EP3220977A1 - Dispositif de dosage pour la distribution d'un fluide médicamenteux - Google Patents

Dispositif de dosage pour la distribution d'un fluide médicamenteux

Info

Publication number
EP3220977A1
EP3220977A1 EP14806559.2A EP14806559A EP3220977A1 EP 3220977 A1 EP3220977 A1 EP 3220977A1 EP 14806559 A EP14806559 A EP 14806559A EP 3220977 A1 EP3220977 A1 EP 3220977A1
Authority
EP
European Patent Office
Prior art keywords
spindle
reservoir
rod
insulin
unit
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Withdrawn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
EP14806559.2A
Other languages
German (de)
English (en)
Inventor
Hanspeter Niklaus
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.)
Meamedical AG
Original Assignee
Meamedical AG
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 Meamedical AG filed Critical Meamedical AG
Publication of EP3220977A1 publication Critical patent/EP3220977A1/fr
Withdrawn legal-status Critical Current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
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
    • 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
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
    • 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
    • A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system

Definitions

  • the invention relates to a metering device for dispensing medicament fluid according to the preamble of claim 1.
  • a metering device which contains a drive device for a piston and a reservoir with the fluid.
  • the piston of the reservoir is displaced and the fluid contained in the reservoir is displaced and administered.
  • Such devices are used as pump devices and manually operated "pens" in insulin treatment, for example, an "injection pen” is known from WO97 / 17095.
  • injection pens and insulin pumps these devices are designed to be as compact, reliable, and safe as possible for the user, and to eject small amounts of drug fluid as accurately and with the least amount of error as possible.
  • An example of an insulin pump is the D-TRONplus pump from Roche Diabetes Care GmbH.
  • the latter has a spindle unit fixedly arranged in the pump and formed from three telescopic spindle stages.
  • a first displacement stage which is movable against the piston of the reservoir, only perform a feed.
  • a second shift stage can perform both a feed and a rotation when driving through a drive stage.
  • the drive stage performs only one rotation in order to to generate thrust of the first or the second shift stage.
  • the drive unit with its permanently connected spindle unit of the D-TRONplus pump is described in W098 / 47552. Since the introduction of insulin pumps, the design, especially the dosing devices, has hardly changed remarkably.
  • the first generation of conventional insulin pumps has a design for the metering device, as it is known for example from the D-TRONplus pump from Roche Diabetes Care GmbH ago.
  • a motor drives directly or indirectly via a gear reduction a spindle unit, which has at least one spindle drive.
  • the spindle unit consists of a spindle nut and a spindle rod, wherein either the spindle nut is driven, so that the spindle rod can extend and exert a shock force on a piston of a reservoir for its propulsion; Alternatively, the spindle rod can be driven in rotation and thus drive the spindle nut axially to advance the piston.
  • Pumps of the first generation have reservoir volumes between approximately 1,600 and 3,200 mm A 3 and thus hold approximately 1 60 to 320 IU 11100 insulin, the spindle pitches vary between approximately 1 .0 and 1 .2 mm / rev and the cross-sectional areas for the displacement of medicament fluid are between about 65 and 15 mm A 2.
  • the spindle unit is located in the reusable part of the pump. This has the consequence that the spindle unit is always arranged in the pump housing and must always be brought back to the starting position by backward process, after which the metering device can be loaded again with a new filled ampoule.
  • the spindle pitches can generally not be made arbitrarily small.
  • spindle pitches of 1 .0 to 1 .2 mm / revolution have been proven for such dosing devices.
  • the time required to retract the spindle is indirectly proportional to the spindle pitch. In other words, the smaller the spindle pitch, the greater the time required for turning the spindle unit back into the initial state.
  • the cross-sectional area for displacing IV drug fluid and the spindle pitch summarized the cross-sectional area for displacing IV drug fluid and the spindle pitch.
  • the first generation of metering devices in the form of insulin pumps has in common that the fluidic path from the ampule via a catheter and a cannula into the subcutaneous tissue of a user leads.
  • the user carries the pump, for example, in his pocket, by advancing the piston IVIedikêtêtnfluid is displaced and delivered via the catheter to the user.
  • the latest generation of dosing devices is worn directly on the body of a user.
  • a catheter for the fluidic connection of pump and user is no longer necessary for such devices.
  • An embodiment of the latest generation - hereinafter referred to as the second generation - is the patch pump Omnipod from Insulet Corporation.
  • the reservoir volume for this commercially available patch pump is 2000 mm A 3 for holding 200 IU U100 insulin.
  • Another second generation patch pump under development is the "MeaPump" of the same Applicant. known from PCT / EP2014 / 059889.
  • This pump also has a reservoir volume of 2000 mm A 3 for holding 200 IU of U100 insulin, this pump being designed with a telescopic spindle integrated in the piston.
  • each spindle drive has a pitch of 0.5 mm / rev, so the overall pitch is 1 .0 mm / rev.
  • the metering device of the company Insulet Corp. is described in WO2013 / 149186. It is a spindle rod fixedly connected to the piston and a spindle nut comprising the spindle rod, with the piston in its initial position, ie before filling with insulin, in its end position.
  • the patch Pumps of the second generation generally have smaller pitches than those of the first generation.
  • the cross-sectional areas of the reservoirs have larger dimensions than the cross-sectional areas of the reservoirs of the first generation.
  • the dimensions and shape of the second-generation cross-sectional surfaces have been adapted to the requirements of patch pumps, the latter being as flat as possible and compact in length.
  • the reservoir areas have changed from cylindrical surfaces to elliptical areas, moreover, the cross-sectional area of the second generation has generally increased compared to the first generation due to the reduced length of the device.
  • the dosing devices of the first generation have the disadvantage that the smallest amounts of medicament fluid can not be delivered with sufficient accuracy.
  • the smallest basal rate increment which in the case of the SpiritPlus pump is 0.0025 IU U100 insulin (0.025 mm A 3), corresponds to exactly one motor step.
  • the smallest basal rate of the SpiritPlus pump is 0.05 lU / h with a concentration of U100, with 20 delivery intervals per 3 hours per hour. This gives the smallest basal rate increment of 0.0025 IU, which is promoted after 3 minutes.
