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
  • A61M5/168—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
• • 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
  • A61M5/16804—Flow controllers
  • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
• • 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
  • A61M5/007—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 for contrast media

Definitions

• the invention relates to an injection device and method which can operate continuously.
• this injection must be continued continuously for the same patient and, in other cases, the device must be rapidly operational so that the transition from one patient to another patient takes place very quickly, c 'That is to say, without having to reinstall the entire injection device. We therefore wish to optimize the preparation time for an injection between each patient.
• the injection devices used so far do not meet the conditions set out above: the quantity of product necessary for the examination of a patient was provided for. In the event that this quantity was insufficient, it was not possible to add more without creating a break in the injection and, in the event that this quantity was too large, the rest of the product was discarded due to the risk of contamination.
• the purpose of the injection device according to the invention is to remedy the drawbacks of the devices of the prior art which have just been mentioned.
• the injection device comprises two independent sources of supply of at least one liquid intended to be injected into a patient by a tube, the injection device comprising, for each of the supply sources, means for interrupting the flow of the liquid and means for detecting that the injection of the liquid contained in the supply source has ended, the interruption means being controlled by the means of detection.
• each supply source is an injection vial
• the injection device further comprising an upstream injection device composed of a first supply tube, d a second supply tube and, for each of the injection vials, of connection means, each of the first and second supply tubes being connected, by means of the connection means, to one of the injection vials, and a downstream injection device comprising a downstream tube and means for pumping the liquid, the downstream tube connecting the pumping means to the patient;
• the upstream injection device further comprises single connection means integral with the first and second supply tubes which can be connected to the pumping means;
• the pumping means include non-return means preventing the liquid flowing in the downstream injection device does not go back into the upstream injection device;
• connection means simultaneously effecting the fixing and the establishment of the circulation of the liquid.
• a method which automatically switches from one power source to another because the means for detecting that the injection of the liquid contained in the power source is completed, the closure of the means for interrupting the flow of the liquid from this supply source on the one hand and the opening of the means for interrupting the flow of the liquid from the other supply source d 'somewhere else.
• FIG. 1 is an exploded view which shows in partial section the different parts to be connected together in the injection device according to the invention;
• - Figure 2 is an enlarged view of some parts of Figure 1;
• FIG. 3 is a sectional view of the connection means in the direction III-III of Figure 2; and - Figure 4 shows schematically the support element on which the parts of Figure 1 are put in place.
• the injection device according to the invention is a double vial system.
• the liquid flow circuit intended to be perfused or injected into the patient forms a T, that is to say a symmetrical double upstream circuit which converges towards a simple downstream circuit connected to the patient.
• the injection device will now be described from upstream to downstream. Since the upstream device comprises two series of absolutely identical elements, we will only describe the left part of this upstream device as it is visible in FIG. 1 while knowing that there is a symmetrical device in the form of the right part of the upstream device comprising exactly the same elements as those which will now be described.
• the upstream injection device 10 firstly comprises a bottle 12 containing the liquid product intended to be injected into the patient. This bottle is closed by an elastic cap 14 at the front end of the stopper of the bottle.
• a striker 16 constitutes means for perforating the injection vial 12 because it makes it possible to pierce the cover 14 of the vial 12 and it is designed so as to allow the flow of liquid from the vial 12 to the elements located downstream of the striker 16.
• the striker 16 comprises a hollow beveled tip 18 extending the upstream end of an internal conduit 20 which passes axially through the striker 16 right through.
• the internal conduit 20 is connected to air intake means in the form of an air intake 22 allowing the penetration of air into the bottle 12 at the hollow point 18 so that the bottle 12 can empty its content.
• a portion of the striker surrounds the tip 18 in the form of a cylindrical side wall 24 of circular section whose inner diameter is barely larger than the outside diameter of the stopper of the bottle.
• This lateral wall 24 is extended radially inwards by a shoulder 26 which will serve as a stop element for the front face of the stopper of the bottle.
• the side wall 24 carries axial slots regularly distributed over its circumference and has an annular flange 28 facing inward.
• This annular rim 28 forms an elastic rim intended to retain the rear of the stopper of the bottle and to avoid an involuntary axial separation movement between the striker and the bottle.
• the bottle 12 is inverted, stopper at the bottom and the tip 18 projects axially beyond the annular rim 28 of the side wall 24.
• the connection between the bottle 12 and the striker 16 will now be described.
