SI21083A - Medicinski ventil s pozitivno pretočno karakteristiko - Google Patents
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- A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
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- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
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Abstract
Ventil za selektivno omogočanje tekočinskega pretoka med prvo in drugo medicinsko pripravo. Ventil ima okrov z vmesnikom, ki je primeren, da sprejme del sklopnika prve medicinske priprave, kot je kateter, in tesnilo, ki je izdelano iz fleksibilnega materiala. Tesnilo ima prvi konec v tekočinski povezavi z vmesnikom, drugi konec, ki je primeren za sprejem druge medicinske priprave, in vsaj eno režo v tekočinski povezavi s prvim koncem in drugim koncem. Reža opredeljuje omejeno tekočinsko pot in sorazmerno majhno notranjo prostornino, ko je v nemotenem stanju, opredeljuje razširjeno tekočinsko pretočno pot in večjo notranjo prostornino po uvedbi drugega medicinskega instrumenta v režo in se umakne, da opredeli omejeno pretočno pot in majhno notranjo prostornino po umiku medicinske priprave od tesnila.ŕ
Description
Ozadje izuma
Področje izuma
Ta izum se na splošno nanaša na medicinski ventil in predvsem na ventil, ki omogoča, ko je priključen med prvo medicinsko pripravo, kot je vir tekočine, in drugo medicinsko pripravo, kot je kateter, tekočinski tok med njima in, ko se prva medicinska priprava odklopi, uvede pozitiven pretok tekočine skozi ventil v smeri druge tekočinske priprave.
Opis stanja tehnike
Rokovanje s tekočinami za parenteralno dovajanje v bolnišnicah in medicinskih napravah rutinsko vključuje uporabo sklopnikov in ventilov za selektivno omogočanje pretoka tekočine med dvema točkama. Ti ventili so značilno nameščeni vzdolž linije tekočinskega toka, ki vodi k pacientu ali drugim namembnim mestom, npr., cev lahko vodi h katetru, ki ima svojo konico nameščeno v pacientu.
-2L·
Ventil je nameščen tako, da se lahko vir tekočine ali druga linija priključijo nanj, da se zagotavlja tok tekočine od vira do pacienta. Ko se odstrani tekočinski vir ali tekočinska linija, se ventil zapre, pri čemer se zatesni linija, ki vodi proti pacientu.
Element, ki je priključen na ventil, lahko obsega cev ali drugo medicinsko pripravo, kot je vod, brizga, IV pribor (tako periferne kot centralne linije), plavutno oblikovana konica ali podobna komponenta, ki je prilagojena za priključitev na medicinski ventil. Na nesrečo imajo ventili po stanju tehnike težavo, ki izvira od odklopitve teh medicinskih priprav od ventila.
Ti ventili opredeljujejo prostor znotraj sebe, skozi katerega naj teče tekočina ali drug material od priprave do linije, na kateri je ventil nameščen. Kadar je medicinska priprava priključena na ventil, značilno zaseda del tega notranjega prostora ventila, pri čemer izpodriva tekočino (ta naj bo kapljevina ali zrak) znotraj ventila.
Problem se pojavi, ko se medicinska priprava odklopi od ventila. Ko se priprava odklopi, več ne zaseda dela prostora v ventilu. Povečanje prostora znotraj ventila povzroči, da se tekočina v ventilu in liniji, na katero je ventil priključen, premakne, da izpolni prostor. Dejansko odstranitev priprave povzroči sesalno silo, ki potegne tekočino v ventil.
V medicinskem priboru je ta premik tekočine zelo nezaželjen. Kadar je ventil priključen na tekočinsko linijo, ki vodi do pacienta, ima premik tekočine skozi linijo proti prostoru v ventilu za posledico vlek krvi od pacienta v smeri ventila. Lahko se pojavi resna težava v tem, da ta kri delno ali popolnoma zamaši kateter blizu njegove konice in več ne deluje ali pa ima lahko celo za posledico strditev krvi v pacientu, kar se lahko izkaže za usodno.
-3d
Poskus pri obvladovanju te težave z mašenjem je bil v tem, da se prekrije notranja površina katetra blizu njegove konice, da se prepreči, da bi se kri lepila na njegove notranje površine. Ta postopek je bil na splošno neuspešen, kar zadeva preprečevanja zamašitve katetra.
Nevarnost zamašitve katetra s krvjo, se močno poveča, kjer je notranji premer katetra majhen (npr. širina 27). Ti majhni katetri pa imajo prednost, da zmanjšujejo poškodbo in neugodje pri vstavljanju v pacienta. Ker imajo ti katetri zelo majhen prehod, lahko celo majhna sila vleka potegne zadostno količino tekočine nazaj skozi kateter proti ventilu, da se v konico katetra uvede kri, ki lahko zamaši prehod katetra.
Premagovanje zgoraj omenjenega problema je še težje, ko se obravnavajo drugi kriteriji, ki jim mora ventil zadoščati. Npr., ventil mora biti izveden tako, da nima zastojnih točk za tekočino. Če se dovoli, da se tekočina zaustavi v enem ali več področjih ventila, lahko pride do razmnoževanja bakterij in drugih težav.
Poleg tega mora ventil imeti notranjo pretočno pot, ki je gladka. Ostri robovi in vogali lahko poškodujejo krvne celice in povzročijo hemolizo.
Zaželjen je ventil, ki odpravlja zgoraj omenjene težave.
Povzetek izuma
V skladu z enim prednostnim izvedbenim primerom medicinski ventil za selektivno omogočanje tekočini, da teče med prvo medicinsko pripravo in drugo medicinsko pripravo, obsega okrov, ki ima vmesnik, kije primeren za sprejem sklopnikovega dela prve medicinske priprave in tesnilo. Tesnilo je izvedeno iz fleksibilnega materiala in ima navzdolnji konec v tekočinski povezavi z vmesnikom, navzgomji konec, ki je primeren za sprejem druge medicinske priprave, in normalno v bistvu zaprt prehod v
-4ψ tekočinski povezavi z navzdolnjim koncem in navzgornjim koncem. Prehod ima sorazmerno majhno notranjo prostornino, ko je v nemotnem stanju, in večjo notranjo prostornino po uvodu druge medicinske priprave v navzgomji konec prehoda. Prehod se umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino po umiku druge medicinske priprave od tesnila (navzgomji konec je v začetku zatesnjen, ko je druga medicinska priprava odstranjena), tako da je tekočina, ki zaseda notranjo prostornino, potisnjena proti navzdolnjem koncu, ko se stene prehoda sesedejo.
Po drugem prednostnem izvedbenem primeru se zagotovi ventilno tesnilo za uporabo v medicinskem ventilu, ki ima vmesnik za tekočinsko povezavo s prvo medicinsko pripravo. Tesnilo obsega prvi konec v tekočinski povezavi z vmesnikom, drugi konec, ki je primeren za sprejem druge medicinske priprave, in vsaj eno režo v tekočinski povezavi s prvim koncem in drugim koncem. Reža opredeljuje omejeno pretočno pot tekočine in sorazmerno majhno notranjo prostornino, ko je v nemotenem stanju, in opredeljuje razširjeno pretočno pot tekočine in večjo notrajo prostornino po uvedbi druge medicinske priprave v režo. Reža se umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino po umiku druge medicinske priprave od tesnila.