  • the engine of the SpiritPlus pump is a Hall sensor-controlled motor with a step size or resolution of 60 degrees.
  • the dosing system When driving short, it happens that due to the low inertia of the drive unit, the dosing system is not able to drive only one motor step. Specifically, it may happen that the motor moves in the desired method of one step, for example, 4 motor steps. As a result, after 6 minutes, 9 minutes and 12 minutes, no further medication fluid is delivered for the metering intervals. Only after a time of 15 minutes, the metering device is controlled again by a control unit to again move a motor step, which again is expected to be inaccuracy of several engine steps. Especially for users who only need the smallest amounts of drug fluid are such systems not optimal. The drug delivery error averages to the longer therapy duration, however, the least basal rate or small booster drug delivery can not be delivered with sufficient accuracy due to the inaccurate positioning of the motor.
  • Such second-generation dosing devices therefore also do not meet the requirements for the dosing accuracy of the smallest dosing rates and dosing increments, as is desirable especially for the therapy of children and adolescents.
  • systems are required that can accurately deliver the smallest basal rates, basal rate increments and small bolus deliveries of drug fluid.
  • This problem of accurate delivery of minute dosage units is well known, especially in the therapy of children and adolescents in insulin pump therapy.
  • the only practical way to remedy this problem is to dilute the insulin concentration.
  • the insulin concentration is generally U100 insulin, with a volume of one milliliter containing 100 IU insulin (International Unit).
  • a diluted insulin containing U40 insulin contains 40 IU per milliliter of drug fluid.
  • U40 insulin In a complex process, the production of U40 insulin is done manually, as dilute insulins are virtually not offered by manufacturers. For example, to prepare U40 insulin, 4 milliliters of U100 insulin and 6 milliliters of diluent are added. medium injected into a vacuum bottle. It should be noted here that the correct diluent is used for the corresponding U1 OO insulin. Likewise, after dilution, the container containing the diluted insulin must be immediately labeled, so that there is no confusion later when using the diluted medication fluid. It is evident that dilution of insulin is laborious and prone to handling errors, which, if improperly carried out, can give rise to considerable risks in therapy.
  • the dosing device when switching from U100 insulin to U40 insulin, the dosing device must also be reprogrammed to distribute the right amount of insulin according to the insulin concentration used.
  • a dilution of U100 insulin is so expensive and is not immune to handling errors of the user.
  • the dilution of insulin is today the only method to improve the dosing accuracy. Diluting the concentration leads to an improvement in the distribution accuracy. Dilution, however, is laborious, not suitable for all insulins, and fraught with errors in use, which can result in serious risks to the user.
  • CSII therapy a continuous, subcutaneous insulin infusion - hereafter called CSII therapy. It is often recommended to dilute the insulin, thereby providing better accuracy for the delivery of smallest doses. Dilution of insulin, however, is critical because it is manageable and there may be a number of user handling errors during the dilution process.
  • the devices of the second generation have cross-sectional areas of approx. 125 mm A 2, while the devices of the first generation have cross-sectional areas of approx. 65 mm A 2 to 1 15 mm A 2.
  • the above-mentioned first and second generation metering devices are metering devices with an ampoule as a reservoir, wherein by displacing the piston located in the reservoir, medication fluid is delivered to the user.
  • the metering cylinder can hold 20% of the daily insulin requirement TDD.
  • the average user requires 50 IU insulin per day; hereinafter, the amount of insulin in the metering cylinder is 10 IU of insulin.
  • Disadvantageous and technically complicated are the constant switching from fluidic connection to the reservoir for mounting the dosing cylinder and subsequent switching to the dispensing of insulin to the user. Due to the constant mounting of the metering cylinder by moving the piston rearward and then delivering it to a user, the metering device must provide an increased total stroke for the discharge of a reservoir for the metered delivery of the reservoir volume. This larger stroke for the discharge of a reservoir adversely affects the energy balance of the metering device.
  • the third generation systems are a new design.
  • the reservoir serves as both a storage reservoir for the medicament fluid and as part of the metering device because the piston of the reservoir itself is displaced.
  • the third generation systems have been strictly separated.
  • the reservoir serves only as a storage container for the drug fluid, while the dosing performs only the delivery of the drug fluid downstream of the reservoir.
  • the dosing cylinder can hold a dosage of 4 to 20 IU, this corresponds to 40 to 200 mm A 3 when using U100 insulin.
  • the ratio of length to diameter of the metering cylinder can be 10: 1 to 1: 1. From this a range for the diameter of the dosing cylinder of 3.70 mm to 6.34 mm can be calculated.
  • the dosing system can also have spindle pitches from 0.5 mm / rev to 2.0 mm / rev.
  • the reservoir can hold 200 to 500 IU U100 insulin, which corresponds to a volume of 2000 to 5000 mm A 3 for a U100 insulin.
  • EP2361646B1 again describes a metering device for the average user who may need 50-100 IU insulin per day. The reservoir therefore has large dimensions.
  • EP2361646B1 gives no information on how to optimize and / or combine metering surfaces and gradients, so that the most accurate metering device for the CSII therapy of children and adolescents can be formed.
  • EP2361 646B1 representing the third generation assumes that the reservoir and the metering cylinder must be separated from each other in order to form the most accurate metering device can.
  • the invention here is a new, contrary way, it has made it its mission to improve a metering device of the first or second generation such that they respect to the dosing accuracy and the size of the reservoir volume, respectively.
  • the dosage is optimal for a CSII therapy of children and adolescents.
  • Dosing devices such as "injection pens” or “pens” are known, for example, from WO 97/17095.
  • the metering device consists of an ampoule with a metering surface F and a manually operable spindle unit.
  • the spindle unit of WO 97/17095 allows the setting of Dosierinkrementen.
  • the metering knob has metering increments in the form of quarter turns of the metering knob. The user rotates in a first step by the desired number of quarter turns and then actuates the Dosierknopf, whereby drug fluid is discharged.
  • injection pens are limited in resolution, and commercially available devices have dosing increments of 0.1 IU insulin, so “injection pens” are of limited use for children and adolescents suffering from type 1 diabetes. For this group of users, insulin pumps are more suitable since these basal rates can virtually continuously increase from 0.05 to 0.1 lU / h.
