EA045245B1 - DEVICE FOR DELIVERY OF MEDICINE - Google Patents

Description

Field of technology

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

State of the art

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

Recently, drug delivery devices have become most widespread among patients suffering from diabetes mellitus, since they allow such patients to independently effectively manage the course of their disease. The ease of use of such devices allows their users not to have any special medical skills and/or any special medical education, and also not to seek help from medical personnel.

The closest analogue of the proposed invention is a device for drug delivery (RU 2696451, A61M 5/178, 08/01/2019). It should be noted that the device according to RU 2696451 contains a housing; a medicine reservoir installed in the housing; a rod installed in the housing with the ability to move so that the drug can be displaced from the specified reservoir; a trigger mechanism configured to generate a driving force; a mechanism for setting the dose, installed at least partially in the housing with the ability to set the dose of the medicinal product and operatively connected to the trigger mechanism; and a rotary drive mechanism functionally connected in the housing to the mechanism for setting the dose and the rod with the possibility of transmitting said drive force to the rod to move it depending on the given dose of the medicinal product.

One of the disadvantages of the device for drug delivery according to RU 2696451 is that in the mode of delivering the drug to the site of its injection to the patient, when transmitting the torque from the mechanism for setting the dose to the rotary drive mechanism, this rotary drive mechanism rotates or rotates together with the mechanism for setting the dose at essentially the same rate, with the result that it can sometimes be difficult to deliver the drug dose to the injection site in the required amount, especially when using highly concentrated insulin as the drug and the required low dose of injection, which may not be set properly due to the above-described interaction features of the rotary mechanism for setting the dose and the rotary drive mechanism. Thus, the user of the drug delivery device according to RU 2696451 can inject the drug in an excessive amount or in an insufficient amount.

Thus, there is a clear need for further improvement of known drug delivery devices, in particular to prevent over- or under-injection of drug into a patient.

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

Disclosure of the invention

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

The problem was solved due to the fact that a device for drug delivery containing a housing; a medicine reservoir installed in the housing; a rod at least partially movably mounted in the housing to allow the medicinal product to be expelled from said reservoir; a trigger mechanism configured to generate a driving force; a dose setting mechanism installed at least partially in the housing to set the dose of the medicinal product and operably connected to the trigger mechanism to allow the dose setting mechanism to be rotated when the trigger mechanism is activated; further comprises a connecting tube functionally connected in the housing to the mechanism for setting the dose, allowing the connecting tube to be rotated when the mechanism for setting the dose is rotated; and a drive tubular piece, which is inserted in the housing into threaded engagement with the connecting tube to enable the drive tubular piece to rotate when the connecting tube is rotated, and which is operatively connected to the rod to enable transmission of at least a portion of said drive force to the rod for its movement depending on from a given dose of the drug.

The proposed device for drug delivery provides a technical result in the form of increasing the accuracy of the dose of the drug delivered to the site of its injection to the patient, especially in the case of delivery of small doses of a highly concentrated drug,

- 1 045245 such as, for example, highly concentrated insulin. Increased accuracy of the delivered dose of the drug is ensured, in particular, due to the possibility of extending the rod to a reduced extension amount and, accordingly, the possibility of squeezing out smaller doses of the drug from the reservoir, which is due to the possibility of introducing the drive tubular part into threaded interaction with the connecting tube and the possibility of its functional connection with a rod providing the possibility of transferring part of the drive force created by the trigger mechanism to the rod for its movement depending on the given dose of the drug.

In addition, the proposed device also provides another technical result, which is to expand the arsenal of technical means for drug delivery.

In another embodiment of the present invention, to provide threaded engagement between the drive tubular piece and the connecting tube, at least a portion of the drive tubular piece may be provided with a spiral groove on its outer side, and the connecting tube may be provided with mating guide projections on its inner side.

In yet another embodiment of the present invention, the helical pitch of the groove of the drive tubular piece can be set such that the drive tubular piece can have a lower rotational speed relative to the housing than the connecting tube.

The proposed drug delivery device according to any of the above-described embodiments of the present invention can be used for administering or injecting into a mammal (for example, a human or an animal) a drug selected from the group consisting of insulins, insulin analogues, hormones, heparins, antihistamines and their derivatives and analogues.

Brief description of drawings

In fig. 1 shows a fully assembled drug delivery device according to the present invention with a cap attached thereto.

In fig. 2 shows a drug delivery device according to the present invention with its cap removed.

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

In fig. 3a is a view of the outer housing shown in FIG. 3, from the side of its distal end.

In fig. 3b is a view of the outer casing shown in FIG. 3, from its proximal end.

In fig. 3 c is an enlarged view of the outer housing from its proximal end, illustrating the septum of the outer housing.

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

In fig. 5 shows a general view of the cartridge being inserted into the holder shown in FIG. 4.

In fig. 6 is an overview view of a drug dose drum with a push button installed used in the drug delivery device of the present invention.

In fig. 6a shows a view of the drug dose drum from its proximal end, from which the push button has been removed.

In fig. 6b shows a push button for the drum shown in FIG. 6a.

In fig. Figure 7 shows a general view of the drum for setting the dose of the medicinal product, on which the connecting sleeve is placed.

In fig. 7a is a general view of a coupling sleeve used in a drug delivery device according to the present invention.

In fig. 7b is a view of the connecting sleeve shown in FIG. 7a, from the side of its distal end.

In fig. 8 is a general view of the drug delivery device of the present invention with the outer casing shown in FIG. 3 and 3a-3c, the connecting sleeve shown in Fig. 7 and 7a, 7b, and the drug dose drum shown in FIG. 6 and 6a, wherein this view illustrates the connecting tube in engagement with the inner housing in engagement with the support sleeve.

In fig. 8a shows part of the device shown in FIG. 8, but with the additionally removed push button shown in FIG. 6b, the ratchet wheel shown in FIG. 11, and the support sleeve shown in FIG. 14 and 14a, 14b.

In fig. 8b is a general view of a connecting tube used in a drug delivery device according to the present invention.

In fig. 8c is a side view of the connecting tube shown in FIG. 8a, from its proximal end.

In fig. 8d is a side view of the connecting tube shown in FIG. 8a, from the side of its distal end.

In 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.

In fig. 10 shows a general view of the annular element that fits onto the threaded screw shown in FIG. 9, in a drug delivery device according to the present invention.

In fig. 11 is a perspective view of a ratchet wheel mounted on a connecting tube in a drug delivery device according to the present invention.

In fig. 12 is a view illustrating the inner body in engagement with the carrier sleeve.

In fig. 12a is a view illustrating a portion of the device shown in FIG. 12, but with the supporting sleeve additionally removed.

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

In fig. 12c is a side view of the inner housing shown in FIG. 12b, from its distal end.

In fig. 13 shows a rod used in a drug delivery device according to the present invention with a disc-shaped member mounted thereon.

In fig. 13a is a general view of a rod used in a drug delivery device according to the present invention.

