WO2002087665A1 - Pump for the time-controlled, metered administration of medicaments - Google Patents

Pump for the time-controlled, metered administration of medicaments Download PDF

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Publication number
WO2002087665A1
WO2002087665A1 PCT/EP2002/004662 EP0204662W WO02087665A1 WO 2002087665 A1 WO2002087665 A1 WO 2002087665A1 EP 0204662 W EP0204662 W EP 0204662W WO 02087665 A1 WO02087665 A1 WO 02087665A1
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WO
WIPO (PCT)
Prior art keywords
pump according
profile
pump
stamp
drugs
Prior art date
Application number
PCT/EP2002/004662
Other languages
German (de)
French (fr)
Inventor
Rüdiger GRÖNING
Original Assignee
Groening Ruediger
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Filing date
Publication date
Application filed by Groening Ruediger filed Critical Groening Ruediger
Publication of WO2002087665A1 publication Critical patent/WO2002087665A1/en

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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
    • 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
    • A61M5/16877—Adjusting flow; Devices for setting a flow rate
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • 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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • 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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • 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
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • 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
    • A61M2005/14533—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons cam actuated
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
    • 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
    • A61M2005/3143—Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms

Definitions

  • the present invention relates to a drug pump with programmable active ingredient release for long-term administration of drugs.
  • Drug pumps are preferably used to deliver drug solutions or drug emulsions parenterally (e.g. subcutaneously, intravenously, intraperitoneally) into humans or animals into the organism over several hours or days at a given uniform or variable delivery rate. Drug pumps are also suitable for oral, rectal and transdermal drug delivery.
  • Implantable infusion pumps (EP00513299B1) and externally portable pumps (EP00168472B1) are described for the parenteral administration of medicinal substances. Pumps can be combined with injection syringes, from which the drug is released by advancing the syringe plunger (EP00142736B). Controlling the release via a threaded rod is described in EP0916353.
  • the object of the present invention is to provide a medicament pump which is simple to use, insensitive to malfunction and inexpensive and which permits an individual dosage of the medicament.
  • This object is achieved by means of a pump for the time-controlled, meterable administration of medicinal substances with a medicinal substance reservoir to which pressure is exerted by means of a stamp, the pressure being exerted by scanning a profile or a plurality of profiles which are applied to plates, disks, cylinders and / or spirals is / are incorporated, regulated and transferred to the stamp via an adapter.
  • the drug reservoir is a column-like or syringe-like construction, for example a cylindrical ampoule or a plunger syringe.
  • a tensile or compressive stress preferably a spring or gas compressive stress, is advantageously applied to the stamp and / or adapter of the pump according to the invention.
  • This tensile or compressive stress serves as a preload or counter pressure to the force by scanning the profile on the adapter and then transferred to the stamp.
  • Adapters and stamps can be connected to one another via a fixed connection unit, for example a rod.
  • profiles are to be understood as so-called cams, gears, shafts, spirals, furrows or similar configurations which are incorporated, for example milled, embossed, punched or cut, onto cards, plates, disks, cylinders, spirals or other three-dimensional supports
  • the material from which the profiles are made is preferably light, but nevertheless so abrasion-resistant and durable that it can withstand being scanned over the long term.
  • the profile is scanned mechanically or electronically.
  • the speed at which the profile is scanned e.g. in which the scanner moves along the profile enables a continuous release of drugs over time. That the speed with which the scanner scans the profile (or several profiles) regulates the delivery of the drugs over time.
  • the amount of drug released is regulated by the amount of pressure exerted on the stamp over the drug reservoir by the adapter.
  • the profile moves or is moved along the scanner.
  • the speed at which the profile moves can regulate the release of the drugs over time.
  • the scanner can interact with the adapter via the profile or it can be connected directly to the adapter his.
  • the latter is the case, for example, when the profile moves along the scanner.
  • a continuous drug delivery over several hours, preferably at least 24 hours, particularly preferably at least 48 hours.
  • the speed of the scanning is regulated by a control unit.
  • the scanner of the pump according to the invention is driven mechanically, electrically, electronically or by a combination of these forces.
  • the scanner can advantageously be driven by a gear train, spring mechanism, spring motor, electric motor, a software-controlled drive unit or a combination thereof.
  • Such drive units are known and can advantageously be in a miniaturized configuration.
  • a simple example of a drive unit can be a clockwork.
  • the medicaments are administered parenterally from the medicament reservoir via a catheter or a cannula.
  • the pump according to the invention also has a device for advancing or resetting the stamp, which makes it possible to increase or reduce the dose delivered by the pump. It advantageously has a flow limiter which limits the maximum delivery rate of the pump. This device is used primarily for patient safety.
  • a particular advantage of the pump according to the invention is that the profile is interchangeable.
  • the exchange can be carried out quickly and easily, for example using plug-in, clamping or screwing devices that are easy for the patient to handle. This enables the patient to quickly and easily adjust the drug delivery according to his current needs or planned activities.
