricle through the same cannula is computer-synchronized with the ventricular systole - contraction. This method practically adds strength to the chamber during contraction. The volume of additional blood that can be added to the weakened chamber during its own contraction is small and amounts to about 30 ml. This system is not intended for the treatment of cardiocirculatory arrest, but only as a support for a weakened heart.

Iz navedenog očigledna je potreba za sistemom, metodom, napravom koji ce omogućiti efektivno prokrvljavanje vitalnih organa (mozga i srca) za vreme zastoja srca. Takva naprava treba da ima dodatne sledece osobenosti: da se moze instalirati- staviti u funkciju za kratko vreme (1-3 minute); da se moze primeniti na svakom mestu gde se žrtva nadje; da je manjeg gabarita tako da moze da bude na raspolaganju lekarima hitne pomoći i na terenu van medicinskih prostorija. From the above, the need for a system, method, device that will enable effective blood supply to vital organs (brain and heart) during cardiac arrest is obvious. Such a device should have the following additional characteristics: it can be installed - put into operation in a short time (1-3 minutes); that it can be applied in every place where the victim is found; that it is smaller in size so that it can be available to emergency doctors in the field outside medical rooms.

Izlaganje suštine pronalaska Presentation of the essence of the invention

Cilj pronalaska je da se napravi sistem brzog pristupa levom srcu odakle bi se krv obogaćena kiseonikom ispumpavala prema mehaničkoj pumpi a potom upumpavala nazad u organizam radi snabdevanja svih organa krvlju u stanju totalnog zastoja srca i cirkulacije. Suštinski concept pronalaska: Jedan pristup levoj komori najkraćim putem; koriscenje anatomije i fiziologije srca. Leva komora u stanju zastoja je zatvoreni pasivni mišićni prostor koji ima ulazni (odbojni) ventil ("check valve"- inflovv valvula mitralna) i izlazni ventil (outflovv valvula aortna). Pri zastoju (arestu) srca i cirkulacije pritisci u ćelom zatvorenom kardiovaskularnom sistemu se izjednačavaju; pritisak u levoj pretkomori je isti kao i u levoj komori a ovaj je siti kao i u aorti ili u desnoj pretkomori. The goal of the invention is to create a system for quick access to the left heart, from where the oxygen-enriched blood would be pumped to a mechanical pump and then pumped back into the body to supply all organs with blood in a state of total cardiac and circulatory arrest. Essential concept of the invention: One approach to the left ventricle by the shortest path; using the anatomy and physiology of the heart. The left ventricle in a state of stagnation is a closed passive muscular space that has an inlet (repulsive) valve ("check valve" - mitral inflow valve) and an outlet valve (aortic outflow valve). When the heart and circulation stop (arrest), the pressures in the entire closed cardiovascular system are equalized; the pressure in the left atrium is the same as in the left atrium, and the pressure in the left atrium is the same as in the aorta or in the right atrium.

Koncept pronalaska je da se najkraćim putem ubaci komunikaciona cev (pristupna kanula) u levu komoru; kroz tu cev prvo se izvlači krv pod negativnim pritiskom iz leve komore- pri cemu se zbog gradijenta pritiska otvara ulazni ventil (mitralna valvula) a zatvara izlazni ventil (aortna valvula). Ovaj manevar rezultira u aspiraciji (ispumpavanju) krvi koja se nalazi u levoj pretkomori i u levoj komori. Izvučena krv se zatim kroz istu komunikacionu cev (pristupnu kanulu) ubacuje pod pritiskom nazad u levu komoru sto zbog novostvorenog gradijenta pritisaka zatvara ulaznu (mitralnu valvulu) i otvara izlaznu aortnu valvulu. Količina krvi koja se pod pritiskom ubacuje u levu komoru veća je od zapremine leve komore. Visak tako ubrizgane krvi izbacuje se kroz izlaznu valvulu u aortu t.j visak krvi pretstavlja udarni volume (stroke volume) svakog pojedinačnog akta ubrizgavanja krvi u levu komoru. The concept of the invention is to insert the communication tube (access cannula) into the left ventricle by the shortest route; blood is first drawn through that tube under negative pressure from the left ventricle - during which, due to the pressure gradient, the inlet valve (mitral valve) opens and the outlet valve (aortic valve) closes. This maneuver results in the aspiration (pumping out) of the blood that is in the left atrium and in the left ventricle. The extracted blood is then injected through the same communication tube (access cannula) under pressure back into the left ventricle which, due to the newly created pressure gradient, closes the inlet (mitral valve) and opens the outlet aortic valve. The amount of blood that is forced into the left ventricle under pressure is greater than the volume of the left ventricle. The excess blood injected in this way is ejected through the outlet valve in the aorta, i.e. the excess blood represents the stroke volume of each individual act of blood injection into the left ventricle.

Navedeni ciljevi se ostvaruju pravljenjem naprave koja se sastoji od pristupne kanule velikog kalibra (large bore access cannula) koja se smesta u srčanu komoru, i pumpe sa većim volumen kapacitetom. Kanula je konstruisana tako da se moze uvesti u srčanu komoru takozvanom perkutanom (preko koze nehiruski) tehnikom preko žice The aforementioned goals are achieved by making a device that consists of a large bore access cannula (large bore access cannula) that is placed in the heart chamber, and a pump with a larger volume capacity. The cannula is designed so that it can be introduced into the heart chamber by the so-called percutaneous (through the skin non-surgical) technique over a wire.

