WO2020204764A2

WO2020204764A2 - Drug delivery device

Info

Publication number: WO2020204764A2
Application number: PCT/RU2020/050063
Authority: WO
Inventors: Петр РОДИОНОВ; Роман КАЗЕЕНКОВ; Федор ТАРАСЕНКО; Михаил ЖМАЙЛО; Руслан ХАФИЗОВ
Original assignee: Общество с ограниченной ответственностью "НЭКСТ БИО"
Priority date: 2019-04-03
Filing date: 2020-03-30
Publication date: 2020-10-08
Also published as: WO2020204764A3; RU2700459C1

Abstract

A drug delivery device, comprising: a housing; a reservoir, which is installed in the housing; a rod, which is mounted movably in the housing; a triggering mechanism, which is capable of creating a drive force; a dose-specifying mechanism, which is functionally connected to the triggering mechanism; a drive mechanism, which is functionally connected in the housing to the dose-specifying mechanism and to the rod so as to be capable of transmitting said drive force to the rod in order to move the latter depending on the specified drug dose, wherein the rod is also provided with a row of teeth, and said device additionally comprises an annular element which is provided with a pawl and is mounted in the housing in such a manner that, during the movement of the rod, the pawl slips along the teeth of the rod.

Description

MEDICINE DELIVERY DEVICE

FIELD OF TECHNOLOGY

The present invention relates to the field of medical technology used to administer or inject drugs, in particular to drug delivery devices.

LEVEL OF TECHNOLOGY

Drug delivery devices are widely used in cases in which a user needs to self-administer or inject a drug, in particular, regularly inject a drug at predetermined doses in accordance with an individual dosage regimen.

Recently, self-drug delivery devices have become the most widespread among patients with diabetes mellitus, the so-called diabetics, since they allow diabetics to effectively manage their disease on their own. The ease of use of such devices allows their users to have no special medical skills and / or any special medical education.

The closest analogue of the present invention is a drug delivery device (EA 201691813 A1; A61M 5/24, A61M 5/315; 03/31/2017), comprising: a body; a reservoir for a medicinal product installed in the housing; a rod installed in the housing with the ability to move with the possibility of displacing the drug from the specified reservoir; a trigger mechanism designed to create a driving force; a mechanism for setting the dose, installed at least partially in the housing with the possibility of setting the dose of the drug and functionally connected to the trigger; drive mechanism, functionally connected in a housing with a mechanism for setting the dose and a rod with the possibility of transferring the specified driving force to the rod for its movement depending on the prescribed dose of the drug.

One of the drawbacks of the device for drug delivery according to EA 201691813 is that when using such a device, the user can re-inject the drug, thereby injecting an excessive dose of the drug, or not injecting the drug at all into the patient, thereby not administering the required dose of the drug. means, which may be due to patient misconceptions about the completion / non-injection of the required dose of the drug, caused, for example, by the user's forgetfulness, the user's distracted memory and / or external distractions.

Thus, there is a clear need for further improvement of known drug delivery devices, in particular to prevent re-injection of a drug or lack of a necessary drug injection.

Therefore, an urgent problem is to develop a drug delivery device that overcomes at least the above-mentioned drawback of the known drug delivery device.

DISCLOSURE OF THE INVENTION

An object of the present invention is to provide a drug delivery device that solves at least the above problem.

The problem is solved due to the fact that in a drug delivery device containing a housing; reservoir for medicine installed in the body; a rod installed in the housing with the ability to move to ensure the displacement of the drug from the specified reservoir; a trigger mechanism designed to create a driving force; a mechanism for setting the dose, installed at least partially in the housing with the possibility of setting the dose of the drug and functionally connected to the trigger; a drive mechanism functionally connected in the housing with a mechanism for setting the dose and a rod with the possibility of transferring the specified driving force to the rod for its movement depending on a given dose of the drug, while the rod is also equipped with a number of teeth, there is additionally an annular element equipped with a pawl and installed in the body in such a way that when the rod moves, the pawl jumps over the teeth of the rod.

The proposed device for drug delivery provides the technical result in the form of providing the possibility of auditory control by the user of the process of injection of a given dose of the drug when using such a device, which allows the user, through sound signals in the form of clicks or other crackling sounds, to focus his attention on the beginning, flow and completion of the injection process of a given dose of the drug.

In addition, the proposed device also provides another technical result, which consists in expanding the arsenal of technical means for drug delivery, using various sound generating means to notify the user about the implementation of the injection process.

In yet another embodiment of the present invention, the stem in the proposed drug delivery device can be additionally equipped with one more row of teeth, and the annular element can be additionally equipped with one more pawl, so that when moving the rod, both dogs jump simultaneously along the corresponding teeth of the rod. The presence of an additional row of teeth on the rod and the presence of one more pawl in the annular element also contributes to the above formulated technical result, which consists in providing the user with the possibility of auditory control of the injection of a given dose of the drug.

In yet another embodiment of the present invention, the distance between two adjacent teeth of the stem corresponds to a unit dose of the drug. The presence of a direct relationship between the distance between two adjacent teeth of the rod and the unit of the drug dose provides both the technical result formulated above, which consists in providing the user with the possibility of auditory control of the injection of a given dose of the drug, and also provides an additional technical result, which consists in providing the possibility of auditory verification by the user the dose of the drug, which may be appropriate in the case of poor eyesight of the user, who may visually incorrectly determine the given dose of the drug that he will inject.

The proposed drug delivery device can be used to administer or inject to a mammal (eg, human or animal) a drug selected from the group consisting of insulins, insulin analogs, hormones, heparins, antihistamines, and their derivatives and analogs.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a fully assembled drug delivery device according to the present invention with a cap on. FIG. 2 shows a drug delivery device according to the present invention with the cap removed from it.

FIG. 3 is a perspective view of an outer housing used in the drug delivery device of the present invention shown in FIG. 1-2.

FIG. Za shows a view of the outer outer casing from the side of its distal end.

FIG. 3b shows a view of the outer outer housing from the side of its proximal end.

FIG. Zc is an enlarged view of the outer shell from its proximal end, illustrating the partition of the outer shell.

FIG. 4 is a perspective view of a cartridge holding holder used in a drug delivery device according to the present invention.

FIG. 5 is a perspective view of the cartridge being inserted into the holder shown in FIG. 4.

FIG. 6 is a perspective view of a medication dose setting drum with a push button installed in the medication delivery device of the present invention.