  • the time-controlled movement of the stamp can be achieved with the aid of several “profiles”.
  • the pump according to the invention is further characterized in that it is portable. In further embodiment variants, the pump according to the invention is characterized in that it is small and light.
  • the pump according to the invention thus has the advantage that it can be individually programmed and, at the same time, is very easy to use due to the use of the profiles according to the invention. Furthermore, due to the simple functional principle, it is very insensitive to faults.
  • the present invention also relates to the use of the pump according to the invention for oral, peroral, rectal or transdermal administration of medicinal substances. Also included is the use of the pump according to the invention for long-term administration of drugs.
  • the pump according to the invention can be used for the treatment of diabetes or for dialysis. For example, insulins and other peptides can be administered as drugs.
  • the invention of the figures is explained in more detail below, but these are not limiting for the present invention:
  • Fig. 1 shows a schematic representation of an embodiment of the pump according to the invention with a wavy profile.
  • Fig. 2 shows a schematic representation of an embodiment of the pump according to the invention in the form of a so-called "pen”.
  • FIG. 3 shows a schematic representation of an embodiment variant of the pump according to the invention with a spiral disk profile 9.
  • 4 a and b show an illustration of an insulin profile provided over 24 hours.
  • Fig. 4 c shows its transfer to a program card.
  • FIG 5 shows an illustration of two different profiles for controlling the drug release from the pumps according to the invention.
  • FIG. 6 shows an illustration of the result of an investigation of the release of insulin from an insulin pump according to the invention controlled by program cards.
  • the drug reservoir 2 is shown in the form of a plunger syringe with a stamp 12.
  • a compressive stress 3 is applied to the stamp, which is connected to an adapter via a rod.
  • the profile 1, which is scanned by a scanner 4, is attached to the adapter that moves in the direction of the arrow.
  • the speed at which the scanner 4 moves in the direction of the arrow is regulated by a drive unit, which is not shown.
  • the time course of the release of the drug (insulin solution) from the drug reservoir 2 (syringe 12) is milled as a wave profile 1 on a program card.
  • the scanner (4) is moved on a threaded rod evenly over 24 hours in the direction of the arrow.
  • This moves the adapter 10, which is under spring pressure (arrow direction 3) (with which the profile 1 is linked in the form of a program card), together with the rod 11, which establishes the connection to the stamp 7, which presses on the drug reservoir.
  • the adapter 10 which is under spring pressure (arrow direction 3) (with which the profile 1 is linked in the form of a program card), together with the rod 11, which establishes the connection to the stamp 7, which presses on the drug reservoir.
  • the results of release studies show that the drug dosage can be controlled variably over a period of 24 hours.
  • the pharmaceutical pump has the form of a so-called insulin pen.
  • the time course of the pumping rate of the drug pump is specified via a profile that is milled into the cylinder 5.
  • the motor 4 guides the scanner 4 uniformly with one revolution within 48 hours along the profile.
  • the piston advance and thus the release from the drug reservoir depends on the profile.
  • a pump with a spiral disk profile is moved by the movement of the profile disk along the scanner 4, a corresponding pressure on the adapter 8 under prestress and ultimately on the stamp above the drug reservoir 2.
  • the profile milled into the program card corresponds to the desired cumulative insulin delivery. If the scanner 4 moves smoothly in the direction of the arrow during the intended period of release, the syringe 12 is used to inject insulin via a catheter.
  • Figure 5 shows two different profiles for controlling drug release.
  • the extent of the release (5.6 mm or 12.9 mm total piston advance) and the course of the active ingredient delivery are predetermined by the different courses.

Abstract

The invention relates to a pump for the time-controlled, metered administration of medicaments, comprising a medicament reservoir, upon which pressure is exerted by means of a plunger. The pressure is regulated by scanning a profile or several profiles, which is/are incorporated into plates, discs, cylinders and/or spirals and said pressure is transmitted to the plunger by means of an adapter.

Description

Pumpe zur zeitlich gesteuerten, dosierbaren Verabreichung von Pump for the timed, metered administration of
ArzneistorfenArzneistorfen
Die vorliegende Erfindung betrifft eine Arzneimittelpumpe mit programmierbarer Wirkstofffreisetzung zur Langzeitverabreichung von Arzneistoffen.The present invention relates to a drug pump with programmable active ingredient release for long-term administration of drugs.
Arzneimittelpumpen werden vorzugsweise verwendet, um über mehrere Stunden oder Tage mit einer vorgegebenen gleichmäßigen oder variablen Abgaberate Arzneistofflösungen oder Arzneistoffemulsionen über Katheder und Kanülen parenteral (z. B. subcutan, intravenös, intraperitoneal) beim Menschen oder Tier in den Organismus einzubringen. Arzneimittelpumpen eignen sich auch für die orale, rektale und transdermale Arzneimttelverabreichung.Drug pumps are preferably used to deliver drug solutions or drug emulsions parenterally (e.g. subcutaneously, intravenously, intraperitoneally) into humans or animals into the organism over several hours or days at a given uniform or variable delivery rate. Drug pumps are also suitable for oral, rectal and transdermal drug delivery.
