WO1998007462A1 - Systeme medical d'injection haute pression - Google Patents

Systeme medical d'injection haute pression Download PDF

Info

Publication number
WO1998007462A1
WO1998007462A1 PCT/EP1997/004502 EP9704502W WO9807462A1 WO 1998007462 A1 WO1998007462 A1 WO 1998007462A1 EP 9704502 W EP9704502 W EP 9704502W WO 9807462 A1 WO9807462 A1 WO 9807462A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
injection
relief valve
catheter
injector
Prior art date
Application number
PCT/EP1997/004502
Other languages
German (de)
English (en)
Inventor
Claus H. Backes
Original Assignee
Backes Claus H
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 Backes Claus H filed Critical Backes Claus H
Priority to EP97941944A priority Critical patent/EP0929332A1/fr
Publication of WO1998007462A1 publication Critical patent/WO1998007462A1/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
    • A61M5/14546—Front-loading type injectors
    • 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
    • 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
    • A61M39/24—Check- or non-return valves
    • 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
    • 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
    • A61M39/24—Check- or non-return valves
    • A61M2039/242—Check- or non-return valves designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
    • 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
    • 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
    • A61M39/24—Check- or non-return valves
    • A61M2039/2473—Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
    • 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
    • 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
    • A61M39/24—Check- or non-return valves
    • A61M2039/2473—Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
    • A61M2039/2486—Guided stem, e.g. reciprocating stopper