  • WO03 / 017914 a glass ampoule is described, which has optimized diameter tolerances, whereby 20 insulin deliveries of each 1 IU can be administered in a required by an ISO standard tolerance.
  • the used insulin concentration is here U200, so that higher demands are placed on the tolerance of the ampoule diameter.
  • the analysis cited in WO03 / 017914 shows that for an insulin with a concentration of U200, the diameter must be between 7.45 and 9.25 mm, in order for the To fulfill the requirement of the standard, which states that after 20 dosing increments of 1 IU, the total distribution of 20 IU must be within a tolerance of +/- 1 IU.
  • Such glass ampoules are primarily used in "injection pens” whose mechanical metering systems have a mechanical displacement accuracy for the piston of only +/- 0.083 mm when dispensing 1 IU.
  • improved systems have an accuracy of +/- 0.055 mm
  • Such dispensers are therefore not particularly suitable for children and adolescents. Insulin pumps that can be loaded with prefilled glass ampoules of the type described are known in the art.
  • D-TRON Plus pump which is a pre-filled Glasam- used with an internal diameter of 9.25 mm.
  • this pump has a telescopic spindle.
  • the corresponding dosing devices belong to the first generation of insulin pumps in which the spindle is arranged in a solid housing and the spindle pitch has values between 1 .0 mm / rev and 1 .2 mm / rev for limiting the return time.
  • Pre-filled glass ampoules with a diameter of 6.85 mm and a volume of 1500 mm A 3 have been used only in manually operated "injection pens" and have the previously derived dispensing tolerance of +/- 0.202 IU
  • the analysis described in WO03 / 017914 only takes into account the diameter tolerances and the displacement tolerances, ie the stroke tolerances due to, for example, spindle pitch errors, for the pistons of the mechanical metering systems, whereby the displacement tolerances of mechanical "injection pens" are specified.
  • WO03 / 017914 makes no statement about the dosing accuracy of insulin pumps, but merely postulates that the higher accuracies dosing systems of insulin pumps must consequently comply with the said standard, since the less accurate mechanical dosing systems of the "injection pens" the standard IS01 1 608-1 In WO03 / 017914, there is thus no information on the accuracy of dosing systems in insulin pumps, nor is there any information as to how such a system can be improved in terms of its accuracy Similarly, the glass ampule filled with U200 insulin disclosed in WO03 / 017914 is not suitable for CSII therapy in children and adolescents.
  • WO2008 / 055689 should be mentioned here for the sake of completeness.
  • This document discloses a method in which the diameter of the ampoule is adjusted depending on the insulin concentration. Basis is an ampoule with a diameter of 9.65 mm for the administration of 11100-insulin. If the concentration is doubled, the area is halved and, conversely, at half the concentration, the area is doubled. This ensures that with the same displacement of the piston, an equal amount of insulin can be administered.
  • This invention according to WO2008 / 055689 does not solve the problem of dosing accuracy of smallest doses, since the same stroke always results for all combinations of area and concentration. A positioning error of the drive unit continues to behave the same for all proposed pairings of area and concentration, which can be achieved with respect to the positioning error of the motor no improvement.
  • the purpose of the invention is to improve a metering device for the precise dispensing of medicament fluid with regard to the distribution accuracy of minute bar-rate increments and small bolus deliveries, which is particularly desirable for children and adolescents, for example, in CSII therapy.
  • the aim is also to optimize the dosing device such that even insulins with a maximum concentration of U100 can be used in the CSII therapy of children and adolescents without the need for diluting the medicinal fluid.
  • the invention aims at further developing the systems of the first and second generation with regard to the dosing accuracy, so that they are particularly suitable for CSII therapy in children and adolescents.
  • the product of the cross-sectional area of the reservoir in the unit mm A 2 and the spindle pitch in the unit mm / angular degree is less than 0.13 mm A 3 / angular degree and the medicament fluid is a liquid insulin with a concentration of U20 to U100 a dosing device is created, which is particularly well suited for CSII therapy in children and adolescents.
  • the sensitivity of the dosing unit to angular errors of a drive unit can be minimized.
  • the sensi- The effectiveness of a parameter is a measure of how strongly its tolerances can affect an output variable.
  • the delivery amount of medication fluid corresponds to the starting quantity or the target quantity to be controlled.
  • the independent variables may be an engine angle, a leadscrew pitch and an equivalent reservoir diameter.
  • the corresponding sensitivity can be determined, this is disclosed in detail in the following description of the invention.
  • the invention has been able to deduce that the sensitivity to the angular error of the drive unit is proportional to the product of the cross-sectional area of the reservoir and the pitch of the spindle unit and is proportional to the insulin concentration. This fact utilizes the present invention to create a metering device that has a minimized error in dispensing smallest doses.
  • the dosing device according to the invention can be suitable for CSII therapy in children and adolescents up to insulin concentrations of at most U100.
  • the metering device according to the invention is particularly suitable. Due to the improved distribution accuracy of the smallest basal rate increments and small amounts of boulules, the therapeutic result can be improved. Therefore, in the CSII therapy of children and adolescents, the metering device according to the invention makes it possible to accurately administer the smallest and smallest dosage amounts by reducing the angular error by reducing the corresponding sensitivity.
  • the invention has theoretically derived and recognized that the sensitivity to the angular error is proportional to the product of cross-sectional area and pitch.
  • the said sensitivity is also proportional to the insulin concentration.
  • the invention therefore proposes to optimize or minimize the product of cross-sectional area and spindle pitch compared to the prior art, so that when using insulins with concentrations of U20 up to a maximum of U100 a CSII therapy for children and adolescents can be significantly improved and thereby a better therapy result, resp. a better glycemic control, can be achieved.
  • a liquid insulin having a concentration of U100 is used as the medicament fluid, since most manufacturers offer only U100 insulin.
  • the reservoir can hold 20 to 100 IU of drug fluid, with the volume at an insulin concentration of 100 U in a range of 200 to 1000 mm A 3. This amount of medication fluid is enough to cover insulin needs for 2 to 4 days without having to refill or replace the reservoir.
