Administering device for transdermal administration of liquid medicinal preparations, particularly insulin
Technical field of the invention
The invention relates to an administering device for transdermal administration of liquid medicinal preparations, particularly insulin, comprising a cylinder adapted for receiving a vial and feeding means adapted for moving the plunger of the vial.
The invention relates first and foremost to an administering device capable of administering the daily doses of insulin to diabetes patients.
Background art
The prior art contains several devices and systems for administering insulin.
A number of insulin administering systems are known from prior art. European patent application EP 0239244 A1 for instance relates to a subcutaneous injection set comprising a valve/connector at the outside surface of the portion adapted to be taped to the skin surface, while the skin- adjacent side comprises a flexible cannula adapted to be inserted into the skin applying suitable means, such as a needle. After the device is installed, the medicament solution is delivered from an external device (syringe, infusion pump, etc.) for prolonged or intermittent subcutaneous administering, without there being a need for inserting the needle again.
A transcutaneous infusion device is disclosed in international patent specification WO 03026728 A1 , which consists of a microinjector placed on the skin having a cannula that may be inserted in a manner similar to what was described above, and replaceable feeder means connectible to the injector for administering medication, the feeder means being actuated by external force, such as by a spring force. Hungarian patent specification HU 222342 B1 relates to a transcorneal medicament delivery system consisting of a medicament container and micro-pins or micro-blades projecting from the side of the container facing the skin and having a length corresponding to the thickness of the corneal layer of the skin. The device is complemented by an electronically controlled pump.
Patent specification US 3,964,482 discloses a drug delivery device for percutaneously administering a drug, consisting of a drug reservoir adapted to be taped to the skin, and a plurality of tube-like micro-pins arranged on the side of the reservoir facing the skin, the drug being delivered applying diffusion or osmotic pressure.
The publication document WO 2009015389 A2 discloses a miniaturised patch pump for subcutaneous administration, operated by an electrochemical cell.
However, of the above cited solutions none is based on forces arising from magnetic interaction as does the solution according to the present invention, applying which the required dose of insulin may easily be delivered from a prefabricated vial and may be administered under the skin.
Disclosure of invention
The objective of the invention is to provide a device for administering insulin that is more advantageous than existing solutions with respect to the physiological strain put on the patients, and also has lower costs.
Similarly to known insulin pumps, the device according to the invention does not require administering multiple injections a day, while at the same time it has significantly lower cost compared to pumps. Currently existing insulin pumps are extremely costly, which makes them hardly accessible or inaccessible for the majority of patients. In addition to their high cost, insulin pumps also have the disadvantage that they have to be replaced every 4 years. The administering device according to the invention is capable of transdermal administration of liquid medicinal preparations, particularly insulin, and comprises a cylinder adapted for receiving a vial and feeding means adapted for moving the plunger of the vial, and is characterised by having a cylinder disposed above the cylinder adapted for receiving the vial, the cylinder being arranged parallel and integrally with the bottom cylinder, first ends of the cylinders are terminated by respective shroud discs, the means adapted for feeding the solution held in the vial and for moving the plunger thereof consisting of interconnected magnets arranged in front of the shroud discs, as well as of a gear and a deflection disc arranged in a coaxial fashion in the open end of the upper cylinder and adapted for winding a pulling cord attached to the magnet on the shaft between the gear and the deflection disc.
In a preferred embodiment of the administering device according to the invention the free end of the upper cylinder - located opposite the end terminated by the shroud disc - is terminated by an easily removable shroud disc comprising lateral clamps and a gear retaining plate, and comprises a cover adapted to cover the gears and the deflection disc from above.
In another preferred embodiment of the administering device according to the invention a reading glass adapted for providing a magnified view of the scale of the inserted vial is disposed on the side surface of the bottom cylinder, the bottom portion having a retaining clamp, where the device further comprises a piece of adhesive tape attached to the retaining clamp of the bottom cylinder.
A further preferred embodiment of the administering device according to the invention comprises additional means for securing the device to the user's body, as well as for feeding the medicament, the additional means consisting of two components: a cannula cover comprising a piece of adhesive tape, and a cover adapted for receiving a feeder needle connected to the closure cap of the vial of the administering device, the cover receiving the feeder needle further comprising lateral clamps attached to the cannula cover.
All preferred embodiments of the administering device according to the invention are made from transparent plastic.