In fig. 14 is a perspective view illustrating a carrier sleeve used in the drug delivery device of the present invention in cooperation with a retaining ring.

In fig. 14a is a view of the support sleeve from its proximal end, illustrating the support sleeve with elastic elements mounted thereon.

In fig. 14b is a view of the carrier sleeve from its proximal end, illustrating the carrier sleeve with the resilient members removed.

In fig. 14c shows a retaining ring having a central hole and provided with three generally identical arcuate holes.

In fig. 15 shows a general view of one of the elastic elements.

In fig. 16 is a perspective view of a blocking ring used in a drug delivery device according to the present invention.

Carrying out the invention

In fig. 1 and 2 show one embodiment of a drug delivery device 100 according to the present invention, used for administering or injecting a drug or drug in liquid form (for example, the hormone insulin in the case of a diabetic patient) into a patient and being an auto-syringe. in the form of a fountain pen (hereinafter referred to as a syringe pen). It should be noted that the user of the syringe pen 100 can be either the patient himself or any other person (for example, a medical worker, a social worker, a relative of the patient, etc.) using such a syringe pen 100 for administration or injection. medicine to the patient.

The pen 100 includes a tubular or cylindrical outer body 1, the overall appearance of which is shown in FIG. 3, wherein the outer body 1 has a cylindrical inner cavity, which is divided by a partition 1.4 into a first outer body compartment and a second outer body compartment, as shown in FIG. 3a-3c.

As shown in FIG. 1-3 and 3a, the outer body 1 at its distal end is also equipped with locking means containing diametrically opposed pairs of locking 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, as well as diametrically opposed a pair of longitudinal grooves 1.3 formed 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, and two diametrically opposed locking projections 1.7 designed to interact with the corresponding longitudinal cutouts 2.9 of the holder described below .

As shown in FIG. 3a-3c, the partition 1.4 in the outer housing 1 is made in the form of a disk-shaped or ring-shaped element equipped with an axial central hole 1.5 and two diametrically opposed arcuate cutouts 1.6, which are made in the partition 1.4 in such a way that they partially surround its central hole 1.5, while the central hole 1.5 of the partition is given a shape and dimensions suitable for the passage of the piston rod 13 through it, as will be described below.

As shown in FIG. 3b and 3c, the outer housing 1 is also equipped in its second compartment with an annular thrust projection 1.9, made on the inner surface of the outer housing 1 at a given distance from its proximal end and the partition 1.4, while the thrust projection 1.9 is designed to rest one of the ends of the connecting bushings 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 locking 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 abutment projection 1.9, while The fixing grooves 1.8 are intended for inserting the fixing ribs 7.1 of the bushing into them, as will be described in more detail below.

As shown in FIG. 3a and 3b, at the proximal end of the outer body 1, opposite its distal end, into which the holder 2 is inserted, there is a viewing window 1.1, designed for visual monitoring of the given dose of the drug.

As shown in FIG. 4, the syringe pen 100 also contains a tubular holder 2 for holding a reservoir 4 with a medicinal product, made in the form of an ampoule or cartridge (see Fig. 5), while the reservoir 4 is divided on its outer side by an annular collar 2.1 into the first part of the holder, designed for its insertion into the first compartment of the outer housing 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 bead 2.1 is essentially 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 configured to be connected to each other to form a single protective casing or a single protective shell, as will be described in more detail below.

In one embodiment of the present invention, the pen 100 may include a body formed of a first body portion having the functions of the outer body 1 described below and a second body portion having the functions of the 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 equipped with a septum (not shown), configured to be pierced to gain access to the medicinal product located in the cartridge 4, and hermetically sealing the cartridge 4 at its distal end. . In addition, the cartridge 4 is provided with a rubber plunger (not shown) that seals the cartridge 4 at its proximal end opposite the distal end of the cartridge 4 and allows the drug to be expelled 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 housing 1, is equipped with a head 2.4. A sleeve with a needle (not shown) can be mounted on the head 4.1 of the cartridge, 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, ensuring communication with the medicine contained in the cartridge 4.

As shown in FIG. 1 and 2, the cap 3 is equipped on its outer side with a clamp 3.1 for securing the pen syringe 100 to an item of clothing.

Moreover, the holder 2 shown in FIG. 4, on its outer surface is equipped with two diametrically opposed holding projections 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 equipped with an annular recess 3.2, made on the inner surface of the cap 3. It should be noted that the cap 3 provides the ability to protect the sleeve with the needle, placed on the head 4.1 of the cartridge, from external influences that can cause, for example, damage to this sleeve and/or its contamination, and removal of the cap 3 with holder 2 or its removal from there makes it possible to perform at least the following actions: placing a sleeve with a needle on the head 4.1 of the cartridge, administering or injecting a given or predetermined dose of the drug to the patient and/or checking the residual amount of the drug in the cartridge 4, which can be carried out thanks to the presence of the viewing windows 2.2, 2.3 described below.

Moreover, the holder 2 shown in FIG. 4, in its second part is equipped with two diametrically opposed small viewing windows 2.2 and two diametrically opposed 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 visual access to different parts of the cartridge 4 inserted into the holder 2, which allows you to visually assess the amount of medicine remaining in the cartridge 4.

The holder 2 shown in FIG. 4, in its first part is provided with locking means provided on the outer side of the holder 2 and containing two diametrically opposed longitudinal cuts 2.9, which are designed in such a way that they divide the proximal end of the holder 2 into essentially two diametrically opposed sectors 2.10, and each of which axially aligned with the corresponding small viewing window 2.2 and large viewing window 2.3. The fixing means of the holder 2 also comprise diametrically opposed pairs of longitudinal ribs 2.8 extending axially from the flanges 2.1 towards the proximal end of the holder 2, and diametrically opposed pairs of snap projections 2.7 made on

- 4 045245 at a given distance from the collar 2.1 and cutouts 2.9.

In addition, the syringe pen 100 includes a dosing mechanism comprising a rotary dosing drum 5 (see Figs. 6 and 6a), formed from a main part 5.2 having a cylindrical internal cavity, and a dose setting head 5.1 made at the proximal end of the drum 5 and providing the ability to step-by-step set the dose when a rotational force is applied to it, while the head 5.1 is made integral with the main part 5.2 of the drum and has an essentially cylindrical internal cavity made open in relation to the internal cavity of the main part 5.2 of the drum. The drum head 5.1 is equipped with a trigger mechanism in the form of a push button 6 (see Fig. 6b) mounted on the proximal end of the drum 5 and designed to be pressed, for example, by the thumb to initiate delivery of a given dose of the drug. In addition, the drum head 5.1 can be equipped with a gripper for setting the dose (not shown) in the form of axial ribs, which can be made on the outer surface of the drum head 5.1 and located around the circumference of the head 5.1 at a given distance from each other to facilitate the ability to control the drum head 5.1 . As shown in FIG. 6b, the push button 6 has a body 6.3, a cap 6.2 and an axial pin 6.1 for entering into the below-described seat 8.10 of the connecting tube 8.