Zur parenteralen Applikation von Arzneistoffen werden implantierbare Infusionspumpen (EP00513299B1) und extern tragbare Pumpen (EP00168472B1) beschrieben. Pumpen können mit Injektionsspritzen kombiniert werden, aus denen das Arzneimittel durch Vorschub des Spritzenkolbens freigesetzt wird (EP00142736B). Eine Steuerung der Freisetzung über eine Gewindestange wird in EP0916353 beschrieben.Implantable infusion pumps (EP00513299B1) and externally portable pumps (EP00168472B1) are described for the parenteral administration of medicinal substances. Pumps can be combined with injection syringes, from which the drug is released by advancing the syringe plunger (EP00142736B). Controlling the release via a threaded rod is described in EP0916353.
Zur Abgabe des Arzneistoffs aus Pumpen werden unterschiedliche Prinzipien verwendet. In U.S. Pat. 4,386,929 und U.S. Pat. 4,265,241 werden unter Druck stehende ballonartige Arzneistoffreservoirs beschrieben, die sich langsam entleeren. Im Weiteren werden in U.S. Pat. 5,100,389 und U.S. Patent 4,744,786 federdruck- und gasdruckbetriebene Spritzenpumpen beschrieben. Bei Pumpen, die mit einer variablen Freisetzungsrate den Arzneistoff abgeben, dienen meist elektronische Steuerungen zur Regelung der Freisetzung. Elektronische Steuerungen sind für Patienten meist schwer zu bedienen. Fehler können dabei auftreten, die den Patienten in eine lebensbedrohliche Situation bringen können. Wird bei Spritzenpumpen der Kolbenvorschub durch Schrittmotoren bewirkt, können Uhgenauigkeiten in der Wirkstoffdosierung auftreten.Different principles are used to deliver the drug from pumps. US Pat. 4,386,929 and US Pat. 4,265,241 describe pressurized balloon-like drug reservoirs that slowly empty. Furthermore, spring pressure and gas pressure operated syringe pumps are described in US Pat. 5,100,389 and US Patent 4,744,786. Pumps that deliver the drug with a variable release rate are mostly electronic Controls for regulating the release. Electronic controls are mostly difficult to operate for patients. Errors can occur that can put the patient in a life-threatening situation. If the piston feed in syringe pumps is effected by stepper motors, accuracy in the dosage of the active ingredient can occur.
Aufgabe der vorliegenden Erfindung ist es, eine Arzneimittelpumpe zur Verfügung zu stellen, die einfach zu bedienen, störunanfällig und kostengünstig ist und eine individuelle Dosierung des Arzneimittels erlaubt.The object of the present invention is to provide a medicament pump which is simple to use, insensitive to malfunction and inexpensive and which permits an individual dosage of the medicament.
Diese Aufgabe wird gelöst, durch eine Pumpe zur zeitlich gesteuerten, dosierbaren Verabreichung von Arzneistoffen mit einem Arzneistoffreservoir auf das über einen Stempel Druck ausgeübt wird, wobei der Druck durch Abtasten eines Profils oder mehrerer Profile, das/die auf Platten, Scheiben, Zylinder und/oder Spiralen eingearbeitet ist/sind, geregelt und über einen Adapter auf den Stempel übertragen wird.This object is achieved by means of a pump for the time-controlled, meterable administration of medicinal substances with a medicinal substance reservoir to which pressure is exerted by means of a stamp, the pressure being exerted by scanning a profile or a plurality of profiles which are applied to plates, disks, cylinders and / or spirals is / are incorporated, regulated and transferred to the stamp via an adapter.
In einer vorteilhaften Ausgestaltung der erfindungsgemäßen Pumpe handelt es sich bei dem Arzneistoffreservoir um eine Säulen- oder Spritzen-ähnliche Konstruktion, beispielsweise eine Zylinderampulle oder eine Kolbenspritze.In an advantageous embodiment of the pump according to the invention, the drug reservoir is a column-like or syringe-like construction, for example a cylindrical ampoule or a plunger syringe.
Vorteilhafter Weise ist auf den Stempel und/oder Adapter der erfindungsgemäßen Pumpe eine Zug- oder Druckspannung, bevorzugt eine Feder- oder Gasdruckspannung, auferlegt. Diese Zug- oder Druckspannung dient als Vorspannung oder Gegendruck zu der Kraft, die durch das Abtasten des Profils auf den Adapter und weiter auf den Stempel übertragen wird. Adapter und Stempel können über eine feste Verbindungseinheit, z.B. eine Stange miteinander verbunden sein.A tensile or compressive stress, preferably a spring or gas compressive stress, is advantageously applied to the stamp and / or adapter of the pump according to the invention. This tensile or compressive stress serves as a preload or counter pressure to the force by scanning the profile on the adapter and then transferred to the stamp. Adapters and stamps can be connected to one another via a fixed connection unit, for example a rod.