(Seldingerovom tehnikom) i dodatno je opremljena sa napravom za dihtovanje kanala kojim se uvodi u telo. Kanula je napravljena od medicinske plastike koja je obložena iznutra heparinom (protiv zgrusavanja) a njen zid moze biti ojačana sa žicanom armaturom (braided) da bi se osigurala stabilnost-nelomljivost (kinck resistant). Na krajnjem delu kanule (u daljnjem textu distalni deo) na spoljnji zid montirana su 2 balona. Jedan unutrašnji manji napravljen od takozvanog nerastegljivog - "noncompliant " materijala (kao stoje Poliurethane); ijedan veći spoljasnji balon napravljen od rastegljivog ("complient") materijala. Manji unutrašnji balon ima strogo odredjen diameter u naduvanom stanju koji treba da onemogući ispadanje cannule iz komore; Spoljnji veliki balon napravljen od rastegljivog materijala pokriva ceo ulazni put pristupne kanule počevši od mesta ulaska kroz kozu pa preko malog balona sve do unutrašnjosti komore. Funkcija velikog balona je da začepi ulazni kanal kroz grudni kos i kroz srčani misic i tako spreci krvarenje iz komore i ulaženje vazduha u komoru. Pumpa moze biti napravljena prevalentno ali ne isključivo u obliku velike šprice sa ugradjenim mehanizmom na elktromotorski pogon. Pristupna cev se povezuje sa pumpom plastičnim flexibilnim crevima odgovarajućeg unutrašnjeg promera a preko adaptera za brzo povezivanje (konektora). Preko grudnog kosa kroz kozu se plasira pristupna kanula u levu srčanu komoru i spoji se sa velikom špricom preko brzih konektora i creva te se oxigenisana krv usisava iz leve komore i iz leve pretkomore a potom se usisani volumen krvi pod većim pritiskom ubrizgava nazad u levu komoru kroz istu pristupnu kanulu. (Seldinger's technique) and is additionally equipped with a device for sealing the channels by which it is introduced into the body. The cannula is made of medical plastic that is coated inside with heparin (anti-clotting) and its wall can be reinforced with wire reinforcement (braided) to ensure stability-unbreakability (kink resistant). 2 balloons are mounted on the outer wall of the end part of the cannula (hereinafter the distal part). One inner smaller one made of so-called non-compliant material (such as Polyurethane); one larger outer balloon made of compliant material. The smaller inner balloon has a strictly defined diameter in the inflated state, which should prevent the cannula from falling out of the chamber; The outer large balloon made of stretchable material covers the entire entrance path of the access cannula starting from the point of entry through the goat and over the small balloon all the way to the inside of the chamber. The function of the large balloon is to block the entrance channel through the chest and through the heart muscle and thus prevent bleeding from the chamber and air entering the chamber. The pump can be made predominantly, but not exclusively, in the form of a large syringe with a built-in electromotor driven mechanism. The access pipe is connected to the pump with plastic flexible hoses of the appropriate internal diameter and via a quick connection adapter (connector). An access cannula is placed through the sternum through the skin into the left heart chamber and connected to a large syringe via quick connectors and hoses, and oxygenated blood is sucked from the left ventricle and from the left atrium, and then the suctioned volume of blood is injected under higher pressure back into the left ventricle through the same access cannula.

System koristi postojanje 2 unidirekcionalne valvule (jednosmerni ventili; check valve=odbojni ventil) u levom srcu: jedne ulazne (inflow mitral valvula) u levu komoru i jedne izlazne (outflovv aortna valvula) iz leve komore. Ako se smanji pritisak u levoj komori zatvara se izlazna valvula a otvara se ulazna valvula sto omogućava izvlačenje aspiriaciju krvi iz celog levog srca (iz leve komore i iz leve pretkomore ). The system uses the existence of 2 unidirectional valves (check valve = check valve) in the left heart: one inlet (inflow mitral valve) into the left ventricle and one outlet (outflow aortic valve) from the left ventricle. If the pressure in the left ventricle is reduced, the outlet valve closes and the inlet valve opens, which allows the aspiration of blood from the entire left heart (from the left ventricle and from the left atrium).

Aspiracioni volume = volumen leve komore + volumen leve pretkomore. Aspiration volume = left ventricular volume + left atrial volume.

Pri brzom ubrizgavanju većeg volumena krvi ili tecnosti u levu komoru pritisak u levoj komori se povećava sto zatvara ulaznu (mitralnu ) valvulu. Posto volumen ubrizgane krvi premašuje kapacitet zastale (arrested-nekucajuce srce)) leve komore visak krvi se izbacuje kroz izlaznu aortnu valvulu u aortu. Deo krvi koji se ovim putem ubrizga u aortu jednak je udarnom volumenu svakog pojedinačnog akta ubrizgavanja. When a large volume of blood or fluid is rapidly injected into the left ventricle, the pressure in the left ventricle increases, which closes the inlet (mitral) valve. Since the volume of injected blood exceeds the capacity of the left ventricle, the excess blood is ejected through the exit aortic valve into the aorta. The part of blood that is injected into the aorta in this way is equal to the stroke volume of each individual act of injection.

Udarni volumen pri ubrizgavanju = total volumen ubrizgavanja minus kapacitet leve komore. Pretpostavivsi da je volumen krvi u levoj pretkomori 80 ml, u levoj komori 100 ml-maximalni volumen usisavanja u pumpu (aspiracije) iznositi ce 180 ml; Injection stroke volume = total injection volume minus left ventricular capacity. Assuming that the volume of blood in the left atrium is 80 ml, in the left ventricle 100 ml - the maximum volume of suction into the pump (aspiration) will be 180 ml;

Kada se naglo ubrizga 180 ml krvi nazad u levu komoru 100 ml ce da ostane u levoj komori a 80 ml ce biti ubačeno u aortu - udarni volume svakog ubrizgavanja iznosi računski 80 ml. When 180 ml of blood is suddenly injected back into the left ventricle, 100 ml will remain in the left ventricle and 80 ml will be injected into the aorta - the stroke volume of each injection is calculated to be 80 ml.

Kratak opis slika nacrta Brief description of the draft images

Slika 1A prikazuje pumpnu napravu na motorni pogon sa špricom velikog Figure 1A shows a motor-driven pump device with a large syringe

volumena. volume.

Slika 1B prikazuje pumpnu napravu u fazi usisavanja (aspiracije). Figure 1B shows the pump device in the aspiration phase.