FIG. 6a shows a view of the drum for setting the dose of a medicament from the side of its proximal end, with the push button shown in FIG. 6 removed from the proximal end of the drum. 6.

FIG. 7 shows a drum for setting a dose of a medicament, on which a connecting sleeve is put on.

FIG. 7a is a perspective view of a coupling sleeve used in the drug delivery device of the present invention.

FIG. 7b shows a view of the connecting sleeve from the side of its distal end. FIG. 8 is a perspective view of a portion of a drug delivery device according to the present invention, obtained by removing the outer casing and drum for setting the dose of a drug, and this view illustrates the connecting tube in cooperation with some other functional components of the device.

FIG. 8a shows a portion of the apparatus shown in FIG. 8, but with the button and ratchet wheel additionally removed from it.

FIG. 8b is a perspective view of a connecting tube used in a drug delivery device according to the present invention.

FIG. 8c is a side view of the connecting tube from its proximal end.

FIG. 8d is a side view of the connecting tube from its distal end.

FIG. 9 is a perspective view of a threaded screw installed in a connecting tube in a drug delivery device according to the present invention.

FIG. 10 is a perspective view of an annular member fitted to the threaded screw shown in FIG. 9 in a drug delivery device according to the present invention.

FIG. 11 is a perspective view of a ratchet wheel being slid over a connecting tube in a drug delivery device of the present invention.

FIG. 12 is a perspective view of a portion of the drug delivery device of the present invention obtained by removing the connecting tube from the portion of the drug delivery device of the present invention shown in FIG. 8, this view illustrates the inner case in interaction with the rest of the functional components of the device. FIG. 12a shows a portion of the apparatus shown in FIG. 12, but with the retaining sleeve additionally removed from it.

FIG. 12b is a perspective view of an inner housing used in a drug delivery device according to the present invention.

FIG. 12c is a side view of the inner housing from its distal end.

FIG. 13 shows a stem with a locking ring and a disc-shaped member fitted thereon used in a drug delivery device according to the present invention.

FIG. 13a is a perspective view of a stem used in a drug delivery device according to the present invention.

FIG. 14 is a perspective view of a retainer sleeve used in a drug delivery device of the present invention.

FIG. 15 is a perspective view of a locking ring used in a drug delivery device according to the present invention.

CARRYING OUT THE INVENTION

FIG. 1 and 2 show one embodiment of a drug delivery device 100 according to the present invention, used for administering or injecting a patient with a drug or drug in liquid form (for example, the hormone insulin in the case when the patient is diabetic), and which is automatic a syringe in the form of a pen (hereinafter referred to as a pen-syringe). It should be noted that both the patient himself and any other person (for example, a medical worker, social worker, patient's relative, etc.) can act as a user of the pen-syringe 100, using such a pen 100 for administering or injecting a medicament into a patient.

The pen 100 comprises a tubular outer body 1, the general view of which is shown in FIG. 3, wherein the outer casing 1 has a cylindrical inner cavity which is divided by a partition 1.4 into a first compartment of the outer casing and a second compartment of the outer casing, as shown in FIG. For-s.

As shown in FIG. 1-3 and 3a, the outer body 1 at its distal end is also provided with fixing means containing diametrically opposite pairs of fixing slots 1.2 made in the cylindrical wall of the outer body 1 at a given distance from the distal end of the outer body 1 and the partition 1.4, and diametrically opposite pairs longitudinal grooves 1.3 made on the inner surface of the outer body 1 in its first compartment and extending axially from the distal end of the outer body 1 towards the partition 1.4.

As shown in FIG. 3a-s, the partition 1.4 in the outer casing 1 is made in the form of a disc-shaped or annular element equipped with an axial central hole 1.5 and two diametrically opposite arcuate notches 1.6, which are made in the partition 1.4 in such a way that they partially surround its central opening 1.5, while the central opening 1.5 of the baffle is additionally provided with two diametrically opposed radial blocking protrusions 1.7 extending substantially over the entire thickness of the baffle 1.4 in the axial direction. It should also be noted that the central bore 1.5 of the baffle is shaped and sized to accommodate the passage of the piston rod 13 therethrough, as will be described below.

As shown in FIG. 3b, the outer body 1 is also equipped in its second compartment with an annular thrust protrusion 1.9, made on the inner surface of the outer body 1 at a predetermined distance from its proximal end, while the stop protrusion 1.9 is designed to abut against it one of the ends of the connecting sleeve 7, as will be described in more detail below. As shown in FIG. 3b, the outer body 1 is also provided in its second compartment with three retaining grooves 1.8, formed circumferentially on the inner surface of the outer body 1 at a predetermined distance from each other and each extending longitudinally substantially from the proximal end of the outer body 1 to the stop projection

1.9, wherein the retaining grooves 1.8 are intended to receive the retaining ribs 7.1 of the sleeve, as will be described in more detail below.

As shown in FIG. Зс, the outer body 1 is also provided in its second compartment with two diametrically opposite groups of radial protrusions, each of which contains three radial protrusions

1.10, wherein every two adjacent radial protrusions 1.10 in each such group form a positioning groove between themselves, which is intended to receive the corresponding positioning protrusion 15.1 of the locking ring, as will be described in more detail below. The radial projections 1.10 shown in FIG. Зс, are essentially located around the circumference of the inner surface of the second compartment of the outer housing 1 near the partition 1.4. In addition, as shown in FIG. Зс, the outer body 1 is provided in its second compartment with two diametrically opposed locking projections 1.11 made on the inner surface of the outer body 1 and extending in the axial direction substantially from the partition 1.4 at a predetermined distance towards the proximal end of the outer body 1, while the locking projections 1.11 are designed to interact with the locking grooves 14.3 of the locking sleeve, as will be described in more detail below.

As shown in FIG. 1-2, at the proximal end of the outer housing 1, opposite its distal end, into which the holder 2 is inserted, a viewing window 1.1 is made, designed for visual control of the prescribed dose of the drug.

As shown in FIG. 4, the pen 100 also contains a tubular holder 2 for holding a reservoir 4 (see Fig. 5) with a drug made in the form of an ampoule or cartridge, while the reservoir 4 is divided from its outer side by an annular shoulder 2.1 into the first part of the holder, intended for insertion into the first compartment of the outer casing 1, and the second part of the holder, completely covered by a removable tubular cap 3, shown in FIG. 1-2, and the diameter of the annular collar 2.1 is substantially equal to the outer diameter of the outer body 1 and the outer diameter of the cap 3. It should be noted that the outer body 1 and the holder 2 are made with the possibility of being connected to each other to form a single protective casing or a single protective shell, as described in more detail below.

