IT8348129A1 - Apparecchio che infonde insulina o glucosio nel soggetto diabetico sulla base di determinazioni di concentrazione di glucosio ottenute senza bisogno di prelievi del sangue del paziente - Google Patents
Apparecchio che infonde insulina o glucosio nel soggetto diabetico sulla base di determinazioni di concentrazione di glucosio ottenute senza bisogno di prelievi del sangue del pazienteInfo
- Publication number
- IT8348129A1 IT8348129A1 ITRM1983A048129A IT4812983A IT8348129A1 IT 8348129 A1 IT8348129 A1 IT 8348129A1 IT RM1983A048129 A ITRM1983A048129 A IT RM1983A048129A IT 4812983 A IT4812983 A IT 4812983A IT 8348129 A1 IT8348129 A1 IT 8348129A1
- Authority
- IT
- Italy
- Prior art keywords
- glucose
- patient
- glucose concentration
- need
- blood sampling
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
- A61B5/14525—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis
- A61B5/14528—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using microdialysis invasively
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
- A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Optics & Photonics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- External Artificial Organs (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Description
DESCRIZIONE
a corredo di una domanda di brevetto per invenzione al titolo:
APPARECCHIO CHE INFONDE INSULINA 0 GLUCOSIO NEL SOGGETTO DIABETICO SULLA BASE DI DETERMINAZIONI DI CONCENTRAZIONI DI GLUCOSIO OTTENUTE SENZA BISOGNO DI PRELIEVI DEL SANGUE DEL PAZIENTE"
'RIASSUMO
parecchio che a mezzo di una pompa preleva da un serbatoio una soluzione salina fisiologica e la fa circolare entro un sistemi, di fibre cave,permeabile alle piccole molecole, inserite nello organismo umano, finch? tale soluzione si pone in equilibrio con i soluti dializzabili dell'organismo stesso e che misura su tale soluzione la concentrazione di glucosio e infonde nell'organismo in base a tale rilievo opportune quantit? di insulina o glucosio.
DESCRIZIONE
invenzione appresso descritta costituisce una innovazione lei campo degli apparecchi attualmente in uso o in studio per la somministrazione automatizzata dell'insulina o del glucosio ? o del glucagone ) nell'individuo diabetico, sulla base di dei terminazioni continue della glicemia, apparecchi noti col nome did" pancreas artificiale".
Tali apparecchi sono schematicamente costituiti da un sensore che determina la concentrazione di glucosio neipaziente 3 da un computer che, sulla base di tali determinazioni e delle
loro variazioni comanda, secondo mn opportuno algoritmo, 1'infu
sione,di idonee quantit? d? insulina o di glucosio. I pochi
apparecchi finora realizzati a tale-scopo incontrano la massima difficolt? e il principale limite alla loro applicazione nell'ot tenere,per un tempo sufficientemente lungo una.attendibile misu fazione continua dei livelli di glucosio del soggetto. Infatti 3ssi-sono dotati di-sensori di glucosio che misurano la glicemijasu prelievo,continuo di sangue venoso, o che vengono-infissi ?iTe^'?^Tnen"^e nel tessuto sottocutaneo, dove determinano la zoncentrazione locale di glucosio. In entrambi-i casi la formazione di.un coagulo sanguigno o di un deposito-di fibrina sulla membrana semipermeabile del sensore rende instabile e precaria
;iel tempo la misura della concentrazione di glucosio.Una solu-
zione parziale di questo problema ? offerta dall?impiego della filtrazione del prelievo sanguigno;che precede la determinazio ne.della glicemia.Anche in questo caso per?..si ha la necessit? li prelevare il sangue e di mantenere la sua.circolazione attra-
verso raccordi ed emofiltri;? inevitabile che,-pur con 1!impie
go di sostanze anticoagulanti, si formino.alla lunga trombi o zoaguli sia.nelle vene del_j?aziente..sottoposte.,a.cateterismo, sia entro il circuito ematico extravascolare.
L?originalit? della presente innovazione consiste nel fatto che con essa viene infusa-,una soluzione salina fisiologica in un circuito di fibre cave (permeabili alle piccole molecole ) impiantate,all'interno dell'organismo del paziente.Nel passaggio attraverso tali fibre cave la soluzione si pone in equilibrio con i soluti dializzabili presenti nell'organismo;una volta che tale equilibrio,? raggiunto, la misurazione di oarametro biochimico della soluzione circolante corrisponde alla misura dello stesso parametro nell'?jrganismo in esame.
Tale principio pu? bene applicarsi alla determinazione continua della concentrazione di glucosio nell'uomo,per la realizzazione di un pancreas.artificiale.