Slika 1C prikazuje pumpnu napravu u fazi ubrizgavanja (injekcije). Figure 1C shows the pump device in the injection phase.

Slika 2A prikazuje uzdužni presek pristupne kanule sa balononima (ne-naduvanim) i sa uvodnim dilatatorom sa žicom vodiljom Figure 2A shows a longitudinal cross-section of an access cannula with balloons (non-inflated) and with a guidewire introducer dilator

Slika 2B prikazuje pristupnu kanilu sa naduvanim balonima. Figure 2B shows the access cannula with inflated balloons.

Slika 2C prikazuje pristupnu kanilu smestenu kroz uvodni "sheath" koji se moze rascepiti posle uvodjenja. (splittable sheath). Figure 2C shows an access cannula placed through an introducer sheath that can be split after introduction. (splittable sheath).

Slika 3 prikazuje uzdužni kosi presek kompletno montirane naprave. Figure 3 shows a longitudinal oblique section of the fully assembled device.

Slika 4A prikazuje uzdužni presek naprave instalirane u poziciji aspiracije. Figure 4A shows a longitudinal section of the device installed in the aspiration position.

Slika 4b prikazuje uzdužni presek instalirane naprave u fazi injekcije. Figure 4b shows a longitudinal section of the installed device in the injection phase.

Detaljan opis pronalaska Detailed description of the invention

Slike 1 (A,B,C) prikazuju jednu moguću varijantu pumpne naprave 100 u skladu sa pronalaskom. Šprica velikog volumena (n.p. > 200 ml) 128 sa čepom 122 montirana je na postolje pricvrscivacem 124 i zatezacima 126 . Konstrukcija postolja sastoji se od baze 102, vertikalnog dela postolja 104,nakošenog dela postolja 106 i prednjeg dela 107 na koga se montira pricvrscivac šprice 124. Sterilna šprica sa čepom se moze ručno montirati i demontirati na postolje zatezacima šprice 126. Na prednjem delu šprica je preko spojnice 130 spojena sa sterilnim medicinskim crevom (tubing) 132 odgovarajućeg promera (n.p. 3/8"- incha-oko 9mm). Cep šprice 122 nastavlja se na klip 120 šprice kojim se cep pokreće napred nazad. Klip šprice 120 je dovoljne duzine koja omogućava njegovo kretanje izvan šprice kroz centralne kanale drzaca klipa 118 na nakoseniom delu postolja 106. Drzaci klipa 118 omogućavaju nesmetano kretanje klipa kroz njihove centralne kanale a pri tome održavaju smer kretanja klipa i onemogućavaju njegovu dislokaciju. Poluga 112 je montirana pomoću klina-stozera za obrtanje 110 na obrtajni deo-spojka naglavak 109 motora 108. Klin stožer za obrtanje 110 omogućava zglobno kružno kretanje poluge . Na kraju prema šprici poluga je pričvršćena za klip 120 pricvrscivacem 114. Mesto pričvršćivanja poluge za klip odredjuje excurzije- hod klipa napred nazad, ovo mesto pričvršćivanja se moze menjati. Pricvrscivac poluge za klip 114 moze se manuelno montirati i demontirati. Motor 108 instaliran je na zadnjem delu nakošenog dela postolja 106, a njegova spojka naglavak za obrtanje 109 spojen je zglobnim stožerom za obrtanje 110 sa polugom 112. Na gornjem delu nakošenog dela 106 montiran je regulator (134) brzine rada motora . Motor i regulator brzine se napajaju strujom iz akumulator- baterija 136 koje su smestene na bazu postolja 102 i pričvršćene zatezacem 138 koji se moze ručno montirati I demontirati. Figures 1 (A,B,C) show one possible variant of the pumping device 100 according to the invention. A large volume syringe (n.p. > 200 ml) 128 with a cap 122 is mounted on the stand with a fastener 124 and clamps 126. The construction of the stand consists of a base 102, a vertical part of the stand 104, an inclined part of the stand 106 and a front part 107 on which the syringe fastener 124 is mounted. A sterile syringe with a cap can be manually mounted and dismantled on the stand with syringe clamps 126. At the front part, the syringe is connected to a sterile medical hose (tubing) via a connector 130. 132 of a suitable diameter (n.p. 3/8"-inch-about 9mm). Syringe pin 122 continues to syringe piston 120 which moves the pin back and forth. Syringe pin 120 is of sufficient length to allow its movement outside the syringe through the central channels of plunger holders 118 on the beveled portion of base 106. Plunger holders 118 allow smooth movement of the plunger through their central channels while maintaining direction of movement of the piston and prevent its dislocation Lever 112 is mounted by means of a pivot pin 110 on the rotating part-coupling head 109 of the engine 108. The pivot pin 110 enables the hinged circular movement of the lever. At the end towards the syringe, the lever is attached to the piston 120 with a fastener 114. The place of attachment of the lever to the piston determines the excursion - the forward and backward movement of the piston, this place of attachment can be changed. The piston lever fastener 114 can be manually assembled and disassembled. The engine 108 is installed on the rear part of the inclined part of the base 106, and its coupling head for rotation 109 is connected by the hinged pivot for rotation 110 with the lever 112. On the upper part of the inclined part 106, the regulator (134) of the motor speed is mounted. The motor and the speed regulator are powered by electricity from the 136 batteries that are located there on the base of the stand 102 and fastened with a tensioner 138 that can be manually assembled and disassembled.

Kada se okretanjem motorne spojke 109 poluga 112 povuče unazad povlaci se i klip šprice 120 sa čepom 122 unazad u poziciju usisavanja (aspiracije) kao na slici 1 B. When the lever 112 is pulled back by turning the motor coupling 109, the syringe piston 120 with the cap 122 is also pulled back into the suction (aspiration) position as in Figure 1 B.