• the point 18 is inserted into the cover 14 of the bottle and the bottle and the striker are brought closer until the stopper is in abutment on the shoulder 26.
• the side wall 24 has moved apart thanks to the slots but, when the stopper is in abutment, the side wall resumes its original shape thanks to the elasticity generated by the slots, and the annular rim 28 abuts above the lateral zone of the rear face of the stopper: the striker 16 and the bottle 12 are integral with one another and the lateral wall 24 makes it possible to axially and laterally support the bottle cap.
• the tip 18 allows axial guidance between the bottle 12 and the striker 16.
• the tip 18, the side wall 24, the shoulder 26 and the annular rim 28 constitute means of support and axial and lateral retention of the stopper of the bottle 12 which allow the bottle 12 to hold upside down vertically without other means of attachment.
• the position of the bottle 12 is therefore entirely ensured by the striker 16.
• the middle part of the striker 16 constitutes the body 29 of the striker 16, this striker body 29 is preferably of generally cylindrical external shape, of circular section, and extends in upstream by an external radial shoulder 27 which makes it possible to connect the side wall 24 to the striker body 29.
• the downstream part of the striker 16 forms a cylindrical section 30 of circular section, the axis of which coincides with the axis of the internal conduit 20.
• the internal conduit 20 ends downstream with a cylindrical wall 32 blocked at its end by a membrane or a preferred latex septum 34.
• the cylindrical wall 32 is surrounded by the cylindrical section 30 which projects axially beyond the membrane 34.
• the downstream part of the striker 16 is connected to a rigid cylindrical element 36 in the form of a pot of circular section whose outside diameter is substantially equal to the inside diameter of the cylindrical section 30 so that there is connection by axial sliding and sliding engagement telescopic with or without friction between the rigid element 36 and the downstream part 30 of the striker 16.
• the bottom of the rigid element 36 is a stop for the downstream end of the cylindrical section 30 of the downstream part of the striker 16.
• the rigid element 36 further comprises an axial hollow point 38 surrounded by the vertical walls of the rigid element 36, this point 38 will penetrate into the preferred septum 34 and be partially contained in the downstream part of the internal conduit 20 of the striker when the rigid element 36 is connected to striker 16.
• a flexible and elastic tube 40 is connected on the one hand to the downstream end of the hollow point 38 of the rigid element 36 and on the other hand to the upstream part of a chamber drop 42.
• the assembly formed by the rigid element 36, the flexible tube 40 and the drop chamber 42 is kept aligned by a rigid ear-shaped support 44 which connects the downstream part of the rigid element 36 to the upstream part of the drop chamber 42 partially surrounding the flexible tube 40 so as to create an upstream section 46 of the flexible tube 40 and a downstream section 48 of the flexible tube 40 on either side of the flexible tube section surrounded by the support 44.
• the striker 16, the rigid element 36, the flexible tube 40 and the drop chamber 42 provide connection means connecting the bottle 12 to a supply tube 50.
• the means for detecting that the injection of the liquid contained in the supply source or vial 12 is completed consist either of means for detecting that the supply source is empty such as an air detector or in means of control of the amount of liquid flowing such as a flow- meter which will be able to stop the flow when the quantity of liquid flowed corresponds to a determined and preprogrammed value.
• An air detector 51 is preferably positioned at the upstream section 46 of the flexible tube.
• This detector 51 can consist of any system making it possible to detect that the flexible tube is not filled with liquid but contains air coming from a problem of flow of the liquid or from the fact that the bottle 12 is empty.
• this air detector 51 may consist of two piezoelectric sensors placed opposite one another on either side of the flexible tube 40 and in contact with the outside of this tube. One sensor will emit an ultrasonic wave and the other sensor will receive this wave after its propagation through the flexible tube 40.
• the electrical signal emitted by the piezoelectric receiver will be different.
• the air detector 51 makes it possible, via a control box 49, to electrically control means 53 for interrupting the flow of the liquid situated at the level of the downstream section 48 of the flexible tube 40.
• These means 53 can close off by pinching the flexible tube 40 so as to close or open the flexible tube upstream of the drop chamber 42.
• an electro-clamp which will preferably be controlled electrically by the air detector 51 via an electrical relay .
• a manual control can also be provided for controlling the means 53 for interrupting the flow of the liquid: it is not provided for switching from one bottle to another, which is carried out automatically as described further, but only when you change one of the two bottles or when you install the two bottles of the device at the start. In both cases, it is then necessary to purge the supply tubes 50 and / or the flexible tubes 40 from their air by filling them with liquid by manually controlling the means 53 for interrupting the flow of the liquid.