The outer diameter of the drum head 5.1 is substantially equal to the outer diameter of the outer body 1 and is larger than the outer diameter of the drum main body 5.2, so that the transition of the proximal end of the drum body 5.2 to the distal end of the drum head 5.1 forms on the outer side an annular shoulder 5.5 shown in FIG. 6. Moreover, as shown in FIG. 6, the drum 5 is additionally equipped with two diametrically opposed limiting projections 5.3, made on the outer surface of the base of the drum part 5.2 and each extending longitudinally from the annular ledge 5.5 towards the distal end of the drum 5.

As shown in FIG. 6, the drum main body 5.2 is also provided on its outer surface with a helical groove 5.4 extending substantially from the drum head 5.1 to a distal end of the drum 5.1 opposite its proximal end. In addition, the drum main body 5.2 may be provided on its outer surface with a scale (not shown), which may be formed from digital marks indicating the number of drug dosage units in a range, for example, from 0 to 60 units in increments of, for example, one at a time unit, and is applied 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. 6a, the main part 5.2 of the drum on its inner surface is also equipped with ratcheting teeth 5.7 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 essentially from the proximal end of the main part 5.2 of the drum at a predetermined distance towards the distal end of the main part 5.2 of the drum, the length of the ratcheting teeth 5.7 corresponding to at least part of the length of the screw 10 or the length of the screw 10. It should be noted that each tooth of the ratcheting teeth 5.7 can correspond, for example, to an increment of a given doses per unit or set of a single dose.

As shown in FIG. 6a, the drum head 5.1 is also provided with pawls 5.6 in the form of a rim of radial inclined 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 the pawls 5.6, so that the annular cavity 5.8 is essentially located between pawls 5.6 and ratchet teeth 5.7.

As shown in FIG. 7, the pen 100 also includes a connecting sleeve 7 having a cylindrical internal cavity and equipped with a viewing window 7.3, the dimensions of which are smaller than the dimensions of the viewing window 1.1 of the outer body and which is equipped with a dose indicator 7.5 for indicating or indicating the number of predetermined dose units of the medicinal product. .

As shown in FIG. 7 and 7a, 7b, the connecting sleeve 7 is also provided with three locking ribs 7.1, made around the circumference of the outer side of the connecting sleeve 7 at a given distance from each other and each extending in the axial direction along at least part of the length of the connecting sleeve 7. The connecting sleeve 7 is also is equipped with two diametrically opposed restrictive cutouts 7.2 made at its proximal end, with which it is put on the drum 5 when assembling the syringe pen 100, and designed to interact with the above-described restrictive protrusions 5.3 of the drum. In addition, the connecting sleeve 7 is equipped on its inner surface with a helical rib 7.4 corresponding in shape and size to at least part of the turn of the above-described spiral groove 5.4 of the drum.

As shown in FIG. 8 and 8a, 8d, the pen 100 also contains a connecting tube 8, divided by solid partitions 8.7 and 8.8 into a proximal compartment defined in the axial direction by the partition 8.7 and the proximal end of the connecting tube 8, with which it is inserted into the drum 5, the distal compartment defined in the axial direction by the partition 8.8 and the distal end of the connecting tube 8 opposite its proximal end, and the central compartment defined in the axial direction by the partition 8.7 and the partition 8.8 and made partially open

- 5 045245 outward to form a cavity 8.3, which has a generally cylindrical shape. The partitions 8.7 and 8.8 on the side of the cylindrical cavity 8.3 are each equipped with an installation hole 8.4, which has a generally round shape, with the installation holes 8.4 located coaxially with each other. As shown in FIG. 8b, the connecting tube 8 is also equipped in its cylindrical cavity 8.3 with a longitudinal internal projection 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 there is a guide groove 8.5 extending in the axial direction direction essentially along the entire length of the inner protrusion 8.9.

As shown in FIG. 8c, the connecting tube 8 is equipped at its proximal end with a seat 8.10, corresponding in shape and size to the axial pin 6.1 of the push button 6.

As shown in FIG. 8c, the connecting tube 8 is equipped at its distal end with four generally identical guide protrusions 8.11, made circumferentially on the inner surface of the connecting tube 8 at a given distance from each other and forming two pairs of diametrically opposed guide protrusions, so that the guide protrusions in each of these the formed pairs of guide protrusions are made mirror symmetrical with respect to each other.

It should be noted that the guide projections 8.11 are curved and each positioned in such a way that they essentially form a section of a helix and generally correspond to the turn of the thread formed by the helical groove 11.6 of the inner cylindrical body 11, as a result of which the helical groove 11.6 of the inner body 11 can be guide protrusions 8.11 are introduced into screw interaction, which are responsive to the specified spiral groove 11.6, ensuring the transfer of part of the rotational or rotary movement of the connecting tube 8 to the inner cylindrical body 11, as will be described in more detail below.

It should also be noted that the characteristics of the spiral groove 11.6 of the inner housing 11, in particular its spiral pitch, are specified or selected in such a way that when the connecting tube 8 screws into contact with the inner housing 11, it is possible to rotate the connecting tube 8 together with the inner housing 11, while when transmitting the torque from the connecting tube 8 to the inner housing 11, this inner housing 11 has a slower rotation or lower rotation speed in comparison with the connecting tube 8 in relation to the outer housing 1, to which the torque is transmitted from the drum 5. Thus, the spiral The groove 11.6 of the inner body 11 is designed in such a way that it essentially allows the inner body 11 to slow down compared to the connecting tube 8, which ultimately allows the rod 13 to be extended by a smaller amount of extension and, therefore, a smaller volume of medicinal product can be squeezed out of the cartridge 4 , as will be described in more detail below.

As shown in FIG. 9, the pen 100 also includes a screw 10 having a stem 10.2 provided with a screw thread 10.2 and a serrated head 10.1, wherein opposite ends of the screw 10 are provided with rounded mounting heads 10.3 arranged coaxially with each other.

Moreover, as shown in FIG. 10, the pen 100 also contains a ring element 12, equipped on its inner surface with a screw rib 12.2, corresponding in shape and size to at least part of the turn of the screw thread 10.2 of the screw 10, and equipped on its outer surface with a radial spike 12.1.

As shown in FIG. 11, the syringe 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 made mirror symmetrical with respect to each other to friend.

As shown in FIG. 12 and 12a-12c, the pen 100 also contains an inner cylindrical body 11, made in the form of a hollow tube or tubular part and equipped on its outer side with an annular retaining collar 11.2, made next to the distal end of the inner body 11, opposite the proximal end of the inner body 11 onto which the connecting tube 8 is mounted or put on, and separating the inner body 11 into an end portion 11.1 axially defined by the retaining collar 11.2 and the distal end of the inner body 11, and a threaded portion 11.5 defined axially by the proximal end of the inner body 11 and a retaining collar 11.2, wherein the retaining collar 11 is integral with the threaded part 11.5 and the end part 11.1. The threaded portion 11.5 is provided on its outer side with a helical groove or helical groove 11.6 extending from the proximal end of the inner body 11 substantially to the retaining collar 11.2, and the end portion 11.1 is provided on its inner surface with a helical thread 11.7, which is shaped and sized suitable for ensuring screw interaction with the above-described guide protrusions 8.11 of the connecting tube 8.