In one embodiment of the present invention, the pen 100 may comprise a body formed from a first body portion that functions as an outer body 1 described below and a second body portion that functions as a holder 2 described below.

As shown in FIG. 5, the cartridge 4 contains a head 4.1, which is made at the distal end of the cartridge 4 and is provided with a septum (not shown), made with the possibility of piercing it to allow access to the medicament in the cartridge 4, and hermetically sealing the cartridge 4 at its distal end ... In addition, the cartridge 4 is equipped with a rubber plunger (not shown), which seals the cartridge 4 at its proximal end opposite the distal end of the cartridge 4, and allows the drug to be displaced from the cartridge 4.

The holder 2 shown in FIG. 4, at its distal end opposite its proximal end, with which it is inserted into the outer body 1, is provided with a head 2.4. 4.1 cartridge head can a sleeve with a needle (not shown) be inserted, so that one of the ends of this needle can pass through the central axial hole 2.6, made in the head 2.4 of the holder, and enter the cartridge 4 inserted into the holder 2, with the provision of communication with the drug contained in cartridge 4.

As shown in FIG. 1 and 2, the cap 3 is provided on its outer side with a clip 3.1 for securing the pen 100 to the garment.

In addition, the holder 2 shown in FIG. 4, on its outer surface is provided with two diametrically opposite retaining protrusions 2.5, each of which is made between the collar 2.1 and the corresponding one of the large viewing windows 2.3, and the cap 3 at its proximal end, with which it is put on the holder 2, is provided with an annular recess 3.2, made on the inner surface of the half pack 3. It should be noted that the cap 3 provides the ability to protect the sleeve with the needle put on the cartridge head 4.1 from external influences that can cause, for example, damage to this sleeve and / or its contamination, and the removal of the cap 3 s holder 2 or its removal from there provides the possibility of performing at least the following actions: pushing the sleeve with the needle onto the cartridge head 4.1, injecting or injecting a predetermined or predetermined dose of the drug to the patient and / or checking the residual amount of the drug in the cartridge 4, which may be implemented due to the presence of the below description new viewing windows 2.2, 2.3.

In addition, the holder 2 shown in FIG. 4, in its second part is equipped with two diametrically opposite small viewing windows 2.2 and two diametrically opposite large viewing windows 2.3 made along the length of the holder 2 between the head 2.4 and the collar 2.1 and aligned with each other in the axial direction. When removing the cap 3 from the second part of the holder 2, small and large viewing windows 2.2, 2.3 provide the ability to visually access different parts of the cartridge 4 inserted into the holder 2, which allows you to visually assess the amount of medication remaining in the cartridge 4.

The holder 2 shown in FIG. 4, in its first part is provided with fixing means made on the outer side of the holder 2 and containing two diametrically opposite longitudinal cuts 2.9, which are made in such a way that they divide the proximal end of the holder 2 into essentially two diametrically opposite sectors 2.10, and each of which axially aligned with corresponding small viewing window 2.2 and large viewing window 2.3. The fixing means of the holder 2 also contain diametrically opposite pairs of longitudinal ribs 2.8, extending in the axial direction from the beads 2.1 towards the proximal end of the holder 2, and diametrically opposite pairs of latching projections 2.7 made at a given distance from the bead 2.1 and cutouts 2.9.

The pen 100 also contains a dispensing mechanism comprising a rotatable dispensing drum 5 (see FIGS. 6 and 6a), formed from a main part 5.2 having a cylindrical internal cavity, and a head 5.1 for setting a dose made at the proximal end of the drum 5 and providing the possibility of step-by-step setting of the dose when a rotational force is applied to it, while the head 5.1 is made in one piece with the main part 5.2 of the drum and has an essentially cylindrical internal cavity made open with respect to the internal cavity of the main part 5.2 of the drum. The head 5.1 of the drum is equipped with a grip 5.3 for setting the dose in the form of axial ribs made on the outer surface of the head 5.1 and located around the circumference of the head 5.1 at a predetermined distance from each other to facilitate the control of the head 5.1 of the drum, and the starting a mechanism in the form of a push button 6 (see Fig. 6b), installed at the proximal end of the drum 5 and designed to be pressed, for example, by the thumb of the hand to initiate delivery of a predetermined dose of the drug. As shown in FIG. 6b, the push button 6 has a main part 6.3, a head 6.2 and an axial pin 6.1, designed to enter the seat 8.10.

The outer diameter of the drum head 5.1 is substantially equal to the outer diameter of the outer casing 1 and exceeds the outer diameter of the barrel body 5.2, so that the transition of the proximal end of the barrel body 5.2 to the distal end of the barrel head 5.1 forms an annular shoulder 5.5 on the outside, as shown in FIG. 5. In addition, as shown in FIG. 6, the drum 5 is additionally equipped with two diametrically opposite limiting projections 5.7 made on the outer surface of the base of the drum part 5.2 and each extending longitudinally from the annular shoulder 5.5 towards the distal end of the drum 5.

As shown in FIG. 6, the main body 5.2 of the drum on its outer surface is also provided with a spiral groove 5.4, extending essentially from the head 5.1 of the drum to the distal end of the drum 5.1, opposite its proximal end, and a scale 5.8 formed from numeric marks reflecting the number of dose units of the drug in in the range from 0 to 60 units with a step of one unit and deposited in a spiral on the outer surface of the main part 5.2 of the drum between the turns of the spiral groove 5.4.

As shown in FIG. 6, the main part 5.2 of the drum on its inner surface is also provided with ratchet teeth 5.9 in the form of identical longitudinal ribs with a trapezoidal cross-section, made around the circumference of the main part 5.2 of the drum at an equal distance from each other and extending in the axial direction substantially from the proximal end of the main part 5.2 reels per preset the distance towards the distal end of the main drum body 5.2, the length of the ratchet teeth 5.9 corresponding to at least part of the length of the screw 10. It should be noted that each tooth of the ratchet teeth 5.9 may correspond to an increment of the assigned dose by one unit or a set of unit dose.