Brief description of drawings
An exemplary embodiment of the administering device according to the invention are explained in detail referring to the attached drawings, where
Fig. 1 shows a side elevation view of the administering device according to the invention,
Fig. 1a shows the arrangement of the gear and the deflection disc of the administering device according to Fig. 1 ,
Fig. 2 is the rear view of the administering device of Fig. 1 ,
Fig. 3 illustrates the administering device according to the invention with a vial inserted and ready for administering medicament,
Fig. 4 shows an additional component for the application of the administering device according to the invention, and
Fig. 5 illustrates the application of the administering device according to the invention.
Best mode of carrying out the invention
The administering device illustrated in Fig. 1 consists of two parallelly arranged plastic cylinders 9a, 9b that have one of their ends covered by a respective perforated shroud disc 6a, 6b. A respective magnet 5a, 5b is disposed in the cylinders 9a, 9b in front of the shroud discs 6a, 6b. The bottom cylinder 9b is adapted to receive the vial 13 containing the medicament to be administered (insulin), with a reading glass 8 aiding the accurate dosing of the medicament being disposed on the side surface of the cylinder 9b, and a retaining clamp 7 adapted for facilitating the attachment of the administering device according to the invention being located at the bottom portion thereof. A coaxially arranged gear 1 and deflection disc 2 are disposed at the open end of the upper cylinder 9a opposite the end where the shroud disc 6a is arranged, the adjacent side surfaces of the upper and bottom cylinders 9a, 9b being in contact with each other. A pulling cord 4 is attached to the magnet 5a disposed in the upper cylinder 9a. The pulling cord 4 is also attached to a deflection disc 2 driven by the gear 1 , and is adapted for feeding medicament from the vial 13 in a manner described later. The pulling cord 4 is preferably implemented as a silk cord. The gear 1 is covered from above by a protective cover 3 tab. The free end - located opposite the end terminated by the shroud disc 6a - of the upper cylinder 9a adapted for receiving the gear 1 is terminated by an easily removable shroud disc 10 having lateral clamps 31 and a gear retaining plate 11.
Fig. 2 shows a rear view of the administering device according to the invention, wherein the configuration of the two cylinders 9a, 9b and the magnets 5a, 5b is clearly visible.
A band of adhesive tape 12, adapted for attaching the administering device to the user's body in a manner described later on, is attached to the retaining clamp 7 of the bottom cylinder 9b.
Fig. 3 illustrates the administering device according to the invention with the vial 13 inserted in the bottom cylinder 9b. The vial 13 is an insulin vial known per se, the plunger 16 of the vial 13 being seated against the magnet 5b disposed in the cylinder 9b. The side surface of the vial 13 comprises a scale 15 for dosage measurement. The scale 15 is disposed under the reading glass 8 of the cylinder 9b to provide for even more accurate dosage measurement. The scale units may be milliliters (ml) or international units (IU).
The free end of the vial 13, extending beyond the open end of the cylinder 9b is fitted with a closure cap 14. Fig. 3 illustrates the operating "ready" state of the administering device according to the invention, wherein the device is ready for administering medicament.
Fig. 4 illustrates additional means required for the application of the administering device according to the invention, consisting of two components: a cannula structure 17 comprising a piece of adhesive tape 27 attached to the user's body, and a cover 22 adapted for receiving a feeder needle 21. The cover 22 adapted for receiving the feeder needle 21 is a fork- shaped component having lateral clamps 24 disposed on the prongs for connection to the cannula cover 17. The cover 22 is connected to a retaining element 23 receiving the closure cap 14 of the vial 13.
The arrangement of the additional means and the application of the administering device according to the invention is described in relation to Fig. 5. After the adhesive tape 27 has been placed on the skin, the structural components are inserted into one another in the direction of the arrows 30.
First, the adhesive tape 27 is placed on the skin in an appropriate location, while at the same time the cannula is also inserted in the skin utilising the insertion needle.
Subsequently, the remaining component of the additional means, i.e. the cover 22 receiving the feeder needle 21 , is inserted in the cannula cover 17, the feeder needle 21 being inserted such that it stops at a distance of 1 mm from the inlet opening 19 of the cannula 18 disposed in the cannula cover 17.