Unter den erfindungsgemäßen „Profilen" sind sogenannte Nocken, Zahnräder, Wellen, Spiralen, Furchen oder ähnliche Ausgestaltungen zu verstehen, die auf Karten, Platten, Scheiben, Zylinder, Spiralen oder anders ausgestalteten, dreidimensionalen Trägern eingearbeitet, beispielsweise gefräst, geprägt, gestanzt oder geschnitten sind. Das Material aus dem die Profile hergestellt werden, ist vorzugsweise leicht, aber dennoch so abriebfest und langlebig, daß es der Abtastung auf Dauer standhält.The “profiles” according to the invention are to be understood as so-called cams, gears, shafts, spirals, furrows or similar configurations which are incorporated, for example milled, embossed, punched or cut, onto cards, plates, disks, cylinders, spirals or other three-dimensional supports The material from which the profiles are made is preferably light, but nevertheless so abrasion-resistant and durable that it can withstand being scanned over the long term.
Bei der erfindungsgemäßen Pumpe wird das Profil mechanisch oder elektronisch abgetastet. Die Geschwindigkeit, mit der das Profil abgetastet wird, z.B. in dem sich der Abtaster an dem Profil entlang bewegt, ermöglicht eine kontinuierliche Freisetzung von Arzneistoffen über die Zeit. D.h. die Geschwindigkeit, mit der der Abtaster das Profil (oder mehrere Profile) abtastet regelt die Abgabe der Arzneistoffe über der Zeit. Die Menge des freigesetzten Arzneimittels wird dabei durch die Höhe des Drucks geregelt, der über den Adapter auf den Stempel über dem Arzneimittelreservoir ausgeübt wird.In the pump according to the invention, the profile is scanned mechanically or electronically. The speed at which the profile is scanned, e.g. in which the scanner moves along the profile enables a continuous release of drugs over time. That the speed with which the scanner scans the profile (or several profiles) regulates the delivery of the drugs over time. The amount of drug released is regulated by the amount of pressure exerted on the stamp over the drug reservoir by the adapter.
In einer Variante der erfindungsgemäßen Pumpe ist es auch denkbar, daß sich das Profil entlang des Abtasters bewegt oder bewegt wird. In diesem Fall kann die Geschwindigkeit mit der sich das Profil bewegt die Freigabe der Arzneistoffe über der Zeit regeln.In a variant of the pump according to the invention, it is also conceivable that the profile moves or is moved along the scanner. In this case, the speed at which the profile moves can regulate the release of the drugs over time.
Erfindungsgemäß kann der Abtaster über das Profil mit dem Adapter in Wechselwirkung stehen oder er kann direkt mit dem Adapter verbunden sein. Letzeres ist zum Beispiel der Fall, wenn sich das Profil entlang des Abtasters bewegt.According to the invention, the scanner can interact with the adapter via the profile or it can be connected directly to the adapter his. The latter is the case, for example, when the profile moves along the scanner.
Vorteilhafter Weise erfolgt eine kontinuierliche Arzneistoffabgabe über mehrere Stunden, bevorzugt wenigstens 24 Stunden, besonders bevorzugt wenigstens 48 Stunden. Die Geschwindigkeit des Abtastens wird dabei über eine Steuereinheit geregelt.Advantageously, there is a continuous drug delivery over several hours, preferably at least 24 hours, particularly preferably at least 48 hours. The speed of the scanning is regulated by a control unit.
Der Abtaster der erfindungsgemäßen Pumpe wird mechanisch, elektrisch, elektronisch oder durch eine Kombination dieser Kräfte angetrieben. Vorteilhaft kann der Abtaster durch ein Zahnradwerk, Federwerk, Federmotor, Elektromotor, eine Software gesteuerte Antriebseinheit oder eine Kombination davon angetrieben werden. Solche Antriebseinheiten sind bekannt und können vorteilhafter Weise in miniaturisierter Ausgestaltung vorliegen. Ein einfaches Beispiel für eine Antriebseinheit kann ein Uhrwerk sein.The scanner of the pump according to the invention is driven mechanically, electrically, electronically or by a combination of these forces. The scanner can advantageously be driven by a gear train, spring mechanism, spring motor, electric motor, a software-controlled drive unit or a combination thereof. Such drive units are known and can advantageously be in a miniaturized configuration. A simple example of a drive unit can be a clockwork.
In Abhängigkeit von dem eingesetzten Profil, über das beim Abtasten mehr oder weniger Kraft (Druck) auf den Adapter und den Stempel ausgeübt wird, erfolgt die Freigabe einer entsprechenden Menge an Arzneistoff.Depending on the profile used, through which more or less force (pressure) is exerted on the adapter and the stamp during the scanning, the release of a corresponding amount of medicinal substance takes place.