Kada se okretanjem motorne spojke 109 poluga 112 pogura unapred i klip 120 sa čepom 122 kreću se unapred t.j šprica 128 se prazni- faza izbacivanja (injekcije) - slika 1C. When by turning the motor coupling 109, the lever 112 is pushed forward and the piston 120 with the plug 122 moves forward, i.e. the syringe 128 is emptied - ejection phase (injection) - picture 1C.

Medicinsko plastično crevo odgovarajuće duzine i promera (n.p. 3/8 incha-9mm) 132 spojeno je sa špricom preko spojnice 130 ili je strukturno integrusano u prednji kraj šprice. A medical plastic hose of suitable length and diameter (n.p. 3/8 inch-9mm) 132 is connected to the syringe via a coupling 130 or is structurally integrated into the front end of the syringe.

Na distalnom kraju plastičnog creva nalazi se conector 131 za brzo spajanje plastičnog creva sa pristupnom kanulom.preko 3-slavinskog konektora 208-slika 3. At the distal end of the plastic hose, there is a connector 131 for quick connection of the plastic hose with the access cannula via the 3-tap connector 208 - Figure 3.

Postolje za špricu kao i poluga i klip šprice mogu biti napravljeno od lakog metala ili stabilne plastike. Slike 2A i 2B prikazuju sistem pristupne kanule 200. Jedan deo duzine cevi pristupne kanile 202 napravljen je od medicinskog polimera armiranog sa tankom žicom cime se osigurava ne lomljivost (kinck resistance). Proximalni deo armiranog dela canule 204 ima zadebljali zid cevi za prolaz kanala za naduvavanje i izduvavanje balona. Deo plastičnog creva integrisan je na proximalni deo pristupne kanule; spojnica-konektor-3-slavinski (3 way stopcock) velikih promera 208 integrisan je na proximalni kraj creva 206. 3-slavinski konektor ima veliki unutrašnji lumen kako se ne bi smanjivao protočni kapacitet pristupne kanule i creva spojnice 205. Pristupna kanula ima distalni široki otvor 210 i najmanje jedan otvor sa strane 211 sto omogućava veliki protok prilikom aspiracije i injekcije. Unutrašnji manji balon 218 ugradjen je na distalni deo spoljnjeg zida cevi pristupne kanule. Ovaj balon se naduvava i izduvava špricom 224 kroz otvor 220 i kanal pristupni 222. Manji unutrašnji balon 218 moze biti napravljen od non-compliant medicinskih polimera n.p polyurethane. Veličina naduvanog balona je tolika da spreci ispadanje pristupne kanule iz komore prilikom jakog ubrizgavanja tecnosti (krvi) u komoru. Preko ovog unutrašnjeg manjeg balona 218 instaliran je spoljnji veći balon 212 prikačen distalno za spoljnji deo armirane cevi 202 pristupne kanule a proximalno za zadebljali deo zida pristupne kanule 204. Veliki balon je napravljen od rastegljivog (compliant) polymera. Ovaj balon se naduvava i zduvava kroz kanal 216 špricom 215 kroz otvor 214. Veliki balon pokriva celu duzinu intrakorporealnog puta pristupne kanule ( od koze kroz medjurebarni prostor, kroz srčani misic do unutrašnjosti leve komore) pružajući zaštitu od krvarenja iz srca i zaštitu od ulaska vazduha spolja ka unutrašnjosti srca.Dilatator uvodničar 230 sa zašiljenim distalnim krajem 232 i proximalnim krajem 234 ima centralni lumen sa proximalnim ulazom 235 i distalnim izlazom 233 kroz koji prolazi žica vodilja 240 oblika J slova 242. Sa izduvanim balonima i sa žicom vodiljom uvedenom do srčane komore kompletan sistem pristupne kanule moze biti placiran- uveden u srce bez hiruske pomoći perkutano (Seldingerovom ) tehnikom. Slika 2C prikazuje pristupnu kanulu 200 smestenu kroz posebnu uvodnu cev- sheath koji se moze posle uvodjenja rascepiri (splittable sheath) 250, koji ima distalni otvoren kraj 252 i proximalni 2- delni deo 254 i 255 za rascep i odstranjenje posle završenog uvodjenja kanule. Ovaj sheath moze biti koriscen za alternativno uvodjenje pristupne kanile u srce cime se donekle štite i structure pristupne kanule a i structure tkiva kroz koje se sistem uvodi. The syringe stand as well as the syringe lever and piston can be made of light metal or stable plastic. Figures 2A and 2B show the access cannula system 200. A portion of the length of the access cannula tube 202 is made of a medical grade polymer reinforced with a thin wire to ensure kink resistance. The proximal part of the reinforced part of the cannula 204 has a thickened wall of the tube for the passage of the channel for inflation and deflation of the balloon. Part of the plastic hose is integrated on the proximal part of the access cannula; a large-diameter 3-way stopcock 208 is integrated into the proximal end of the hose 206. The 3-way stopcock has a large internal lumen so as not to reduce the flow capacity of the access cannula and connector hose 205. The access cannula has a distal wide opening 210 and at least one side opening 211 that allows for high flow during aspiration and injection. The inner smaller balloon 218 is installed on the distal part of the outer wall of the access cannula tube. This balloon is inflated and deflated with a syringe 224 through the opening 220 and the access channel 222. The smaller inner balloon 218 can be made of non-compliant medical polymers such as polyurethane. The size of the inflated balloon is such that it prevents the access cannula from falling out of the chamber during a strong injection of liquid (blood) into the chamber. Over this inner smaller balloon 218 is installed an outer larger balloon 212 attached distally to the outer part of the reinforced tube 202 of the access cannula and proximally to the thickened part of the wall of the access cannula 204. The large balloon is made of a stretchable (compliant) polymer. This balloon is inflated and deflated through the channel 216 with the syringe 215 through the opening 214. The large balloon covers the entire length of the intracorporeal path of the access cannula (from the skin through the intercostal space, through the heart muscle to the interior of the left ventricle) providing protection from bleeding from the heart and protection from the entry of air from the outside to the inside of the heart. proximal entrance 235 and distal exit 233 through which the J-shaped guide wire 240 passes 242. With deflated balloons and with the guide wire introduced to the heart chamber, the complete access cannula system can be placed - introduced into the heart without surgical assistance percutaneously (Seldinger's) technique. Figure 2C shows an access cannula 200 positioned through a separate splittable sheath 250 having a distal open end 252 and a proximal 2-part portion 254 and 255 for splitting and removal after cannula insertion is complete. This sheath can be used for the alternative introduction of the access cannula into the heart, which somewhat protects the access cannula structures and the tissue structures through which the system is introduced.