V skladu z nadaljnjim prednostnim izvedbenim primerom je zagotovljen postopek za povzročanje pozitivnega toka v smeri prve medicinske priprave od ventila, ki povezuje prvo medicinsko pripravo z drugo medicinsko pripravo in ima prirejeno tesnilo. Tesnilo je prilagojeno tako, da sprejme vsaj del druge medicinske priprave in zagotavlja tekočinsko povezavo med prvo in drugo medicinsko pripravo. Postopek obsega korake odstranjevanja druge medicinske priprave od tesnila in omogočanje, da se tesnilo umakne od velike notranje prostornine na sorazmerno majhno notranjo prostornino, tako da se odstrani katerakoli tekočina znotraj tesnila v smeri prve medicinske priprave.
-5V skladu z nadaljnjim izvedbenim primerom je zagotovljen postopek, s katerim se prepreči, da bi kri tekla od pacienta v kateter, ko se odstrani brizga z ventila med brizgo in katetrom. Postopek obsega korake priključevanja navzdolnjega konca ventila na kateter in vstavljanja konca brizge v režo, ki tvori navzgomji konec normalno v bistvu zaprtega tesnilnega prehoda, ki je nameščen v podajnem tesnilu in je v tekočinski povezavi z navzdolnjim koncem ventila. To povzroči, da se prehod tesnila odpre, medtem ko se zagotavlja tesnilni stik med brizgo in navzgomjim koncem prehoda ventila. Ta postopek nadalje obsega korake vbrizgavanja tekočine od brizge skozi prehod tesnila do katetra in v pacienta ter odstranjevaja brizge, pri čemer se omogoči, da se stene prehoda tesnila povrnejo v svoj v bistvu zaprt položaj, medtem ko se v začetku vzdržujejo stik tesnila med navzgomjim koncem in brizgo. To zagotavlja silo, ki potisne tekočino v prehodu proti katetru.
V skladu z nadaljnjim prednostnim izvedbenim primerom je zagotovljen medicinski ventil, ki selektivno omogoča, da tekočina teče med prvo medicinsko pripravo in drugo medicinsko pripravo skozi povezano tesnilo. Ventil obsega vmesnik, ki je primeren za sprejem dela sklopnika prve medicinske priprave, in držalo tesnila v tekočinski povezavi z vmesnikom.
V skladu z nadaljnjim prednostnim izvedbenim primerom sistem za dodajanje tekočine krvnemu obtoku pacienta obsega kateter, ki ima navzgomji konec in navzdolnji konec, kije primeren, da se dovede v tekočinsko povezavo s krvno žilo, in brizgo, ki je primerna za iztiskanje tekočine v kateter. Sistem nadalje obsega ventil, ki ima spojnik, ki je primeren za povezavo z navzgomjim koncem katetra in za zagotavljanje selektivne tekočinske povezave med brizgo in katetrom. Ventil nadalje obsega tesnilo, kije izdelano iz fleksibilnega materiala. Tesnilo ima navzdolnji konec v tekočinski povezavi s spojnikom, navzgomji konec, ki je primeren za sprejemanje brizge, in normalno v bistvu zaprt prehod v tekočinski povezavi z navzdolnjim
-6koncem in navzgomjim koncem. Prehod ima sorazmerno majhno notranjo prostornino, ko je v nemotenem stanju, in ima veliko notranjo prostornino, potem ko se uvede brizga v navzgomji konec prehoda. Prehod se umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino po odstranitvi druge medicinske priprave s tesnila - navzgomji konec je v začetku zatesnjen, ko se brizga odstrani, tako da se tekočina, ki zaseda notranjo prostornino, potisne proti navzdolnjemu koncu, ko se stene prehoda sesedejo.
V skladu z nadaljnjim prednostnim izvedbenim primerom je zagotovljen postopek izdelave medicinskega ventilnega tesnila take vrste, da ima telo, ki je izdelano iz fleksibilnega materiala in vsaj eno režo, ki je izoblikovana znotraj telesa med priležnimi prvimi in drugimi stenami reže. Postopek obsega oblikovanje prvega in drugega surovca, od katerih vsak obsega eno od prvih in drugih sten reže in obodni del roba, in stiskanje prvega in drugega surovca skupaj tako, da sta prva in druga stena reže obrnjeni druga proti drugi. Postopek nadalje obsega oblikovanje dodatne količine fleksibilnega materiala v vsaj del obodnih robnih predelov prvega in drugega surovca tako, da prvi in drugi surovec in dodatni material tvorijo enotno maso, v kateri je izoblikovana reža.
V skladu z nadaljnim prednostnim izvedbenim primerom kateter za vzpostavljanje tekočinske povezave med medicinsko pripravo in krvnim obtokom pacienta obsega podolgovati kateter ali kanulo, ki ima proksimalni konec, distalni konec in vsaj en osni lumen, ki se razteza vzdolž kanule. Kateter nadalje obsega ventil za selektivno odpiranje in zapiranje proksimalnega konca kanule. Ventil obsega okrov, ki ima vmesnik, ki je primeren za povezavo s proksimalnim koncem kanule, in tesnilo. Tesnilo je izdelano iz fleksibilnega materiala in ima distalni konec v tekočinski povezavi z vmesnikom, proksimalni konec, ki je primeren za sprejem medicinske priprave, in normalno v bistvu zaprt prehod v tekočinski povezavi z distalnim koncem in proksimalnim koncem. Prehod ima sorazmerno majhno notranjo prostornino, ko je
-7n nemotenem stanju, in večjo notranjo prostornino, potem ko se uvede medicinska priprava v proksimalni konec prehoda. Prehod se umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino, potem ko se odstrani medicinska priprava od tesnila, pri čemer je proksimalni konec v začetku zatesnjen, ko se medicinska priprava odstrani, tako da se tekočina, ki zaseda notranjo prostornino, prisili proti distalnemu koncu, ko se stene prehoda sesedejo.
V skladu z nadaljnjim prednostnim izvedbenim primerom kateter obsega podolgovato kanulo, ki ima proksimalni konec, distalni konec in vsaj en notranji lumen. Distalni konec je primeren za vstavljanje v vaskulaturo pacienta. Kateter nadalje obsega ventil, ki je povezan s proksimalnim koncem kanule. Ventil ima tesnilo, ki opredeljuje omejeno pretočno pot v njenem nemotenem stanju in ki se lahko raztegne, da opredeli povečano pretočno pot, da omogoči tekočinsko povezavo mimo proksimalnega konca kanule. Tesnilo se lahko nadalje umakne, da opredeli omejeno pretočno pot, medtem ko hkrati prisili vsako tekočino znotraj povečane pretočne poti v kanulo.