In einer Ausgestaltungsvariante, in der auf den Adapter und Stempel eine Zug- oder Druckspannung auferlegt ist, heißt das: je höher der Druck ist, der über das Profil auf den Adapter ausgeübt wird, umso mehr wird der Vorspannung, die auf dem Adapter und Stempel aufgelegt ist entgegengewirkt und umso weniger Druck wird letztendlich auf den Stempel ausgeübt. Dies hat zur Folge, daß weniger Arzneistoff freigesetzt wird. In einer anderen Ausgestaltungsvariante kann beispielsweise durch das Abtasten eines spiralförmigen Profils, vergleichbar einer Schraubwirkung, der Druck auf den Adapter und Stempel erhöht werden, was zur Folge hat, daß mehr Arzneistoff aus dem Reservoir freigesetzt wird. Als Beispiel für eine solche Ausgestaltungsvariante ist eine Kugelschreiber-ähnliche Pumpe, wie z.B. ein sogenannter „InsulinPen" denkbar. Erfindungsgemäß handelt es sich bei dieser Art „Pen" um eine Injektionsspritze mit zeitlich steuerbarer Dosierung des Wirkstoffs. Eine individuelle Handbetätigung zur Dosierung von Insulin ist über den Mechanismus Pen weiterhin möglich.In a design variant in which tensile or compressive stress is imposed on the adapter and stamp, this means: the higher the pressure that is exerted on the adapter via the profile, the more the preload that is applied to the adapter and stamp is counteracted and the less pressure is ultimately exerted on the stamp. As a result, less drug is released. In another embodiment variant, for example, by scanning a spiral profile, comparable to a screw action, the pressure on the adapter and stamp can be increased, with the result that more drug is released from the reservoir. A pump similar to a ballpoint pen, such as a so-called "InsulinPen", is conceivable as an example of such an embodiment variant. An individual manual operation for dosing insulin is still possible using the Pen mechanism.
In einer vorteilhaften Ausgestaltung der erfindungsgemäßen Pumpe erfolgt die Verabreichung der Arzneistoffe aus dem Arzneistoffreservoir über ein Katheder oder eine Kanüle parenteral.In an advantageous embodiment of the pump according to the invention, the medicaments are administered parenterally from the medicament reservoir via a catheter or a cannula.
Die erfindungsgemäße Pumpe weist ferner eine Vorrichtung zum Voroder Rückstellen des Stempels auf, wodurch eine Erhöhung oder Reduktion der durch die Pumpe abgegebenen Dosis möglich ist. Vorteilhafter Weise verfügt sie über einen Durchflußbegrenzer, der die maximale Abgaberate der Pumpe begrenzt. Diese Vorrichtung dient vor allem der Sicherheit des Patienten.The pump according to the invention also has a device for advancing or resetting the stamp, which makes it possible to increase or reduce the dose delivered by the pump. It advantageously has a flow limiter which limits the maximum delivery rate of the pump. This device is used primarily for patient safety.
Ein besonderer Vorteil der erfindungsgemäßen Pumpe ist, daß das Profil austauschbar ist. Der Austausch kann unkompliziert und schnell, z.B. über Steck-, Klemm- oder Schraubvorrichtungen erfolgen, die für den Patienten einfach zu handhaben sind. Dies ermöglicht dem Patienten eine schnelle, umkomplizierte Anpassung der Arzneistoffabgabe je nach seinen aktuellen Bedürfnissen oder geplanten Aktivitäten. In einer Variante der erfindungsgemäßen Pumpe kann die zeitlich gesteuerte Bewegung des Stempels mit Hilfe von mehreren „Profilen" erreicht werden.A particular advantage of the pump according to the invention is that the profile is interchangeable. The exchange can be carried out quickly and easily, for example using plug-in, clamping or screwing devices that are easy for the patient to handle. This enables the patient to quickly and easily adjust the drug delivery according to his current needs or planned activities. In a variant of the pump according to the invention, the time-controlled movement of the stamp can be achieved with the aid of several “profiles”.
Ein weiterer Vorteil der erfindungsgemäßen Pumpe ist, daß diese Profile einfach, schnelle und preiswert, aber dennoch präzise hergestellt werden können. Sie werden auf die individuellen Ansprüche des Patienten, hinsichtlich der erforderlichen Menge Arzneistoff, die der Patient über den gesamten Tag oder noch längere Zeit zu sich nehmen muß, zugeschneidert.Another advantage of the pump according to the invention is that these profiles can be manufactured simply, quickly and inexpensively, but nevertheless precisely. They are tailored to the patient's individual requirements with regard to the required amount of drug that the patient must consume throughout the day or for a longer period.
