WO2001026711A2 - Appareil de perfusion en continu - Google Patents

Appareil de perfusion en continu Download PDF

Info

Publication number
WO2001026711A2
WO2001026711A2 PCT/GB2000/003828 GB0003828W WO0126711A2 WO 2001026711 A2 WO2001026711 A2 WO 2001026711A2 GB 0003828 W GB0003828 W GB 0003828W WO 0126711 A2 WO0126711 A2 WO 0126711A2
Authority
WO
WIPO (PCT)
Prior art keywords
medicament
reservoir
pump
delivery tube
syringe
Prior art date
Application number
PCT/GB2000/003828
Other languages
English (en)
Other versions
WO2001026711A3 (fr
Inventor
Maurice Andrew Jackson
Michael David Reed
Original Assignee
The Royal Wolverhampton Hospital Nhs Trust
Dumex-Alpharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Royal Wolverhampton Hospital Nhs Trust, Dumex-Alpharma filed Critical The Royal Wolverhampton Hospital Nhs Trust
Priority to AU75448/00A priority Critical patent/AU7544800A/en
Priority to EP00964520A priority patent/EP1222000A2/fr
Publication of WO2001026711A2 publication Critical patent/WO2001026711A2/fr
Publication of WO2001026711A3 publication Critical patent/WO2001026711A3/fr

Links

Classifications

    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps

Definitions

  • This invention relates to continuous infusion apparatus, in particular for the infusion of medicaments and especially the continuous intravenous infusion of medicaments to control agitation and fits.
  • Diazemuls® an oil-in-water emulsion containing diazepam, is particularly suitable for treating these conditions as it and its principal metabolite are potent anxiolytic agents with antiepileptoigenic properties as well as possessing a sedative effect.
  • the hitherto recommended manner of accomplishing continuous infusion of Diazemuls® and similar medicaments is to mix the medicament with an aqueous 5% or 10% dextrose solution and then to infuse over a period of 6 hours.
  • the present invention provides an apparatus for the continued infusion of a medicament, said apparatus comprising a reservoir for the medicament, operatively connected with a delivery tube and a needle, in which the reservoir and the delivery tube are each made from or substantially fully internally coated with a non-halogenated polymeric plastics material.
  • This invention recognises that adequate continuous control of the dosage of a medicament cannot effectively be accomplished using repeated bolus injections of that medicament. Such a method is time-consuming and can be inaccurate.
  • This invention further recognises that the recommended manner of accomplishing continual infusion is ineffective with many medicaments due to the strong adherence of the medicament to the polyvinyl chloride used to make currently-available bags and associated delivery equipment.
  • This invention provides a simple and safe delivery system for the continuous infusion of such medicaments, enabling the dosage of the medicament to be controlled.
  • the material used to make or coat the reservoir and delivery tube is a low-sorbent material.
  • Suitable materials include polyolefins such as polyethylene and polypropylene.
  • the reservoir may be contained in a syringe, if the medicament is to be used undiluted or in a bag, if the medicament is to be used diluted.
  • the apparatus may further comprise one or more valves to control the flow of the medicament through the apparatus.
  • Such valves may be manually or automatically operated.
  • the medicament may be infused under the action of gravity.
  • a pump may be used to control and/or meter the flow of the medicament through the apparatus.
  • This pump may be a roller-type or peristaltic pump.
  • the pump when the reservoir is contained in a syringe, the pump comprises a syringe pump which operates by controlling the movement of the piston within the syringe.
  • a syringe pump When a syringe pump is used to control the rate of infusion, it must be capable of delivering at a rate of 0.2 ml per hour.
  • the medicament is a benzodiazepine-based substance such as diazepam.
  • this material is customarily supplied as an emulsion, known as Diazemuls®.
  • This formulation reduces the risk of localised pain and thrombophlebitis.
  • Diazemuls® is licensed for control of acute muscle spasm due to tetanus or poisoning and for the control of convulsions, status epilepticus, and for the management of severe acute anxiety or agitation including delirium tremens.
  • Diazemuls® This invention allows an extension of the uses of Diazemuls®.
  • the medication can now be used for general sedation, including alcohol and drug withdrawal. Following the invention it has been used to control violence in patients.
  • Diazemuls® is particularly difficult to infuse using the hitherto-recommended method for continuous infusion. It cannot be easily mixed with dextrose or saline solutions and tends to precipitate out of its emulsion.
  • a diazepam emulsion has been found to remain stable for up to 28 days when stored in apparatus according to the present invention.
  • the present invention will be illustrated, merely by way of example, in the following description and with reference to the accompanying drawing.
  • the single drawing figure is a schematic view of an apparatus according to the present invention.
  • Undiluted Diazemuls® or alternatively Diazemuls® diluted with 10% or 20% Intralipid solution, is drawn up into a 50 ml polyethylene syringe 2.
  • This syringe comprises a main body 3 and a piston 4.
  • the syringe is mounted in a syringe pump 5 which controls the volume of a reservoir 6 of Diazemuls® by depressing the piston 4.
  • the syringe 2 is in fluid communication with a hollow needle 7 via a giving set shown generally at 8.
  • the needle 7 is designed for insertion into a patient, and is preferably inserted into a peripheral vein.
  • the giving set 8 includes a delivery tube 10, a connector 11 to connect one end of the delivery tube 10 to the syringe 2 and a connector 12 to connect the opposite end of the delivery tube 10 to the needle 7.
  • a valve 9, incorporated into connector 12, may be manually operable to prevent or allow flow of the Diazemuls® through the apparatus. All components of the giving set are manufactured from polyethylene.
  • the pump 5 must be capable of steady infusion at rates as low as 0.2 ml per hour, for example in order to cater for the needs of a patient particularly sensitive to Diazemuls®.
  • infusion may be started at a low rate, for example, 0.5 ml / hr, and increased in stepwise intervals of, for example, 0.5 ml / hr until control of symptoms is achieved.
  • Diazemuls® is an optically opaque liquid, the pump must be capable of operating to effectively dispense such a liquid at the low rates required. This means that common methods such as optical feedback to sense the position of the syringe cannot be used.
  • This apparatus enables safe and effective continuous infusion of Diazemuls® and similar medicaments.
  • the increased stability of the solution means that administration by means of this apparatus can take place on an outpatient basis if appropriate, or even at home.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Cet appareil de perfusion en continu d'un médicament émulsionné comprend un réservoir (6) relié à une aiguille par l'intermédiaire d'un tube (10) et d'un ensemble d'apport, et il est caractérisé en ce que le réservoir (6) et le tube d'apport (10) sont réalisés chacun à partir d'une matière plastique polymère non halogénée (par exemple du polyéthylène ou du polypropylène), ou sont sensiblement revêtus sur l'intérieur d'une telle matière plastique.
PCT/GB2000/003828 1999-10-12 2000-10-05 Appareil de perfusion en continu WO2001026711A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU75448/00A AU7544800A (en) 1999-10-12 2000-10-05 Continuous infusion apparatus
EP00964520A EP1222000A2 (fr) 1999-10-12 2000-10-05 Appareil de perfusion en continu

