SI8811574A - Insufflator for giving powder medicines, previous dosed in capsules - Google Patents

Abstract

An insufflator for administering medication in the form is described powder previously dosed into capsules consisting of body that has an air inlet opening and practical vertical air outlet duct carrying the drug in shape powder, as well as from a composition with opposite positions needles of a known capsule punching type, wherein said capsule placed in a suitable bay. The bearing is located in an element that can rotate according to said body. The specified rotating element may occupy at least two different positions; first position, v by which the capsule can be axially punctured by the above opposite positioned, practically horizontal needles; and the second position, 90 degrees facing relative to the first position in which the openings are located is indicated on opposite sides of the capsule coaxial with the foregoing air outlet ducts.

Description

INSUFLATOR FOR THE ADMINISTRATION OF DUSTED MEDICINES PRE-DOSAGEED IN CAPSULES

The present invention relates to insufflators for the administration of medicines in the form of the finest (micronized) powder and previously dosed into capsules made of hard gelatin or other non-toxic material. Said insufflators have a capsule puncture element, through which a stream of air is then passed through which removes the powder from the capsule and serves as a delivery agent. Air current is produced by a suitable hand pump.

Several types of insufflators are known in which the capsule (operculum), which contains a drug in the form of micronized powder, in an amount such that it takes up about 1/3 of the internal volume of the capsule, is placed in a convenient tray inside the apparatus and then punctured or otherwise opened as a stream of air would flow through the tray and pull out the spraying drug.

Said puncturing element consists of one or more needles, typically two coaxial needles arranged opposite, to make two openings in the capsule, on the opposite side, for the air flowing through them and to extract the drug contained in the capsule. See, for example, U.S. patent 3 906 950 in which the needles are oriented vertically. Such an insufflator, however, in addition to being very complicated, has the disadvantage of friction which, when the capsule is punctured with two oppositely oriented, vertical needles from the puncture element, a noticeable amount of powder, due to the combined effect of the force of gravity acting on the powder in the capsule and the pulling force by which the lower needle acts on the powder being discharged from the capsule is dropped from the capsule. The action of the air current produced by the lower hand pump in this case is not directed so as to completely withdraw all the powder that has fallen out of the capsule, resulting in the loss of the dusted drug. Moreover, in the long run, the powder precipitates especially in the pump, causing the insufflator to be cleaned periodically. ,

A similar but far simpler insufflator was manufactured by FISION LIMITED, England, under the trademark RINOFLATORE. It consists of a single upwardly oriented puncture needle which is coaxial with the capsule ' and air current. The needle is, in fact, long enough to pierce the capsule from side to side. This insufflator exhibits the same, if not greater, defects than previously described, in terms of powder exiting the lower orifice and accumulating inside the apparatus. This is further confirmed by the fact that, with this insufflator, there is also a brush on the market for erasing the powder that is collected in the interior.

The following known apparatus is described in U.S. Pat. patent 4 013 075 and can be used both as an inhaler and as an insufflator. In this apparatus, the capsule is also vertically oriented and parallel to the outlet for air current. The capsule opens by cutting off two caps located on opposite sides. As before, in this apparatus a noticeable amount of powder is lost when the caps are cut off at the ends of the capsule.

It is an object of the present invention to provide an insufflator for the administration of powdered medicaments which have previously been dosed into capsules, the insufflator being made readily and allowing the use of all the powder contained in the capsule in practice.

Said objectives are achieved by an insufflator according to the present invention, consisting of a body having an air inlet and essentially a vertical air outlet carrying the spraying drug, as well as an element consisting of two opposite-known needles for punching a capsule. wherein said capsule is positioned in a suitable tray. The invention is characterized in that the capsule holder (operculum) is made in an element that can rotate and occupy at least two different positions with respect to said body: a first position, or a capsule puncture position, in which the capsule can be axially punctured opposite to the arranged, practically horizontal needles of said punching element; and a second position, or ejection position, which is substantially 90 ° rotated relative to said first position, wherein the opposite openings made in the capsule are now coaxial with said input-output channel; in the said second position is the lower end of the air outlet duct in communication with the top of the capsule bay, while the bottom of said bay is in communication with the air inlet port.