• the drip chamber 42 is a flexible and elastic transparent cylindrical tube with circular section, of diameter much greater than that of the flexible tube 40, and the two ends of which are closed by a cover through which opens either the flexible tube 40, on the side upstream, ie the supply tube 50, on the downstream side.
• the downstream end of the drop chamber 42 preferably carries a circular filter 52 which retains in the drop chamber the particles which could have entered the infusion device: for example rubber particles or plastic particles from the cap 14 of the bottle 12, of the membrane 34 or of the bevelled tip 18 of the striker 16.
• This filter 52 also serves as a jet breaker when large flow rates (10 ml / s or more) pass through the injection device.
• a plastic filter can be used with 25 ⁇ m openings.
• the contents of the drop chamber 42 serve as buffer stock and bubble trap, in particular in the case of the change of the bottle which will be described later.
• the stock of liquid contained in the drop chamber 42 makes it possible to prevent air from arriving in the supply tube 50 placed downstream of the drop chamber 42: if air enters the level d '' a feed tube 50, it would be necessary to purge all upstream injection device 10 of its air and liquid would be lost.
• connection means 54 which are preferably in the form of a rigid element with internal conduit 56 in the form of T, visible in Figure 3, which allows the double upstream circuit to form a single outlet 58.
• connection means 54 which are preferably in the form of a rigid element with internal conduit 56 in the form of T, visible in Figure 3, which allows the double upstream circuit to form a single outlet 58.
• Each of the two inlet ends of the T-shaped internal conduit 56 is integral with one of the first and second tubes food 50.
• the rigid element 54 also has, in its outlet part, a structure very close to the downstream part of the striker 16: a cylindrical section 60 of circular section surrounds the end of the outlet 58 of the internal conduit 56 which is a wall cylindrical 62 blocked at its end by a preferred latex septum 64.
• This septum 64 plays the same role as the septum 34 of striker 16: its opening allows the introduction of a perforating element in the shape of a point which will be maintained and, when this tip is removed, the septum closes due to its elasticity which guarantees the tightness of the circuit upstream of this septum.
• the septum 64 constitutes sealing means which block the third end of the internal conduit 56 and which are intended to cooperate with the upstream end of the pumping means.
• the outlet part of the rigid element 54 is intended to be connected to a rigid cylindrical element 66, with hollow point 68, of structure identical to that of the rigid element 36.
• the rigid element 66 is placed upstream of the means pumping 72 and is intended to cooperate with the rigid element 54 in the same way as the rigid element 36 with the downstream part of the striker 16.
• the preferred septum 64 is intended to surround so elastic a hollow point 68 located at the upstream end of the pumping means 72.
• a telescopic sliding engagement between the cylindrical section 60 and the rigid cylindrical element 66 makes it possible to fix them to one another and causes the penetration of the hollow point 68 in the septum 64.
• connection means 54 further comprise means for partially closing off the internal conduit 56 allowing the circulation of the liquid either from the two inlet ends of the internal conduit 56 towards the outlet end 5 8 of the internal conduit 56, ie from only one of the two inlet ends towards the outlet end 58, the other inlet end being closed.
• the partial closure means preferably consist of a three-way valve: three inlets and one outlet allow, depending on the rotational position of this valve relative to the connection means 54, to use or not the two inlets of liquid.
• This valve is not intended to be handled during injection, it will be used for example before an injection requiring only one bottle in order to condemn a branch of the upstream injection device 10.
• the motor module 84 constitutes a pump body on which the other elements of the injection device will be hooked.
• the engine module 84 firstly comprises a pump motor with an output shaft, a control panel 86 of the injection device and a metal support 88 for the striker 16.
• the support 88 is a cylinder of circular section with an axial bore opening out and a wide longitudinal slot which extends from one end of the support 88 over part of its length and which opens onto the bore.
• the axial bore has an upper section whose diameter is wider than that of the lower section; the transition zone between the upper section and the lower section forming an annular shoulder.
• the inside diameter of the lower section corresponds to the outside diameter of the striker body 29, which allows the lower section of the bore of the support 88 to constitute an annular element which surrounds the striker body 29 with a small clearance, resulting in movement. transverse of the striker very limited, its axial movement being limited by a stop between the annular shoulder of the support 88 and the external annular shoulder 27 of the striker 16.