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9924072.3 1999-10-12
GBGB9924072.3A GB9924072D0 (en) 1999-10-12 1999-10-12 Continuous infusion apparatus

Publications (2)

Publication Number Publication Date
WO2001026711A2 true WO2001026711A2 (fr) 2001-04-19
WO2001026711A3 WO2001026711A3 (fr) 2001-10-11

Family

ID=10862552

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/003828 WO2001026711A2 (fr) 1999-10-12 2000-10-05 Appareil de perfusion en continu

Country Status (4)

Country Link
EP (1) EP1222000A2 (fr)
AU (1) AU7544800A (fr)
GB (1) GB9924072D0 (fr)
WO (1) WO2001026711A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004009162A1 (fr) * 2002-07-24 2004-01-29 Disetronic Licensing Ag Pompe de perfusion, procede, programme de commande et composant semi-conducteur pour l'administration dosee d'un liquide medical

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4790829A (en) * 1983-08-24 1988-12-13 Russell Bowden Reusable injection catheter
GB2153687B (en) * 1984-02-04 1987-04-01 Smith & Nephew Ass Drug administration sets having polybutadiene tubing
US4585435A (en) * 1984-05-31 1986-04-29 The Telescope Folding Furniture Co., Inc. Extension set for drug delivery
US4863429A (en) * 1987-06-30 1989-09-05 Baldwin Brian E Syringe driver/syringe/tube connecting set fluid delivery arrangement, and tube connecting sets therefor
JP2542775B2 (ja) * 1992-10-12 1996-10-09 株式会社オプテック 薬液注入装置
DE19504414C2 (de) * 1995-02-10 1996-12-05 Pharmacia Gmbh Schlauch für einen medizinischen Behälter

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004009162A1 (fr) * 2002-07-24 2004-01-29 Disetronic Licensing Ag Pompe de perfusion, procede, programme de commande et composant semi-conducteur pour l'administration dosee d'un liquide medical
EP2484392A1 (fr) * 2002-07-24 2012-08-08 F. Hoffmann-La Roche AG Pompe de perfusion pour l'administration dosée d'un liquide médical

Also Published As

Publication number Publication date
EP1222000A2 (fr) 2002-07-17
AU7544800A (en) 2001-04-23
WO2001026711A3 (fr) 2001-10-11
GB9924072D0 (en) 1999-12-15

Similar Documents

Publication Publication Date Title
US5188603A (en) Fluid infusion delivery system
US5116316A (en) Automatic in-line reconstitution system
US5356379A (en) Disposable ambulatory infusion pump assembly
US5059174A (en) Fluid infusion delivery system
AU604594B2 (en) Drug delivery cartridge with protective cover
AU665355B2 (en) Apparatus for patient-controlled infusion
US4804366A (en) Cartridge and adapter for introducing a beneficial agent into an intravenous delivery system
US4432756A (en) Parenteral controlled therapy
US4484909A (en) Parenteral therapy using solid drug
EP0435859B1 (fr) Système d'administration auto-amorçante adapté pour l'addition d'un remède
US4548599A (en) Parenteral controlled therapy
US4525162A (en) Parenteral controlled delivery
US4552556A (en) Parenteral controlled therapy
EP1222000A2 (fr) Appareil de perfusion en continu
EP1960019B1 (fr) Ensemble de régulation d'écoulement comprenant une vanne et un régulateur d'écoulement
US5205818A (en) Patency maintenance system
AU600734B2 (en) Drug delivery apparatus having chamber with chimney
EP0435860B1 (fr) Adapteur pour connecter un flacon pour administrer un remède à un patient
EP0436504B1 (fr) Récipient pour libérer un remède dans un système d'administration
AU2244595A (en) Patency maintenance system

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
AK Designated states

Kind code of ref document: A3

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A3

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

WWE Wipo information: entry into national phase

Ref document number: 2000964520

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 2000964520

Country of ref document: EP

NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Ref document number: 2000964520

Country of ref document: EP