Slika 3 pokazuje kompletiran sistem napravu za kardiocirkulatorno oživljavanje - pumpnu napravu 100 sa montiranom pristupnom kanilom 200 . Shodno jednoj varijanti pronalaska plastična creva povezivaci i spojnice imaju lumen veći od lumena pristupne kanule sa ciljem da se smanji otpor protoka krvi i/ili tecnosti prilikom injekcije i aspiracije. Figure 3 shows the complete system device for cardiocirculatory resuscitation - pump device 100 with mounted access cannula 200. According to one variant of the invention, the plastic hose connectors and connectors have a lumen larger than the lumen of the access cannula with the aim of reducing the resistance to the flow of blood and/or liquid during injection and aspiration.

Slika 4A Prikazuje sistem sa instaliranom kanilom u srce žrtve u fazi aspiracije (izvlavenja krvi iz levogsrca). Ulazni ventil u levu komoru (mitralna valvula) je otvorena dozvoljavajući drenažu krvi iz leve komore, leve pretkomore i cak i iz plućnih vena koje se bez prepreke ulivaju u levu pretkomoru. Izlazni ventil leve komore (aortna valvula) je za vreme aspiracije (manjeg pritiska u levoj komori) zatvorena. Veliki rastegljivi balon zapusava ceo put ulaska pristupne kanule, dok mali nerastegljivi balon unutar leve komore sprečava ispadanje kanule kroz pristuni put. Slika 4B prikazuje sistem instaliran u srce žrtve za vreme faze injekcije (ubrizgavanja krvi u srce nazad). Ulazni ventil u levu komoru (mitralna valvula ) je zatvorena zbog povećanog pritiska u levoj komori, izlazni ventil leve komore (aortna valvule) je otvorena zbog pritiska u levoj komori koji je veći od pritiska u aorti a visak krvi koji ne moze da stane u ne-kucajucu-pasivnu levu komoru izbacuje se u aortu. U slučajevima otezane aspiracije krvi iz leve komore, dodatna količina tecnosti (n.p. hladni fiziološki rastvor) moze se usisati u špricu preko infuzije koja se moze instalirati na otvor sa strane (side-arm) tro-krakog konektora 208 i ubrizgati kao dodatak "volumena" Figure 4A shows the system with a cannula installed in the victim's heart during the aspiration phase (drawing blood from the left heart). The inlet valve to the left ventricle (mitral valve) is open, allowing the drainage of blood from the left ventricle, the left atrium, and even from the pulmonary veins, which flow freely into the left atrium. The outlet valve of the left ventricle (aortic valve) is closed during aspiration (lower pressure in the left ventricle). A large distensible balloon occludes the entire entry path of the access cannula, while a small non-distensible balloon inside the left ventricle prevents the cannula from falling out through the access path. Figure 4B shows the system installed in the victim's heart during the injection phase (injecting blood back into the heart). The inlet valve to the left ventricle (mitral valve) is closed due to increased pressure in the left ventricle, the outlet valve of the left ventricle (aortic valve) is open due to the pressure in the left ventricle being greater than the pressure in the aorta, and the excess blood that cannot fit into the non-beating-passive left ventricle is ejected into the aorta. In cases of delayed aspiration of blood from the left ventricle, an additional amount of fluid (e.g., cold saline) can be aspirated into the syringe via an infusion that can be installed on the side-arm of the three-arm connector 208 and injected as additional "volume".

tecnosti. Ovim dodatkom se moze povećati količina ubrizgavanja tecnosti u slucajevim liquids. With this addition, the amount of liquid injection can be increased in certain cases

otezane aspiracije krvi. Takodje ovim sistemom se moze postići veoma brzo hladjenje ( hvpotermija) organizma koja je pri aktu oživljavanja veoma poželjno. Nadalje ovim putem se najbrže mogu injicirati svi potrebni lekovi u cirkulaciju uključujući i lekove protiv zgrusavanja krvi (n.p.heparin). prolonged blood aspiration. This system can also achieve very fast cooling (hypothermia) of the body, which is very desirable during the act of reviving. Furthermore, this is the fastest way to inject all necessary drugs into the circulation, including anti-clotting drugs (e.g. heparin).

Kombinovana varijanta motorizovanog i ručnog pokretanja(ova varijanta nije na crtežima) klipa je takodje moguća . A combined variant of motorized and manual starting (this variant is not on the drawings) of the piston is also possible.

U slučajevima gde bi se pokušaj oživljavanja circulacije na opisan način t.j. pristupom samo levom srcu produžio ili bio nedovoljno efikasan moguća je primena naprave sa dve šprice I dve pristupne kanile jedna za levu jedna za desnu komoru srca (ova varijanta nije prikazana crtežima.) Dve šprice su instalirane paralelno na postolje; pristupne kanile se placiraju u vrh desne i u vrh leve komore te se jednim jednim mehanizmom ispumpava i upumpava ista količina krvi iz desne komore i iz leve komore sto bi značilo da je volumen krvi koji se ubacuje u pluća jednak volumenu krvi koji se izbacuje iz leve komore. In cases where an attempt to revive the circulation in the described manner, i.e. with access only to the left heart prolonged or insufficiently effective, it is possible to use a device with two syringes and two access cannulas, one for the left and one for the right chamber of the heart (this variant is not shown in the drawings.) Two syringes are installed in parallel on the stand; access cannulae are placed in the top of the right and in the top of the left ventricle, and the same amount of blood is pumped out and pumped in from the right ventricle and from the left ventricle with a single mechanism, which would mean that the volume of blood entering the lungs is equal to the volume of blood ejected from the left ventricle.