V skladu z nadaljnjim izvedbenim primerom postopek uvajanja tekočine v vaskulaturo pacienta obsega vstavljanje distalnega konca kanule v vaskulaturo pacienta. Kanula ima ventil, ki je povezan z njenim proksimalnim koncem, in ventil obsega okrov in tesnilo. Postopek nadalje obsega vstavljanje medicinske priprave v tesnilo, delovanje medicinske priprave, tako da prisili tekočino skozi kanulo in v vaskulaturo pacienta, in odstranjevanje medicinske priprave od tesnila. Tesnilo je izdelano iz fleksibilnega materiala in ima distalni konec v tekočinski povezavi s kanulo, proksimalni konec primeren za sprejem medicinske priprave in normalno v bistvu zaprt prehod v tekočinski povezavi z distalnim in proksimalnim koncem. Prehod ima sorazmerno majhno notranjo prostornino, ko je v nemotenem stanju, in veliko notranjo prostornino, potem ko se uvede medicinska priprava v proksimalni konec prehoda. Prehod se umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino po odstranitvi medicinske priprave s tesnila. Proksimalni konec tesnila je
-8v začetku zatesnjen, ko se odstrani druga medicinska priprava, tako da se katerakoli tekočina, ki zaseda notranjo prostornino, prisili proti distalnemu koncu, ko se stene prehoda sesedejo.
V skladu z nadaljnjim prednostnim izvedbenim primerom postopka za olajšanje nadomestitve prvega sklopnika, ki je v tekočinski povezavi s kanulo, s tesnilom, ki se lahko preluknja, v tekočinski povezavi s pacientovo vaskulaturo z drugim spojnikom s tesnilom, ki se lahko preluknja, obsega vstavljanje ventila med prvi spojnik s tesnilom, ki se lahko preluknja, in proksimalni konec kanule. Ventil obsega okrov in tesnilo, ki je nameščeno znotraj okrova. Tesnilo opredeljuje omejeno pretočno pot v njenem nemotenem stanju in je zmožno razširitve, da opredeli razširjeno pretočno pot, da omogoči tekočinsko povezavo mimo proksimalnega konca kanule. Tesnilo je nadalje zmožno umika, da se opredeli omejena pretočna pot, medtem ko se hkrati vsaka tekočina znotraj povečane pretočne poti potisne v kanulo. Postopek nadalje obsega odstranjevanje prvega spojnika s tesnilom, ki se lahko preluknja, od proksimalnega konca ventila, tako da se omogoči tesnilu, da se umakne, da opredeli omejeno pretočno pot, in povezovanje drugega spojnika s tesnilom, ki se lahko preluknja, z ventilom, s čimer se povzroči, da se ventil razširi, da opredeli povečano pretočno pot.
Za namene povzetka izuma in glede na stanje tehnike doseženih prednosti so bile doslej zgoraj opisane določene naloge in prednosti izuma. Seveda je treba razumeti, da ni potrebno, da se vse naloge ali prednosti dosežejo v skladu s katerimkoli posebnim izvedbenim primerom izuma. Tako npr. strokovnjaki s področja prepoznajo, da se izum lahko uresniči ali izvede na način, ki doseže ali optimira eno prednost ali skupino prednosti, kot so bile tukaj razložene, ne da bi nujno dosegel druge cilje ali prednosti, kot so bile pojasnjene ali svetovane doslej.
Vsi ti izvedbeni primeri so predvideni, da so znotraj okriva izuma, ki je tukaj opisan. Ti in drugi izvedbeni primeri predloženega izuma bodo laže razumljivi strokovnjakom
-9s področja iz sledečega podrobnega opisa prednostnih izvedbenih primerov, ki se sklicujejo na predložene slike, izum pa ni omejen na enega ali več posebnih prednostnih izvedbenih primerov.
Kratek opis slik
Potem ko so bile tako povzete splošno narava izuma in bistvene značilnosti in prednosti, bodo za strokovnjake s področja določeni prednostni izvedbeni primeri in njihove modifikacije postali bolj jasni iz podrobnega opisa, ki se sklicuje na slike, ki sledijo in na katerih je:
slika 1 shematičen pogled na uporabo v skladu z izumom za povezovanje katetra s tekočinskim virom, kot je brizga;
slika 2 pogled na ventil v perspektivi;
slika 3 čelni pogled na ventil;
slika 4 stranski pogled na ventil;
slika 5 pogled na tesnilo v perspektivi za uporabo v ventilu;
slika 6A čelni pogled na tesnilo;
slika 6B čelni pogled na tesnilo v prerezu;
slika 7A stranski pogled na tesnilo;
slika 7B stranski pogled na tesnilo v prerezu;
slika 8 čelni pogled na tesnilo z vrsto shematskih pogledov v prerezu za vstavitev medicinske priprave v tesnilo;
slika 9 Čelni pogled v prerezu okrova za uporabo v ventilu;
slika 10 stranski pogled v prerezu ventila in brizge pred vstavitvijo brizge v ventil; slika 11 stranski pogled v prerezu ventila z brizgo, kije polno vstavljena; slika 12 čelni pogled v prerezu ventila z brizgo, kije polno vstavljena; slika 13 stranski pogled v prerezu na ventil z brizgo, ki je delno izvlečena; slika 14 stranski pogled v prerezu na ventil z brizgo, ki je še bolj izvlečena glede na sliko 13;
-10/10 slika 15 stranski pogled na alternativni izvedbeni primer ventila z delno vstavljeno brizgo;
slika 16 stranski pogled na alternativni izvedbeni primer ventila s polno vstavljeno brizgo;
slika 17 čelni pogled na ventil, kot se uporablja z brizgo, ki ima Luerjevo zaporo;
slika 18 stranski pogled na alternativni izvedbeni primer okrova ventila;
slika 19A-19E shematični pogledi na postopek izdelave tesnila;
slika 20 pogled na nadoblikovalno ploščo, ki se uporablja za izdelavo tesnila;
slika 21 delni pogled v prerezu na kateter, ki vključuje ventil po predloženem izumu in vodilno žično cev;
slika 22 pogled v perspektivi na kateter s slike 21, ki je vstavljen v pacientovo roko; in slika 23 delni pogled v prerezu na sklopnik povezan z ventilom katetra, s tesnilom, ki se lahko preluknja.
Podroben opis prednostnih izvedbenih primerov
Slike 1-9 prikazujejo ventil 20 v skladu s prednostnim izvedbenim primerom izuma. Slika 1 prikazuje posebno uporabo ventila 20, za katero je zelo primeren. Seveda se ventil 20 lahko uporablja na mnogo drugih načinov.
Kot je prikazano na sliki 1 se ventil 20 na koristen način uporablja, da selektivno kontrolira pretok tekočine proti prvi medicinski pripravi (kot je tukaj prikazani kateter 22) od druge medicinske priprave (na splošno obsega tekočinski vir, kot je brizga 24 po ISO standardu). V tej razporeditvi je kateter 22 priključen na en konec ventila 20 in ima konico 26 vstavljeno v pacientovo roko. Brizga 24 ima kanulamo konico ali Luer 28, ki je vstavljen v drugi konec ventila 20, ki je izoblikovan, da sprejme Luer 28 brizgalke 24, ne da bi bila na Luer nameščena igla.