As shown in FIG. 12b, 12c, the end part 11.1 is also provided with three arcuate projections or segments 11.3, made generally in the middle of the end part 11.1 from its outer side and located around the circumference of the end part 11.1 at a given distance with respect to each other

- 6 045245 to a friend, wherein the specified middle of the end part 11.1 is made thickened, as a result of which it has a larger outer diameter compared to the remaining parts of the end part 11.1 of the inner body 11, and the transition of the distal end of the end part 11.1 into its thickened middle forms on the outer side the annular shoulder visible in FIG. 12s. In addition, the end part 11.1 is equipped on its outer side with inclined radial teeth 11.4, made around the circumference of the end part 11.1 at equal or identical distances from each other, in particular with a shift of 18°, to form a gear rim or ring essentially located between a thickened middle of the end part 11.1 and a retaining collar 11.2.

Moreover, as shown in FIG. 13 and 13a, the syringe pen 100 contains a piston rod 13 in the form of an axial rod, equipped 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 the screw thread 11.7 of the inner body 11, with In this case, a portion of the screw thread 13.3 is cut or removed from two diametrically opposed sides of the piston rod 13 in the axial direction along substantially its entire length to form two diametrically opposed flat surfaces 13.1, so that the piston rod 13 is sized and shaped to fit through the central a hole 1.5 made in the partition 1.4 of the outer housing 1, preventing or blocking the possibility of rotation of the piston rod 13.

Moreover, as shown in FIG. 13a, the distal end of the piston rod 13 is equipped with a seating head 13.2, designed for putting on a disk-shaped element 16, designed to interact with the plunger of the cartridge 4.

As shown in FIG. 14 and 14a, 14b, the syringe pen 100 also contains a carrier sleeve 14, made in the form of a cylindrical part having a substantially cylindrical internal cavity, and the carrier sleeve 14 is equipped with three generally identical arcuate sectors 14.1, made around the circumference on the inside of the carrier sleeve 14 at equal distances from each other to obtain three spaces or openings of substantially the same size, each formed between corresponding two adjacent arcuate sectors 14.1. In addition, the supporting sleeve 14 is equipped with three more generally identical arcuate sectors 14.9, also made along the circumference on the inner side of the supporting sleeve 14 at an equal distance from each other to obtain three spaces or gaps of essentially the same dimensions, each formed between the corresponding two adjacent arcuate sectors 14.1, and the arcuate sectors 14.9 are displaced in the axial direction relative to the arcuate sectors 14.1 so that they are located further from the distal end of the carrier sleeve 14. The arcuate sectors 14.9 are made and located around the circumference of the inner side of the carrier sleeve 14 in such a way that they in shape and size correspond to the gaps formed by the arcuate sectors 14.1, and the arcuate sectors 14.1 are made and located around the circumference of the inner side of the bearing sleeve 14 in such a way that they correspond in shape and size to the gaps formed by the arcuate sectors 14.9, so that the arcuate sectors 14.1 in combination with arcuate sectors 14.9 form a substantially closed circle or closed ring formed on the inside of the support sleeve 14, as shown in FIG. 14b, and between the arcuate sectors 14.1 and the arcuate sectors 14.9, a generally annular space is formed, suitable for freely rotating the above-described arcuate segments 11.3 of the inner body 11. Thus, the annular space formed between the arcuate sectors 14.1 and the arcuate sectors 14.9, provides the possibility of free rotation of arcuate segments 11.3 in it, caused by rotation or rotation of the inner housing 11 around its axis, while arcuate sectors 14.1 and arcuate sectors 14.9 block or prevent the possibility of axial displacement or movement of arcuate segments 11.3 and, accordingly, axial movement of the inner housing 11 when it is rotated or turned.

Moreover, as shown in FIG. 14, the support sleeve 14 has at its distal end, opposite its proximal end, with which it is placed on the end portion 11.1 of the inner body 11 so as to enclose or surround this end portion 11.1 on its outer side, two diametrically opposed axial cutouts 14.2, so formed that they divide the distal end of the support sleeve 14 into substantially two diametrically opposed arcuate portions 14.5, which are shaped and sized suitable for insertion into respective arcuate cutouts 1.6 of the septum, and each of which is provided with an arcuate hook 14.4 designed to engage the septum 1.4 outer casing 1.

Moreover, as shown in FIG. 14a, 14b, the support sleeve 14 has at its proximal end axial cutouts 14.8, forming three separate groups of axial cutouts and designed in such a way that an elongated arcuate protrusion 14.3 is formed between each two adjacent groups of axial cutouts, and axial cutouts 14.8 in each of these groups The axial cutouts are formed by three shortened arcuate segments 14.7, which are located one after the other along the circumference of the bearing sleeve 14 and are separated from each other by corresponding axial cutouts from the axial cutouts 14.8. Thus, the support sleeve 14 is provided at its proximal end with three elongated arcuate protrusions.

- 7 045245 pavements 14.3 located around the circumference of the bearing sleeve 14 at the same distance from each other, while between each two adjacent elongated arcuate protrusions 14.3 there are three shortened arcuate segments 14.7, of which the central shortened arcuate segment is separated from each of the two outer shortened ones arcuate segments with a corresponding axial cutout from the axial cutouts 14.8. The elongated arcuate projections 14.3 are each provided with an arcuate hook 14.6, the arcuate hooks 14.6 being designed to engage a retaining ring 17 described below.

As shown in FIG. 14c, the pen 100 also includes a retaining ring 17 having a central hole 17.1 shaped and sized to accept a threaded portion 11.5 of the inner body 11 and provided with three generally identical arcuate holes 17.2 formed around the central hole 17.1 at substantially equal distances from each other around the circumference of the retaining ring 17, the arcuate holes 17.2 being shaped and sized to accept corresponding elongated arcuate projections 14.3 so as to engage the arcuate hooks 14.6 with the retaining ring 17. It should also be noted that the retaining ring 17 is designed to be put on the threaded part 11.5 of the inner body 11 from the side of its proximal end, as a result of which the retaining ring 17 is seated on the threaded part 11.5 of the inner body 11 adjoining the retaining collar 11.2 from the side of the threaded part 11.5 of the inner body 11. Thus, when the elongated arcuate protrusions 14.3 of the carrier sleeve 14 are inserted into the corresponding arcuate holes 17.2 of the retaining ring 17 with the engagement of the arcuate hooks 14.6 of the carrier sleeve 14 behind the retaining ring 17 and the arcuate parts 14.5 of the carrier sleeve 14 are inserted into the corresponding arcuate cutouts 1.6 of the partition of the outer casing 1 with gear arched hooks 14.4 for the partition 1.4, the supporting sleeve 14 is on one side rigidly fastened with the possibility of detachment with the retaining ring 17 with a tight fit of the retaining ring 17 to the retaining collar 11.2 and on the other side rigidly fastened with the possibility of detachment with the outer casing 1, which allows holding the carrier the sleeve 14 in the required position in relation to the end part 11.1 of the inner body 11, in particular in relation to the arcuate segments 11.3 and the radial teeth 11.4 of the inner body 11 and, accordingly, prevents the possibility of axial movement of the supporting sleeve 14 and the retaining ring 17 and the possibility of their rotation or rotation in relation to the inner body 11, however, the inner body 11, in particular its end part 11.1 and threaded part 11.5, remains capable of rotation or rotation in relation to the supporting sleeve 14 and the retaining ring 17 secured thereto.