  • this preferred dosing device will allow the insulin in the reservoir to be used for 2 to 4 days, so that the insulin used will not need to be diluted with a starting concentration of U100 to improve the distribution accuracy, and so on U100 insulin can be used directly and that smallest and small doses can be administered accurately by reducing the angular error by reducing the corresponding sensitivity.
  • U100 insulin can be used directly and that smallest and small doses can be administered accurately by reducing the angular error by reducing the corresponding sensitivity.
  • the improved results can be improved with the smallest possible increase in distribution and small bolus amounts.
  • a metering device which utilizes U100 insulin may also have a more compact design than metering devices which use lower insulin concentrations.
  • the maximum sensitivity for the diameter error of the cross-sectional area can be defined by a lower limit for the diameter, whereby the metering device according to the invention can deliver large metered quantities with a defined maximum error.
  • the cross-sectional area has an area of more than 24 mm A 2.
  • the sensitivity to the diameter error is proportional to the inverse of the diameter.
  • the metering device may have a cross-sectional area which is in a range of 24 mm A 2 to 58 mm A 2, the equivalent diameter being in a range of 5.5 mm to 8.5 mm. If the diameter is reduced too much, the average distribution error increases over a long time interval of, for example, 24 hours. It has been found that it is precisely the preferred range for the equivalent diameter of 5.5 mm to 8.5 mm that has optimum properties, both with regard to tolerances for the accuracy of the long-term release, but also with regard to the manufacturability of a real metering device with such dimensions.
  • the spindle pitch of the metering device may preferably be in a range from 0.2 mm / revolution to 1 .0 mm / revolution, that is to say in a range from 0.00056 mm / angular degree to 0.0028 mm / angular degree after conversion from mm / revolution to mm / angular degree.
  • the product of the preferred cross-sectional areas and the preferred spindle pitches provides a preferred design range for the metering device of the present invention. Especially with these preferred combinations of cross-sectional area and spindle pitch results in minimized sensitivities to the angular error of the drive unit, which thus designed systems for CSII therapy of children and adolescents are particularly well suited.
  • Another, particularly favorable design range is for the equivalent diameter of 6.4 to 7.5 mm and for the spindle pitch at 0.3 to 0.9 mm / revolution.
  • a design range for the metering device in which the product of the cross-sectional area of the reservoir in the unit mm A 2 and the spindle pitch of the spindle unit in the unit mm / angular degree smaller is 0.08 mm A 3 / angle degree and the cross-sectional area is greater than 32.2 mm A 2, which corresponds to a diameter of 6.4 mm.
  • the preferred dosing system has a reduced sensitivity to angular misalignments of the engine, whereby small and smallest Dosiermengen can be distributed very accurately. This can be compared to the prior art, a further improvement in the delivery of smallest Dosierinkrementen achieve; In addition, the long-term failure of the payout can be further improved over the third-generation systems.
  • the drive unit has a motor as a drive member and a driven by the engine gearbox with a reduction for the reduction of the motor angle. Reductions in a range from 200 to 2000 for the motor angle are particularly favorable; through such high reductions, the sensitivity to a motor angle error can be further reduced. It is advantageous if the spindle unit is formed from only one spindle nut and a spindle rod. In this case, both the spindle nut can be rotationally driven and extend the spindle rod, o- the spindle rod to be rotationally driven, which leads to an extension of the spindle nut.
  • the spindle unit is arranged in the piston itself and is driven by a driver rod arranged on the transmission output, wherein the driver rod forms an axial stop for detaching the driver. Supporting the spindle unit in the conveying state.
  • the spindle unit can be used only for single use with the reservoir.
  • the support of the spindle unit on the driving rod is advantageous, because a force acting on the spindle unit force can be determined by a force sensor arranged under the driving rod, this force can be used by a control unit for monitoring the reservoir with respect to occlusions.
  • the metering device can also accommodate partially filled reservoirs.
  • the spindle unit can be supported on its running on the drive rod stop and subsequently dispense drug fluid dosed. Since the force sensor can detect an approach to the drive rod, a control unit can determine the amount of drug fluid in the reservoir. The calculation of the amount of medication fluid is therefore possible because the total stroke of the spindle unit is the same for all reservoirs and corresponds to an equivalent number of motor steps. After driving the spindle unit to its stop formed on the driving rod, the number of motor steps made can be subtracted from the total number of motor steps until it is driven up. The remaining motor steps correspond to the motor steps still available for delivery of drug fluid. From these, the remaining amount of medication in the reservoir can be determined at any time.
  • the spindle rod is firmly connected to the piston and the spindle rod is driven by the driving rod.
  • an external thread of the spindle rod engages in an internal thread of a non-rotating spindle nut and thus forms a spindle drive.
  • the spindle rod in an initial state before be filled with the filling of the reservoir and the piston together with the spindle unit for filling the reservoir with a Aufziehstange be displaced.
  • the user fills the reservoir by hand, thereby connecting the reservoir to a reservoir via an adapter so that the reservoir and the reservoir are in fluidic communication.
  • the air in the reservoir is displaced into the reservoir.
  • the user can move the piston rearwardly via the mounting rod, whereby medication fluid flows from the reservoir into the reservoir and thus the reservoir is filled.
  • a filling of the reservoir which can largely be done automatically via the metering device itself.
  • the spindle rod is initially in an extended position, the piston is accordingly in its uppermost position.
  • the user first connects the reservoir to the drive unit by inserting the reservoir into a housing and bringing the spindle rod of the reservoir into engagement with the drive rod of the drive unit. Subsequently, he establishes the fluidic communication between the reservoir and the reservoir by first connecting the adapter having a connecting needle to the reservoir and then connecting the reservoir to the adapter, whereby the fluidic communication is established via the connection needle.
  • the piston can move backwards, with medication fluid flowing into the reservoir.
  • a control unit can determine the motor steps and use this to automatically determine the amount of medicament fluid in the reservoir.
  • the axial support of the spindle nut over the wall of the reservoir has the advantage that during filling no axial force can act on the drive unit.