With the insufflator of the invention, the capsule is punctured while the rotating element is in the first position, preventing the powder from falling out of the capsule. during puncture due to the pull force of punching needles acting on the powder in it. ,

The rotating element is then rotated 90 ° to bring it to said second position so that the opposite openings in the capsule become coaxial with the air outlet. The capsule bearing, as well as its interior (the capsule is now pierced), are in contact with the air inlet as well as the outlet duct.

In fact, a small amount of powder can escape from the lower capsule opening when the rotating element rotates 90 ° and returns to its second position. This amount of powder, however, is very small, since the effect of onions occurs in the mass of the powder particles over the lower capsule opening. Thus, only those particles that are below the arch or, rather, below the dome formed above the lower opening, can fall out. The diameter of the opening will, of course, be the smallest possible while satisfying the need to pass a sufficiently strong stream of air to extract the powder from the capsule. According to Torn, the amount of powder escaping from the capsule is practically negligible, and in any case significantly smaller than when the capsule is punctured with vertically directed needles.

From the foregoing it is possible to understand how simple and easy the insufflator of the present invention is to make and use.

In particular, a rotating element comprising a capsule tray. may conveniently be a circle. and be placed in a suitable circular recess made in the body of the insufflator. The various parts of the insufflator may be made of non-toxic thermoplastic material.

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In the insufflator according to the invention, the air inlet will be in communication with a conventional hand pump, preferably consisting of a container made of non-toxic elatstomer, the interior of which is in communication with the air inlet. The said container is provided with a non-return or safety valve for the purpose of extracting ambient air.

A similar valve can also be fitted at the air inlet so that the specified small amount of powder prevents it from falling into the elastomer container.

The insufflator body according to the invention may preferably be provided with a lifting element in order to lift said rotary member from the body and thereby facilitate capsule placement. Said lifting element may be a simple externally operated pusher, say a button, with the pusher acting on the inside of the rotating member. Pressing a finger on such a button is sufficient to remove the moving element and to facilitate its repositioning.

- 4 The turntable may, for its part, also have a similar lifting element, designed to remove emptied capsules from the tray.

The capsule can also be positioned without the need for a rotating element to be lifted from the insufflator body. Alternatively, it may be possible to position the lid while the rotating member is in the third position, in which the capsule bearing is coaxial with a radial mounting opening made in the insufflator body. The diameter of such aperture is large enough to allow the capsule to be placed in its tray. In this case, the ejection of the emptied capsule may be facilitated by the installation of a lifting element of said type suitable to radially eject the emptied capsule through said mounting opening after the rotating member is repositioned in said third position.

The invention will be more easily understood by the following description of an illustrative, non-limiting embodiment, together with the accompanying drawings, in which:

1 is a front view of an insufflator of the present invention provided with a protective cover;

- Figure 2 is a side view of the same insufflator;

- Figure 3 is a top view of the same insufflator;

- Figure 4 is a partial, enlarged cross-section along line IV-IV in Figure 3;

5 is a partial, enlarged cross-section along line V-V of FIG. 1; and *

6 is a less enlarged cross-section along line VI-VI in FIG.

In Figures 1, 2 and 3, the external appearance of the insufflator according to the present invention can be seen. In particular, 1 represents a container made of a non-toxic elastomer which acts as a pump to be operated manually by pressing said container 1. It is provided with a non-return or safety valve 2, sketched in the drawings, which allows the elastic container 1 to be pressed after pressing. filled with air. Pressing the elastic container 1 creates the air current required to operate the insufflator.

Figures 1, 2 and 3 also show a removable cover 3 enclosing the insufflator body. In said cover 3, a slit 4 is made through which a pen 5 is provided, the function of which will be explained below.