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Ko je tako povezan, ventil 20 omogoča, da tekočina teče od brizge 24 proti katetru 22 in v pacienta. Ventil 20 je tudi tako izveden, da je tekočinski tok skozi ventil 20 preprečen, ko se brizga 24 odklopi. Ko se brizga 24 odklopi, ventil 20 razen tega tvori pozitiven tekočinski tok, to se pravi tok tekočine v smeri proti pacientu in se s tem prepreči, da bi kri vstopila v kateter 22 in povzročila povezane neugodne učinke.
Slike 2-4 prikazujejo prednostni izvedbeni primer ventila 20 v skladu z izumom. Ventil 20 obsega sorazmerno tog okrov in sorazmerno fleksibilno in podajno tesnilo 32, kije nameščeno na ali v okrovu 30. Okrov 30 ima vmesnik 34 z Luerjevo zaporo na svojem spodnjem koncu, da olajša povezovanje ventila 20 z mnogo medicinskimi pripravami. Strokovnjak s področja bo zlahka cenil, da so številne druge vrste vmesnikov ali spojnikov primerne za uporabo namesto Luerjeve zapore 34, kot je npr. Luerjev drsni spojnik ali zaskočni cevni spojnik.
Tesnilo 32 ima režasto odprtino 36 (najbolje vidna na sliki 2), ki je izoblikovana tako, da omogoča, da Luer 28 brizge 24 (glej sliko 1) vstopi v tesnilo 32 ob uporabi zmernega pritiska s strani uporabnika. Brizgin Luer 28 tako vstopi v režo 38 (glej sliko 3), ki je izoblikovana v notranjosti tesnila 32. S tako vstavljenim brizginim Luerjev 28 tesnilo dovoljuje, da tekočina, ki jo izbrizga brizga 24 skozi Luer 28, teče skozi režo 38 in Luerjevo zaporo 34 in v kateter 22 ali drugo medicinsko pripravo, ki je priključena na Luerjevo zaporo 34.
Slike 5-7B prikazujejo tesnilo 32, ki je odstranjeno iz okrova zaradi jasnega prikaza. Tesnilo 32 ima telo 40, ki lahko zavzame obliko plošče, ki ima plosko, na splošno pravokotniško obliko. Kot vse tesnilo 32 je telo 40 prednostno izvedeno iz oblikovane silikonske gume durometer 50 ali pa je alternativno izvedeno iz sintetičnega poliizoprena. Na enem koncu telesa 40 je izoblikovan plosk, na splošno pravokotniški vrat 42 in na splošno krožna prečna prirobnica 44. Vrat 42 je nameščen med prvo in drugo stransko razširitvijo 43a, 43b, ki imata rameni 43c, 43d, ki obsegata tiste
-12to predele stranskih razširitev, ki so najbližji prirobnici 44. Telo 40, vrat 42 in prirobnica 44 tako tvorijo enotno enoto, znotraj katere je izoblikovana (prednostno v bistvu planama) reža 38. Reža 38 se razteza od režine odprtine 36 (najbolje razvidna na sliki
2) v prirobnici 44 do pretočnega lumna 46, ki je izoblikovan v koncu telesa 40 nasproti prirobnici 44. Pretočni lumen 46 je prednostno v bistvu valjast in s središčem v osi, ki je v bistvu vzporedna ali kolineama z vzdolžno osjo tesnila. Reža 38 je prednostno v bistvu planama in virtualno ničelne debeline, razen ko je Luer priključen. Reža 38 tako tvori - v svojem nemotenem stanju, to se pravi, ko brizgin Luer 28 ni bil vstavljen v tesnilo 32 - močno omejeno tekočinsko pretočno pot od odprtine 36 reže do pretočnega lumna 46. Kot se uporablja tukaj v povezavi s potjo pretoka, omejen pomeni pot toka od odprtine 36 reže do pretočnega lumna 46. Kot se tukaj uporablja v povezavi s potjo toka, omejeni pomeni pot toka, ki ne dovoljuje prehoda bodisi nobene tekočine ali le klinično zanemarljive količine tekočine.
Prednostna konfiguracija reže in pretočnega lumna 46 je najbolje razvidna s slik 6A7B. Reža 38 ima del 48 telesa znotraj telesa 40 tesnila 32. Na ugoden način je del 48 telesa področje največje širine, prednostno okoli 0,580 cm (0,228 cole), reže 38. Reža 38 seže do točke ali področja 50 najmanjše širine, ki je prednostno nameščena znotraj vratu 42. Na ugoden način je v področju 50 najmanjše širine reža 38 prednostno široka okoli 0,305 cm (0,120 cole). Z drugimi besedami, širina reže 38 v delu 48 telesa je skoraj dvakratnik tiste v področju 50 z najmanjšo širino. Od področja 50 najmanjše širine se reža 38 širi navzven do odprtine 36 reže, kjer doseže prednostno širino okoli 0,501 cm (0,200 cole). Stožčasta konfiguracija deluje kot uvodni del za vstavljanje brizginega Luerja 28 v režo 38. Reža 38 ima lahko tudi ploske vogale 52 na svojem spodnjem koncu nasproti vratu 42. V svojem spodnjem koncu se reža 38 povezuje s pretočnim lumnom 46, da se olajša tekočinska komunikacija med režo 38 in pretočnim lumnom 46. Pretočni lumen 46 ima prednostno uvodni odsek 54 in raven prehod 56 do reže 38. Prednostni notranji premer pretočnega lumna 46 je okoli 1,016 cm (0,040 cole).
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Na stranskih pogledih slik 7A in 7B se lahko vidi, da ima tesnilo 32 presek v obliki črke T pred vstavitvijo v okrov 30, pri čemer prirobnica 44 tvori prečni del črke T. Gledano s strani, je reža 38 enakomerno tanka, to se pravi nobene ali skoraj nobene debeline, ko poteka od vrha tesnila 32 proti pretočnemu lumnu 46. Vendar po namestitvi v okrov 30 se debelina reže 38 (gledano s strani) nekoliko spreminja, kot bo v nadaljnjem podrobneje pojasnjeno.
Slike 8A-8D prikazujejo učinke s stališča tesnjenja spremenljive širine reže 38 po vstavitvi brizginega Luerja 28 v režo 38. (Brizgin Luer 28 ni prikazan na sliki 8A iz razloga jasnosti). Slika 8B prikazuje razporeditev reže 38 in brizginega Luerja 28 v področju 50 najmanjše širine, ko je bil Luer 28 polno vstavljen v režo 38. Zaradi sorazmerne ožine reže 38 v področju 50 se reža 38 opre v bistvu ob celoten obod brizginega Luerja 28 na tem položaju in stvori sorazmerno tesno bot tesnila med režo 38 in Luerjem 28. Z drugimi besedami obod odprte reže 38 v področju 50 je manjši od oboda Luerja 28.
