RU2659632C1 - Device for foaming and administering a medicament - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine and is intended to create a foam of a medicament and introduce it into a vein or cavity of an organ and can be used in vascular surgery for sclerotherapy, for example, “vascular asterisks”. Object of invention is to eliminate the drawbacks and simplify the device for preparing the sclerosing foam according to the Tessari method. Device is represented by a cylinder, the open end of which is closed by a lid with a finger rest and retainers that coincide with the recesses on the outer wall of the cylinder, and at the closed end of the cylinder there is a conical protrusion with a through hole having an expansion, which opens into the cavity of the cylinder and contains a dissector in the form of a cruciform plate with capillaries opening under it, which communicate with an air channel extending in the thickening of the cylinder wall, having an expansion at the open end of the cylinder with rounded convex ends congruent with rounded ends of a cylindrical shutter with a lever, which at right angles is rigidly fixed to the wall of the shutter and exits through the longitudinal slit in the walls of the cylinder and the cover. In addition, the expansion communicates with the cylinder cavity and out through the opening that passes through the bottom of the lid. Use of the technical solution optimizes formation of the sclerosing foam by simplifying the design of the device. Use of the device eliminates the use of additional devices (syringes and a special three-component tap).

EFFECT: use of the device allows to increase antimicrobial protection due to the reduction in the amount of movement of the sclerosing drug.

5 cl, 3 dwg

Description

The invention relates to medicine, and is intended to create a foam of a medicinal product and inject it into a vein or body cavity, and can be used in vascular surgery for sclerotherapy, for example, “spider veins”.

It is known that foam of a sclerosing preparation (ethoxysclerol or fibrovane) is prepared according to the Tessari method [2, 3, 11], which includes a device from two syringes, a special three-component tap and a container with a sclerosing preparation. For the formation of foam (a mixture of sclerosing drug and air in a ratio of 1: 4), the surgeon manually performs 10-20 pumpings of the drug to form high-quality foam. In addition to air, biocompatible gases such as CO _{2 are used} .

When analyzing patent sources, it was found that devices with a different design are used, which has the form of a syringe with hermetic reservoirs with different substances and a piston mechanism, which includes a piston chamber, a piston, and a piston rod [4-10].

Known devices do not meet the requirements of the task in connection with the design features that do not allow foaming sclerosing drug.

Close to the proposed device is a technical solution according to the patent of the Russian Federation 2246321, A61M 5/178, publ. 02/20/2005 [6], which is made in the form of a syringe with sealed tanks and a piston mechanism, including a piston cylinder, a piston and a piston rod. In the lumen of the piston cylinder, a device for communication between the tanks is made, including a sequentially separating piston and a compression device in the form of a housing or frame made in the projection of its outer cylindrical part around the perimeter. The hollow internal clearance of the housing or frame is made with the exit to the projection of the piston, inward from its outer perimeter. The separation piston is made with the possibility of simultaneously forming two connections with the piston cylinder and the compression device, as well as with the possibility of moving into the lumen of the compression device with simultaneous compression or shape change. The compression device is configured to create a message between the tanks.

A significant disadvantage of the prototype [6] is the inability to form a foam from a sclerosing drug. In addition, aseptic and antiseptic disorders are possible when filling the cylinder of a foam prepared from a different method from a sclerosing preparation.

The task of the invention is to remedy the shortcomings and simplify the device for the preparation of foam sclerosing drug according to the Tessari technique.

In FIG. 1-3 - illustrations to the description of the device for foaming a drug:

in FIG. 1 - general view of the device;

in FIG. 2 - the internal structure of the device in a longitudinal section;

in FIG. 3 - the internal structure of the device at cross sections (AA ¹ , BB ¹ , CC ¹ , DD ¹ and EE ¹ ).