• the striker body 29 and the external annular shoulder 27 of the striker 16 constitute the zones by which the striker 16 is held.
• the striker 16 When it is inserted in its support 88, the striker 16 is in fact completely surrounded by the support 88.
• the bottle can be placed by the through end of the upper section of the bore of the support 88 and a fixing system makes it possible to position the support 44 in the form of an ear in the longitudinal slot of the support 88 so that the tip 38 of the rigid element 36 passes through the septum 34 of the striker 16. Thanks to the support 88, the bottle 12 remains inverted and straight despite its weight, avoiding any movement of the striker 16 which can be much lighter than the bottle if the striker is made of plastic for example.
• the periphery of the striker body 29 carries a coding for the recognition of the bottle 12 by the motor module 84 of the pumping means with the type and volume of the liquid contained in the bottle 12. Thanks to this coding, the device of injection according to the invention recognizes the bottle during the insertion of the striker 16 and bottle 12 assembly into the support 88. It is possible to conceive an optical coding with a bar code reader for example or a mechanical coding.
• This mechanical coding is preferably constituted by a flexible membrane which detects the number and / or the position of spikes arranged on the periphery of the striker body 29. This membrane being disposed on the wall of the lower section of the bore of the support 88.
• the motor module 84 further comprises rails 90 which allow the peristaltic cassette 72 to slide in the motor module 84 so that when it is in abutment, the peristaltic cassette 72 is positioned exactly so that the motor output shaft pump drives the moving parts 74 of the peristaltic cassette 72 and so that the tip 68 of the rigid element 66 penetrates the septum 64.
• the rigid element 54 hooks to a place on the motor module 84 provided for this purpose which includes guide grooves 92.
• These grooves 92 constitute means for hooking the rigid element 54 because they are complementary to the lateral guide projections 94 included on the rigid element 54 on either side of an axis of symmetry.
• the pumping means 72, 84 consist of a motor module 84 comprising rails 90 and at least one slot and of a peristaltic cassette 72 comprising longitudinal grooves 77 complementary to the rails 90 and at least one elastic tongue 73 including 1 ' free end carries a hooking lug 75 intended to be inserted into said slot for precise positioning between the motor module 84 and the peristaltic cassette 72.
• the body of the peristaltic cassette 72 carries two elastic tabs 73 forming a clip which cooperates with the housing of the motor module 84 in which the cassette is inserted.
• the elastic tabs 73 bend towards the interior of the cassette due to the hooking lugs 75 which are projecting from the outside. to the body of the cassette.
• the tabs 75 come opposite the slots of the motor module and, due to the elasticity of the tabs 73, these tabs 75 are inserted into the slots which blocks any movement between the cassette 72 and the motor module 84.
• To release the cassette it is necessary to press manually on the part of the tongues 73 which remains outside the module so as to disengage the tabs 75 from their slot.
• the rigid element 66 constitutes the upstream end of the downstream injection device 70 which will now be described in relation to FIG. 2.
• the downstream injection device 70 comprises pumping means preferably made up of a peristaltic cassette 72 and an external motor module 84 whose output shaft rotates the moving parts 74 of the peristaltic cassette 72.
• the peristaltic cassette 72 is crossed by a tube 76, the upstream end of which is connected to the rigid element 66.
• the engine module 84 also includes pressure and air detection means in the form of sensors.
• the output shaft and the detector means can move simultaneously, preferably horizontally, so that the output shaft cooperates with the moving parts 74 in view of 1 ' driving of the moving parts 74 by the output shaft and that the detector means are positioned around the downstream end part of the tube 76 in order to check the pressure and the absence of air in the liquid which arrives towards the patient.
• the downstream end of the tube 76 of the peristaltic cassette 72 is connected to a downstream tube 78 which will guide the liquid to the patient.
• the strikers 16 When using the injection system according to the invention, the strikers 16 are inserted into their support 88, the bottles 12 are connected to the corresponding striker 16 and the rigid elements 36 to the corresponding striker 16, the rigid supports in the form of d ear 44 being fixed to support 88 so that the flow of liquid is vertical between each bottle 12 and the corresponding drop chamber 42.
• the peristaltic cassette 72 and the connection means 54 are removably embedded in the motor module so that the means connection 54 can cooperate with the rigid element 66 as described above and so that the output shaft of the motor module can be positioned automatically to rotate the moving parts 74 of the peristaltic cassette 72.