  • the filling with a retracting rod is particularly advantageous, because in this case the piston is advanced with its integrated spindle unit as a whole. currency During filling, there are no relative displacements between the piston and the spindle unit and the elements of the spindle drives, such as, for example, spindle nuts and spindle rods.
  • the spindle unit in the piston it is possible to calculate the remaining number of motor steps on the basis of the constant total stroke and the number of motor steps until the spindle unit reaches its stop. Ultimately, this can always determine the remaining, still available amount of drug fluid at any time.
  • a further advantageous embodiment of the spindle unit is formed in that the spindle rod can be rotationally driven by the driving rod and the spindle rod can have an external thread engaging with an internal thread of a rotationally secured spindle nut and such a spindle drive can be formed.
  • the spindle nut is firmly connected to the piston, so that the piston can perform only a translational movement in the promotion of medicament fluid.
  • a translational movement of the piston is preferable to a rotational and translational movement at the same time, since in the latter seals arranged on the piston can rotate due to the piston rotation, whereby the friction can increase and the tightness of the reservoir can no longer be guaranteed.
  • two possibilities are conceivable for the filling.
  • the piston is in a retracted position. at the beginning of the filling.
  • the filling is done manually by the user moving the piston forward via a retractable rod to move the air into the reservoir. Subsequently, he can move the piston backward and draw drug fluid into the reservoir, and here also for the preparation of the fluidic connection, an adapter can be used with a Kochleitnadel.
  • a further advantageous and preferred embodiment, which is particularly suitable for filling, is formed in that the piston can be in an extended position prior to filling.
  • the spindle rod can be prevented from displacement in the conveying direction by an axial stop provided on the wall of the reservoir.
  • the spindle rod When turning back the drive rod, the spindle rod can be supported on the wall of the reservoir, so that the piston can move backwards and medication fluid can flow from the reservoir into the reservoir.
  • the spindle rod can be made in two parts. In this case, one part may be designed as a spindle rod driven by the driving rod with an external thread; the second part may be designed as a disc, wherein in the rearward process the disc can receive an axial force of the spindle rod at an inner radius and the disc can transmit the axial force at an outer radius to the wall of the reservoir.
  • the disc can moreover be held against rotation against the wall of the reservoir.
  • the axial force can act on an inner diameter of the disc, the reverse rotation due to friction generated between the spindle rod and the fixed disc results in reduced lost torque.
  • the preferred two-part embodiment of the spindle rod thus reduces the energy consumption during filling, in that the axial reaction force during filling is not absorbed directly by the wall of the reservoir, but rather by a force acting on the wall of the reservoir.
  • Be formed stop which has a significantly smaller diameter than the diameter of the reservoir.
  • the spindle rod is driven by the drive rod of the transmission, wherein the spindle rod may have a slot for axially receiving the drive rod.
  • the slot and the drive rod can be made profiled, by such a connection only a drive torque should be transmitted.
  • the wall of the reservoir can be surrounded by an outer wall in the axial direction and the outer wall can be firmly connected to a housing.
  • the outer wall can ensure that external pressure on the outer wall due to deformation of the outer wall can not cause unwanted discharge.
  • the connection is made from the outer wall to the housing via a bayonet connection.
  • the bayonet connection axially secures the reservoir both in the feed direction and in the opposite direction. This ensures that the bayonet connection can absorb the axial force created during filling of the reservoir. Similarly, the bayonet connection takes in promotion the corresponding axial forces in the opposite direction.
  • the anti-rotation of the spindle nut can be made via a groove and cam connection between the reservoir and the spindle nut.
  • a further advantageous embodiment of the anti-rotation device can be produced in that the spindle nut can have radial wings, via which the spindle nut can be supported on an inner wall of the outer wall and thus the spindle nut can be secured against rotation.
  • the outer wall may have an elliptical, that is not circular contour.
  • the radially outwardly projecting wings of the spindle nut simplify the construction and assembly, the function of preventing rotation of the spindle nut in no way is compressed.
  • the rotation can also be created by the fact that projections of the spindle nut in the form of, for example, wings can engage in elongated, formed on the reservoir wall slots.
  • the proposed dosing device is particularly suitable for dosing insulin in an insulin pump.
  • the metering device is particularly suitable for the continuous, subcutaneous infusion of insulin - CSII therapy - in children and adolescents.
  • the smallest dosing increments of, for example, 0.0025 IU, the lowest basal rates of, for example, 0.04 IU / h and the smallest bolus deliveries of, for example, 0.1 IU, can be accurately delivered by means of the dosing device according to the invention.
  • the therapeutic result can be improved.
  • the everyday life for users a dilution of the drug fluid up to an insulin concentration of U100 can be omitted because the inventive metering device allows a more accurate dosage of smallest Dosiermengen and so thinning to improve the accuracy of the distribution in example U100 insulin no longer necessary power.
  • the use of the metering device according to the invention as an insulin pump, especially when used in children and adolescents, is particularly advantageous.
  • the present invention also makes it possible that the reservoir can be filled by the metering device itself.
  • the advantage here is particularly that during filling no axial force acts on the drive rod.
  • An axial reaction force is absorbed only by the bayonet connection and the housing. It is important that no axial tensile force acts on the driving rod during filling.
  • the piston can be firmly connected to the drive unit, such axial tensile forces act. te on the spindle unit and the drive unit, whereby a reversal of the axial bearing clearance can take place.
  • the invention has surprisingly been able to show by a theoretical derivation that only the sensitivity for the angular error can be influenced by the insulin concentration. Both the diameter error sensitivity and the spindle pitch error sensitivity can not be affected by the insulin concentration. This realization is new.
  • the invention has also been able to show that an optimization of the product of spindle pitch and cross-sectional area of the reservoir has an equivalent effect on the metering accuracy, such as a reduction of the concentration itself.
  • the invention has been able to show that the sensitivities for the equivalent diameter of the cross-sectional area and the Spindle pitch are proportional to the respective reciprocals of diameter and spindle pitch and these affect the distribution accuracy of large amounts of drug fluid.