Sliki 8C in 8D prikazujeta, da se reža 38, kjer je širša (to se pravi, v delu 48 telesa reže in prehodu od področja 50), ne dotika več celotnega oboda brizginega Luerja 28, pri čemer pušča reže 57 na eni ali obeh straneh in koncu Luerja 28. Z drugimi besedami obod odprte reže v delu 48 telesa je večji od oboda Luerja 28. Kot bo podrobneje razpravljano pozneje, ta razporeditev tesnjenja reža-Luer blizu vrha reže 38 in prostornina, ki jo lahko zasede tekočina (v obliki rež 57), pod tesnjenjem reža-Luer pospešuje pozitivno pretočno funkcijo za ventil 20, ko se odstrani brizgin Luer 28.
Slike 3, 4 in 9 prikazujejo prednostno konfiguracijo okrova 30 in namestitev tesnila 32 v njem. Okrov 30 je prednostno izveden iz oblikovanega polikarbonata ali alternativno izveden iz kateregakoli primernega termoplastičnega materiala. Okrov 30 ima držalo 58 tesnila, kije pritrjeno na Luerjevo zaporo 34; držalo tesnila ima prednostno valjasto
-14konfiguracijo, vendar ima lahko katerokoli obliko ali konstrukcijo, ki zadošča, da drži tesnilo 32 na ali v okrovu 30, ne da bi motilo delovanje ventila 20. Držalo tesnila ima osno odprtino 60 nasproti Luerjevi zapori 34 in prvo in drugo stransko odprtino 62a, 62b, ki imata prvi in drugi vrhnji rob 63a, 63b, ki obsegata robove stranskih odprtin najbliže osni odprtini 60. Pretočna kanula 64 (najbolje vidna na sliki 9) se razteza od Luerjeve zapore 34 proti osni odprtini 60 in vsebuje notranji lumen 66, ki je v tekočinski povezavi z lumnom 68 v Luerjevi zapori 34. Pretočna kanula 64 je prednostno v bistvu valjasta ali v obliki prerezanega stožca in centrirana okoli osi, ki je v bistvu vzporedna ali kolineama z vzdolžno osjo okrova 30. Par izrastkov 70 je nameščen na koncu držala 58 tesnila blizu osne odprtine 60, da omogoča Luerjevi zapori ali drugi vijačni zvezi (ni prikazana), da vijačno vprime okrov 30 pri osni odprtini 60.
Kot je najbolje vidno na slikah 3 in 4, je največ tesnila 32 nameščenega znotraj držala 58 tesnila s prvo in drugo stransko razširitvijo 43a, 43b tesnila 32, ki sega od prve in druge stranske odprtine 62a, 62b. Pretočni lumen 46 tesnila 32 je nameščen tako, da se pretočna kanula 64 razteza vsaj delno v pretočni lumen, pri čemer omogoča tekočinsko povezavo med tesnilom 32 in Luerjevo zaporo 34. Prirobnica 44 pokriva osno odprtino 60 in se dotika priležnih robov odprtine. Prednostno je razdalja med osno odprtino 60 in vrhnjima robovoma 63a, 63b stranskih odprtin 62a, 62b rahlo večja od razdalje med prirobnico 44 in ramenoma 43c, 43d stranskih razširitev 43a, 43b. Ta razporeditev ima za posledico uporabo natezne sile ali predobremenitve na tesnilo 32 med prirobnico 44 in stranskima razširitvama 43a, 43b. Predobremenitev nastane, ko se rameni 43c, 43d opreta ob vrhnja robova 63a, 63b, in prirobnica opre ob robova osne odprtine 60. Predobremenitev povzroči, da prirobnica 44 zavzame rahlo skodelasto oblikovano ali konkavno konfiguracijo, ko se robovi osne odprtine 60 oprejo ob spodnjo stran prirobnice 44. Skodelasto oblikovana prirobnica 44 tako služi kot uvod za vstavljanje brizginega Luerja 28 v odprtino 36 (najbolje razvidno na sliki
2) in teži, da do zaprtosti zmečka odprtino 36 reže in tako ojači zmožnost tesnila 32,
-15da prepreči pretok tekočine. Predobremenitev tudi prepreči gubanje tesnila vzdolž njegove vzdolžne osi in vzdržuje stranice reže 38 v tesni bližini vzdolž celotne dolžine. Predobremenitev tako omogoča sorazmerno tenko režo pod prirobnico 44, ki ojačuje tesnilno delovanje reže 38.
Slike 10 do 14 prikazujejo delovanje ventila 20, ko je brizgin Luer 28 vstavljen v in odstranjen iz reže 38. Slika 10 prikazuje ventil 20 pred vstavitvijo brizginega Luerja 28; v tej točki reža 38 opredeljuje v bistvu zaprto ali zelo omejeno pretočno pot skozi tesnilo 32, ki je označeno z zelo tanko (ali v bistvu neobstoječo) debelino Tmin poti med stenama 72a, 72b reže. Ta tanka ali neobstoječa debelina Tmin poti prevladuje vzdolž večine ali v bistvu celotne poti reže 38 pod prirobnico 44. Ta pogoj omejuje tok tekočine skozi tesnilo 32, tako da zatesni kateter 22 (glej sliko 1) ali drugo medicinsko pripravo, kije priključena na Luerjevo zaporo 34. V tej točki reža 38 tudi opredeljuje sorazmerno majhno notranjo prostornino Vmin znotraj tesnila 32 med stenama 72a, 72b reže. (Kot se tukaj uporablja glede na notranjo prostornino tesnila, sorazmerno majhna pomeni prostornino, ki je bodisi neobstoječa ali klinično po velikosti zanemarljiva). V tem začetnem stanju je tesnilo 32 nameščeno na pretočni kanuli 64, tako da se v bistvu nič od pretočne kanule 64 ne razteza v režo 38.
Sliki 11 in 12 prikazujeta ventil 20, potem ko je bil brizgin Luer 28 popolnoma vstavljen v režo 38. Tesnilo 32 je bilo tudi raztegnjeno ali potisnjeno navzdol na pretočno kanulo 64, katere vsaj del prodre v samo režo 38. V tej točki reža 38 opredeljuje razširjeno pretočno pot skozi tesnilo 32, s tem da sta se steni 72a, 72b reže razširili do širine Tmax poti. Tesnilo 32 tako dovoljuje tekočini, da teče med brizgo 42 in katetrom 22. Poleg tega reža 38 sedaj opredeljuje večjo ali naj večjo notranjo prostornino Vmax. Vmax obsega celoten prostor med stenama 72a, 72b reže, zmanjšan za prostornino, ki jo zavzema kanula (ne pa notranji lumen) brizginega Luerja 28, in za del pretočne kanule 64, je prodrla v režo 38. V skladu s tem pod tlakom, ki se
-16izvaja preko brizge 24, del tekočine, ki v bistvu ustreza Vmax, sedaj napolni režo 38 med stenama 72a, 72b reže. To je tudi prikazano kot reži 57 na slikah 8C in 8D.