As shown in FIG. 6a, the drum head 5.1 is also equipped with pawls 5.6 in the form of a crown of radial oblique teeth, made around the circumference of the inner surface of the head 5.1, and an annular cavity 5.8 formed in the axial direction between the distal end of the drum head 5.1 and pawls 5.6, so that the annular cavity 5.8 is essentially is located between pawls 5.6 and ratchet teeth 5.9.

As shown in FIG. 7, the pen 100 also contains a connecting sleeve 7 having a cylindrical inner cavity and equipped with an inspection window 7.3, the dimensions of which are smaller than the size of the inspection window 1.1 of the outer housing and which is equipped with a dose indicator 7.5 indicating the number of prescribed dosage units of the drug.

As shown in FIG. 7 and 7a-b, the connecting sleeve 7 is also provided with three fixing ribs 7.1, made around the circumference of the outer side of the connecting sleeve 7 at a predetermined distance from each other and each extending axially at least along part of the length of the connecting sleeve 7. The connecting sleeve 7 is also equipped with two diametrically opposite restrictive notches 7.2, made at its proximal end, with which it is put on the drum 5 when assembling the syringe-pen 100. In addition, the connecting sleeve 7 on its inner surface is provided with a helical rib 7.4 corresponding in shape and size at least parts of the turn of the spiral groove 5.4 of the drum.

As shown in FIG. 8 and 8a-d, the pen 100 also contains a connecting tube 8, separated by solid partitions 8.7 and 8.8 to the proximal compartment, specified in the axial direction by the septum 8.7 and the proximal end of the connecting tube 8, with which it is inserted into the drum 5, the distal compartment, specified in the axial direction by the septum 8.8 and the distal end of the connecting tube 8 opposite its proximal end, and the central compartment, specified in the axial direction by the partition 8.7 and the partition 8.8 and made partially open outward to form a cavity 8.3 having a generally cylindrical shape. The partitions 8.7 and 8.8 on the side of the cylindrical cavity 8.3 are each provided with a locating recess 8.4 having a generally circular shape, while the locating recesses 8.4 are located coaxially with each other. As shown in FIG. 8b, the connecting tube 8 is also provided in its cylindrical cavity 8.3 with a longitudinal internal protrusion 8.9 made on the inner surface of the connecting tube 8 and extending in the axial direction from the partition 8.7 to the partition 8.8, while in the internal projection 8.9 a guide groove 8.5 is made, passing in the axial direction along substantially the entire length of the inner projection 8.9.

As shown in FIG. 9, the pen 100 also contains a screw 10 having a leg 10.2 provided with a screw thread 10.2, and a toothed cap 10.1, while the opposite ends of the screw 10 are provided with rounded setting heads 10.3, located coaxially with each other.

In addition, as shown in FIG. 10, the pen 100 also contains an annular element 12 provided on its inner surface with a helical rib 12.2 corresponding in shape and size to at least a part of the screw thread 10.2 and provided on its outer surface with a radial spike 12.1.

It should be noted that the threaded screw 10 and the annular member 12 are also part of the dispensing mechanism used in the pen 100 according to the present invention. As shown in FIG. 11, the pen 100 also contains a ratchet wheel 9, equipped with a rim 9.1 of inclined axial teeth and a rim 9.2 of inclined axial teeth, each made on the outer surface of the ratchet wheel 9, while the inclined axial teeth in the rims 9.1, 9.2 are mirror-symmetrical and located circumferential offset relative to each other.

As shown in FIG. 12 and 12a-c, the pen 100 also contains an inner body 11 made in the form of a hollow tube and provided on its outer side with an annular retaining collar 11.2, made near the distal end of the inner body 11, opposite the proximal end of the inner body 11, on which the connecting tube 8 is inserted or put on, the inner body 11 having a threaded part that extends from the distal end of the inner body to the retaining collar 11.2 and which is provided with a screw thread 11.4 on its inner surface. In addition, as shown in FIG. 12b-c, two diametrically opposite holes 11.3 are made in the inner housing 11, located at a predetermined distance from the retaining collar 11.2. As shown in FIG. 12b-c, the inner body 11 is also provided with two diametrically opposite longitudinal grooves 11.1, each formed on the outer surface of the inner body 11 and extending each axially substantially from the proximal end of the inner body 11 to the corresponding opening 11.3, while the longitudinal grooves 11.1 are sized and a shape suitable for receiving the longitudinal projections 8.6 of the connecting tube 8 therein.

In addition, as shown in FIG. 13 and 13a, the pen 100 comprises a piston rod 13 in the form of an axial rod, provided on its outer side with a screw thread 13.3, made essentially along the entire length of the piston rod 13 and designed to form a threaded connection with a screw thread 11.4 of the inner housing 11, and two diametrically opposed longitudinal grooves 13.4 (can also be grooves or recesses), intersecting each screw thread 13.3 in the axial direction and each extending substantially along the entire length of the piston rod 13, while one of these grooves 13.4 is provided with a number of oblique teeth 13.1 made each after the other, essentially along the entire length of this recess 13.4 and extending at an acute angle to the axis of the piston rod 13, while the distance between two adjacent teeth 13.1 of the rod essentially corresponds to a unit dose of the drug.

In addition, as shown in FIG. 13 a, the distal end of the piston rod 13 is equipped with a seating head 13.2, designed to put on it a disc-shaped element 16, which is designed to act with the plunger of the cartridge 4.

As shown in FIG. 14, the pen 100 also includes a locking sleeve 14 having a substantially cylindrical inner cavity and provided at its proximal end with diametrically opposite pairs of projections 14.1 located around the outer surface of the locking sleeve 14, each pair of projections 14.1 forming a locking groove therebetween 14.3, designed to interact with the locking lugs 1.11 of the outer casing. In addition, the fixing sleeve 14 has, at its distal end opposite its proximal end, two diametrically opposed axial notches 14.2, which are intended to pass through them the positioning projections 15.1 of the ring and which are made in such a way that they divide the distal end of the fixing sleeve 14 essentially into two diametrically opposite arcuate sectors 14.5, which have been shaped and sized to fit into the corresponding arcuate cutouts 1.6 of the partition, and each of which is provided with an arcuate hook 14.4 designed to engage with the partition 1.4 of the outer body. As shown in FIG. 15, the pen 100 also comprises a ring-shaped locking element or locking ring 15 having a central opening 15.2 shaped and sized for the piston rod 13 to pass therethrough, and provided on its outer side with diametrically opposite pairs of positioning projections 15.1 intended to enter the corresponding positioning grooves formed by the radial protrusions 1.10 of the outer housing 1, with each pair of positioning protrusions 15.1 forming a locking groove 15.4 between them, designed to interact with the corresponding locking protrusion 1.11. The blocking ring 15 is additionally equipped on its inner side with a dog 15.3, the tip of which is designed to engage with the teeth 13.1 of the rod with the possibility of slipping over them, while the tip of the dog 15.3 slipping over the teeth 13.1 of the rod provides the possibility of generating sounds in the form of clicks or other crackling sounds.