As shown in FIG. 14a, the support sleeve 14 is also provided with three generally identical spring or elastic elements 15, each in the form of a curved or curved elongated plate element shown in FIG. 15, or leaf spring. As shown in FIG. 15, each of the elastic elements 15 is curved so that it has a free end 15.2, a trapezoidal fastening part 15.3 and a free elongated part 15.4 provided with a hook or pawl 15.1, wherein the trapezoidal fastening part 15.3 is connected to the free elongated part 15.4 by means of a curved transition 15.5. As shown in FIG. 14a, each of the elastic elements 15 passes through two central axial cutouts of the axial cutouts 14.8 of the supporting sleeve 14, separating the central shortened arcuate segment of the shortened arcuate segments 14.7 from the two outer shortened arcuate segments of the shortened arcuate segments 14.7, such that its trapezoidal fastening part 15.3 encloses said central shortened arcuate segment on the outer side of the carrier sleeve 14 with at least partial contact therewith, and the free end 15.2 and the curved transition 15.5 enclose each corresponding one of the specified outer shortened arcuate segments on the inner side of the carrier sleeve 14 at least with a partial fit to the male shortened arcuate segment, which ensures rigid fastening of each of the elastic elements 15 on the supporting sleeve 14, while the free elongated part 15.4 of each elastic element 15 with the pawl 15.1 turns out to be facing the cylindrical internal cavity of the supporting sleeve 14. In addition, it should be noted that as a result of connecting the elastic elements 15 with the support sleeve 14 in the manner described above, their dogs 15.1 are oriented in the required manner in the internal cavity of the support sleeve 14, so that the tips of these dogs 15.1 can be brought into interaction or engagement each with a corresponding one of the radial teeth 11.4 of the inner body 11, while the pawls 15.1 of the elastic elements 15 mounted on the supporting sleeve 14 are generally located in a circle at the same distance from each other, in particular the tips of the pawls 15.1 are located in a circle with an angular displacement or a shift of 120° relative to each other to friend.

Thus, when the inner body 11 is rotated or rotated relative to the supporting sleeve 14, which, together with the elastic elements 15 attached to it, has a fixed position relative to the end part 11.1 of the inner body, in the mode of delivering a given dose of the drug to the injection site of this dose the patient is provided with the opportunity to jump over at least one of the pawls 15.1 along the corresponding one of the radial teeth 11.4 internal

- 8 045245 of the housing 11, which results in the generation or creation of sounds in the form of clicks or other crackling sounds audible to the user. In particular, in the mode of delivery of a given dose of a drug to the injection site of this dose to the patient, rotation of the inner body 11 by 6° leads to the jumping of only one of the existing three pawls 15.1 along the corresponding one of the radial teeth 11.4, shifted or displaced along the outer circumference of the end part 11.1 of the inner body 11 by 18° relative to each other, so that when the inner body 11 is rotated, for example, by 18°, each of the pawls 15.1 can jump only once over the corresponding one of the radial teeth 11.4 of the inner body 11. As a result, each of The existing 20 radial teeth 11.4 are made every 18°, and the 120° offset between every two pawls 15.1 essentially corresponds to 6 and 2/3 (six point two thirds) of the radial teeth 11.4. The pawls 15.1 are offset or offset circumferentially relative to the radial teeth 11.4 in such a way that every 6°, as a result of the interaction of one of the pawls 15 with the corresponding one of the radial teeth 11.4, a click or crackling sound is generated or created when the inner housing 11 rotates or turns in one direction, namely in the direction corresponding to the mode of delivery of a given dose of the drug to the injection site of this dose to the patient, or the possibility of further rotation or rotation of the internal housing 11 is blocked when rotating or turning the internal housing 11 in the opposite direction when dialing or setting the dose of the drug agent to be delivered to the site of injection of this dose to the patient.

In one of the embodiments of the present invention, the elastic elements 15, each equipped with a pawl 15.1, can be made integral with the supporting sleeve 14 in such a way that their pawls 15.1 are properly located and oriented in the internal cavity of the supporting sleeve 14, as described above. In another embodiment of the present invention, the elastic elements 15, each equipped with a pawl 15.1, can be secured to the carrier sleeve 14 from its inner side in such a way that their pawls 15.1 are properly located and oriented in the internal cavity of the carrier sleeve 14, as described above. In yet another embodiment of the present invention, the elastic elements 15, each equipped with a pawl 15.1, can each be inserted into a special through hole or special through holes made or formed in the support sleeve 14 in such a way that their pawls 15.1 are properly located and oriented in the internal cavity of the bearing sleeve 14, as described above.

According to one embodiment of the present invention, the support sleeve 14 may be provided with at least one elastic element 15 with a pawl 15.1 positioned and oriented to interact with the radial teeth 11.4 to jump over the corresponding one of these radial teeth 11.4 with each rotation or rotating the inner housing 11 to a given rotation angle corresponding to a unit dose of the drug.

In fig. 16 shows a disk-shaped element 16, put on the seating head 13.2 of the piston rod 13 (see Figs. 13 and 13a) and designed to interact with the plunger of the cartridge 4 to enable the required amount of medicine to be squeezed out of the cartridge 4.

When assembling the pen syringe 100, the retaining ring 17 is pushed or pushed onto the inner cylindrical body 11 from its proximal end until it stops against the retaining collar 11.2. Subsequently, when assembling the pen syringe 100, elastic elements 15 are secured to the carrier sleeve 14 in such a way that their free elongated parts 15.4, equipped with pawls 15.1, face at a given angle into the internal space of the carrier sleeve 14, and the tips of the pawls 15.1 are located in a circle in the inner space. space of the bearing sleeve 14 with a shift of 120°. Next, the supporting sleeve 14 with elastic elements 15 attached to it is put on the inner body 11 from the side of its distal end, ensuring that the elongated arcuate protrusions 14.3 are inserted into the corresponding arcuate holes and the arcuate hooks 14.6 are engaged with the retaining ring 17, as a result of which the supporting sleeve 14 is essentially completely surrounds the end portion 11.1 of the inner body to ensure the required position with respect to this end portion 11.1, the pawls 15.1 of the elastic elements 15 enter into proper interaction with the corresponding radial teeth 11.4, and the arcuate segments are placed in the annular space formed between the arcuate sectors 14.1 and the arcuate sectors 14.9, while the bearing sleeve 14 becomes unable to perform axial movement in the direction from the retaining collar 11.2.