Definitions

  • the present invention relates to a medical high-pressure injection system in which an injector, for example contrast medium, is used to inject into a patient via a catheter connected to the injector.
  • an injector for example contrast medium
  • Medical high-pressure injection systems of this type are preferably used in angiography, especially in digital subtraction angiography. This is a radiological diagnostic procedure to visualize the blood vessels.
  • X-ray contrast media are injected into the aterial vascular system through special, highly flexible catheters, the outlet opening of which is placed in the area of the area of interest. So that such catheters can also be inserted into smaller blood vessels, the outside diameter and thus also the available flow cross section must be relatively small.
  • catheters for smaller blood vessels have an outer diameter between approximately 1.0 to 2.1 mm and an inner diameter between 0.4 to 1.2 mm. Since the contrast medium can be injected at delivery rates of up to 30 ml / s, very high injection pressures of up to over 80 bar are required for a short time.
  • automatic, mechanical, medical high-pressure injection devices are usually used, which allow a presetting of the injection volume, delivery rate and maximum injection pressure.
  • These are, for example, piston injectors with interchangeable injection cylinders made of polyethylene.
  • These cylinders are usually used in a pressure sleeve that almost completely encloses the cylinder and protects it against bursting at high operating pressures.
  • the inside diameter of the pressure sleeve is about 0.5 mm larger than the outside diameter of the injection cylinder.
  • the injection cylinder and catheter are connected to each other via a flexible tube for the injection of the contrast medium into the patient.
  • the injection cylinder used expands in the sense of an elastic deformation until its outer surface lies firmly against the inside of the pressure cuff.
  • the connecting tube and catheter There are also elastic expansions on the connecting tube and catheter, the deformation of the catheter being negligible due to the higher material strength and the smaller diameter.
  • Measurements have shown that the volume enclosed by the injection cylinder and connecting hose can increase by up to 10 ml under the influence of pressure.
  • a corresponding proportion of the injection volume set on the injector is therefore initially used to expand the injection cylinder and connecting tube before the desired volume flow is established at the catheter outlet.
  • the injection pressure in conventional high-pressure injection systems drops continuously to the value of the ambient pressure.
  • the elastic deformation of the injection cylinder and supply hose also decreases in the same way.
  • a disadvantage of such medical high-pressure injection systems is that the volume fraction of the injection medium stored due to the expansion of the material is displaced when the elastic deformation decreases after the injection, when there is no pressure on the contrast medium, and is expelled at the end of the catheter.
  • This run-on or dripping results in motion blurring when using contrast media in angiography in the X-ray images. As a result, the image quality is considerably impaired and reliable diagnosis is made more difficult.
  • a further disadvantage of such high-pressure injection systems is that when examining smaller arteries, where contrast medium volumes between 4 and 10 ml and
  • the volume flow of the contrast medium emerging at the end of the catheter primarily follows the restoring forces of the contracting injection cylinder or the connecting tube, but not that on
  • Injector set delivery rate Under these conditions, it is therefore hardly possible to achieve the desired rapid influx of contrast medium in smaller blood vessels.
  • the medical high-pressure injection system has an injector and a catheter connected to the injector.
  • a shut-off device is provided between the injector and the catheter. The flow of the injection medium from the injector to the catheter can be interrupted by this shut-off device.
  • the shut-off element can be designed as a valve, pressure valve or check valve.
  • the check valve can be different
  • valve is designed such that it is adjustable.
  • the pre-set volume is maintained exactly at an almost constant delivery rate from the start of injection to the end of injection.
  • shut-off device as a check valve that the valve seals against reverse flows against the direction of flow of the injection agent in the patient, thereby reliably preventing accidental suction of patient blood when the piston of the injection cylinder is retracted, and thus contamination of the connecting hose and injection cylinder is avoided.
  • the check valve can be set to different pressures, for example by varying the spring preload and / or spring rate. This has the advantage that the user can be offered a range of valve systems with different opening pressures, so that the user can adapt the opening pressure to the injection pressure required, depending on the application.
  • the drain opening of the shut-off element is connected directly to the catheter.
  • the shut-off device is an open-close valve.
  • the inlet opening and / or the outlet opening of the shut-off element has a Luer lock connection.
  • the shut-off device is a disposable item.
  • the advantage of this design is that it can effectively prevent contamination of the injection agent.
  • FIG 1 schematically shows the medical according to the invention
  • FIG. 2 shows a cross section through the shut-off device of the medical high-pressure injection system according to the invention in the closed state
  • Figure 2a shows a cross section through the shut-off device in an open state.
  • the high-pressure injection system has an injector 6 with an injection cylinder 4 and a pressure cuff 5.
  • the inner diameter of the pressure cuff 5 is approximately 0.5 mm larger than the outer diameter of the injection cylinder 4, so that the injection cylinder 4 can be exchanged without problems.
  • the outlet opening of the injection cylinder 4 is connected to the inlet opening 7 of the shut-off element 1 via a connecting hose 2.
  • the shut-off device 1 is in this embodiment is designed as a check valve. However, any device is also possible as a shut-off device 1 through which the flow of injection medium can be abruptly interrupted even at high pressures. This is also possible, for example, with valves other than a check valve, for example with an open-close valve.
  • a catheter 3 is connected to the outlet opening 9 of the shut-off element 1, the outlet opening of which is inserted into the patient in order to inject the injection agent into the patient.
  • FIG. 2 shows a cross section of a check valve used in this exemplary embodiment as a shut-off device 1.
  • This check valve has a female Luer lock attachment at its inlet opening 7, which is connected to the injection cylinder 4 via the connecting hose 2.
  • the connecting hose 2 has a male Luer lock attachment at the corresponding end for connection to the check valve.
  • this has a male luer lock attachment 10 for connection to a female luer lock attachment of the catheter 3.
  • the check valve has a valve body 11, which in the idle state shown in FIG. 2 is pressed by the spring 12 onto the contact surface 13 of the valve housing and thus seals the inlet opening 7 against the outlet opening 9 for the flow of injection agent with its sealing lip.
  • the spring 12 has an attachment in the valve housing in the region of the outlet opening 9 and an attachment on the valve body 1 1 at its other end.
  • the opening pressure of the valve caused by the spring 12 is selected such that when the inlet opening 7 from against the valve body 1 1 a pressure of a predetermined size is exceeded, the spring 12 is compressed. Characterized the valve body 1 1 is lifted from its contact surface and pushed back so far that its sealing lip clears the passage for the injection agent in the direction of the outlet opening.
  • the injection pressures at which the check valve opens can be up to 80 bar. However, if the spring 12 is selected accordingly, the check valve can also open at lower pressures.
  • the check valve can be adjusted using different springs or by varying the spring preload and / or the spring rate.
  • Figure 2a shows the check valve of Figure 2 in an open state.
  • a pressure in the direction of the outlet opening 9 is applied by the injection means against the valve body 11, which pressure is large enough to compress the spring 12 so that the sealing lip of the valve body 11 no longer bears against the contact surface 13 of the valve housing, so that the injection means from the inlet opening 7 past the valve body 1 1 through the spring turns of the spring 12 to the outlet opening 9 can flow.
  • the spring turns of the spring 12 there is therefore sufficient space for the injection medium to flow even when the check valve is open.
  • the catheter 3 is inserted into the patient in such a way that the outlet opening of the catheter 3 is placed in the area of interest, for example, for angiography.
  • the Luer lock connection of the inlet opening of the catheter is connected to the luer lock connection 10 of the outlet opening 9 of the check valve 1.
  • the Luer lock connection 8 of the inlet opening 7 is connected to a Luer lock connection of a connecting hose, which in turn is connected at its other end to the outlet opening of the injection cylinder 4.
  • the contrast medium required for the angiography is located in the injection cylinder 4, the connecting tube 2 and the inlet opening 7 of the check valve 1.
  • pressure is now applied against the contrast medium located in the injection cylinder 4.
  • the contrast medium transfers the pressure to the injection cylinder 4 and the connecting tube 2, causing them to expand.
  • the pressure that is applied by the contrast medium in the inlet opening 7 against the valve body 11 increases. If the pressure exceeds a certain value, for example 120 bar, the check valve 1 opens.
  • the injection of the contrast medium via the catheter 3 into the patient begins.
  • both the injection cylinder 4 and the connecting tube 2 are thus already in an expanded state at the start of the injection, so that the entire volume of contrast medium is expelled at the end of the catheter and not during the injection period, i.e. during the piston movement on the injector 6 only part of the contrast medium volume expands the injection cylinder 4 and the connecting tube 2.
  • the interstationary phase is reduced to a minimum until the selected delivery rate at the catheter outlet is reached, so that a rapid flooding of contrast medium is achieved even with small injection volumes.
  • the check valve 1 counteracts a drop in pressure by closing immediately after the injection pressure has fallen below. This prevents that due to a contraction of the injection cylinder 4, which is deformed elastically under the pressure of the contrast medium, and the connecting tube 2, further contrast medium runs out of the outlet opening of the catheter 3 into the patient or can drip. Furthermore, the check valve 1 causes the injection cylinder 4 and the connecting hose 2 to remain in the expanded state. This is advantageous for a further, subsequent injection process. If the check valve 1 is in its closed state and thereby prevents the contrast medium from running or dripping, the necessary x-rays are taken.
  • contrast medium can be injected again.
  • the pressure on the contrast medium is increased again by the piston of the injector 6, so that when the set value at the check valve 1 is exceeded, the check valve 1 opens and contrast medium is injected into the catheter 3 at the desired injection pressure and from there into the patient.