In one embodiment of the present invention, both recesses 13.4 of the stem can be provided with oblique teeth 13.1, and the locking ring 15 on its inner side can be provided with two diametrically opposite pawls 15.3 designed to enter the corresponding longitudinal recesses 13.4 so that the tips of the pawls 15.3 engage with corresponding teeth 13.1 of the rod so that the tips of both pawls 15.3 can substantially simultaneously engage the teeth of the respective rows of teeth 13 so that they can slip over them as the piston rod 13 moves through the central hole 15.2 of the locking ring.

It should be noted that in different embodiments of the present invention, the outer casing 1 and the inner casing 11, the connecting tube 8, the fixing sleeve 14 and the connecting sleeve 7 may have and other designs. In particular, in some embodiments of the present invention, the outer casing 1 and / or the inner casing 11 may be formed as a tube, sleeve, drum, cup, cylindrical element, cylindrical part, or the like. In other embodiments of the present invention, the connecting tube 8 may be a sleeve, drum, cup, cylindrical element, cylindrical piece, or the like. In other embodiments of the present invention, the fixing sleeve 14 and / or the connecting sleeve 7 may be in the form of a tube, drum, cup, cylindrical element, cylindrical part, or the like.

When assembling the pen 100 into the outer body 1 from the side of its proximal end, the locking ring 15 is first installed or inserted, so that the locking ring 1 is located in the second compartment of the outer body 1, essentially next to the partition 1.4, and the positioning protrusions 15.1 fit tightly into the corresponding positioning grooves formed by radial protrusions 1.10 of the outer casing 1, as a result of which the locking ring 15 is located coaxially with the outer casing 1 and fixed with respect to it in a given position, in which the pawl 15.3 is axially aligned with the corresponding one of the locking protrusions 1.7. It should also be noted that the connection formed by the positioning projections 15.1 and the above-described positioning grooves prevents the locking ring 15 from rotating or rotating with respect to the outer housing 1.

Subsequently, when assembling the pen-syringe 100 on the inner body 11 from the side of its proximal end, the locking sleeve 14 is pushed or put on until it stops against the retaining collar 11.2 so that the retaining sleeve 14 essentially completely surrounds the distal end of the inner housing 11, and the retaining collar 11.2 prevents further axial movement the fixing sleeve 14 towards the distal end of the inner housing 11.

Further, the piston rod 13 is inserted into the inner body 11 with the fixing sleeve 14 put on it from the side of its proximal end, followed by the introduction of the screw thread 13.3 of the rod into interaction with the screw thread 11.4 of the inner body 11, which ensures the screwing of the distal end of the piston rod 13 in the axial direction in the threaded part of the inner body 11 in such a way that a part of the piston rod 13 protrudes or extends beyond the distal end of the inner body 11.

Subsequently, the inner body 11 provided with a fixing sleeve 14 fitted on the inner body 11 in the above-described manner and a piston rod 13 screwed into the inner body 11 in the above-described manner is installed or inserted into the outer body 1 provided with a locking ring 15 inserted into the outer body 1 in the above-described way, from the side of its proximal end so that the protruding part of the piston rod 13 passes through the central hole 15.2 of the ring and the central hole 1.5 of the baffle and partially extends beyond the baffle 1.4 into the first compartment of the outer casing 1, while the locking protrusions 1.7 enter the corresponding longitudinal grooves 13.4 of the rod, and the pawl 15.3 of the locking ring enters the corresponding one of these longitudinal grooves 13.4 of the rod with its tip engaging with the very first tooth of the teeth 13.1 of the rod, closest to the distal end of the piston rod 13. In addition, with the above-described insert of the inner housing mustache 11 into the outer body 1 the end of the distal end of the inner body 11 abuts in the axial direction against the fixed locking ring 15, and the fixing sleeve 14 enters with its arcuate sectors 14.5 into the arcuate notches 1.6 of the partition, ensuring the engagement of the arcuate hooks 14.4 for the partition 1.4 the outer body from the side of its first compartment, and the locking projections 1.11 of the outer body enter the locking grooves 14.3 of the sleeve, while the locking ring 15 in the axial direction is within the fixing sleeve 14, and the positioning projections 15.1 of the ring pass through the corresponding axial notches 14.2. It should be noted that as a result of this stage of assembly of the pen 100, the locking ring 15 is located generally coaxially between the piston rod 13 and the locking sleeve 14, and the locking sleeve 14 is located coaxially between the inner body 11 and the outer body 1. In addition, the connection formed by the longitudinal grooves 13.4 of the rod and the locking protrusions 1.7 of the outer casing, inserted into the corresponding longitudinal grooves 13.4, prevent or block the possibility of rotation of the piston rod 13, while the connection formed by a particular oblique tooth 13.1 of the rod and a pawl 15.3 of the locking ring meshed with this oblique tooth 13.1 also contributes further to preventing or blocking the possibility of rotation of the piston rod 13.

It should also be noted that the connection formed by the locking projections 1.11 and the corresponding locking grooves 14.3 prevents or blocks the possibility of rotational movement or rotation of the locking sleeve 14 with respect to the outer and inner housings 1, 11, and the arcuate hooks 14.4 engaged and holding the locking sleeve 14 with the retaining collar 11.2 prevent the axial movement of the fixing sleeve 14 with respect to the outer and inner housings 1, 11. In addition, the abutment of the distal end of the inner housing 11 against the fixed locking ring 15 and the interaction between the engaged fixing sleeve 14 and the retaining collar 11.2 provides fixing the position of the inner housing 11 with the piston rod 13 screwed into it, which prevents the possibility of axial movement of the inner housing 11 in relation to the piston rod 13.