Die erfindungsgemäße Pumpe zeichnet sich ferner dadurch aus, daß sie transportabel ist. In weiteren Ausführungsvarianten zeichnet sich die erfindungsgemäße Pumpe dadurch aus, daß sie klein und leicht ist.The pump according to the invention is further characterized in that it is portable. In further embodiment variants, the pump according to the invention is characterized in that it is small and light.
Die erfindungsgemäße Pumpe weist somit den Vorteil auf, daß sie individuell programmierbar ist, und gleichzeitig aufgrund des Einsatzes der erfindungsgemäßen Profile sehr einfach zu bedienen ist. Weiterhin arbeitet sie aufgrund des einfachen Funktionsprinzips sehr störunanfällig.The pump according to the invention thus has the advantage that it can be individually programmed and, at the same time, is very easy to use due to the use of the profiles according to the invention. Furthermore, due to the simple functional principle, it is very insensitive to faults.
Gegenstand der vorliegenden Erfindung ist auch die Verwendung der erfindungsgemäßen Pumpe zur oralen, peroralen, rektalen oder transdermalen Verabreichung von Arzneistoffen. Umfaßt ist ferner auch die Verwendung der erfindungsgemäßen Pumpe zur Lanzeitverabreichung von Arzneistoffen. Hierbei kann die erfindungsgemäße Pumpe zur Behandlung von Diabetes oder zur Dialyse Verwendung finden. Als Arzneistoffe können beispielsweise Insuline und andere Peptide verabreicht werden. Nachfolgend wird die Erfindung der Figuren näher erläutert, die jedoch nicht limitierend für die vorliegenden Erfindung sind:The present invention also relates to the use of the pump according to the invention for oral, peroral, rectal or transdermal administration of medicinal substances. Also included is the use of the pump according to the invention for long-term administration of drugs. The pump according to the invention can be used for the treatment of diabetes or for dialysis. For example, insulins and other peptides can be administered as drugs. The invention of the figures is explained in more detail below, but these are not limiting for the present invention:
Fig. 1 zeigt eine Schematische Darstellung einer Ausführungsvariante der erfindungsgemäßen Pumpe mit einem wellenförmigen Profil.Fig. 1 shows a schematic representation of an embodiment of the pump according to the invention with a wavy profile.
Fig. 2 zeigt eine Schematische Darstellung einer Ausführungsvariante der erfindungsgemäßen Pumpe in Form eines sogenannten „Pens".Fig. 2 shows a schematic representation of an embodiment of the pump according to the invention in the form of a so-called "pen".
Fig. 3 zeigt eine Schematische Darstellung einer Ausführungsvariante der erfindungsgemäßen Pumpe mit einem spiralförmigen Scheibenprofil 9.3 shows a schematic representation of an embodiment variant of the pump according to the invention with a spiral disk profile 9.
Fig. 4 a und b zeigen eine Darstellung eines über 24 Stunden vorgesehenen Insulinprofils.4 a and b show an illustration of an insulin profile provided over 24 hours.
Fig. 4 c zeigt dessen Übertragung auf eine Programmkarte.Fig. 4 c shows its transfer to a program card.
Fig. 5 zeigt eine Darstellung von zwei unterschiedlichen Profilen zur Steuerung der Arzneistofffreigabe aus den erfindungsgemäßen Pumpen.5 shows an illustration of two different profiles for controlling the drug release from the pumps according to the invention.
Fig. 6 zeigt eine Darstellung des Ergebnisses einer Freisetzungsuntersuchung von Insulin aus einer erfindungsgemäßen, mit Programmkarten gesteuerten Insulinpumpe.FIG. 6 shows an illustration of the result of an investigation of the release of insulin from an insulin pump according to the invention controlled by program cards.
Die Darstellung gemäß Fig. 1 betrifft eine Pumpe mit einer wellenförmigen Profil. Das Arzneistoffreservoir 2 ist in Form einer Kolbenspritze mit Stempel 12 dargestellt. Auf den Stempel, der über eine Stange mit einem Adapter verbunden ist, ist eine Druckspannung 3 angelegt. An dem Adapter ist das Profil 1 angebracht, das durch einen Abtaster 4 abgetastet wird, der sich in Pfeilrichtung bewegt. Die Geschwindigkeit mit der sich der Abtaster 4 in Pfeilrichtung bewegt, wird über ein Antriebseinheit geregelt, die nicht dargestellt ist.1 relates to a pump with an undulating profile. The drug reservoir 2 is shown in the form of a plunger syringe with a stamp 12. A compressive stress 3 is applied to the stamp, which is connected to an adapter via a rod. The profile 1, which is scanned by a scanner 4, is attached to the adapter that moves in the direction of the arrow. The speed at which the scanner 4 moves in the direction of the arrow is regulated by a drive unit, which is not shown.