Next, a piston rod 13 is inserted into the inner housing 11 with a supporting sleeve 14 placed on it from its proximal end, followed by the screw thread 13.3 of the rod being inserted into interaction with the screw thread 11.7 of the inner housing 11, which ensures that the distal end of the piston rod 13 is screwed in the axial direction in end portion 11.1 of the inner housing 11 such that a portion of the piston rod 13 projects or extends beyond the distal end of the inner housing 11, as shown, for example, in FIG. 12a.

Subsequently, the inner casing 11, equipped with a support sleeve 14, put on the inner casing 11 in the manner described above, and a piston rod 13, screwed into the inner casing 11 in the manner described above, is installed or inserted into the outer casing 1 from its proxy side

- 9 045245 small end in such a way that the protruding part of the piston rod 13 passes through the central hole 1.5 of the partition 1.4 and partially extends beyond the limits of the partition 1.4 into the first compartment of the outer housing 1. In addition, when inserting the inner housing 11 into the outer housing 1 as described above, the supporting sleeve 14 enters with its arcuate parts 14.5 into the arcuate cutouts 1.6 of the partition 1.4, ensuring the engagement of the arcuate hooks 14.4 with the partition 1.4 of the outer body 1 from the side of its first compartment, which ensures rigid fastening of the carrier sleeve 14 with the outer body 1, preventing the possibility of rotation of the carrier sleeve 14 with respect to to the outer casing 1 and the inner casing 11 and additionally preventing the possibility of axial movement of the bearing sleeve in relation to the inner casing 11 and the outer casing 1, which ultimately makes it possible to fix the required position of the bearing sleeve 14 in relation to the end part 11.1 of the inner casing 11.

It should be noted that as a result of this step in assembling the pen 100, the support sleeve 14 is located coaxially between the inner housing 11 and the outer housing 1, and the inner housing 11 becomes unable to move axially with respect to the outer housing 1. In addition, the rod insert 13 into the central hole 1.5, made in the partition 1.4 of the outer housing 1, prevents or blocks the possibility of rotation or rotation of the piston rod 13.

When further assembling the pen syringe 100, the connecting sleeve 7 is mounted or put on the drum 5 by inserting the screw edge 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 ledge 5.5 of the drum, ensuring that the limiting protrusions 5.3 snap into place. restrictive cutouts 7.2 with the possibility of exiting interaction with them, which as a result ensures screwing of the drum 5 with its distal end into the connecting sleeve 7 from its proximal end. It should be noted that as a result of putting the connecting sleeve 7 on the drum 5, it is located coaxially with the drum 5, and the dose indicator 7.5 points to the zero dose mark, which can be visible through the viewing window 7.3.

Next, 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 housing 1 so that the drum 5 is located coaxially with the outer housing 1, and the connecting sleeve 7 is located concentrically between the outer housing 1 and drum 5, while the end of the proximal end of the outer casing 1 abuts the annular ledge 5.5 of the drum, so that the head 5.1 of the drum is outside the outer casing 1 and is essentially adjacent to the proximal end of the outer casing 1. In addition, when inserting the drum 5 with a connecting sleeve 7, put on it in the manner described above, into the outer housing 1 from the distal end of this outer housing 1, the end of the distal end of the connecting sleeve 7 essentially abuts against the thrust protrusion 1.9 of the outer housing, and the locking ribs 7.1 of the sleeve engage in frictional interaction with the locking grooves 1.8 of the outer housing, ensuring that the connecting sleeve 7 is fixed in relation to the outer housing 1 in a given orientation, in which the viewing window 7.3 is aligned with the viewing window 1.1 in such a way that the dose indicator 7.5 and the dose mark of the medicinal product, to which the dose indicator 7.5 can point, are visible through viewing window 1.1 of the outer casing. Thus, the locking grooves 1.8 and the locking ribs 7.1, introduced into interaction with each other, in combination with the annular thrust protrusion 1.9 and the annular ledge 5.5, into which the corresponding ends of the connecting sleeve 7 abut, prevent the possibility of rotation and axial movement of the connecting sleeve 7 with respect to to the outer housing 1 and the drum 5. It should also be noted that the restrictive protrusions 5.3, snapped into the restrictive cutouts 7.2, prevent the possibility of unintentional rotation of the drum 5 and, accordingly, unintentional dialing or setting the dose of the drug, while restrictive protrusions 5.3 must be removed from interaction with restrictive cutouts 7.2.

Next, when assembling the syringe pen 100, the ring element 12 is screwed onto the threaded screw 10 in such a way that the ring element 12 is located coaxially with the threaded screw 10 and rests against the toothed cap 10.1 of the screw, which corresponds to the initial position of the ring element 12 on the toothed screw 10. In addition, , when assembling the pen syringe 100, the toothed screw 10 with the ring element 12, screwed onto the screw 10 in the manner described above, is installed in the cylindrical cavity 8.3 with the possibility of rotation in such a way that the installation heads 10.3 fit into the corresponding installation holes 8.4, and the radial tenon 12.1 of the ring element enters the guide groove 8.5 of the connecting tube, so that 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 cap 10.1 of the screw to the partition 8.7, while the position of the ring element 12 on the threaded screw 10 essentially corresponds to the dose of the drug specified by the user. In addition, when assembling the syringe pen 100, the ratchet wheel 9 is mounted 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.

Later, when assembling the syringe pen 100, the connecting tube 8, equipped with a ratchet

- 10 045245 forest 9, mounted on the connecting tube 8 in the manner described above, and a screw 10, equipped with a ring element 12 screwed onto it and installed in the cylindrical cavity 8.3 in the manner described above, is installed or inserted into the drum 5 from the side of its proximal end, ensuring the insertion of the guide protrusions 8.11 of the connecting tube 8 into threaded interaction with the spiral groove 11.6 of the inner body 11, which ensures that the threaded part 11.5 of the inner body 11 is screwed into the connecting tube 8 from the side of its distal end almost until the end of the distal end of the connecting tube 8 stops in the retaining ring 17. As a result of execution In this assembly operation, the connecting tube 8 is located concentrically between the inner body 11 and the drum 5.

When the drum 5 is rotated in the direction of setting or setting the dose of the medicinal product, the connecting tube 8 rotates or rotates, ensuring its axial movement relative to the outer housing 1 and the internal housing 11 and without ensuring rotation or rotation of the inner housing 11, which is blocked as a result of the interaction of one of the pawls 15 with the corresponding one of the radial teeth 11.4.

When turning the drum 5 in the direction of delivery of a given dose of the drug, it is possible to transfer at least part of the torque from the connecting tube 8 to the inner housing 11 due to the presence of a threaded connection between them, which as a result can lead to rotation of the inner housing 11 together with the connecting tube 8, wherein the inner housing 11 has a slower rotation or lower rotation speed in comparison with the connecting tube 8 in relation to the outer housing 1, which ensures that essentially only a portion of the driving force generated when the button is pressed is transmitted to the rod 13 from the inner housing 6 and, therefore, ensures that the rod 13 extends to a smaller extension, which may result in the possibility of squeezing out a smaller volume of the drug squeezed out by the rod 13 from the cartridge 4, which is especially useful when delivering drugs, in particular highly concentrated insulin.