During the further assembly of the pen-syringe 100, the connecting sleeve 7 is pushed or put on the drum 5 by inserting the helical rib 7.4 of the sleeve into screw interaction with the spiral groove 5.4 of the drum until the end of the proximal end of the connecting sleeve 7 stops in the annular shoulder 5.5 of the drum, ensuring that the restrictive protrusions 5.7 are snapped limiting cutouts 7.2 with the possibility of getting out of interaction with them, which as a result ensures screwing of the drum 5 with its distal end into the connecting sleeve 7 from the side of its proximal end. It should be noted that as a result of putting the connecting sleeve 7 on the drum 5, it turns out to be located coaxially with the drum 5, and the dose indicator 7.5 indicates the zero dose mark, visible through the viewing window 7.3.

Further, when assembling the pen-syringe 100, the drum 5 with the connecting sleeve 7 put on it is inserted with its distal end into the outer body 1 in such a way that the drum 5 is located coaxially with the outer body 1, and the connecting sleeve 7 is located concentrically between the outer body 1 and drum 5, while the end of the proximal end of the outer housing 1 abuts against the annular shoulder 5.5 of the drum, so that the head 5.1 of the drum is outside the outer housing 1 and essentially adjoins the proximal end of the outer housing 1. In addition, when inserting the drum 5 with a connecting sleeve 7, put on the drum 5 in the above-described manner, into the outer body 1 from the distal end of the outer body 1, the end of the distal end of the connecting sleeve 7 essentially abuts against the thrust protrusion 1.9 of the outer body, and the locking ribs 7.1 of the sleeve enter into frictional interaction with the locking grooves 1.8 external housing with locking connector sleeve 7 in relation to the outer casing 1 in a given orientation, in which the inspection the window 7.3 is aligned with the viewing window 1.1 in such a way that the dose indicator 7.5 and the drug dose mark, which is indicated by the dose indicator 7.5, are visible through the viewing window 1.1 of the outer case. Thus, the fixing grooves 1.8 and fixing ribs 7.1, brought into interaction with each other, in combination with the annular stop shoulder 1.9 and the annular shoulder 5.5, against which the corresponding ends of the connecting sleeve 7 abut, prevent the possibility of rotation and axial movement of the connecting sleeve 7 in relation to to the outer casing 1 and the drum 5. It should also be noted that the restrictive protrusions 5.7, snapped behind the restrictive cutouts 7.2, prevent the possibility of unintentional rotation of the drum 5 and, accordingly, inadvertently typing or setting the dose of the drug, while the restrictive projections 5.7 must be removed from interaction with restrictive cutouts 7.2.

Further, when assembling the pen 100, the annular element 12 is screwed onto the threaded screw 10 so that the annular element 12 is located coaxially with the threaded screw 10 and abuts against the toothed head 10.1 of the screw, which corresponds to the initial position of the annular element 12 on the toothed screw 10. In addition In addition, when assembling the pen-syringe 100, the toothed screw 10 with the annular element 12 screwed onto the screw 10 in the above-described manner is installed in the cylindrical cavity 8.3 with the possibility of rotation in such a way that the locating heads 10.3 enter the corresponding locating recesses 8.4, and the radial pin 12.1 of the annular element enters the guide groove 8.5 of the connecting tube, so that the rotation of the screw 10 in the cylindrical cavity 8.3 provides the possibility of axial rectilinear movement of the ring element 12 along the length of the toothed screw 10 from the toothed head 10.1 of the screw to the partition 8.7, while the position of the ring element 12 on the threaded screw 10 by essentially corresponds to the dose of the drug given by the user. In addition, when assembling the pen-syringe 100, the ratchet wheel 9 is pushed or put on the connecting tube 8 in such a way that it is located coaxially with the connecting tube 8, and the pawls 8.2 engage with the corresponding teeth of the ring gear 9.2.

Subsequently, when assembling the pen-syringe 100, the connecting tube 8, equipped with a ratchet wheel 9 fitted on the connecting tube 8 in the above-described manner, and a screw 10 provided with an annular element 12 screwed onto it and installed in the cylindrical cavity 8.3 in the above-described manner, is installed or inserted into the drum 5 from the side of its proximal end, ensuring that it is pushed on or pulled over the proximal end of the inner body 11 in such a way that the connecting tube 8 is located concentrically between the inner body 11 and the drum 5, and the possibility of axial movement of the connecting tube 8 with respect to the inner body 11 when the drum 5 is rotated in the direction of setting the dose of the drug; and the ability to rotate the inner housing 11 together with the connecting tube 8 when the drum 5 is rotated in the direction of delivering the predetermined dose of the drug. In particular, when inserting the connecting tube 8 with its distal end into the drum 5, the shoulder 8.1 of the proximal end of the connecting tube 8 together with the ratchet wheel 9 are completely in the head 5.1 of the drum, while the part of the ratchet wheel 9, which is not provided with rims 9.1 on its outer surface, 9.2 oblique axial teeth, is located in the annular cavity 5.8 of the head and abuts with its end face against the ends of ratchet teeth 5.9 at the proximal end of the main part 5.2 of the drum. In addition, when the connecting tube 8 is inserted with its distal end into the drum 5, the teeth of the toothed cap 10.1 of the screw interact with the ratchet teeth 5.9 of the drum, which provides the possibility of turning the toothed screw 10 around its axis, while the connection formed by the guide groove 8.5 of the connecting tube and the radial spike 12.1 of the annular element inserted into this guide groove 8.5 prevents the annular element 12 from turning around the threaded screw 10 when the torque is transferred from the drum 5 to the screw 10 ...

In addition, when the connecting tube 8 is put on the inner body 11, the longitudinal projections 8.6 of the connecting tube 8 enter the corresponding longitudinal grooves 11.1 of the inner body 11 with the possibility of axial movement of the longitudinal projections 8.6 along the corresponding longitudinal grooves 11.1, which ensures the possibility of axial movement of the connecting tube 8 in relation to the inner body 11. It should also be noted that the connection formed by the longitudinal projections 8.6 and the longitudinal grooves 11.1, into which these longitudinal projections 8.6 are inserted, also provides the possibility of transferring the torque from the connecting tube 8 to the inner body 11, which as a result can lead to a joint rotation of the connecting tube 8 and the inner body 11 when the drum 5 turns.