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

Abstract

L'invention concerne un système médical d'injection haute pression destiné à l'injection sous haute pression d'une préparation injectable chez un patient. A cet effet, le système d'injection haute pression comporte un injecteur (6) relié à un cathéter (3). Selon l'invention, il est prévu entre l'injecteur (6) et le cathéter (3) un organe de blocage (1) pouvant stopper l'écoulement de la préparation injectable entre l'injecteur (6) et le cathéter (3). Cet organe de blocage (1) est avantageusement un clapet antiretour qui s'ouvre lorsque la pression d'injection dépasse une certaine valeur et se ferme lorsque la pression d'injection tombe au-dessous de cette valeur.
PCT/EP1997/004502 1996-08-20 1997-08-18 Systeme medical d'injection haute pression WO1998007462A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP97941944A EP0929332A1 (fr) 1996-08-20 1997-08-18 Systeme medical d'injection haute pression

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19633530.2 1996-08-20
DE19633530A DE19633530A1 (de) 1996-08-20 1996-08-20 Medizinisches Hochdruckinjektionssystem

Publications (1)

Publication Number Publication Date
WO1998007462A1 true WO1998007462A1 (fr) 1998-02-26

Family

ID=7803121

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1997/004502 WO1998007462A1 (fr) 1996-08-20 1997-08-18 Systeme medical d'injection haute pression

Country Status (3)

Country Link
EP (1) EP0929332A1 (fr)
DE (1) DE19633530A1 (fr)
WO (1) WO1998007462A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8574200B2 (en) 2002-05-30 2013-11-05 Medrad, Inc. Dual syringe injector system
US9108047B2 (en) 2010-06-04 2015-08-18 Bayer Medical Care Inc. System and method for planning and monitoring multi-dose radiopharmaceutical usage on radiopharmaceutical injectors