Il vantaggio dell'applicazione della presente invenzione consiste nel fatto che per la determinazione in continuo della concentrazione di glucosio nel soggetto in esame non ? necessario alcun prelievo di sangue,n? l'impiego di sostanze antico^ gulanti, le quali possono provocare nel paziente disturbi nellq coagulazione d?l'Lasangueiezrare regioni?allergiche. Inoltre 1'aoplicazione di un pancreas artificiale realizzato in base alla presente invenzione pu? durare por funghi periodi,non essendovi il pericolo di ostruziori1e1-ildel/l1)'''ciirc?uiti n? malfunzionamento del sensore di glucosiQ.fpqfr fonazione di coaguli sangui gni o depositi di fibrill?i S?u t-a|lefapparecchio\ir?fatti,coaguli ematici e deposizioni?d? fibrina potranno'formarsi-solo all'estemo delle fibre c'avd impiantate;"tuttavia essi .non potranno. n? ostruire.la-.ilibbra circolazione,della,.soluzione?salina allo?? interno delle fibre-impiantate,-n? impedire-i-l raggiungimento iell?equilibrio delle concentrazioni djLglucosio tra.ambiente1. intemp.:ed ambiente esterno,alle fibreii'eavp?, date ;le piccol^.di mensio?ni della motlecola-del-glucos??io,? .1-?jOpportuna lunghezza lei circuito che.consente un!ampia?superficie di scambio.
Ouest'ultima caratteristica del presente apparecbhio rappre senta un decisivo vantaggio rispetto agli 'apparecchi che impiegano un elettrodo sensore di glucosio direttamente infisso nel sottocutaneo, fornito di una piccolissima |uperficie.permeabile al glucosio su cui la deposizione di coaguli o di fibrina compromette la funzionalit? del sensore.
Il circuito di^fibre cave entro il quale circola la^soluzio?-e pu? essere varamente impiantato^osservando.le owip regole d:. sterilit? ed aseps/i entro l?organismo del paziente. a seconda che l'impiego del pancreas artificiale oggetto della presente nvenzione debba essere di lunga o di breve durata, Se ? previa sta una durata breve (di alcuni giorni ) il circuito di.fibre cave pu? essere.comodamente inserito in una vena periferic| come un comune catetere venoso. Se invece ?.previsto un i?pie~ $o pi? prolungato ( settimane o mesi ), il circuito pu?^essere applicato nel sottpcutaneo al?-'modo di!un catetere-elettrodo di pace-maker cardiaco,o spinto pel cavo peritoneale sotto la guida di un tr?-quarti.^ ?nseritO'?in cavit?1pr?vio pneumoperitoneo Le fibre possono anche essere avvolte a forma di una spirale, allogiate in un dischetto-supporto di materiale plastico biocompatibile, impiantabile nel sottqciitaneo,previa incisione dei tegumenti in anestesia locale.
COMPONENTI DELL'APPARECCHIO
Ilmodello di pancreas artificiale.funzionante in base alla invenzione sop:rav?sp;osta ? cost'itu*itoid?4'(Vve.di fig:u?ra ) :
1) Circuito imoiantabile di fibre*cavel^eminermeabili^-in materia? le biocompatibile '(tes1.1poliacriI?nitrile?;;o polietilene'),gi? sopradescritto,da.inserire entro?l'organismo del pazienter? Esso ? connesso?in entrata e in uscitala due condottici raccoi do in materialejplastico biocompatibile, che fuoriescono*$al corpo del pazienta. II.raccordo di entrata ? collegato a,
2) Una micropompa a solenoide o piezoelettrica per m?zzo1della quale una soluzi?ne salina fisiologica1'sterile ? prelevata da 5)?Un serbatoio,e>fatta circolare entro il circuito di fibre :ave permeabili,ialle piccole molecole?.1'Dal raccordo di,uscita la soluzione, ormai!equilibrata con la;concentrazione dilglqfco?io del paziente ? convogliata ad ,
l?) Uh sensore,,djiglucosio che nella presente realizzazione ? ii tipo enzimaticQ-potjsnzianetricQ. Superato il sensore,.la solu-:ione ? raccolta in un
-5)-Recipiente collettore apparecchio acitcuito aperto-) oppure ? reimmessa pel serbatoio 3) per?rientrare in circolo apparecchio a.circuito chiuso). I segnali,jprovenienti dal-senore di glucosio sono elaborati da
) Uh computer che in base ad algoritm>?o ntrotco dalla letteratura omanda
) Una micropompa solenoide
precisione opportune quantit? di insulina,^oppure
Un?altra microjjompa,che infonde gl'jiposio,prelevando tali
31.e-10) due-appositi,serbatoi. I-.condottft!tper.1'infusione di
L?llbullllct O- g--X1-UL-Ub-XOj -J--? iUd--LcI-Xd-.1-L?-plastdc^biocanpatibile; si riuniscono in S
il) Un catetere;a*1doppio lume a "canine diVfucile ",che viene introdotto nel cavo peritoneale del paziente. '
?2) Un visore a??cristalli liquidi mostra ih1ogni momento la con centrazione'di glucosib misurata.Sono;'pred?sposti cqllegamenti per un registratore delle concentrazioni,di.glucosio m^prae e delle quantit? di insulina e glucosio-infuse.