Thus, the rotation of the drum 5 in the direction of setting the dose of the drug, in particular in the clockwise direction, when the user sets the required dose of the drug, provides the possibility of axial movement of the connecting tube 8 with respect to the inner body 11 away from its distal end, and rotation of the drum 5 in the direction of delivery of a predetermined dose of the drug, in particular, in the counterclockwise direction, when the user delivers a predetermined dose of the drug to the injection site, allows the connecting tube 8 and the inner housing 11 to rotate in the counterclockwise direction. Subsequently, when assembling the pen-syringe 100, a spring (not shown) is installed or inserted into the seat 8.10 of the connecting tube from the proximal end of the drum 5, so that this spring rests on the bottom of the seat 8.10 with one of its ends. Then a button 6 is inserted into the proximal end of the connecting tube 8, so that the main part 6.3 of the button and the axial pin 6.1 of the button enter the seat 8.10, and the head 6.2 of the button is located outside the head 5.1 of the drum, while the spring inserted into the seat 8.10 turns out planted or put on the axial pin 6.1 of the button with the provision of an abutment with its other end against the corresponding one of the horizontal ledges of the axial pin 6.1 of the button, which, as a result, ensures that the seated button 6 is pushed and, accordingly, the button 6 can be returned to its original position after it has been released.

Further, when assembling the syringe-pen 100 on the head 13.2 of the piston rod, made on the distal end of the piston rod 13, the disc-shaped element 16 is inserted or put on.

Further, when assembling the pen syringe 100, the cartridge 4 is inserted into the holder 2 from the side of its proximal end, ensuring the placement of the cartridge head 4.1 in the inner cavity of the holder head 2.4.

Further, when assembling the pen-syringe 100, the holder 2 with the cartridge 4 inserted into it is inserted in its first part into the first compartment of the outer body 1, so that the longitudinal ribs 2.8 of the holder come into frictional interaction with the corresponding longitudinal grooves 1.3 of the outer body, the ends of the sectors 2.10 of the holder along at least partially abut against the partition 1.4 of the outer casing, and the latching projections 2.7 of the holder snap into the fixing slots 1.2 of the outer casing, which ensures a tight fit of the first part of the holder 2 in the first compartment of the outer casing 1 against the end stop the distal end of the outer body 1 into the collar 2.1 and fixing the holder 2 with respect to the outer body 1 in a predetermined orientation, in which the corresponding small viewing window 2.2 and the large viewing window 2.3 are aligned axially with the viewing window 1.1. Thus, when the holder 2 is inserted into the outer body 1, the above-described fixing means of the holder 2 interact with the above-described fixing means of the outer body 1, thereby preventing the holder 2 from being rotated and axially displaced with respect to the outer body 1. In addition, upon insertion of the holder 2 into the outer housing 1, the disc-shaped element 16 interacts with the plunger of the cartridge 4 to enable the required amount of the drug to be squeezed out of the cartridge 4.

As the final stage of assembling the pen-syringe 100 on the holder 2 from its distal end, the cap 3 can be pushed or put on, so that the retaining protrusions 2.5 come into frictional interaction with the annular recess 3.2, ensuring a tight fit of the cap 3 on the second part of the holder 2 until it stops end of the proximal end of the cap 3 into an annular collar 2.1. If necessary, for example, to check the amount of medication, to replace or initially insert a sleeve with a needle (not shown) on the cartridge head 4.1 and / or to inject the medication remaining in the cartridge 4 by the user, the cap 3 can be removed or removed from the holder 2 by the application of an appropriate force to it in a direction generally opposite to the direction of putting on the cap 3 on the holder 2, while the applied force should ensure that the annular recess 3.2 of the cap leaves the frictional interaction with the retaining projections 2.5 of the holder.