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6402718B1 (en) 1992-08-17 2002-06-11 Medrad, Inc. Front-loading medical injector and syringe for use therewith
US5383858B1 (en) 1992-08-17 1996-10-29 Medrad Inc Front-loading medical injector and syringe for use therewith
DE19723648C1 (de) 1997-06-05 1998-08-27 Disetronic Licensing Ag Vorrichtung zur dosierten Verabreichung einer Medikamentflüssigkeit
CN1174780C (zh) * 1999-12-07 2004-11-10 梅德拉股份有限公司 注射器组件及清除该组件中空气的方法
US6652489B2 (en) 2000-02-07 2003-11-25 Medrad, Inc. Front-loading medical injector and syringes, syringe interfaces, syringe adapters and syringe plungers for use therewith
US6626862B1 (en) 2000-04-04 2003-09-30 Acist Medical Systems, Inc. Fluid management and component detection system
AUPQ867900A0 (en) 2000-07-10 2000-08-03 Medrad, Inc. Medical injector system
US7666169B2 (en) 2003-11-25 2010-02-23 Medrad, Inc. Syringe and syringe plungers for use with medical injectors
US8926569B2 (en) 2006-03-15 2015-01-06 Bayer Medical Care Inc. Plunger covers and plungers for use in syringes and methods of fabricating plunger covers and plungers for use in syringes
USD847985S1 (en) 2007-03-14 2019-05-07 Bayer Healthcare Llc Syringe plunger cover
USD942005S1 (en) 2007-03-14 2022-01-25 Bayer Healthcare Llc Orange syringe plunger cover
USD1002840S1 (en) 2007-03-14 2023-10-24 Bayer Healthcare Llc Syringe plunger
WO2010108289A1 (fr) * 2009-03-24 2010-09-30 Jean-Denis Rochat Dispositif de perfusion
US9174003B2 (en) 2012-09-28 2015-11-03 Bayer Medical Care Inc. Quick release plunger
CA2942754C (fr) 2014-03-19 2019-10-15 Bayer Healthcare Llc Systeme d'introduction d'une seringue dans un injecteur
JP6713456B2 (ja) * 2014-09-11 2020-06-24 オスプレイ メディカル インコーポレイテッド 分流された媒体を収集し再使用するためのリザーバ
US9480797B1 (en) 2015-10-28 2016-11-01 Bayer Healthcare Llc System and method for syringe plunger engagement with an injector
PL3758777T3 (pl) 2018-02-27 2023-06-12 Bayer Healthcare, Llc Mechanizm sprzęgający tłoczek strzykawki

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE866987C (de) * 1951-08-24 1953-02-12 Wolfgang Dr Med Gercke Medizinische Injektionsspritze
US2999499A (en) * 1958-07-11 1961-09-12 Cutter Lab Flexible check valve
GB1192986A (en) * 1967-08-31 1970-05-28 Eschmann Bros & Walsh Ltd Intravenous Valve Assembly
US3557778A (en) * 1968-11-18 1971-01-26 Elbert L Hughes Blood specimen collection assembly
GB2084298A (en) * 1980-09-09 1982-04-07 Baxter Travenol Lab Sleeve valve for parenteral administration device
US4681132A (en) * 1986-05-23 1987-07-21 Halkey-Roberts Corporation Check valve with preset cracking pressure
EP0447985A1 (fr) * 1990-03-15 1991-09-25 Abbott Laboratories Pompe volumétrique

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE833841C (de) * 1949-01-01 1952-03-13 Bernh Draeger Injektionsverfahren
SE9303484D0 (sv) * 1993-10-22 1993-10-22 Siemens Elema Ab Förfarande och anordning för mätning av flödesmotståndet hos en kateter vid ett implanterat infusionssystem för läkemedel
US5533978A (en) * 1994-11-07 1996-07-09 Teirstein; Paul S. Method and apparatus for uninterrupted delivery of radiographic dye

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE866987C (de) * 1951-08-24 1953-02-12 Wolfgang Dr Med Gercke Medizinische Injektionsspritze
US2999499A (en) * 1958-07-11 1961-09-12 Cutter Lab Flexible check valve
GB1192986A (en) * 1967-08-31 1970-05-28 Eschmann Bros & Walsh Ltd Intravenous Valve Assembly
US3557778A (en) * 1968-11-18 1971-01-26 Elbert L Hughes Blood specimen collection assembly
GB2084298A (en) * 1980-09-09 1982-04-07 Baxter Travenol Lab Sleeve valve for parenteral administration device
US4681132A (en) * 1986-05-23 1987-07-21 Halkey-Roberts Corporation Check valve with preset cracking pressure
EP0447985A1 (fr) * 1990-03-15 1991-09-25 Abbott Laboratories Pompe volumétrique

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8574200B2 (en) 2002-05-30 2013-11-05 Medrad, Inc. Dual syringe injector system
US9108047B2 (en) 2010-06-04 2015-08-18 Bayer Medical Care Inc. System and method for planning and monitoring multi-dose radiopharmaceutical usage on radiopharmaceutical injectors
US9463335B2 (en) 2010-06-04 2016-10-11 Bayer Healthcare Llc System and method for planning and monitoring multi-dose radiopharmaceutical usage on radiopharmaceutical injectors

Also Published As

Publication number Publication date
EP0929332A1 (fr) 1999-07-21
DE19633530A1 (de) 1998-02-26

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