Der zeitliche Verlauf der Freisetzung des Arzneimittels (Insulin-Lösung) aus dem Arzneistoffreservoir 2 (Spritze 12) ist als Wellenprofil 1 auf einer Programmkarte eingefräst. Der Abtaster (4) wird auf einer Gewindestange gleichmäßig über 24 Stunden in Pfeilrichtung bewegt. Dadurch wird der unter Federdruck (Pfeilrichtung 3) stehende Adapter 10 (mit dem das Profil 1 in Form einer Programmkarte) verknüpft ist) zusammen mit der Stange 11 , welche die Verbindung zu dem Stempel 7 herstellt, der auf das Arzneistoffreservoir drückt, bewegt. Und zwar jeweils nur in dem Ausmaß, wie durch das auf der Programmkarte eingefräste Profil 1 möglich ist. Die Ergebnisse von Freigabeuntersuchungen zeigen, daß die Arzneistoffdosierung variabel über einen Zeitraum von 24 Stunden gesteuert werden kann.The time course of the release of the drug (insulin solution) from the drug reservoir 2 (syringe 12) is milled as a wave profile 1 on a program card. The scanner (4) is moved on a threaded rod evenly over 24 hours in the direction of the arrow. This moves the adapter 10, which is under spring pressure (arrow direction 3) (with which the profile 1 is linked in the form of a program card), together with the rod 11, which establishes the connection to the stamp 7, which presses on the drug reservoir. And only to the extent that is possible through the profile 1 milled on the program card. The results of release studies show that the drug dosage can be controlled variably over a period of 24 hours.
In der Variante gemäß Fig. 2 besitzt die Arzneimittelpumpe die Form eines sogenannten Insulin-Pens. Der zeitliche Verlauf der Pumprate der Arzneimittelpumpe ist über ein Profil vorgegeben, das in den Zylinder 5 eingefräst ist. Durch den Motor 6 wird der Abtaster 4 gleichmäßig mit einer Umdrehung innerhalb von 48 Stunden entlang des Profils geführt. Der Kolbenvorschub und damit die Freisetzung aus dem Arzneistoffreservoirs ist abhängig von dem Verlauf des Profils.In the variant according to FIG. 2, the pharmaceutical pump has the form of a so-called insulin pen. The time course of the pumping rate of the drug pump is specified via a profile that is milled into the cylinder 5. The motor 4 guides the scanner 4 uniformly with one revolution within 48 hours along the profile. The piston advance and thus the release from the drug reservoir depends on the profile.
In der Variante gemäß Fig. 3 eine Pumpe mit spiralförmigen Scheibenprofil wird durch die Bewegung der Profilscheibe entlang des Abtasters 4 wird ein entsprechender Druck auf den unter Vorspannung 8 stehenden Adapter und letztendlich auf den Stempel über dem Arzneistoffreservoir 2 übertragen. Bei der Darstellung gemäß Fig. 4 a, b, c entspricht das in die Programmkarte eingefräste Profil der gewünschten kumulativen Insulinabgabe. Bei einer gleichmäßigen Bewegung des Abtasters 4 in Pfeilrichtung während der vorgesehene Zeitdauer der Freisetzung wird aus der Spritze 12 über ein Katheder die Insulin-Injektion vorgenommen.In the variant according to FIG. 3, a pump with a spiral disk profile is moved by the movement of the profile disk along the scanner 4, a corresponding pressure on the adapter 8 under prestress and ultimately on the stamp above the drug reservoir 2. 4 a, b, c, the profile milled into the program card corresponds to the desired cumulative insulin delivery. If the scanner 4 moves smoothly in the direction of the arrow during the intended period of release, the syringe 12 is used to inject insulin via a catheter.
Fig. 5 zeigt zwei unterschiedliche Profile zur Steuerung der Arzneistofffreigabe. Durch die unterschiedlichen Verläufe wird das Ausmaß der Freisetzung (5,6 mm bzw. 12,9 mm Gesamtkolbenvorschub) und der Verlauf der Wirkstoffabgabe vorgegeben.Figure 5 shows two different profiles for controlling drug release. The extent of the release (5.6 mm or 12.9 mm total piston advance) and the course of the active ingredient delivery are predetermined by the different courses.
Das vorgegebene Profil gemäß Fig. 6 (geschlossenen Kreise) entspricht dem in Abb. 4 dargestellten Profil. Das Ergebnis der Anwendungsuntersuchung (offene Kreise) zeigt, daß die vorgesehene Freisetzung mit hoher Genauigkeit durch die Pumpe eingehalten werden kann. 6 (closed circles) corresponds to the profile shown in FIG. 4. The result of the application study (open circles) shows that the intended release can be maintained with high accuracy by the pump.