• the peristaltic cassette 72 and the module motor can be replaced by a peristaltic pump such as one of those which have been described in French patent applications Nos. 2 383 333 and 2 644 212.
• the complete circuit is then purged of its air and filled with liquid before connect it to the patient and start the injection or infusion by pumping the liquid from one of the two vials 12, the flexible tube 40 of the other vial being pinched by the flow interrupting means 53 some cash.
• the air detector 51 controls the flow interrupting means 53 which will close the flexible tube 40 corresponding to the empty bottle and the other bottle takes over to supply the device by means of the 'automatic opening of the interruption means 53 corresponding to this other bottle.
• This system allows the same patient to inject up to twice the content of a vial without stop the injection: just pump on the second bottle when the first bottle is empty.
• the cassette peristaltic 72 prevents the return to the upstream circuit 10 of the liquid having entered the downstream circuit 70 because it is occlusive: when the peristaltic cassette 72 does not pump the liquid from upstream to downstream, its rest position is such that the flexible tube 76 which passes through it is closed by pinching. This property allows the peristaltic cassette 72 to constitute liquid non-return means in the form of means for occluding the tube 76 which are included in the peristaltic cassette 72
• safety means comprising a self-breaking plastic tab 80 which breaks when the peristaltic cassette is introduced into the motor module.
• This system includes electrical sensors which will block the operation of the injection device if they detect the absence of the tongue 80 when the peristaltic cassette 72 is introduced into the engine module, in an intermediate position preceding the step where the tab 80 is broken.
• the cassette must nevertheless be able to be used only once, even if the operator needs to re-introduce the peristaltic cassette 72 into the motor module 84 once the tab 80 is broken.
• the starting point of the time delay is the rupture of the tongue 80 and for the duration of this time delay, it is possible to start an injection while after the end of the time delay, it is impossible to carry out an injection.
• the detection system 82 prevents the use of the same peristaltic cassette 72 for a second injection. It is also possible that each supply source or bottle 12 provides a different liquid. This can allow the successive injection of two different products during the same medical examination.
• One application is NMR scanner radiology for which one liquid is an active liquid called “contrast product" and the other liquid is a neutral purge liquid, for example a glucose solution or a physiological saline, which makes it possible to drive towards the patient the active liquid remaining in the downstream injection device 70 when the injection of active liquid is complete, that is to say when the bottle of active liquid is empty or when the flow of active liquid flow has reached a predetermined value.

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• 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)
• Magnetic Resonance Imaging Apparatus (AREA)
• Nozzles (AREA)

Priority Applications (9)

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Publications (1)

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Citations (5)

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• 1996
  • 1996-08-20 ES ES96929349T patent/ES2175122T3/es not_active Expired - Lifetime
  • 1996-08-20 RU RU98105151/14A patent/RU2188672C2/ru not_active IP Right Cessation
  • 1996-08-20 US US09/029,130 patent/US5968014A/en not_active Expired - Lifetime
  • 1996-08-20 CZ CZ98561A patent/CZ56198A3/cs unknown
  • 1996-08-20 HU HU9901390A patent/HUP9901390A3/hu unknown
  • 1996-08-20 CA CA002227973A patent/CA2227973C/en not_active Expired - Lifetime
  • 1996-08-20 AU AU68781/96A patent/AU700190B2/en not_active Ceased
  • 1996-08-20 DE DE69620890T patent/DE69620890T2/de not_active Expired - Lifetime
  • 1996-08-20 CN CN96196524A patent/CN1131077C/zh not_active Expired - Lifetime
  • 1996-08-20 KR KR1019980701222A patent/KR19990043990A/ko not_active Withdrawn
  • 1996-08-20 WO PCT/FR1996/001297 patent/WO1997007842A1/fr not_active Ceased
  • 1996-08-20 JP JP9509905A patent/JPH11511346A/ja active Pending
  • 1996-08-20 EP EP96929349A patent/EP0846008B1/fr not_active Expired - Lifetime
  • 1996-08-20 AT AT96929349T patent/ATE216605T1/de not_active IP Right Cessation
  • 1996-08-20 PL PL96325202A patent/PL325202A1/xx unknown
• 1998
  • 1998-02-24 NO NO980774A patent/NO980774L/no unknown
• 2007
  • 2007-05-31 JP JP2007145999A patent/JP4988438B2/ja not_active Expired - Fee Related

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