  • 1 a shows a first design range for a metering device according to the invention compared to the design ranges of the systems of the first and second generation
  • FIG. 2a shows a first embodiment of a reservoir with an integrated spindle unit and a Aufziehstange in an initial state in longitudinal section
  • FIG. 2b shows the reservoir shown in FIG. 2a connected to a drive unit for forming a metering device according to the invention in longitudinal section
  • FIG. 3a shows a second embodiment of a metering device according to the invention in an initial state before filling in longitudinal section
  • FIG. 4b the reservoir shown in Fig. 4a in cross-section to the longitudinal axis
  • 5a shows a third embodiment of a reservoir with an integrated spindle unit and a Aufziehstange in an initial state in longitudinal section
  • FIG. 5b shows the reservoir connected to a drive unit shown in FIG. 5a for forming a metering device according to the invention in FIG
  • the invention has set itself the goal of designing a metering device such that a delivery of the smallest Dosiermengen can be done accurately and precisely.
  • Basis for the optimization of such a system is the error propagation law according to Gauss, which is generally described here in a first step and is then applied to a metering device.
  • a metering device can be optimized in such a way that it can provide improved accuracy in the discharge of smallest metered quantities.
  • the Gauss error propagation law is applied. This is described by the following general equation for a function with three independent variables f (x lt x 2 , x 3 ):
  • the error of a function with three variables can therefore be calculated by deriving the function according to the respective variable and adding it with its tolerance.
  • the approach of Gauss states that not the derivatives multiplied by their tolerance add, but their squares. A single square of errors therefore corresponds to a variance, with which the three error variants add up. Finally, if you want to get the fault tolerance for the entire system, then the root must be taken from the total error variance.
  • the derivatives are referred to as sensitivities in mathematics.
  • the first step is to determine the size of interest and to analyze.
  • a connection must be deduced between an output variable and independent input variables.
  • the transfer function can be determined from motor angle to metered amount. Assuming that the motor angle is reduced by a reduction, and a spindle unit is used with a constant pitch, it can be determined in a first step, the stroke on the spindle in function of the motor angle.
  • l Ah in mm is the stroke
  • ⁇ is the motor angle in angular degrees
  • i is the gear reduction
  • p is the pitch of the spindle in mm / angular degree.
  • the volume can be multiplied by a factor for concentration, which finally allows to determine the administered dose amount AU.
  • this factor is 0.1, which means that a volume of 10 mm 3 A by a factor of 0.1 has to be multiplied, to thereby determine the amount of insulin delivered in units IU.
  • a volume of 10 mm A 3 therefore contains 1 IU of insulin at a concentration of U100 insulin.
  • C insulin is the factor for the conversion of one volume to the amount of insulin in the unit IU (International Unit).
  • the dispensed quantity AU to IU insulin can be derived according to the independent variables.
  • the latter are the slope p, the equivalent diameter of the reservoir D t and the motor angle ⁇ .
  • the motor angle error considered in a broader sense, can be any angular error of the drive unit, that is to say an angle error, that of the components motor and transmission in a row caused by example friction or tolerance errors on the gears. Accordingly, the angle error can be considered as any error in which a predetermined angle of a control unit can not be correctly implemented by the drive unit. At the output of the transmission thereby an angle error is caused for the spindle unit.
  • Deriving the function according to the independent variables yields the sensitivities.
  • the Gauss error propagation law is applicable when the independent variables are independent and normally distributed. It is assumed here that these conditions are met. The three sensitivities are listed below.
  • the sensitivity to the motor angle is proportional to the product of the spindle pitch and cross-sectional area of the reservoir.
  • the product of spindle pitch and cross-sectional area of the reservoir must be minimized. So both factors - spindle pitch and cross-sectional area - have to be chosen as small as possible.
  • the previously derived sensitivities can be further simplified by describing the angle ⁇ as a function of the amount of insulin AU to be released. For the sensitivities we now get new, the following simplified representations.
  • both the sensitivity for the diameter and the sensitivity for the spindle pitch can not be influenced by the concentration of the insulin C InsuUn .
  • concentration of the insulin has only a direct impact on the sensitivity of the engine angle error. This can be directly influenced by the insulin concentration, which, for example, halves the error by using U50 insulin in comparison to U100 insulin.
  • An improvement in the distribution accuracy can be achieved not only by a concentration dilution of insulin; according to the sensitivity for the angular error, the distribution accuracy can be substantially improved by an optimized choice of the parameters diameter and spindle pitch. Because the product
  • Both the sensitivity for the diameter and the sensitivity for the slope are indirectly proportional to the diameter, respectively to the spindle pitch.
  • the systems of the third generation have very small diameter for the metering cylinder, whereby the corresponding diameter error in the distribution increases unfavorably.
  • dAU which takes into account the error squares of diameter, spindle pitch and angle error, the following equations result:
  • Table 4 also shows the tolerances used for the calculation. Both the error squares of the independent factors and the total error in the unit IU insulin have been summarized in Table 4.
  • the tolerance for the spindle pitch is +/- 1% of the pitch.
  • the tolerance for the diameter is +/- 0.05 mm for all diameters. The tolerances used correspond to today's production tolerances.
  • the first and second generation metering devices have the smallest errors for large payloads, due to the smallest sensitivities for the diameter and the leadscrew pitch.
  • the third generation system has the biggest error for large payload volumes.
  • the third generation system has the greatest diameter sensitivity. Therefore, when distributing large doses, third generation systems have a large payout error.
  • the sensitivity for the spindle pitch is proportional to the inverse of the slope. A reduction of the spindle pitch with constant tolerances therefore leads to an enlargement of the corresponding error square. Miniaturization of the parameters, as may be the case with third generation systems, increases the sensitivities.
  • the dosing device according to the invention has a better accuracy both compared to the third generation systems and to the first and second generation systems.
  • the metering device according to the invention has similar or better distribution accuracies in the area of the smallest metering quantities in comparison to a system of the third generation. In the field of large doses, it has only marginally worse performance compared to the first and second generation systems.
  • the metering device according to the invention can dispense smallest metering quantities accurately and even achieves or even exceeds the performance of the systems of the third generation.
  • the metering device according to the invention has an error even in the case of large metering quantities, which is only marginally greater than that of the systems of the first and second generations.
  • the system according to the invention performs significantly better than the systems known from the prior art.