Primena pronalaska Application of the invention

Opisana naprava moze biti korištena kao alternativa za oživljavanje pacijenata sa zastojem srca i cirkulacije u slučajevima kada uobocajene mere oživljavanja ne daju rezultat kao poslednji pokušaj da se žrtva ne ostavi da umre. Ima veliki broj žrtava sa zastojem srca koji su dovoljno zdravi da je šteta da ih se ostavi da umru posle neuspelog pokušaja oživljavanja samo externom masagom (pritiskanjem na grudni kos). Ako profesionalni spasioc iscrpi sve tradicionalne raspoložive mogućnosti da uspostavi spontanu cirkulaciju žrtve sa zastojem srca naprava opisana ovim pronalsakom moze da se primeni: Punkcija vrha leve komore (left ventricular apex) sa 17 gauge vascularnom iglom kroz peti medjurebarni prostor leve srednje-klavikularne linije. Za punkciju nije potrebna nikakva aparativna kontrola ; crvena boja kroz punkcionu iglu aspirisane krvi dokaz je da krv potiče iz leve komore t.j da je punktirana leva komora. Kroz punkcionu iglu ubrizga se sredstvo protiv zgrusavanja krvi (heparin). The described device can be used as an alternative for reviving patients with cardiac and circulatory arrest in cases where normal resuscitation measures do not give results as a last attempt to prevent the victim from dying. There are a large number of cardiac arrest victims who are healthy enough that it would be a shame to leave them to die after a failed attempt at resuscitation with external massage (chest pressure) alone. If the professional rescuer exhausts all traditional available options to establish spontaneous circulation of the victim with cardiac arrest, the device described by this invention can be applied: Puncture of the top of the left ventricle (left ventricular apex) with a 17 gauge vascular needle through the fifth intercostal space of the left mid-clavicular line. Puncture does not require any apparatus control; the red color through the puncture needle of the aspirated blood is evidence that the blood originates from the left ventricle, i.e. that the left ventricle has been punctured. An anti-clotting agent (heparin) is injected through the puncture needle.

Placiranje J- formne žice vodilje kroz iglu u levo srce; posle odstranjenja igle naprava pristupne kanule 200 (Fig.2A) sa introducerom-uvodnicarom 230 uvodi se preko koze-per Seldinger tehnikom preko žice u levu komoru; dilatator 230 se odstrani, troslavinski konektor (3-way stopcock) 208 se zatovori; prvo se naduva mali unutrašnji balon 218 injekciom tecnosti kroz kanal 222. Tada se naduva i spoljnji veći rastegljivi balon 214 kroz kanal 216 sto osigurava stabilizaciju kanule unutar puta pristupa (Fig. 4A). Pumpna naprava 100 sa špricom velikog volumena 128 se spoji sa pristupnom kanulom 200 pomoću 3- slavinskog konektora 208 (Fig.3), 3 -slavinski konektor se otvori i preko otvora sa strane (side-conectora) instalira se flaša infusion tecnosti (hladan fiziološki rastvor sa heparinom-protiv zgrusavanja). Preko ovog otvora sa strane moze se izbaciti eventualno prisutni vazduh u šprici. U veliku špricu aspirira se oko 100 ml fiziološkog rastvora iz infuzije te se 3-slavinski konektor otvori u smeru da se oslobodi pravac kretanja is šprice u kanilu i nazad te se poene sa aspiraciom krvi iz leve komore u veliku špricu (slika 4A) i nastavi sa ubrizgavanjem krvii tecnosti iz šprice u levu komoru (slika 4B). Ako nema dovoljno krvi u levom srcu tokom aspiracije dodatna količina tecnosti moze biti aspirisana iz " infusora" prikačenog sa strane (sidearm) na sistem . Posle eventualnog uspesnog uspostavljanja spontane kardiocirkulatorne funkcije, velika šprica moze biti odvojena a pristupna kanula moze biti ostavljena instalirana sa infusiom za dodavanje tecnosti ili lekova ili električnih pomagala (pecemaker sonda). Posle uspesnog završetka oživljavanja mesto pristupa srcu moze biti zbrinuto hiruški ili sa kateter baziranom tehnikom zasivanja ili implantaciom zapusivaca mvocardnog zida (oceluderom) bez hiruske intervencije. Alternativno, pristupna kanula moze biti instalirana upotrebom "splittable" sheatha 250 (Fig.2C). Placement of a J-shaped guide wire through the needle into the left heart; after removal of the needle, the access cannula device 200 (Fig. 2A) with the introducer-introducer 230 is introduced through the goat-per Seldinger technique through the wire into the left ventricle; the dilator 230 is removed, the 3-way stopcock 208 is made; first, a small inner balloon 218 is inflated by injecting fluid through channel 222. Then, an outer larger expandable balloon 214 is inflated through channel 216, which ensures stabilization of the cannula within the access path (Fig. 4A). The pump device 100 with the high-volume syringe 128 is connected to the access cannula 200 using the 3-tap connector 208 (Fig.3), the 3-tap connector is opened and a bottle of infusion fluid (cold saline with heparin-anti-clotting) is installed through the side-connector. Any air present in the syringe can be ejected through this opening on the side. About 100 ml of physiological solution from the infusion is aspirated into the large syringe, and the 3-valve connector is opened in the direction to release the direction of movement from the syringe to the cannula and back, and begin with the aspiration of blood from the left ventricle into the large syringe (Figure 4A) and continue with the injection of blood and fluid from the syringe into the left ventricle (Figure 4B). If there is not enough blood in the left heart during aspiration, an additional amount of fluid can be aspirated from the "infusor" attached to the side (sidearm) of the system. After eventual successful establishment of spontaneous cardiocirculatory function, the large syringe can be detached and the access cannula can be left installed with the infusion for adding fluids or drugs or electrical aids (pacemaker probe). After the successful completion of resuscitation, the access point to the heart can be managed surgically or with a catheter-based suturing technique or implantation of a myocardial wall stopper (oceludera) without surgical intervention. Alternatively, an access cannula can be installed using a splittable sheath 250 (Fig.2C).