Figures 4, 5 and 6 show how the interior of the insufflator is made. It is composed of a body 6 with an inlet duct 7 for air in communication with

- 5 to the inside of the container 1. The body 6 also has an outlet duct 8 for air containing the drug powder. In the illustrated embodiment, the exit channel 8 is provided with an adapter 9 whose upper end is anatomically shaped to allow the drug powder to be aspirated through the nostrils.

Both the inlet channel 7 and the outlet channel 8 are, through openings 10, 11, in communication with the central cylindrical cavity 12 (Figures 516) made in the body 6, into which a circular element 13 can be placed from the outside. can be rotated in the cavity 12. The rotating element 13 has a diametrical bay 14 into which a hard gelatin capsule (operculum) 15 can be placed. The capsule contains a medicine in the form of micronized powder. The bearing 14 on the axially opposite sides has two openings 16, 17, which contact said respective openings 10 and 11 when said pivot element 13 is in the position shown in Figures 4, 5 and 6, i.e. in the so-called second position. Thus, when the rotating element 13 is in the second position, the bearing 14 is in communication both with the inlet channel 7 and through it with the pump 1 and with the outlet channel 8.

The rotating element 13 can rotate between two positions, that is, between a position already called the second position and a position that is rotated 90 ° relative to said second position, which we will call the first position. When the rotating element 13 is in its first position, the openings 16, 17 are coaxial with two opposite needles 18, 19 which are attached to the button 20, 21, and they can be pushed horizontally to one another through opposite sliding openings 22, 23 made in body 6. Buttons 20, 21 are provided with return springs 24, 25.

When the rotating element 13 is in its first position of the buttons 20 and 21, pushing the needles 18, 19 through the corresponding openings 26, 27 made in the wall of the cavity 12 and through said corresponding openings 16, 17, thereby penetrating the capsule 15 previously inserted into its bearing 14 , at the top of both spherical caps of said capsule. Thus, two opposite and virtually coaxial openings are made on the capsule. After turning the rotary element 13 to its second position, said openings come, together with the openings 16 and 17 of the bearing 14, into the same axis with the corresponding openings 10 and 11 which are in communication with the inlet duct 7 and the outlet duct 8 for air. Thus, a straight, vertical path for air current is provided, coaxial with capsule 15.

- 6 A plate pusher 28 is mounted at the bottom of cylindrical cavity 12 (Figures 5 and 6). Said thrust is attached to one end of the handle 29 extending through an opening 31 made at the back of the body 6. A button 30 is secured from the other end of the handle 29.

The assembly consisting of the plate 28, the handle 29 and the button 30 is a device for ejecting and easily removing the rotating element 13 from the cavity 12. By pushing the button 30, the rotating element 13 is actually pushed outwards, which facilitates its removal from the body 6 When the pivot element 13 is removed, it is easy to place the capsule 15 in the tray 14.

From Figures 4 and 6 it can be seen that the tray 14, on both side walls, preferably has several protrusions 32 by means of which the capsule 15 is held in its position within the tray 14. The protuberances 32 condition that the capsule 15 must be inserted into the tray 14 with slight pressure. This prevents it from falling out accidentally during insufflator charging.

The insufflator is also provided with an element for ejecting the capsule from the rotating element 13 (see Figures 5 and 6) after use. The ejection element consists of a saddle-shaped pusher 34 which is mounted on the bottom of the tray 14 (see Figures 6 and 5). The saddle 34 is connected to an outer pen 5 which passes through a slot 36 made on the outer side of the rotating element 13. The pen 5 is attached to the saddle 34. When the rotating element 13 is ejected from the cylindrical cavity 12, it is possible to gently press the vertical edge 35 of the pen 5 , eject the powder capsule 15. Pen 5 is also used to rotate the rotating element 13 to the desired position, as well as to grasp the rotating element 13 during extraction.