Upon initial use of the fully assembled pen 100, the user needs to remove the cap 3 from the holder 2 and insert or slide a sleeve with a needle (not shown) onto the cartridge head 4.1. To set or set the required dose of the drug, the user needs to grip the head grip 5.3 with his fingers and apply a pivotal force to the head 5 in a clockwise direction (i.e., in the direction of setting the drug dose), sufficient to exit the restrictive protrusions 5.7 of the drum from interaction with the restrictive notches 7.2 of the connecting sleeve, which will lead to the rotation of the entire drum 5 in a clockwise direction, while as the drum 5 rotates, the drum 5 will gradually move out of the outer housing 1, as a result of which the head 5.1 of the drum, equipped with a pressure button 6, will move away from the proximal end of the outer housing 1. In addition, as the drum 5 rotates clockwise, the drum 5 will transmit, through the connection formed by the ratchet teeth 5.9 of the drum and the teeth of the toothed head 10.1 of the screw, introduced into interaction with these ratchet teeth five. 9, the moment of rotation from the drum 5 to the screw 10, as a result of which the threaded screw 10 will rotate around its axis clockwise with the provision of axial movement of the annular element 12 along the length of the threaded screw 10 from the toothed head 10.1 of the screw to the partition 8.7, while the position of the annular element 12 on the threaded screw 10, after the user stops turning the drum 5, essentially corresponds to the drug dose set by the user, which can then be delivered to the drug injection site on the patient's body. Thus, the distance the annular element 12 moves along the length of the threaded screw 10 towards the septum 8.7 substantially corresponds to the drug dose set by the user by rotating the drum 5 in the direction of the drug dose setting. In addition, as the drum 5 rotates clockwise, the user will see in the viewing window 1.1 one of the marks of the 5.8 scale, which is indicated by the pointer 7.5 of the connecting sleeve and which essentially corresponds to the number of dose units the drug specified by the user. The drum 5, which is extended from the outer housing 1 when it is rotated in the direction of setting the dose of the drug, will essentially pull the connecting tube 8 along with it in the extension direction (achieved due to the above-described gear connections between the drum 5, the ratchet wheel 9 and the connecting tube 8) while ensuring its axial movement with respect to the inner body 11 away from its distal end (achieved due to the above-described connection formed between the connecting tube 8 and the inner body 11). In addition, when the drum 5 is turned in the direction of setting the dose of the drug, accompanied by the vision of the drum 5 from the outer case, the drum dogs 5.6 jump over the teeth of the crown 9.1 of the ratchet wheel with the generation of sound signals in the form of clicks and crackles, which allows the user to control through hearing , during the process of setting the required dose of the drug. It should also be noted that, if necessary, the user of the pen-syringe 100 will be able to reduce the predetermined dose of the drug by turning the drum 5 in the opposite direction, that is, counterclockwise, while the pawls 5.6 of the drum will engage with the teeth of the crown 9.1 of the ratchet wheel, and the teeth the crown 9.2 of the ratchet wheel will slide over the dogs 8.2 of the connecting tube, which will also be accompanied by the generation of sound signals in the form of clicks and crackles, which will allow the user to control, through hearing, during the process of adjusting or adjusting the required dose of the drug. In addition, when the drum 5 is rotated counterclockwise to decrease the predetermined dose of the drug, the annular element 12 will move along the length of the threaded screw 10 in the opposite direction, that is, towards the toothed head 10.1 of the screw. To deliver the required dose of the drug to the site of its administration or injection to the patient, the user of the pen 100 applies a generally axial pressing force to the outer surface of the button cap 6.2 for a certain period of time, which leads to pressing the button 6 and, accordingly, the compression of the spring (not shown), by means of which the button 6 is pressed in the seat 8.10. Pressing the button 6 provides the transmission, by means of the axial pin 6.1 of the button, at least part of the force applied by the user to the connecting tube 8, which ensures that the dogs 8.2 of the connecting tube enter into rigid interaction with the teeth of the rim 9.2 of the ratchet wheel, which in turn, in particular due to the above-described toothed connections between the drum 5, the ratchet wheel 9 and the connecting tube 8, it leads to the rotation of the connecting tube 8 together with the drum 5 in the counterclockwise direction, that is, in the direction of delivery of a given dose of the drug. The connecting pipe 8, due to the above-described connection between the connecting pipe 8 and the inner body 11, transmits a torque to the inner body 11, which causes the inner body 11 to rotate in a counterclockwise direction. The rotation of the inner body 11, in turn, provides, thanks to the above-described threaded connection between the inner body 11 and the piston rod 13 and the above-described locking means for blocking the rotation of the piston rod 13, the axial displacement of the piston rod 13 provided at its distal end with a disc-shaped element 16, with displacement medication from the cartridge 4 due to the pushing force applied by the disc-shaped member 16 to the plunger (not shown) of the cartridge 4 from the proximal end of this cartridge 4. In other words, the inner body 11 in the pen 100 acts as a drive mechanism that provides the conversion turning of the drum 5 into the axial movement of the piston rod 13 due to the above-described functional connections formed between the inner housing 11, the piston rod 13 and the drum 5. Thus, the push button 6 makes it possible to create a driving force, which is subsequently transmitted by means of the drum 5 functionally connected to connecting tube 8, to the connecting tube 8, then from the connecting tube 8, functionally connected to the inner body 11, to the inner body 11 and further from the inner body 11, functionally connected to the piston rod 13, to the piston rod 13 for its axial movement. As a result, the axial movement of the piston rod 13 when the drum 5 is rotated in the direction of delivery of a predetermined dose of the drug leads to the advancement, by means of the disc-shaped element 16, of the plunger (not shown) of the cartridge 4 towards the distal end of the cartridge 4, ensuring the supply of the drug displaced from cartridge 4, to the place of administration or injection of the drug to the patient, while the amount of movement of the piston rod 13 and, accordingly, the amount by which the piston rod 13 will move the plunger of the cartridge 4 depends solely on the dose level of the drug in dose units set by the user through the drum 5 as described above.

It should be noted that during the axial movement of the piston rod 13 caused by the rotation of the drum 5 in the direction of delivery of a given dose of the drug, it passes, in particular, through the central hole 15.2 of the locking ring 15 and engages with the tip of its dog 15.3 for the inclined teeth 13.1 of the rod, while as the rod moves forward in the axial direction, the tip of the pawl 15.3 sequentially skips over each individual tooth 13.1 of the rod, that is, the tip of the pawl 15.3 jumps from one particular tooth 13.1 of the rod to the next tooth 13.1 of the rod, which as a result, provides the ability to generate sound in the form of clicks or other crackling sounds audible to the user. The sound accompaniment of the transition of the tip of the dog 15.3 from one particular tooth 13.1 of the rod to the next tooth 13.1 of the rod, created as the rod moves through the locking ring 15, in general, are sound signals in the form of clicks and crackles generated by a pen-syringe 100 in the mode of delivery of a given dose of the drug at the injection site of this dose to the patient, which allows the user, in particular a visually impaired user or a user with distracted attention, to control, through hearing, the course of the process of delivering a predetermined dose of the drug to the injection site on the patient's body. Thus, the recess 13.4 of the stem provided with a series of oblique teeth 13.1, in combination with the locking ring 15 provided with a pawl 15.3 configured to engage with one of the teeth 13.1 of the stem, essentially form a sound generating mechanism or a sound feedback mechanism indicating to the user , by means of audible sound signals in the form of clicks or crackling, at the beginning, continuation and / or completion of the process of delivering a given dose of the drug to the injection site.

The above-described drug delivery device 100 can be used to administer or inject to a mammal (eg, human or animal) a drug selected from the group consisting of insulins, insulin analogs, hormones, heparins, antihistamines, and derivatives and analogs thereof.

Claims

CLAIM

1. A device for drug delivery, comprising: a housing,

a reservoir for a medicinal product installed in the body, a rod installed in the body with the ability to move with the possibility of displacing the medicine from the specified reservoir,

a starting mechanism made with the possibility of creating a driving force,

a mechanism for setting the dose, installed at least partially in the housing with the possibility of setting the dose of the drug and functionally connected to the trigger,

a drive mechanism functionally connected in the housing with a mechanism for setting a dose and a rod with the possibility of transmitting the specified driving force to the rod for its movement depending on a given dose of a drug,

characterized in that

the rod is also provided with a number of teeth, and the specified device additionally contains an annular element equipped with a pawl and installed in the housing in such a way that when the rod moves, the pawl jumps over the teeth of the rod.

2. The device according to claim 1, in which the rod is additionally equipped with one more row of teeth, and the annular element is additionally equipped with one more dog, so that when the rod moves, both dogs jump simultaneously over the corresponding teeth of the rod.

33

SUBSTITUTE SHEETS (RULE 26)

3. The device of claim. 1, in which the distance between two adjacent teeth of the rod corresponds to a unit dose of the drug.

4. The use of a drug delivery device according to any one of claims. 1-3 for injection of a drug selected from the group consisting of insulins, analogs of ninsulins, hormones, heparins, antihistamines, and their derivatives and analogs.

34

SUBSTITUTE SHEETS (RULE 26)