In addition, when the connecting tube 8 is inserted with its distal end into the drum 5 by the shoulder 8.1 of the proximal end of the connecting tube 8 together with the ratchet wheel 9, they are completely located in the head 5.1 of the drum, while the part of the ratchet wheel 9 that is not equipped with rims 9.1 on its outer surface , 9.2 inclined axial teeth, is located in the annular cavity of the head and rests its end against the ends of the ratchet teeth 5.7 at the proximal end of the main part 5.2 of the drum. In addition, when inserting the connecting tube 8 with its distal end into the drum 5, the teeth of the toothed cap 10.1 of the screw interact with the ratcheting teeth 5.7 of the drum, which makes it possible to rotate the toothed screw 10 around its axis, with the connection formed by the guide groove 8.5 of the connecting tube and the radial tenon 12.1 of the annular element inserted into this guide groove 8.5 prevents the possibility of rotation of the annular element 12 around the threaded screw 10 when transmitting the torque from the drum 5 to the screw 10.

Thus, rotation of the drum 5 in the direction of setting the dose of the medicinal product, in particular in the clockwise direction, makes it possible for the pawls 5.6 of the drum to interact with the teeth of the rim gear 9.1 and the possibility of interaction of the teeth of the rim gear 9.2 with the pawls 8.2 of the connecting tube in such a way that a transformation occurs the rotary movement of the drum 5 to rotate the connecting tube 8 to ensure its axial movement relative to the inner body 11 away from its retaining collar 11.2, and the rotation of the drum 5 in the direction of delivery of a given dose of the drug, in particular in the counterclockwise direction, makes it possible interaction of the pawls 5.6 of the drum with the teeth of the ring gear 9.1 and the possibility of interaction of the teeth of the gear 9.2 with the pawls 8.2 of the connecting tube in such a way that the torque is transmitted from the drum 5 to the connecting tube 8 and further from the connecting tube 8 to the inner housing 11, which results in leads to a joint rotation of the drum 5, the connecting tube 8 and the inner housing 11 in the same direction, that is, in the counterclockwise direction, however, as described above, when the torque is transmitted to the inner housing 11, it has a slower rotation or lower rotation speed in comparison with the connecting tube 8 and the drum 5 in relation to the outer housing 1, which makes it possible to deliver an accurate dose of the drug to the site of its injection to the patient, which is of particular relevance when using highly concentrated insulin as a delivered drug.

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 one of its ends rests on the bottom of the seat 8.10. Then, a button 6 is inserted into the proximal end of the connecting tube 8, so that the button body 6.3 and the button axial pin 6.1 fit into the seat 8.10, and the button head 6.2 is located outside the drum head 5.1, with a spring (not shown) inserted into the seat 8.10 turns out to be seated or put on the axial pin 6.1 of the button, ensuring that its other end rests on the corresponding one of the horizontal ledges of the axial pin 6.1 of the button, which as a result ensures the girth of the seated button 6 and, accordingly, the possibility of returning the button 6 to its original position after it is released.

Next, when assembling the syringe pen 100, a disk-shaped element 16 is mounted or put on the head 13.2 of the piston rod, made at the distal end of the piston rod 13.

Next, when assembling the pen syringe 100, the cartridge 4 is inserted into the holder 2 from its proximal end to ensure that the cartridge head 4.1 is placed in the internal cavity of the holder head 2.4.

Next, when assembling the pen syringe 100, the holder 2 with the cartridge 4 inserted into it is inserted first into the first compartment of the outer body 1, so that the longitudinal ribs 2.8 of the holder enter into frictional interaction with the corresponding longitudinal grooves 1.3 of the outer body, the ends of the sectors 2.10 of the holder are at least at least partially rest against the partition 1.4 of the outer case, the snap protrusions 2.7 of the holder snap into the fixing slots 1.2 of the outer case, and the locking protrusions 1.7 of the outer case are inserted with emphasis into the corresponding longitudinal cutouts 2.9 of the holder, which ensures a tight fit of the first part of the holder 2 in the first compartment of the outer case 1 until the end of the distal end of the outer housing 1 abuts the collar 2.1 and provides fixation of the holder 2 in relation to the outer housing 1 in a given orientation, in which the corresponding small viewing window 2.2 and 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 locking means of the holder 2 are engaged with the above-described locking means of the outer body 1, thereby preventing the holder 2 from rotating and axially moving with respect to the outer body 1. Moreover, when inserting holder 2 in the outer housing 1, the disk-shaped element 16 interacts with the plunger of the cartridge 4 to ensure the possibility of squeezing out the required amount of medicine from the cartridge 4.

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

When using the fully assembled pen syringe 100 for the first time, the user must remove the cap 3 from the holder 2 and push or slide a needle hub (not shown) onto the cartridge head 4.1.

To establish or set the required dose of the drug, the user needs to grasp the head 5 with his fingers, in particular, if there is a grip on the head, and apply a rotating force to it in the clockwise direction, sufficient to release the restrictive protrusions 5.3 of the drum from interaction with the restrictive cutouts 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 is rotated, there will be a corresponding gradual extension of the drum 5 from the outer casing 1, as a result of which the head 5.1 of the drum, equipped with a push button 6, will be removed from the proximal end of the outer housing 1. In addition, as the drum 5 is rotated clockwise, the drum 5 will transmit, through the connection formed by the ratchet teeth 5.7 of the drum and the teeth of the toothed head 10.1 of the screw, brought into interaction with these ratchet teeth 5.7, a torque from drum 5 onto the screw 10, as a result of which the threaded screw 10 will rotate around its axis in the same direction, ensuring axial movement of the annular element 12 along the length of the threaded screw 10 from the toothed cap 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 substantially corresponds to the dose of the drug specified or dialed by the user. In addition, as the drum 5 is rotated clockwise, the user can see through the viewing window 1.1 one of the scale marks, which is indicated by the indicator 7.5 of the connecting sleeve and which essentially corresponds to the number of drug dose units set or dialed by the user. The drum 5 extending from the outer housing 1 when rotated in the direction of setting the dose of the drug will essentially pull the connecting tube 8 along with it in the direction of extension (achieved through the above-described gear connections between the drum 5, the ratchet wheel 9 and the connecting tube 8) ensuring its rotational axial movement relative to the inner housing 11 away from its retaining collar 11.2.