Sliki 13 in 14 prikazujeta delovanje reže 38, potem ko je bil brizgin Luer 28 odstranjen iz ventila 20. Ko brizgin Luer 28 in pretočna kanula 64 zapustita režo, se steni 72a, 72b reže umakneta do v bistvu svoje začetne konfiguracije, da ponovno opredelita ožjo širino poti (ki se približuje Tmin) med njima. Ta umik sten 72a, 72b reže zmanjšuje prostornino med stenami; to se pravi, notranja prostornina znotraj reže 38 se zmanjša od Vmax. Tako se količina tekočine znotraj reže mora zmanjšati od Vmax. Zato umikajoči se steni 72a, 72b reže potisneta tekočino od reže 38, ko se je brizgin Luer 28 umaknil.
Tako izpodrinjena tekočina ne more izteči iz reže 38 skozi vrh tesnila 32. Kot je bilo podrobno opisano zgoraj v povezavi s slikama 8A in 8B, reža 38 vzdržuje tesnost tesnila proti brizgi Luerja 28 v področju 50 najmanjše širine, ko se je brizgin Luer 28 odstranil. Razen tega izpodrinjena tekočina ne more steči v notranjost brizge 24 v nobenem času, ki je relevanten za uporabo ventila 20. Zato mora v bistvu vsa izpodrinjena tekočina izstopiti iz reže 38 skozi pretočno kanulo 64 in Luerjevo zaporo 34, kar ima za posledico pozitiven tok od ventila 20 po odstranitvi brizginega Luerja
28.
Slike 15-18 prikazujejo spremembe na ventilu 20, kije bil zgoraj opisan, pri čemer so spremembe lahko pod določenimi pogoji delovanja zaželjene. Kot je npr. razvidno s slik 15 in 16, ima lahko okrov 30 režo 74, ki poteka navpično med osno odprtino 60 in eno ali obema stranskima odprtina 62a, 62b. Reža omogoča držalu 58 tesnila, da se razpre, ko se Lueijev drsni spojnik 28 (v nasprotju z Luerjevo zaporo 76, ki je prikazana na sliki 17) vstavi v tesnilo 32. Za razpiranje se je ugotovilo, daje ugodno pri uporabi ventila 20 z Luerjevim drsnim spojnikom 28, ko je za ventil 20 manj verjetno, da stisne ali zmečka Luer 28 iz tesnila 32.
-17I?
Slika 18 prikazuje alternativno konfiguracijo okrova 30 z ukrivljenim izgledom ali izgledom v obliki tokovnic v primerjavi z zgoraj opisanim okrovom. Obe tedve vrsti okrova ali vrsta, ki je bila zgoraj opisana, lahko imajo zunanjo prevleko ali plast sorazmerno mehkega, upogljivega materiala, kot je termoplastičen elastomer, da se poveča udobje operaterja in poudari pojem ventila 20, ki zagotavlja povezavo brez uporabe ostrih, prebadajočih elementov, kot so igle ali rezila.
Slike 19A-21 prikazujejo prednostni postopek za izdelavo tesnila 32. Najprej se par surovcev 202a, 202b oblikuje med prvim in drugim oblikovalnim parom 204a, 204b oz. 206a, 206b. Vsak surovec 202 ima na splošno raven odsek 208, ki v izdelanem tesnilu 32 tvori steno reže 38 (glej slike 6A-7B). Del 210 prirobnice je tudi integralno oblikovan v oba surovca 202. Stranice prirobičinega dela 210 so zamaknjene od zgornje stranice ravnega dela 208, da se zagotovi prostor za nadoblikovani material (podrobneje bo obravnavano spodaj), da teče med in povezuje prirobičine dele 210. Oblikovanje surovcev 202 se doseže z uporabo običajnih postopkov in opreme, prednostno z injektiranjem termično strdljivega materiala v votlino, ki se izoblikuje med oblikovalnima paroma 204a, 204b in 206a, 206b, in gretjem kalupov in/ali materiala, da se nastavi temperatura določenega uporabljenega materiala. Lahko se uporabi tlak, če je potrebno, da se prepreči, da bi material iztekel med polovicama kalupa.
Po tej začetni stopnji oblikovanja se polovici 204a, 206a kalupa, medtem ko sta surovca 202a, 202b še nameščena v njih, stisneta skupaj z nadoblikovalno ploščo 212, ki je nameščena med kalupnima polovicama, kot je prikazano na slikah 19B in 19C. Nadoblikovalna plošča 212, najbolje je vidna na sliki 20 (z obrisom surovcev 202 je tudi vidna na skici), nasplošno obsega ravno ploščato telo 214 z nadoblikovalno odprtino 216, kije vrezana v telo 214. Nadoblikovalna odprtina 216 ima raven obod, ki se ujema z zunanjimi robovi izdelanega tesnila 32 in lahko vključuje trn 218, ki štrli
-18Μ iz spodnjega dela odprtine 216 in tvori pretočni lumen 46 (glej slike 6A-7B) med nadoblikovalnim postopkom, kar bo podrobneje obravnavano spodaj. Kontaktne stranice kalupnih polovic 204a, 206a in nadoblikovalne plošče 212 so na ugoden način v bistvu ravne. Tako kalupni polovici 204a, 206a, plošča 212 in surovca 202a, 202b opredeljujejo oblikovalno votlino ali prostornino 220 med stenami nadoblikovalne odprtine 216 in zunanjimi robovi surovcev 202a, 202b in med stranicama kalupnih polovic 204a, 206a.
Z oblikovalnim aparatom (oblikovalni polovici 204a, 206a in nadoblikovalna plošča 212), ki je sestavljen, kot je prikazano na sliki 19C, se v oblikovalni aparat vbrizga dodaten termično strdljiv material, da zapolni oblikovalno votlino 220 in oblikuje preostanek tesnila 32. Prednostno se dodaten material vbrizga takoj (to se pravi po nekaj sekundah), potem ko so bili surovci 202 oblikovani in medtem ko so še nekoliko topli od začetnega oblikovanja. Dodaten material, ki je bil vbrizgan v oblikovalno votlino 220, poveže robove surovcev 202 in tvori robove reže 38 v izdelanem tesnilu
32. Z drugimi besedami, preostanek tesnila se nadoblikuje v sendviču surovcev 202. Prednostno se surovca 202 stisneta skupaj z zadostno silo med postopkom nadoblikovanja, da se prepreči, da bi se dodaten material preselil med dotičnima površinama surovcev 202. To ohranja odprtost reže 38, s tem da preprečuje stik stranic surovcev 202, da bi se povezali druga z drugo med nadoblikovalnim korakom.
Naoblikovalna plošča 212 je lahko izdelana v debelini, kije približno ista kot debelina sendviča surovcev 202a, 202b, da se opredeli oblikovalna votlina 220, ki obsega, kot je bilo opisano zgoraj, odprt prostor med stenami nadoblikovalne odprtine 216 in zunanjih robov predoblikovancev 202a, 202b in med stranicama kalupnih polovic 204a, 206a. Ta nadoblikovalna odprtina ima tako tudi debelino približno enako tisti od sendviča surovcev in ves ali skoraj ves nadoblikovalni material, ki se tja vbrizga, se veže le na robove surovcev 202a, 202b. V alternativnem izvedbenem primeru ima nadoblikovalna plošča 212 lahko debelino, ki je večja od sendviča predoblikovancev.