The design of the proposed device includes a cylinder (1) made of a transparent material (Fig. 1), the open end (2) of which is closed by a cover (3) (Fig. 2) with latches (4) that are combined with recesses on the outer wall of the cylinder (1 ) In the cavity of the cylinder (1) there is a piston (5), the distal end of which has the form of a convex hemisphere (Fig. 2), to which the piston rod (6) is rigidly fixed, passing through the hole of the cylindrical protrusion (7) of the inner surface of the cover (3), having a finger rest on the outer surface (8). The free end of the piston rod (6) is also provided with a finger rest (9). At the closed end (10) of the cylinder (1) is a conical protrusion (11) for the needle (Figs. 1 and 2). The through hole (12) of the conical protrusion (11) has an extension (13), inside of which there is a divider (14) in the form of a cross-shaped plate (Fig. 3, section AA ¹ ). Through the hole (15), the extension (13) communicates with the cavity of the cylinder (1). In the expansion (13) under the divider (14), capillaries (16) open, which communicate with the air channel (17) (Fig. 2 and Fig. 3, section AA ¹ ). The air channel (17) passes in the thickening (18) of the cylinder wall (1) to its open end (2) (Figs. 1, 2 and 3 of section AA1, BB1, CC1 and DD1). The air passage (17) ends with an extension (19) with rounded convex ends (Fig. 3, section DD ^1), which are congruent with the rounded ends of the cylindrical shutter (20) with a lever (21) (Figs. 2 and 3 are sectional DD ^1), which rigidly fixed at right angles to the cylindrical shutter (20) and goes out through the longitudinal slot (22) in the walls of the cylinder (1) and cover (3) (Figs. 1, 2 and 3, section DD ¹ ). The expansion of the air channel (19) through the hole (23) communicates with the cavity of the cylinder (1) and through the hole (24) passing in the bottom of the cover (3), to the outside (Fig. 2 and 3, section DD ¹ and EE ¹ ). The convex hemisphere at the distal end of the piston (5) is made to prevent the possibility of overlapping holes (23) communicating the cylinder cavity (1) with the expansion (19) of the air channel (17) when moving the piston (5) to its extreme rear position (Fig. 2) . The total cross section of the capillaries (16) is several times smaller than the cross section of the air channel (17), and the diameter of the hole (15) connecting the extension (13) with the cylinder cavity (1) is smaller than the diameter of the through hole (12) of the conical protrusion ( eleven). To improve the quality of the foam in the cavity of the cylinder (1), the air can be replaced with CO ₂ gas by pumping it through the hole (24) in the cover (3), which at the outlet has a cone-shaped extension for the CO ₂ container connector.

Device Operation Algorithm

The device is sterilized in a blister pack and used once. A cylinder shutter (20) closes the hole (24) and opens the hole (19) for air from the cylinder (1) to enter the air channel (17) when moving the piston (5) towards the open end (2) of the cylinder (1). After inserting a needle into an ampoule (vial) with a sclerosing preparation (ethoxysclerol or fibrovane), the 1-3 fingers of the left hand hold the palm rest (8), and 1-3 fingers of the right hand begin to tighten the piston rod (6) together with the piston (5 ), which increases the pressure in the cavity of the cylinder (1) distally from the piston and the air rushes into the air channel (17), and then with great pressure into the capillaries (16) and into the expansion (13), filled with a solution of a sclerosing drug, which divider (14 ) is divided into several streams, which improves the quality of nivaniya drug. The increase in air flow in the capillaries (16) is due to their smaller total cross section than the cross section of the air channel (17), and the slow emptying of the expansion (13) into the cylinder cavity (1) is associated with a large diameter of the through hole (12) of the conical protrusion (11) than the diameter of the hole (15) connecting the extension (13) with the cavity of the cylinder (1). After foaming the sclerosing preparation, the surgeon blocks the communication of the cylinder cavity (1) with the air channel (17) by moving the lever (21) towards the blind end (10) of the cylinder (1). Then, after closing the opening (19) of the air channel (17) with a cylindrical shutter, sclerotherapy of the intradermal veins is performed.