The closure cap 14 of the vial 13 inserted into the administering device is then punctured with the tip of the feeder needle 21 disposed in the cover 22, and at the same time the closure cap 14 of the vial 13 is secured in the retaining element 23. Next, the feeder needle 21 is secured to the inlet opening 19 of the cannula cover 17 using the lateral clamps 24 of the cover 22. Finally, the adhesive tape 12 of the retaining clamp 7 attached to the bottom cylinder 9b of the device according to the invention is also placed on and secured to the user's skin.
After that, the magnet 5b, disposed in the bottom cylinder 9b and connected by magnetic force to the magnet 5a, may be moved towards the gear 1 by carefully and gradually turning the gear 1 located in the open end of the upper cylinder 9a and thus winding the pulling cord 4 attached to the magnet 5a on the shaft 28. At the same time, the magnet 5b pushes forward the plunger 16 of the vial 13 and thereby administers under the user's skin the insulin contained therein through the feeder needle 21 and the cannula 18.
The administered amount of insulin may be checked utilising the scale
15 disposed on the vial 13. The view of the scale 15 is magnified by a reading glass 8 disposed on the cylinder 9b such that the dosage may be read more accurately from the scale. As soon as the plunger 16 reaches the desired position relative to the scale 15, the magnets 5a, 5b may be made fully aligned in an instant by detaching the gear 1 by slightly lifting the shroud disc 10 together with the retaining plate 11 and thereby eliminating the magnetic push effect. Thereby, the administering process is terminated. For accurate dosage the above steps have to be carried out during each administering operation.
It has to be noted here that in case a magnet is built in the plunger 16 of the vial 13, it is not necessary to install the magnet 5b in the bottom cylinder 9b of the device. In this case a higher-capacity insulin vial 13 may be applied. The administering process is the same as described above, with the difference that the magnet 5a in the upper cylinder 9a is brought into operating connection with the magnet disposed in the plunger 16 of the vial 13, and thus the medicament is administered by moving the plunger 16.
After the administering process has been completed, the administering device is placed in a position parallel with the user's body surface, thereby improving comfort of use.
In case the vial 13 becomes spent and has to be replaced, or the entire device has to be removed for some other reason, first the retaining clamp 7 connected to the bottom cylinder 9b of the device is removed from the adhesive tape 12 such that the feeder needle 21 and the inventive administering device is pulled rearwards by unlatching the retaining clamps 7, and then the feeder needle 21 and its cover 22 are pulled out from the closure cap 14 of the vial 13 before removing the administering device according to the invention. The above described steps are carried out while the administering device is in a position perpendicular to the user's body.
Subsequently, the empty vial 13 is removed from the cylinder 9b, and a new vial is inserted, and then, after inserting the closure cap 14 of the vial 13 into the retaining element 23 of the cover 22, the closure cap 14 is connected once again to the feeder needle 21 by puncturing it, and the administering process is repeated in the above described manner.
The administering device according to the invention has the following advantages:
- it may be used multiple times,
- due to its size it is lightweight and is comfortable to wear,
- calculating with a 30-day cure the needle has to be introduced only 10 times, compared to the conventional practice requiring 150 introductions (120 bolus and 30 basal doses),
- the additional components (such as the cannula 8, etc.) have to be replaced every 3 days
- bolus doses are administered from the vial inserted into the magnetic syringe, while the basal dose (24-hour effect, administered once a day) is administered in the conventional way at the location of the insertion needle. The basal insulin dose may also be administered without an extra needle introduction by "disconnecting" the magnetic syringe and the vial contained therein from the adhesive tapes, and administering the insulin at the syringe location (at the connector of the feeder needle),
- after "disconnecting" the magnetic syringe the user may take a shower or bath and may sleep more comfortably,
- the device may be applied without problems in case of hypoglycemia or hyperglycemia, 1
- the device is applicable for transdermal administration of all types of liquid medicament,
- the administering device according to the invention may be manufactured according to the product safety regulations applicable for injections, preserving the sterility of the product.
List of reference numerals
1 gear
2 deflection disc
3 cover
4 pulling cord
5a magnet
5b magnet
6a shroud disc
6b shroud disc
7 retaining clamp
8 reading glass
9a cylinder
9b cylinder
10 shroud disc
11 retaining plate
12 adhesive tape
13 vial
14 closure cap
15 scale
16 plunger
17 cannula cover
18 cannula
19 inlet opening
20 connector
21 feeder needle
22 cover
23 retaining element
24 lateral clamp adhesive tape connecting element adhesive tape shaft