As indicated, the insufflator of the present invention can conveniently be made of a non-toxic plastic material that is thermally treated, while an elastic container 1 acting as a pump is made of a non-toxic elastomer. Springs 24 and 25 and pins 18 and 19 can be made of a suitable non-toxic plastic material or metal.

Although the operation of the insufflator should be evident from the description and drawings so far, we will briefly describe it in order to provide a better understanding.

The first step obviously consists in removing the protective cover 3. Then the rotating element 13 is removed from the cavity 12 of the body 6; the capsule 15 is inserted into the tray 14 in the rotating element 13; the rotating element 13 is positioned in the cavity 12 while simultaneously positioning the element 13, by means of the pen 5, in the first position in which the openings 16 and 17 on the rotating element 13 are coaxial with the needles 18 and 19; press the button 20, 21 to push the capsule 15 axially on both sides; the rotating element 13 is brought to its second position by means of a pen 5 (i.e. rotated 90 °), thereby opening the openings 16 and 17 to the openings 10 and 11; adapter 9 is inserted into the desired cavity (for example in the nostril), or its outlet is positioned near the surface to be treated; press the elastic container 1 several times; the rotating element 13 is removed again; the empty capsule 15 is removed from it by gently pressing the edge 35 of the pen 5; the rotating element 13 is mounted in the cavity 12; and the protective cover 3 is returned again.

From all of the above it is easy to conclude that it has a very simple structure and that it is also simple and reliable and not apparatus from earlier science.

that the insufflator of the present invention is easy to manufacture. The way they used it led to the disadvantages they had

Claims (10)

Claims 1. An injector for the administration of pre-dosed capsule-shaped medicaments consisting of a body having an air inlet and a virtually vertical air duct carrying the powder drug, as well as a composition with two opposite-positioned needles of a known type for enclosing a capsule, wherein said capsule is housed in a suitable housing, characterized in that the capsule seat is positioned in an element which can be rotated relative to said body, and said element can occupy at least two positions a first position or position for punching a capsule in which the capsule can be axially punctured by means of two oppositely positioned, practically horizontal needles of said punching assembly; and a second position, practically 90 ⁰ is rotated relative to said first position in which the openings are penetrated on opposite sides of the capsule coaxial with said output channel and in which the lower end of the outlet channel in conjunction with the top bed of the capsule, while is the lower end of said cot in conjunction with the air outlet. 2. An insufflator according to claim 1, characterized by te®, that the rotary element can be detached from said body. An insufflator according to claim 2, characterized in that the rotary element is housed in a cylindrical cavity within said body and is coaxial therewith. An insufflator according to claim 3, characterized in that a pusher is disposed in the lower part of the cylindrical cavity, which is movable parallel to the axis of rotation of the rotating element and which can be moved from the outside of the body in order to - 2 facilitated the separation of the rotating element from said body. An insufflator according to claims 2 to 4, characterized in that a pusher is mounted on the bottom of the capsule bay which is movable parallel to the axis of rotation of the rotating element and which can be moved from the outside of said rotating element to eject an empty capsule from its cradle when the rotating member is separated from said body. An insufflator according to any one of the preceding claims, characterized in that the rotary element is provided with a spring extending outwards to facilitate rotation of said rotary element. An insufflator according to claims 5 and 6, characterized in that said spring is secured to said pusher to eject the capsule from its cradle. 8. The insufflator according to claim 1, characterized in that the rotatable member can occupy a third position in which the capsule bearing is coaxial with a radial opening to accommodate the capsule made in the body of the insufflator, wherein the diameter of said opening is positioning the capsule large enough to accommodate the capsule in its place. An insufflator according to claim 8, characterized by the test that a pusher is mounted in the insufflator body which is movable vertically to the axis of rotation of the rotating member and which can be moved from the outside of said body to facilitate ejection of the empty capsule through said mounting opening when the rotary member is in said third position. An insufflator according to any one of the preceding claims, characterized by the fact that * a non-return or safety valve is provided at the air inlet -3Dust leakage through said opening