13) Batterie ricariqabili alimentano il^sieterna.
Questo modello di pancreas artif?q.ial? ? facilmente realizzabile in volumi idonei per un uso port?tile, che non costringa il paziente a stare a letto e gli consenta invece un'attivit? pressoch? normale?. Il circuito sopra descritto,nel suo tipo RIVENDICAZIONI
1) apparecchio ,che,'a.mezzo di una pompa,'/preleva da un.serbate una soluzione.salinaifisiologica sterile e??la fa circolare,entro un sistemaci fibpe cave, inserite'dentro l'organismo umano,permeabili'alle piccole molecole,.'finche tale soluzione si pone in*equilibrio
lili dell'organiamo stesso,e che'.misufa'su tale soluzione^ D pi? parametri biiochimici, rapresentativi..degli stessi pararne tri de11'organismo in esame ed eventualmente infonde medicamenti sulla base del monitoraggio effettuato?
Claims (1)
- 2) Apparecchio .tome,?da rivendicazioneil che.misura dOra conce-n-dtra zione di glucosio^dell,'organismo,'umano e'somministra .automaticmente insulina.p glucosio,in relazione,ai tassi di..glucosio,,;c|e terminati. fi-'i '3) Apparecchio^ccme,da rivendicazioneil.realizzato in forma,poifatile durante?le abituali.attivit? dell.'u?mo, o in forma Impiantabile entro l*organismo umano.4) Apparecchi? ?pome?da-rivendicazione?2jre?lizzato in forma portatile durante?'ie normalr-attivit?ia?ll^uomo?, o'in forma impiantabile entro.1'organismo umano.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT8348129A IT1170375B (it) | 1983-04-19 | 1983-04-19 | Apparecchio che infonde insulina o glucosio nel soggetto diabetico sulla base di determinazioni di concentrazioni di glucosio ottenute senza bisogno di prelievi del sangue del paziente |
| US06/598,787 US4633878A (en) | 1983-04-18 | 1984-04-10 | Device for the automatic insulin or glucose infusion in diabetic subjects, based on the continuous monitoring of the patient's glucose, obtained without blood withdrawal |
| EP84830120A EP0134758A3 (en) | 1983-04-18 | 1984-04-17 | Device for the controlled insulin or glucose infusion in diabetic subjects |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT8348129A IT1170375B (it) | 1983-04-19 | 1983-04-19 | Apparecchio che infonde insulina o glucosio nel soggetto diabetico sulla base di determinazioni di concentrazioni di glucosio ottenute senza bisogno di prelievi del sangue del paziente |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| IT8348129A0 IT8348129A0 (it) | 1983-04-19 |
| IT8348129A1 true IT8348129A1 (it) | 1984-10-19 |
| IT1170375B IT1170375B (it) | 1987-06-03 |
Family
ID=11264708
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT8348129A IT1170375B (it) | 1983-04-18 | 1983-04-19 | Apparecchio che infonde insulina o glucosio nel soggetto diabetico sulla base di determinazioni di concentrazioni di glucosio ottenute senza bisogno di prelievi del sangue del paziente |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US4633878A (it) |
| EP (1) | EP0134758A3 (it) |
| IT (1) | IT1170375B (it) |
Families Citing this family (335)
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| US3837339A (en) * | 1972-02-03 | 1974-09-24 | Whittaker Corp | Blood glucose level monitoring-alarm system and method therefor |
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| DE2737922A1 (de) * | 1977-08-23 | 1979-03-08 | Fresenius Chem Pharm Ind | Kuenstliche endokrine druese |
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1984
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Also Published As
| Publication number | Publication date |
|---|---|
| IT1170375B (it) | 1987-06-03 |
| IT8348129A0 (it) | 1983-04-19 |
| EP0134758A2 (en) | 1985-03-20 |
| US4633878A (en) | 1987-01-06 |
| EP0134758A3 (en) | 1986-03-19 |
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