To deliver the required dose of the drug to the site of its administration or injection to the patient, the user of the syringe 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, compression of the spring (not shown), through which button 6 is pressed into seat 8.10. Pressing the button 6 ensures that at least part of the force applied by the user is transferred to the connecting tube 8, which in turn, in particular due to the above-described gear connections between the drum 5, the ratchet wheel 9 and the connecting tube 8, causes the connecting tube 8 to rotate together with drum 5 in a counterclockwise direction, that is, in the direction of delivery of a given dose of the drug. The connecting tube 8, thanks to the above-described threaded connection between the connecting tube 8 and the inner casing 11, transmits a torque to the inner casing 11, which leads to the rotation of the inner casing 11 together with the connecting tube 8 in the counterclockwise direction, while the inner casing 11, thanks to a specially specified or selected spiral pitch of the groove 11.6 of the inner housing 11, interacting with the mating guide protrusions 8.11, has a slower rotation or lower rotation speed in comparison with the connecting tube 8 in relation to the outer housing 1, to which the torque is transmitted from the drum 5.

The rotation of the inner body 11 around its axis in turn provides, thanks to the above-described threaded connection between the inner body 11 and the piston rod 13 and the above-described means for locking the possibility of rotation of the piston rod 13, axial movement of the piston rod 13, equipped at its distal end with a disk-shaped element 16, with the displacement of the drug from the cartridge 4, which occurs due to the pushing force applied by the disk-shaped element 16 to the plunger (not shown) of the cartridge 4 from the proximal end of this cartridge 4. It should be noted that the slower rotation of the inner housing 11 in comparison with the connecting tube 8 in relation to the outer housing 1 essentially results in the fact that only part of the driving force created by the user when pressing the button 6 is transmitted to the rod 13, which allows the rod 13 to be extended by a small amount and, therefore, a smaller volume of medicinal product is squeezed out of the cartridge 4. Thus, it is possible to increase the accuracy of the volume of the dose delivered to the site of its injection to the patient, in particular due to more accurate extrusion of the dose by the rod 13 from the cartridge 4.

In other words, as described above, the inner housing 11 in the pen 100 functions as a drive mechanism and is essentially a drive tubular piece that converts the rotation of the drum 5 into an axial movement of the piston rod 13 due to the above-described functional connection formed between the drum 5 , the inner body 11 and the piston rod 13. Thus, the push button 6 makes it possible to create a driving force, which is subsequently transmitted, through the drum 5, functionally connected to the connecting tube 8, to the connecting tube 8, then from the connecting tube 8, functionally connected with the inner housing 11, onto the inner housing 11 and then from the inner housing 11 operatively connected to the piston rod 13, onto the piston rod 13 for its axial movement away from the proximal end of the inner housing 11, the amount of axial movement of the rod 13 being substantially equal to the dose of the drug specified or dialed by the user. As a result, the axial movement of the piston rod 13 when turning the drum 5 in the direction of delivery of a given dose of the drug leads to the advancement, through the disk-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 site 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 advance the plunger of the cartridge 4, depend solely on the dose level of the drug in dose units previously set by the drum 5, as described above.

It should be noted that when 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, occurs, in particular, rotation or rotation of the inner housing 11 and, consequently, the interaction of the pawls 15.1 of the elastic elements with the corresponding radial teeth 11.4 of the inner housing depending on the size of the dose of the drug specified or dialed by the user to be delivered to the site of its injection to the patient, ensuring at least one jump of at least one of the dogs 15.1 along the corresponding radial teeth 11.4, while the jumping of the dogs 15.1 along the corresponding radial teeth 11.4 occurs sequentially or alternately, resulting in the ability to generate sound in the form of clicks or other popping sounds audible to the user. Thus, in the case of turning the inner housing 11, for example, by 24°, every 6° of rotation, one of the pawls 15.1 jumps along the corresponding one of the radial teeth, while the pawls 15.1 jumps in a sequential order or alternately: first, when turning the first 6 ° one of the pawls 15.1 jumps over creating the first click, then when turning the next 6° the other pawl jumps over from

- 13 045245 pawls 15.1 with the creation of a second click, then when turning the next 6°, the remaining pawl from pawls 15.1 jumps, creating a third click, and when turned to the remaining 6°, another pawl from pawls 15.1 jumps, the jumping of which initially caused the creation the first click, creating a fourth click, causing one of the pawls 15.1 to make two hops, and each of the other two pawls 15.1 to make one hop, thus creating four consecutive clicks. The sound accompaniment of the transition of the tip of one of the pawls 15.1 through the top of a particular one of the radial teeth 11.4, created as the inner body 11 is rotated in the mode of delivering a given dose of the drug to the injection site of this dose to the patient, generally represents sound signals in the form of clicks and crackles, produced by the pen 100, which allows a user, particularly a visually impaired or inattentive user, to monitor, through hearing, the progress of the delivery of a predetermined dose of drug to an injection site on the patient's body. Thus, the radial teeth 11.4 of the inner body, in combination with the elastic elements 15, each provided with a pawl 15.1 configured to engage a corresponding one of the radial teeth 11.4 of the inner body, form an essentially sound-generating mechanism or sound feedback mechanism indicating to the user, by means of audible sound signals in the form of clicks or crackles, to begin, continue and/or complete the process of delivering a given dose of the drug to the injection site.

It should also be noted that in the present invention, at least one of the following structural parts of the proposed pen 100 may be formed as a cylindrical part, a cylindrical element, a cylindrical body, a tubular body, a tube, a tubular element, a tubular part, a sleeve , sleeves or the like: outer casing 1, inner casing 11, drum 5, connecting tube 8 and support sleeve.

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

Claims (4)

1. Device (100) for drug delivery, comprising a housing (1); a reservoir (4) for a medicinal product installed in the housing (1); rod (13), at least partially installed in the housing (1) with the ability to move so as to allow the drug to be displaced from the specified reservoir (4); a trigger mechanism (6) configured to create a driving force; mechanism (5) for setting the dose, installed at least partially in the housing (1) with the ability to set the dose of the medicinal product and functionally connected to the trigger mechanism (6) with the ability to rotate the mechanism (5) for setting the dose when the trigger mechanism is activated (6), characterized in that it additionally contains a connecting tube (8) functionally connected in the housing (1) to the mechanism (5) for setting the dose, allowing the connecting tube (8) to rotate when turning the mechanism (5) to set the dose ; and a driving tubular part (11), which is inserted in the housing (1) into threaded interaction with the connecting tube (8) to allow the driving tubular part (11) to rotate when turning the connecting tube (8) and which is functionally connected to the rod (13) with the possibility of transmitting at least part of the specified driving force to the rod (13) for its movement depending on the given dose of the medicinal product. 2. The device according to claim 1, in which, to ensure the specified threaded interaction between the drive tubular part (11) and the connecting tube (8), at least part of the drive tubular part (11) is provided on its outer side with a spiral groove (11.6), and The connecting tube (8) is equipped on its inner side with matching guide protrusions (8.11). 3. The device according to claim 2, in which the helical pitch of said helical groove (11.6) is set in such a way that the driving tubular part (11) has a lower rotation speed relative to the body (1) than the connecting tube (8). 4. Use of a drug delivery device (100) according to any one of claims 1 to 3 for injection of a drug selected from the group consisting of insulins, insulin analogues, hormones, heparins, antihistamines and their derivatives and analogues.