-1943
Ta debelejša, alternativna nadoblikovalna plošča s tem opredeljuje oblikovalno votlino, ki vključuje tudi odprt prostor, ki nastane med kalupnima polovicama 204a, 206a in zunanjima (to se pravi, obrnjenima proč od reže v sestavljenem tesnilu) stranicama predoblikovancev 202a, 202b. Kalupni polovici 204a, 206a sta prednostno oblikovani s štrlinami, rebri, kanali, režami ali podobnim, da se stvori tak prostor med tem alternativnim nadoblikovalnim korakom, medtem ko se surovca stisneta skupaj, kot je lahko potrebno med nadoblikovanjem. V tem izvedbenem primeru se torej nadoblikovani material veže na oba robova in na zunanje stranice surovcev 202a, 202b. Z drugimi besedami, ta alternativni nadoblikovalni korak vključuje vzbrizgavanje nadoblikovanega materiala v oblikovalno votlino, ki obdaja večino ali ves sendvič surovca in ne le nadoblikovanje le na robovih surovcev.
Prednostno je, daje material, ki se doda v nadoblikovalnem koraku, podoben tistemu, ki se uporablja v oblikovanju surovcev 202; v drugih izvedbenih primerih pa material surovca in nadoblikovalni material lahko obsegata različne, vendar nič manj primerne materiale za izdelavo tesnila, kot je bilo obravnavano zgoraj. Zato se, kot je bilo uporabljeno tukaj, fleksibilen material nanaša na kakršenkoli material, kije izbran iz razreda primernega tesnilnega materiala, kot je bilo opisano.
Potem ko je nadoblikovanje končano, se kalupni polovici 204a, 206a odstranita od plošče 212 tesnila, ki sedaj vsebuje v bistvu popolno tesnilo 32, kot je razvidno s slik 19D in 19E. Popolno tesnilo 32 se zlahka odstrani od tesnilne plošče 212 in tako oblikovano tesnilo obsega, kot je bilo zgoraj obravnavano, enotno maso oblikovanega materiala z režo, nameščeno v njem.
Sklicujoč se na sliki 21 in 22, je prikazan sklop 300 katetra in ventila, ki se lahko uporabi za dovajanje tekočin pacientovi vaskulaturi. Sklop 300 katetra in ventila obsega podolgovato kanulo in ventil 304, priključen na kanulo na njenem proksimalnem koncu. V enem izvedbenem primeru kanula 302 predstavlja PICC
-20kanulo. Teži se k temu, da je ventil 304 na splošno enak ventilu 20, ki je bil zgoraj podrobno opisan; vendar, kot je prikazano na sliki 21, je ventil 304 lahko priključen na kanulo 302 preko zaskočnega sklopnika 306, ki je izoblikovan skupaj z ventilom 304. Seveda se lahko uporabijo druge vrste povezave, vključno z adhezivom, kemičnim vezanjem, navoji in/ali ultrazvočno varjenim spojem, vendar ne omejeno na to. Da se olajša vstavljanje katetra 302 v pacientovo vaskulaturo, se lahko uporabi vodilna žična cev 308 znotraj lumna kanule 302, ki se razteza skozi tesnilo 32 ventila 304. V primeru, da kanula 302 vključuje odprtino na njenem distalnem koncu, se vodilna žična cev lahko zavije v krvni obtok pacienta in zatem lahko sklop kanule 302 in ventila 304 zdrsne distalno po vodilni žični cevi 308, dokler distalni konec kanule 302 tudi ne doseže pacientovega krvnega obtoka. Zatem se lahko vodilna žična cev 308 odstrani in pusti kanula 302 na mestu v krvnem obtoku, kar je za strokovnjake s področja razumljivo. Alternativno se vodilna žična cev 308 in kanula 302 lahko hkrati namestita v tekočinsko povezavo s krvnim obtokom pacienta in se zatem vodilna žična cev odstrani.
V primeru, da kateter 302 ne vključuje bodisi vodilne žične cevi, lumna v njej ali odprtine na distalnem koncu kanule 302, vodilna žična cev 308 lahko ni potrebna. Če se uporabi takšna kanula 302, se lahko uporabi uvajalna igla, ki jo strokovnjaki s področja poznajo, da se uvede sklop 300 katetra in ventila. Uvajalna igla je lahko razprte vrste, tako da se uvajalna igla lahko umakne iz pacienta, čim je kanula 302 primemo nameščena z njenim distalnim koncem v pacientovem krvnem obtoku. Sklop 300 katetra in ventila se lahko uvede v krvni obtok pacienta, s tem da se uporabijo številni postopki, ki so poznani na področju za uvajanje katetrov v pacienta. Uporaba sklopa 300 katetra in ventila s kakršnimkoli postopkom vstavljanja je znotraj obsega predloženega izuma. Razen tega se ventil 304 lahko uporabi s katerimkoli katetrom 302, ki ga poznajo strokovnjaki s področja.
-21Slika 22 prikazuje kateter 302 v tekočinski povezavi s pacientovo vaskulaturo preko mesta vstavljanja na pacientovi roki. Vendar se lahko uporabi katerokoli drugo primemo mesto vstavljanja za kateter 302. Kot je bilo zgoraj obravnavano se lahko uporabijo različni postopki vstavljanja. Npr., običajna uvajalna nožnica ali igla (ni prikazana) se lahko najprej namesti v uvajalno mesto in se kateter 302 z ali brez vodilne žične cevi 308 namesti v njej, potisne skozi uvajalno nožnico, dokler distalni del kanule 302 ne leži znotraj pacientove vaskulature. Alternativno se vodilna žična cev 308 sama lahko najprej vstavi skozi nožnico in v ciljno žilo in kanula 302 zatem napreduje preko vodilne žične cevi skozi nožnico in v žilo. S katerimkoli izmed teh postopkov vstavljanja je uvajalna nožnica lahko na ugoden način lupljive vrste, tako da se pospeši lahko odstranjevaje nižnice, potem ko je bila vodilna žična cev in/ali kanula potisnjena skoznjo in v pacienta. Kot nadaljnja alternativa se kateter 302 lahko vstavi brez pomoči uvajalne igle ali nožnice. Kjer se uporablja vodilna žična cev 308, se prednostno umakne, potem ko je bil vstavljen sklop 300, s čimer se sprosti kateter 300 za uporabo kot priprava za dovajanje tekočine ali odvzemanje tekočine.
Po vstavitvi distalnega dela kanule 302 v pacientovo vaskulaturo ventil 304 deluje kot katetrova ležiščna puša, da se olajša povezava med in/ali izmenjava različnih medicinskih priprav h kanuli kot tudi dovajanje tekočin pacientu skozi kanulo. Vse izmed teh funkcij se lahko izvajajo, medtem ko se ohranijo prednosti ventila 20, ki so bile podrobno obravnavane zgoraj, to se pravi značilnost pozitivnega pretoka, za tekočino tesno tesnjenje kanule in tako naprej. Npr., brizgina konica Luerjevega tipa (glej slike 1, 10 do 17) se lahko vstavi ventil 304 in brizga deluje, tako da uvaja tekočino skozi ventil 304 in kanulo 302 in v vaskulaturo pacienta. Po umaknitvi brizgine konice ventil 304 zatesni proksimalni konec kanule 302 in povzroči pozitiven tok, kot je bilo zgoraj obravnavano. Alternativno se lahko skozi kanulo 302 in ventil 304 odvzame kri.