  • the system according to the invention can deliver the entire metered quantity with an accuracy of +/- 1.86% after a discharge interval of 1 hour.
  • a first generation or second generation system achieves only a fault tolerance of +/- 5.1 6%, respectively +/- 4.71%, while the third generation system has an error of +/- 2.45%.
  • the error after one hour for the system according to the invention is 2.26%.
  • this error is 10.07% relevant.
  • a dilution of the insulin in the ratio of 1/5, ie U20 insulin must be made.
  • the metering device according to the invention is able to dispense small metered quantities very precisely, the error of the motor angle being minimized for small metering quantities. Likewise, the metering device according to the invention is able to dispense large quantities of medicament fluid very accurately. For large doses, the percentage error of the motor angle tends to zero (the absolute value remains constant), the error of the diameter due to diameter tolerances and the error of the spindle pitch due to pitch tolerances are essential here.
  • the inventive system can therefore smallest Dosing much more accurate dumping than the prior art, which is formed by the systems of the first and second generation.
  • Fig. 1 b has over the entire metering good properties with respect to the distribution accuracy. This range is particularly suitable for CSII therapy in type 1 diabetes in children and adolescents using undiluted U100 insulin.
  • Fig. 1 c a further limited scope of the invention is shown. In this area, metering devices can be formed which have further improved distribution accuracy.
  • the area shown in Fig. 1 c has a cross-sectional area which is greater than 32.2 mm A 2, this corresponds to a diameter for the reservoir of 6.4 mm.
  • the product of cross-sectional area and slope is represented by the upper boundary line.
  • the third generation systems have a new design with a reservoir and a metering cylinder separated therefrom. These systems are presented here for the sake of completeness. Only the first and second generation systems, as well as the embodiment according to the invention belong to the same category in which the reservoir itself has a movable piston for the delivery of medication fluid.
  • First and second generation metering devices, as well as the invention, can be considered as syringe pumps in which a piston of a reservoir is displaced by a drive unit and thus drug fluid is delivered.
  • a reservoir A having an integrated spindle unit S.
  • the spindle unit S consists of a spindle rod 1 and a spindle nut 2, wherein in the embodiment shown, the spindle nut 2 is movable.
  • the reservoir A has an inner wall 3, on which a piston K is guided.
  • the piston K itself is directly connected to the spindle nut 2.
  • Between the inner wall 3 and the piston K are sealing points 4, which are formed here in the form of O-rings 5.
  • the reservoir A has, in addition to the inner wall 3, which here has an inner diameter of 7.2 mm, an outer wall 6. Inner wall 3 and outer wall 6 are firmly connected.
  • the outer wall 6 also has locking cams 7, via which the reservoir A can be connected to a fixed housing 8.
  • FIG. 2b shows a metering device D according to the invention.
  • the reservoir A having the integrated spindle unit S is connected to a drive unit M after filling, thereby forming the metering device D.
  • the reservoir A is connected to a fixed housing 8.
  • a motor 15 of the drive unit M drives via a gear 16, in which case a planetary gear 17 and a deflection gear 18 are present, a driving rod 19 to rotate.
  • the total reduction i is composed of the reduction of the planetary gear 17 and the reduction of the deflection gear 18 in the form of a spur gear.
  • the motor has for positioning Hall sensors, which have a motor increment of 60-angle degree of the motor angle.
  • the exemplary embodiment shown in FIG. 2b has a reduction i of 920, a spindle pitch p of 0.5 mm / revolution and a diameter Di of 7.2 mm.
  • this has a fluidic connection from the connecting needle 13 to the subcutaneous tissue of a user.
  • a cannula leading into the subcutaneous tissue can ensure the connection of the user with the dosing device.
  • the double-walled embodiment of the reservoir A shown in FIGS. 2a to 2c has various advantages.
  • the oval running outer wall 6 ensure the rotation of the spindle nut 2.
  • the outer wall 6 protects the actual reservoir A from impacts and the like.
  • a pressure on the outer wall 6 leads to no compression of the inner reservoir cylinder.
  • Such a double-walled reservoir A requires no further solid housing, as provided, for example, in dispensers of the first generation to protect the ampoule.
  • FIGS. 2a to 2c can also be designed with an alternative anti-twist device.
  • the rotation can be done via a groove and wedge connection between the inner wall and the spindle nut.
  • the inner wall is extended towards the drive unit.
  • a mounting rod is suitable.
  • FIGS. 3a and 3b another embodiment is shown.
  • This exemplary embodiment is similar in construction to the example of FIGS. 2a to 2c, since here too a spindle rod 1 is rotationally driven and a non-rotating spindle nut 2 executes a linear movement.
  • the spindle nut 2 and the associated piston K are in an upper position.
  • the spindle nut 2 moves backwards and sucks insulin from a storage container into the reservoir A and thus fills the reservoir A.
  • the spindle rod 1 must be able to support itself when the piston K is moved backwards. This support is advantageously carried out on the inner wall 3.
  • the wall 3 therefore has a stop 21 for the spindle rod 1.
  • the drive unit changes its direction of rotation. By rotating the spindle rod 1 in the feed direction, the spindle rod 1 moves to a stop 22 formed on the driver rod 19. In the direction of advance, therefore, the spindle rod 1 is supported on the driver rod 19.
  • the spindle rod 1 When filling the reservoir A, however, the spindle rod 1 is supported on the inner wall 3 of the reservoir A.
  • the rotation of the spindle nut 2 can be done via longitudinal grooves and cams between the inner wall and spindle nut 2.
  • the exemplary embodiment of FIGS. 3 a and 3 b therefore has the advantage that the reservoir A can be filled by the drive unit M itself, so that the laborious filling can be spared the user.
  • the support of the spindle rod S on the inner wall 3 during filling is very advantageous because it can be ensured that during filling no axial forces on the drive rod 19 and the drive unit M are passed. Only the bayonet connection 14, which is provided for such forces, is claimed with forces in the filling and the subsequent delivery of drug fluid.
  • Filling via the drive unit M is also advantageous in that a control unit can calculate the filling volume on the basis of the rearward engine steps. It is therefore possible to accurately fill the reservoir A with a volume determined by the user.
