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EP1222000A2 - Continuous infusion apparatus - Google Patents

Continuous infusion apparatus

Info

Publication number
EP1222000A2
EP1222000A2 EP00964520A EP00964520A EP1222000A2 EP 1222000 A2 EP1222000 A2 EP 1222000A2 EP 00964520 A EP00964520 A EP 00964520A EP 00964520 A EP00964520 A EP 00964520A EP 1222000 A2 EP1222000 A2 EP 1222000A2
Authority
EP
European Patent Office
Prior art keywords
medicament
reservoir
pump
delivery tube
syringe
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP00964520A
Other languages
German (de)
French (fr)
Inventor
Maurice Andrew Jackson
Michael David Reed
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Xellia Pharmaceuticals ApS
Royal Wolverhampton Hospitals NHS Trust
Original Assignee
Dumex Alpharma AS
Royal Wolverhampton Hospitals NHS Trust
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 Dumex Alpharma AS, Royal Wolverhampton Hospitals NHS Trust filed Critical Dumex Alpharma AS
Publication of EP1222000A2 publication Critical patent/EP1222000A2/en
Withdrawn legal-status Critical Current

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

An apparatus for the continued infusion of an emulsified medicament, comprising a reservoir (6), connected via a delivery tube (10) and a giving set to a needle (7), in which the reservoir (6) and the delivery tube (10) are each made from, or substantially internally coaed with, a non-halogenated polymeric plastics material (for example polyethylene or polypropylene).

Description

CONTINUOUS INFUSION APPARATUS
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.
The control of chronic anxiety, agitation and fits is a sizeable medical problem that crosses a number of traditional medical fields. Significant agitation, frequently developing into fits, occurs in patients who are terminally ill, who are suffering from withdrawal symptoms following drug or alcohol abuse or who have a chronic condition such as status epilepticus.
These patients are currently treated in practice with repeated bolus injections of a suitable medicament, such as Diazemuls® . 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.
Preferably, 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. Alternatively, 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. In a preferred embodiment, 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. 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.
Preferably the medicament is a benzodiazepine-based substance such as diazepam. For injection purposes, 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.
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.
This invention recognises that 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.
It has been found that the stability of the medicament is enhanced by use of an apparatus according to the present invention. For example, 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®. Alternatively, 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. It is possible to use the pump 5 to deliver an initial bolus injection if rapid relief of symptoms is required. It is also possible to program the pump 5 to vary the amount of Diazemuls® delivered. Although 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.

Claims

1. An apparatus for the continuous infusion of a medicament, said apparatus comprising a reservoir (6) , for the medicament, operatively connected with a delivery tube (10) , and a needle (7) in which the reservoir (6) and the delivery tube (10) are each made from, or substantially fully internally coated with, a non-halogenated polymeric plastics material .
2. An apparatus according to Claim 1 in which the material used to make or coat the reservoir (6) and the delivery tube (10) comprises a low sorbent material .
3. An apparatus according to Claim 2 in which the material comprises a polyolefin.
4. An apparatus according to Claim 2 or 3 in which the material comprises polyethylene or polypropylene.
5. An apparatus according to any preceding claim in which the reservoir (6) is contained in a syringe (2) .
6. An apparatus according to any preceding claim further comprising a valve (9) to control the flow of the medicament through the apparatus.
7. An apparatus according to any preceding claim further comprising a pump (5) , to control and/or meter the flow of the medicament through the apparatus.
8. An apparatus according to Claim 7 as dependent from Claim 5 in which the pump (5) comprises a syringe pump capable of delivering the medicament at a rate of about 0.5 ml/hr or lower.
9. An apparatus according to Claim 8 in which the pump (5) is capable of delivering the medicament at a rate of about 0.2 ml/hr or lower.
10. An apparatus according to any one of Claims 7 to 9 in which the medicament is optically opaque.
11. An apparatus according to any preceding claim in which the medicament comprises an emulsion.
12. An apparatus according to Claim 10 or 11 in which the medicament comprises an emulsion containing diazepam.
EP00964520A 1999-10-12 2000-10-05 Continuous infusion apparatus Withdrawn EP1222000A2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9924072 1999-10-12
GBGB9924072.3A GB9924072D0 (en) 1999-10-12 1999-10-12 Continuous infusion apparatus
PCT/GB2000/003828 WO2001026711A2 (en) 1999-10-12 2000-10-05 Continuous infusion apparatus

Publications (1)

Publication Number Publication Date
EP1222000A2 true EP1222000A2 (en) 2002-07-17

Family

ID=10862552

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00964520A Withdrawn EP1222000A2 (en) 1999-10-12 2000-10-05 Continuous infusion apparatus

Country Status (4)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10233622A1 (en) * 2002-07-24 2004-02-12 Disetronic Licensing Ag Infusion pump, method, control program and semiconductor component for the metered administration of a medical liquid

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 (en) * 1992-10-12 1996-10-09 株式会社オプテック Chemical injection device
DE19504414C2 (en) * 1995-02-10 1996-12-05 Pharmacia Gmbh Hose for a medical container

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0126711A2 *

Also Published As

Publication number Publication date
WO2001026711A3 (en) 2001-10-11
AU7544800A (en) 2001-04-23
GB9924072D0 (en) 1999-12-15
WO2001026711A2 (en) 2001-04-19

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