Moguća je i primena pronalaska sa ciljem da se održi minimalna circulacija i prokrvljenost organa žrtve koja nema izgleda za preživljavanje. Ovo dolazi u obzir u uslovima savremene medicine gde se pokušava da se spasu organi žrtve za donorstvo u osoba koja imaju potpisan pristanak za donaciju organa u slučaju neizbezne smrti. Poznato je da osobito u ratnim uslovima ima puno žrtava ciji organi mogu da spasu živote drugih ljudi ali mogućnosti očuvanja organa takvih žrtava do mesta gde se explantacija moze uraditi su veoma ograničene cime se gubi vredan reservoar organa za donaciju. Ovaj pronalazak uveliko pojednostavljuje očuvanje organa takvih žrtava. It is also possible to apply the invention with the aim of maintaining minimal circulation and blood supply to the organs of a victim who has no chance of survival. This comes into consideration in the conditions of modern medicine where attempts are made to save the victim's organs for donation to persons who have signed consent for organ donation in case of imminent death. It is known that, especially in war conditions, there are many victims whose organs can save the lives of other people, but the possibilities of preserving the organs of such victims to the point where explantation can be done are very limited, which results in the loss of a valuable reservoir of organs for donation. This invention greatly simplifies the preservation of the organs of such victims.

Primena ovog pronalaska je prvenstveno orijentisana humanoj medicine ali indikacije za primenu su takodje vazece i za veterinarsku medicine t.j primena pronalaska je ista za sve sisare. The application of this invention is primarily oriented towards human medicine, but the indications for application are also valid for veterinary medicine, i.e. the application of the invention is the same for all mammals.

Brojčane oznakeu crtežima (reference numerals) Reference numerals in drawings

100 pumpna naprava 100 pumping device

102 baza postolja 102 pedestal base

104 vertikalni deo postolja 106 nakošeni deo postolja 107 prednji deo postolja 104 vertical part of the stand 106 inclined part of the stand 107 front part of the stand

108 motor 108 engine

109 spojka naglavak motora -za rotiranje 110 stožer za obrtanje poluge 112 poluga 109 clutch engine head - for rotation 110 pivot for turning the lever 112 lever

114 pricvrscivac poluge za klip šprice 118 drzasci kroz cije kanale prolazi klip 120 klip šprice koji se nastavlja na cep šprice 122 cep šprice 114 lever attachment for the syringe piston 118 holders through which the piston passes 120 syringe piston that continues on the syringe pin 122 syringe pin

124 peicvrscivac šprice za postolje 126 zatezivaci šprice za postolje 128 šprica 124 Syringe sharpener for stand 126 Syringe tensioners for stand 128 Syringe

130 spojnica creva sa špricom 131 konektor za povezivanje creva šprice sa pristupnom kanilom 132 plastično crevo na šprici 134 regulator brzine rada motora 136 akumulator baterije 130 hose connector with syringe 131 connector for connecting the syringe hose with the access cannula 132 plastic hose on the syringe 134 engine speed regulator 136 battery accumulator

138 zatezivac akumulatora baterija za postolje 200 sistem pristupne kanile 202 armirani deo pristupne kanile 138 battery tensioner for stand 200 access cannula system 202 access cannula reinforced part

202 armirani deo pristupne kanile 202 reinforced part of the access cannula

204 armirani deo kanile sa zadebljalim zidom 206 deo creva integrisan u pristupnu kanilu 208 spojnica sa 3 otvora veikih promera 210 krajnji distalni otvor pristupne kanile 211 bočne rupe pristupne kanile 204 reinforced part of the cannula with a thickened wall 206 part of the hose integrated into the access cannula 208 connector with 3 openings of large diameters 210 distal end opening of the access cannula 211 side holes of the access cannula

212 veliki (spoljni) rastegljivi balon. 212 large (external) stretch balloon.

214 ulaz za naduvavanje i izduvavanje velikog balona 215 šprica za naduvavanje i izduvavanje velikog balona 216 kanal za naduvavanje i izduvavanje velikog balona 218 manji nerastegljivi balon 214 inlet for inflating and deflating a large balloon 215 syringe for inflating and deflating a large balloon 216 channel for inflating and deflating a large balloon 218 smaller non-stretchable balloon

220 ulaz za naduvavanje I izduvavanje malog balona 222 kanal za naduvavanje i izduvavanje malog balona 224 šprica za naduvavanje i izduvavanje malog balona 230 veliki prosirivac (dilatators) uvodničar 232 krajnji zašiljeni deo dilatatora 220 inlet for inflating and deflating a small balloon 222 channel for inflating and deflating a small balloon 224 syringe for inflating and deflating a small balloon 230 large expander (dilators) introducer 232 pointed end part of the dilator

233 otvor za prolaz žice na krajnjem kraju dilatatora 234 proximaIni (početni) deo dilatatora 235 otvor za prolaz žice na početnom delu dilatatora 240 žica vodilja 233 opening for the passage of the wire at the extreme end of the dilator 234 proximaIni (initial) part of the dilator 235 opening for the passage of the wire at the initial part of the dilator 240 guide wire

242 krajnji "J oblikovani" deo žice vodilje 250 uvodničar (sheath) koji se moze rascepiti 252 krajnji deo uvodnika sheath koji se moze rascepiti 254 početni deo- krak uvodnivara sheatha koji se moze rascepiti 255 drugi krak početnog dela sheatha uvodničara koji se moze rascepiti 242 end "J-shaped" part of the guide wire 250 introducer (sheath) that can be split 252 end part of introducer sheath that can be split 254 initial part - introducer arm of the sheath that can be split 255 second leg of the initial part of introducer sheath that can be split

500 žrtva koja treba da bude reanimirana. 500 victim to be resuscitated.