  • a control unit can calculate the filling volume on the basis of the rearward engine steps. It is therefore possible to accurately fill the reservoir A with a volume determined by the user.
  • After filling the spindle rod 1 moves to the at the merstange 19 trained stop 22.
  • a force sensor 23 Under the Mitauerstange 19 is a force sensor 23, which can monitor an axial, acting on the spindle unit S force during promotion.
  • the force sensor 23 has primarily the task of detecting occlusions, as well as it can detect an approach of the spindle rod 1 on the stop 22 formed on the driving rod 19.
  • FIG. 4 a shows a reservoir A analogous to the construction of FIGS. 3 a and 3 b.
  • the reservoir A of Fig. 4a differs in that the spindle rod 1 has been made in two parts.
  • a stop disk 24 is also provided in FIG. 4a. This is firmly connected to the inner wall 3.
  • the stop disk 24 now has a stop 28 for the spindle rod 1, wherein an effective radius 29 for the support of the spindle rod 1 on the stop disk 24 can be reduced.
  • the loss torque generated between the spindle rod 1 and its axial stop 28 can be significantly reduced.
  • Fig. 4a thus has the advantage that the torque losses occurring during the backward process can be reduced by carrying out the support between the spindle rod 1 and its stop 28 formed on the stop disk at a smaller radius 29.
  • the axial force is transmitted to the inner wall 3 at an outer radius 30 via the stop disk.
  • the stop disk 24 is non-rotatably and axially secured to the inner wall 3.
  • Fig. 4b a view is shown transversely to the longitudinal axis, in which the two-part design of the spindle rod 1 is clearly visible.
  • FIGS. 5a and 5b show a further exemplary embodiment for manual filling.
  • the piston K is now connected to the spindle rod 1.
  • the spindle nut 2 is secured against rotation and can be supported on a trained on the drive rod 19 stop 22 at feed.
  • the spindle rod 1 in turn has a slot 20 into which the driving rod 19 can engage.
  • the spindle rod 1 both a rotation generated by the driving rod 19 and a provoked by the non-rotating spindle nut 2 linear motion.
  • the spindle nut 2 may be connected to a mounting rod 12 in order to carry out the filling of the reservoir A by hand.
  • a radial wing 10 is suitable as an element for the rotation, which can be supported on the inner wall 1 1.
  • FIGS. 6a and 6b show a further exemplary embodiment. This is intended for automatic filling.
  • the non-rotating spindle nut 2 is supported during the filling of the inner wall 3 at the stop 21 of the reservoir.
  • profilings are used for the rotation between the spindle nut 2 and the inner wall 3.
  • simple groove and wedge connections between the components which are intended to prevent rotation of the spindle nut 2.
  • An axial displacement of the spindle nut 2 is prevented by turning back through the stop 21, in the opposite direction, the spindle nut 2 abuts against its formed on the drive rod 19 axial stop 22nd
  • the spindle rod 1 has an external thread 25 and the spindle nut 2 has an internal thread 26. External thread and internal thread thus form a spindle drive 27. It is noted that a reversal of spindle nut 2 and spindle rod 1 is conceivable. This means that not the spindle rod 1 is driven off rotationally, but the spindle nut 2. In this case, the spindle rod 1 must be carried out against rotation. Whereby the previously discussed solutions can be used for anti-rotation. LIST OF REFERENCES

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Abstract

L'invention concerne un dispositif de dosage pour la distribution d'un fluide médicamenteux, ledit dispositif de dosage (D) comprenant une unité tige (S) présentant un pas (p) constant, une unité d'entraînement (M) pour l'entraînement en rotation de l'unité tige (S), un réservoir (A) pour le fluide médicamenteux, le réservoir (A) présentant une paroi (3) qui définit une surface de section transversale (Q) du réservoir (A) et un piston (K) se trouvant dans le réservoir (A), l'entraînement en rotation de l'unité tige (S) provoquant un mouvement de translation du piston (K), de telle sorte que le piston (K) peut être déplacé par rapport à la paroi (3) du réservoir (A) pour refouler le fluide médicamenteux. Selon l'invention, par le fait que le produit de la surface de section transversale (Q) du réservoir (A), en mm^2, et du pas (p) de la tige, en mm/degré d'angle, est inférieur à 0,13 mm^3/degré d'angle et que le fluide médicamenteux est de l'insuline liquide présentant une concentration dans la plage de U20 à U100, on obtient un système de dosage qui convient en particulier pour la thérapie par perfusion sous-cutanée continue d'insuline (CSII) pour les enfants et les adolescents, pour lesquels une précision de distribution exacte est importante pour un bon contrôle de la thérapie.
EP14806559.2A 2014-11-18 2014-11-18 Dispositif de dosage pour la distribution d'un fluide médicamenteux Withdrawn EP3220977A1 (fr)

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US11980739B2 (en) 2020-08-18 2024-05-14 Becton, Dickinson And Company Double-acting, telescoping screw-driven pump mechanism disposed externally to reservoir in fluid delivery device
DE102022116513B3 (de) 2022-07-01 2023-08-10 Lenus Infusionstechnik Gmbh & Co. Kg Dosiersystem

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DE19840992A1 (de) * 1998-09-08 2000-03-09 Disetronic Licensing Ag Drucküberwachung eines bei einer Infusion oder Injektion dosiert zu verabreichenden Produktfluids
DE19947826B4 (de) * 1999-10-05 2006-06-08 Disetronic Licensing Ag Vorrichtung zur dosierten Verabreichung eines injizierbaren Produkts
US6786890B2 (en) * 2002-01-25 2004-09-07 Novo Nordisk A/S Linear actuator and a medical delivery device comprising such linear actuator
EP1759727A1 (fr) * 2005-09-02 2007-03-07 F.Hoffmann-La Roche Ag Dispositif d'infusion avec unité de contrôle
WO2013004308A1 (fr) * 2011-07-06 2013-01-10 F. Hoffmann-La Roche Ag Dispositif pour injection automatique et détection d'occlusion
CH705428A2 (de) * 2012-12-18 2013-01-31 Tecpharma Licensing Ag Vorrichtung zur Verabreichung eines fluiden Produktes.

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