-2222,
Razmišlja se, da se lahko katerakoli primerna medicinska pripravi priključi na ventil 304, tako kot IV vrečke, dodatne kanule in drugo, za namene prenosa tekočine ali za druge željene namene. Kot je razvidno s slike 23, je sklopnik 400 lahko priključen na ventil 304 in doveden v tekočinsko povezavo s kanulo 302 in pacientom. Ta razmestitev lahko zagotovi nekaj prednosti v primerih, pri katerih je potrebna uporaba enotnega sklopnika. Npr., ko je potrebno, da se nadomesti sklopnik 400, se lahko odstrani iz tekočinske povezave s kanulo 302 brez izpostavljanja kanule (ali pacientove vaskulature) odprtemu zraku in nadomesti s podobnim sklopnikom ali katerokoli drugo medicinsko pripravo. Kot je bilo predhodno obravnavano, ventil 304 ponovno zatesni kanulo 302, medtem ko se sklopnik 400 zamenja, kar tudi preprečuje, da bi kri tekla od pacienta in iz proksimalnega konca kanule 302, ko ni sklopnika 400. Tako kateter 300 na ugoden način preprečuje tako infekcijo kot izgubo krvi, ko se uporablja v običajnih kliničnih uporabah. Kot je prikazano na sl. 23, je lahko tak sklopnik 400 CLAVE® sklopnik, ki ga prodaja ICU Medical, Inc. Vendar se katerikoli sklopnik ali druga medicinska priprava ali naprava lahko namesti v tekočinsko povezavo z ventilom 304, da se uvaja tekočina v pacienta ali pacientu odvzame kri, vključujoč, vendar ne omejeno na sklopnike, ki se prebadajo, sklopnike, ki so brez igel, medicinske cevne vode, brizge ali katerokoli drugo medicinsko pripravo ali napravo. Tako lahko na ugoden način sklop 300 katetra 302 in ventila 304 tvori zaprto ležišče za kateter, ki se lahko obriše in preprečuje infekcije pacienta ali pomotno izgubo krvi med drugimi prednostmi.
Ventil 304 se lahko uporablja s standardno ležiščno pušo katetra. Tako sta ventil 304 in kateter 302 lahko integralna enota ali odstranljivo zavarovana z Luerjevimi navoji, kot je prikazano na sliki 23, ali drugim pritrdilnim mehanizmom, ki je poznan strokovnjakom s področja. Na sliki 23 kateter 302 vključuje integralno ležiščno pušo 303 na njegovem proksimalnem koncu. Distalni konec ventila 304 se navojno spne z ležiščno pušo 303, da se namesti ventil 304 v tekočinsko povezavo s katetrom 302 brez puščanja. Po namestitvi sklopnika 400 v tem izvedbenem primeru odstranitev
-23sklopnika 400 povzroči, da ventil 304 stvori pozitiven premik in preprečuje, da bi distalni konec katetra 302 okludiral. Tesnilo 32 ventila 304 se lahko čisti, kot je bilo tukaj obravnavano, in nov sklopnik iste vrste ali različne vrste se lahko namesti v tekočinsko povezavo z ventilom 304, ki povzroči, da se tesnilo 32 odpre in se vzpostavi tekočinski tok med sklopnikom 400 in pacientom skozi ventil 304 in kateter 302.
Čeprav je bil ta izum obravnavan v povezavi z določenimi prednostnimi izvedbami in primeri, bodo strokovnjaki s področja razumeli, da se predloženi izum razteza preko specifično prikazanih izvedbenih primerov na druge alternativne izvedbene primere in/ali uporabe izuma in očitne modifikacije in njihove izvedbene primere. Tako se predvideva, da naj okvir predloženega izuma, ki je bil tukaj opisan, ne bo omejen s posameznimi izvedbenimi primeri, ki so bili zgoraj opisani, vendar naj bo določen le s primernim branjem zahtevkov, ki sledijo.
Claims (9)
- Patentni zahtevki1. Tesnilo ventila za uporabo v medicinskem ventilu, ki ima vmesnik za tekočinsko povezavo s prvo medicinsko pripravo, pri čemer tesnilo obsega:prvi konec v tekočinski povezavi z vmesnikom, drugi konec, kije primeren za sprejem druge medicinske priprave, in vsaj eno režo v tekočinski povezavi s prvim koncem in drugim koncem, kjer reža opredeljuje omejeno tekočinsko pretočno pot in sorazmerno majhno notranjo prostornino, ko je v nemoten stanju, opredeljuje razširjeno tekočinsko pretočno pot in veliko notranjo prostornino po uvedbi druge medicinske priprave v režo in začetek pretoka tekočine skozi tesnilo, in se vsaj delno umakne, da opredeli omejeno pretočno pot in sorazmerno majhno notranjo prostornino po prenehanju pretakanja tekočine.
- 2. Tesnilo po zahtevku 1, v katerem ima reža področje najmanjše širine, ki vzdržuje v bistvu tekočinsko tesen stik proti v bistvu celotnemu obodu druge medicinske priprave v področju blizu navzgomjega konca tesnila.
- 3. Tesnilo po zahtevku 1, ki obsega:pretočni lumen, kije izoblikovan v prvem koncu v tekočinski povezavi s tekočinsko pretočno potjo;vrat, kije izoblikovan blizu drugega konca; in prečno prirobnico na drugem koncu, pri čemer ima prečna prirobnica vsaj eno odprtino v tekočinski povezavi s tekočinsko pretočno potjo.
- 4. Tesnilo po zahtevku 1, nadalje obsegajoče pretočni lumen v drugem koncu in je pretočni lumen centriran na osi, ki je v bistvu vzporedna z ali kolineama z vzdolžno osjo tesnila.-2525
- 5. Tesnilo po zahtevku 3, v katerem tesnilo obsega v bistvu pravokotno ploščo fleksibilnega materiala in vrat je koplanaren s telesom.
- 6. Tesnilo po zahtevku 1, v katerem tekočinska pretočna pot obsega režo in odprtina poti obsega odprtino reže in kjer je pot v bistvu planama v nemoten stanju.
- 7. Tesnilo po zahtevku 6, v katerem reža nadalje obsega:področje najmanjše širine; in področje večje širine na strani področja najmanjše širine, oddaljenem od odprtine reže;kjer se širina reže oži od odprtine reže proti področju najmanjše širine.
- 8. Tesnilo po zahtevku 3, nadalje obsegajoče:prvo in drugo stransko razširitev, kjer je širina tesnila med razširitvama večja od širine področja vratu.
- 9. Tesnilo po zahtevku 1, v katerem je tesnilo prilagojeno, da tvori v bistvu za tekočino tesno bariero pred in po vstavitvi druge medicinske priprave.
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