AV aortna valvula srca AV aortic valve of the heart

LA leva pretkomora srca LA left atrium of the heart

LV leva komora srca LV left ventricle of the heart

MV mitralna valvula srca MV mitral valve of the heart

Claims (5)

1. Naprava za oživljavanje kardio-cirkulatornog zastoja naznačena time sto se sastoji od: a pumpne naprave na motorni pogon (100), b kanule velikog lumena za pristup srčanoj komori (200), c elemenata za povezivanje pumpne naprave (100) sa kanulom (200);1. Device for reviving cardio-circulatory arrest indicated by that which consists of: a motor-driven pump device (100), b large-lumen cannula for access to the heart chamber (200), c elements for connecting the pump device (100) to the cannula (200); 2. Naprava po zahtevu 1 naznačena time sto je pumpna naprava (100) opremljena mehanizmom za motorni pogon koji omogućava ponavljane brze aspiracije i brze injekcije velike količine tecnosti; naznačena time stoje pristupna kanula (200) opremljena elementima (212) za zapusavanje puta kojim prolazi kroz grudni kos i kroz srčani misic do unutrašnjosti srčane komore , pomenuta kanula (200) opremljena elementima za sopstvenu stabilizaciju (218) unutar srčane komore.2. Device according to the request 1 indicated by that that the pumping device (100) is equipped with a motor drive mechanism that enables repeated rapid aspiration and rapid injection of a large amount of liquid; indicated by that there is an access cannula (200) equipped with elements (212) for blocking the path that passes through the rib cage and through the heart muscle to the interior of the heart chamber, said cannula (200) equipped with elements for its own stabilization (218) inside the heart chamber. 3. Naprava po zahtevu 2 naznačena time sto se pumpna naprava (100) sastoji od šprice velikog volumena (128) ciji je klip (120) funkcionalno povezan sa sistemom poluge (112), koja šprica velikog volumena na svom distalnom kraju sadrži duzinu creva (132) za spajanje sa pristupnom kanulom (200). 3. Device according to request 2 indicated by that that the pumping device (100) consists of a high-volume syringe (128) whose piston (120) is functionally connected to a lever system (112), which high-volume syringe contains at its distal end a length of hose (132) for connection to the access cannula (200). Naprava po zahtevu 3 naznačena time stoje pristupna canula (200) opremljena elementima (230,240,250) za nehirusko-perkutano -direktno kroz grudni kos - brzo uvodjenje - placiranje u komoru zastalog srca, koja pomenuta pristupna kanula (200) sadrži u svom proximalnom kraju integrisano crevo (206) koje crevo se proximalno završava sa tro-krakom spojnicom (208) za brzo spajanje sa pumpnom napravom (100) koja pomenuta trokraka spojnica sluzi za odstranjenje eventualno prisutnog vazduha u sistemu kao i za dovodjenje dodatne tecnosti preko infusora .Device according to request 3 indicated by that there is an access cannula (200) equipped with elements (230,240,250) for non-surgical-percutaneous -directly through the chest - rapid introduction - placement in the chamber of a stagnant heart, which said access cannula (200) contains in its proximal end an integrated hose (206) which hose ends proximally with a three-pronged coupling (208) for quick connection to a pumping device (100) which the mentioned three-pronged connector serves to remove any air present in the system as well as to supply additional liquid through the infuser. 5. Naprava za oživljavanje kardio-cirkulatornog zastoja nazanacena time sto se sastoji od pumpne naprave (100) koja pumpna naprava se sastoji od šprice velikog volumena (128) sa ugradjenim mehanizmom na motorni pogon (108), koji motorni pogon je snabdeven energijom bateriskog akumulatora (136) koji mehanizam na motorni pogon uključuje sistem poluge (112), koja pomenuta poluga omogućava ponavljane pokrete klipa šprice (120), koji pokreti klipa šprice omogućavaju ponavljano usisavanje u špricu i ispumpavanje iz šprice većih količina tecnosti, ,koja pomenuta šprica (128) se moze ručno montirati i demontirati u imobilizaciono postolje (102,104,106,107), koja pomenuta šprica (128) sadrži duzinu creva (132) na svom distalnom kraju, koje crevo se moze spojiti preko spojnice (131) sa pristupnom kanulom (200) preko tro-krakog konektora (208), koja pomenuta kanula je opremljena elementima (230,240,250) za perkutano - nehirusko uvodjenje u srčanu komoru , koja kanula je snabdevena elementima (212, 218) za zapusavanje puta kojim prolazi kroz grudni kos i srčani misic do unutrašnjosti komore zastalog srca.( 1\/l5. Device for reviving cardio-circulatory arrest marked by it which consists of a pumping device (100) which pumping device consists of a high-volume syringe (128) with a built-in motor-driven mechanism (108), which motor drive is powered by a battery pack (136), which motor-driven mechanism includes a lever system (112), which said lever enables repeated movements of the syringe piston (120), which movements of the syringe piston enable repeated suction into the syringe and pumping out of larger quantities of liquid, which said syringe (128) can be manually assembled and disassembled in the immobilization stand (102,104,106,107), which said syringe (128) contains a length of hose (132) at its distal end, which hose can be connected via a coupling (131) to an access cannula (200) via three-pronged connector (208), which said cannula is equipped with elements (230,240,250) for percutaneous - non-surgical introduction into the heart chamber, which cannula is equipped with elements (212, 218) for blocking the path that passes through the chest and heart muscle to the inside of the chamber of the stopped heart. (1\/l
RS20100468A 2010-11-02 2010-11-02 CARDIO-CIRCULATORY DEVICE DEVICE RS20100468A2 (en)

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