Positive effect

The use of the proposed technical solution optimizes the foam formation process of the sclerosing drug by simplifying the design of the device. The use of the device eliminates the use of additional devices (syringe and special three-component tap). The use of the device allows to increase antimicrobial protection due to a decrease in the amount of drug movement from the device to the container with a sclerosing drug.

Sources of information taken into account

1. Copyright certificate 1393435, A61M 11/02, publ. 05/17/1988.

2. Kirienko A.I., Bogachev V.Yu., Zolotukhin I.A. Compression sclerotherapy (a practical guide for doctors) / Ed. Academician of RAS and RAMS B.C. Savelyeva / A.I. Kiriyenko, V.Yu. Bogachev, I.A. Zolotukhin. - M.: Publishing House of the NCCSSH im. A.N. Bakuleva RAMS, 2004 .-- 40 p.

- 2009. - №4. - С. 12-19.3. Mishalov V.G. The main aspects of the treatment of various manifestations of varicose veins through the use of sclerosing foam / V.G. Mishalov, I.I. Teslyuk //

- 2009. - No. 4. - S. 12-19.

4. US patent 5785682, A61M 5/178, publ. 07/28/1998.

5. RF patent 2183111, A61J 1/06, publ. 06/10/2002.

6. RF patent 2246321, A61M 5/178, publ. 02/20/2005.

7. RF patent 2264231, A61M 5/178, publ. 11/20/2005.

8. Patent RU 2356508, A61B 17/56, publ. 05/27/2009.

9. RF patent 2530667, A61M 5/178, publ. 10/10/2014.

10. Patent for utility model RU 23387, A61J, publ. 06/20/2002.

11. Kharitonova S.E. The choice of sclerotherapy method in the treatment of patients with varicose veins of the lower extremities: the dissertation ... candidate: 01/14/17 / Haritonova Svetlana Evgenievna; [Place of defense: National Medical and Surgical Center. N.I. Pirogov of the Ministry of Health of the Russian Federation]. - Moscow, 2016 .-- 111 s.

Claims (5)

1. A device for foaming and administering a drug, made in the form of a syringe with sealed reservoirs and a piston mechanism, characterized in that it is represented by a cylinder, the open end of which is closed by a lid with an emphasis for fingers and clamps, which are combined with recesses on the outer wall of the cylinder, and at the closed end of the cylinder there is a conical protrusion with a through hole having an extension that opens into the cylinder cavity and contains a divider in the form of a cross-shaped plate with openings on by capillaries that communicate with the air channel passing in the thickening of the cylinder wall, and the air channel at the open end of the cylinder has a cylindrical extension with rounded convex ends, congruent with rounded ends of the cylindrical shutter, placed in the expansion of the air channel and having a lever that is under the direct the angle is rigidly fixed on its wall with the exit through the longitudinal slot in the walls of the cylinder and the cover, in addition, the expansion of the air channel can communicate with the cavity cylinder and through the hole passing in the bottom of the cover, out. 2. The device according to p. 1, characterized in that the piston rod passes through the hole of the cylindrical protrusion rigidly aligned with the inner surface of the cover, and the free end of the piston rod has a palm rest. 3. The device according to p. 1, characterized in that the distal end of the piston is made in the form of a convex hemisphere to prevent the possibility of overlapping holes that communicate with the cylinder cavity with the expansion of the air channel when moving the piston to its extreme rear position. 4. The device according to claim 1, characterized in that the total cross section of the capillaries is several times smaller than the cross section of the air channel, and the diameter of the hole connecting the extension of the hole of the conical protrusion to the cylinder cavity is smaller than the hole of the conical protrusion. 5. The device according to p. 1, characterized in that to improve the quality of the foam in the cylinder cavity, the air can be replaced by CO ₂ gas pumped through an opening in the bottom of the lid, which at the outlet has a cone-shaped extension for the container connector with CO ₂ .

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