Claims

Ansprüche Expectations
1. Pumpe zur zeitlich gesteuerten, dosierbaren Verabreichung von Arzneistoffen mit einem Arzneistoffreservoir (2) auf das über einen Stempel (7) Druck ausgeübt wird, wobei der Druck durch Abtasten eines Profils (1) oder mehrerer Profile mittels eines Abtasters (4), das/die auf Platten, Scheiben, Zylinder und/oder Spiralen eingearbeitet ist/sind, geregelt oder gesteuert und über einen Adapter (10) auf den Stempel (7) übertragen wird.1. Pump for the timed, metered administration of drugs with a drug reservoir (2) on which pressure is exerted by means of a stamp (7), the pressure being obtained by scanning a profile (1) or several profiles by means of a scanner (4), the / which is / are incorporated on plates, disks, cylinders and / or spirals, regulated or controlled and transferred to the stamp (7) via an adapter (10).
2. Pumpe gemäß Anspruch 1 , dadurch gekennzeichnet, daß auf den Stempel (7) und/oder Adapter (10) eine Zug- oder Druckspannung, bevorzugt eine Feder- oder Gasdruckspannung, auferlegt ist.2. Pump according to claim 1, characterized in that on the stamp (7) and / or adapter (10) a tensile or compressive stress, preferably a spring or gas compressive stress, is imposed.
3. Pumpe gemäß einem der Ansprüche 1 oder 2, dadurch gekennzeichnet, daß das/die Profil/e (l)austauschbar ist/sind.3. Pump according to one of claims 1 or 2, characterized in that the profile (s) (l) is / are interchangeable.
4. Pumpe gemäß einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß das Profil (1) in Form von Nocken, Zahnrädern, Wellen, Spiralen, Furchen oder Kombinationen davon ausgebildet ist.4. Pump according to one of claims 1 to 3, characterized in that the profile (1) is designed in the form of cams, gears, shafts, spirals, furrows or combinations thereof.
5. Pumpe gemäß einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß das Profil (1) mechanisch oder elektronisch abgetastet wird.5. Pump according to one of claims 1 to 4, characterized in that the profile (1) is scanned mechanically or electronically.
6. Pumpe gemäß einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß der Abtaster (4) mechanisch, elektrisch, elektronisch oder durch eine Kombination davon angetrieben wird.6. Pump according to one of claims 1 to 5, characterized in that the scanner (4) is driven mechanically, electrically, electronically or by a combination thereof.
7. Pumpe gemäß einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß der Abtaster (4) durch ein Zahnradwerk, Federwerk, Federmotor, Elektromotor, eine Software gesteuerte Antriebseinheit (6) oder eine Kombination davon angetrieben wird.7. Pump according to one of claims 1 to 6, characterized in that the scanner (4) by a gear train, spring mechanism, spring motor, Electric motor, a software-controlled drive unit (6) or a combination thereof is driven.
8. Pumpe gemäß einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß die Arzneistoffabgabe über einen Zeitbereich von mehreren8. Pump according to one of claims 1 to 7, characterized in that the drug delivery over a time range of several
Stunden, bevorzugt wenigstens 24 Stunden erfolgt.Hours, preferably at least 24 hours.
9. Pumpe gemäß einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß sie transportabel ist.9. Pump according to one of claims 1 to 8, characterized in that it is portable.
10. Pumpe gemäß einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß die Verabreichung der Arzneistoffe aus dem Arzneistoffreservoir über ein Katheder oder eine Kanüle (13) parenteral erfolgt.10. Pump according to one of claims 1 to 9, characterized in that the administration of the drugs from the drug reservoir via a catheter or a cannula (13) takes place parenterally.
11. Pumpe gemäß einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß sie eine Vorrichtung zum Vor- oder Rückstellen des Stempels (7) aufweist.11. Pump according to one of claims 1 to 10, characterized in that it has a device for advancing or resetting the stamp (7).
12. Pumpe gemäß einem der Ansprüche 1 bis 11 , dadurch gekennzeichnet, daß sie einen Durchflußbegrenzer aufweist, der die maximale Abgaberate der Pumpe begrenzt.12. Pump according to one of claims 1 to 11, characterized in that it has a flow limiter which limits the maximum delivery rate of the pump.
13. Verwendung der Pumpe gemäß einem der Ansprüche 1 bis 12 zur oralen, peroralen, rektalen oder transdermalen Verabreichung von Arzneistoffen.13. Use of the pump according to one of claims 1 to 12 for oral, peroral, rectal or transdermal administration of drugs.
14. Verwendung der Pumpe gemäß einem der Ansprüche 1 bis 12 zur Lanzeitverabreichung von Arzneistoffen. 14. Use of the pump according to one of claims 1 to 12 for long-term administration of drugs.
5. Verwendung der Pumpe gemäß einem der Ansprüche 1 bis 12 zur Behandlung von Diabetes oder zur Dialyse. 5. Use of the pump according to one of claims 1 to 12 for the treatment of diabetes or for dialysis.
PCT/EP2002/004662 2001-04-26 2002-04-26 Pump for the time-controlled, metered administration of medicaments WO2002087665A1 (en)

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