MXPA96004633A - Valve for inhalac devices - Google Patents

Abstract

The present invention relates to a valve assembly for an inhalation device, characterized in that it comprises: a housing comprising a first part having an inhalation perforation extending therethrough, and a second part having a perforation of Inhalation and an exhalation perforation extending therethrough, wherein the first and second portions are operatively coupled so that the inhalation perforations form a continuous inhalation channel and the exhalation perforation forms an adjacent and separate ezhalation channel. to the inhalation channel, a first valve placed in the inhalation channel, the first valve is shifted to a closed position and opened by an inhalation force, a second valve is placed in the exhalation channel, the second valve is shifted to a closed position, and opened by an exhalation force, and inhalation perforations and d and exhalation are placed so that when inhaling a patient, air passes through only the inhalation channel and as the patient exhales, air passes through only the exhalation channel.

Description

VALVE FOR INHALATION DEVICES FIELD OF THE INVENTION The present invention relates to a valve designed to be used in particular in inhalation devices having a container, a so-called separator. The valve has a housing comprising a first part that is adapted to be mounted on an outlet opening of the body of the inhalation device, a second part on which a buccal part or a mask can be mounted to the face, the first and second parts with a hole defining an inhalation channel, a first membrane provided in the inhalation channel and a second membrane, as described in the preamble of claim 1. Such a device is described in British Patent GB 2,230,456. In particular, the invention relates to a separating device to be attached to a metered dose inhaler, a so-called aerosol device for use in the treatment of infants and young children. With reference to bronchial diseases, REF: 23196 such as bronchitis and asthma, between young children and infants, it is a problem to make them inhale the medicinal substances. When asthma for example makes its appearance among young children such as infants from 6 months to 4.5 - 5 years, it is especially difficult to have children inhale the prescribed medicinal substances, properly in the proper way. It is also a wish among parents that the devices used should be easy to use, as much as possible.

BACKGROUND OF THE INVENTION People suffering from bronchial diseases such as asthma, have a limited lung capacity and the strength of breathing is limited. This is even more apparent when the patient is a small child or an infant. It is therefore of paramount importance that a device that is designed for use by a small child or infant is constructed in a manner that reduces the inhalation force and the ability to inhale the required amount of substance. It is also important that the puff volume be small, and that the dead space, for example, the space defined between the valve outlet / inlet outlet and the outlet of the valve / mouth piece / face mask, be as small as possible in order to avoid or at least minimize the rebreathing of the exhalation air, for example, C02. It is therefore important that the valve mounted on the separator at its outlet opening be constructed in a manner that gives the smallest possible resistance and minimum dead space, and that it works in the required manner, also when subjected to forces of weak inhalation.

BACKGROUND OF THE INVENTION Several different devices have been developed to be used for inhalation treatment in young children and infants. Most of them are stationary devices that have to be placed in hospitals, and which are expensive and complicated. These often act with pumps that provide a flow of air for the infant to inhale, which means that no force is required at all from the infant. These devices have shown to be very good. A stationary device shows a number of inconveniences for the user, and in the case of small children and infants, also for the parents. As the capacity of inhalation of an infant is limited, the administration will consume time, which of course is also an inconvenience. Devices known in the prior art are provided with one-way valves to prevent the exhalation air from entering the separator body. These valves require a certain inhalation flow to open and a small child or infant is not able to generate the inhalation flow required to open the valve in the proper manner. In US Patent No. 5,012,803 a separator is described having a thin diaphragm of plastic or elastomeric material, provided in the inhalation channel, acting as an inhalation valve and an exhalation valve located in a specially designed face mask. No special efforts have been made in order to minimize dead space inside the valve, and this space is not designed for use by young children or infants. British Patent GB 2,230,456 describes a separator for young children. This is provided with an inhalation valve and an exhalation valve. The inhalation valve comprises? N. disc that is diverted to a closed position e which the latter rests against an annular seat by means of a spring. Other types of inhalation valves could be used, such as for example a conical diaphragm valve. The inhalation valve must be constructed in such a way that it opens as soon as the pressure on the outlet side is less than the pressure on the inlet side, and the difference must be low. The exhalation valve comprises a disk trapped inside a cylindrical chamber. Valves known in the prior art have various drawbacks. These are constructed with and parts that are complicated to assemble and expensive to produce. In the valve described in the aforementioned British Patent GB 2,230,456, the inhalation valve and the exhalation valve are both mounted within the same chamber. No efforts have been made in this construction to minimize dead space. On the contrary, due to the construction with a separate exhalation valve provided within the same chamber as the inhalation valve, the dead space is increased. In addition, the inhalation valve comprises a centrally placed disc, which moves axially during inhalation. The particles in the inhalation flow will be obstructed by the valve disc and will lead to a reduction of the substance to be inhaled, as well as to a fouling of the valve. In addition, the placement of the exhalation valve inside the inhalation chamber will lead to the humidity coming from the exhalation air remaining inside the inhalation chamber, and due to this the particles contained in the inhalation airflow will adhere to the walls of the camera. The reduction of the substance will have to be compensated, which could be done by administering a higher dose, and allowing the child to inhale for a longer time. This is of course undesirable when it comes to small children or infants. In addition, in known devices the valves are difficult to disassemble and to clean.

THE INVENTION It is therefore an object of the present invention to provide a valve that is aimed at reducing the drawbacks of known devices, and is simple and inexpensive to produce. This solution is achieved by the characterizing features of claim 1, the second part of the valve housing is provided with a second hole, said second hole defining the exhalation channel, two channels are provided separated from each other and placed adjacent one to the other. Additional preferred embodiments are described in dependent claims 2 through 9. It is also an object of the present invention to provide a use of a valve as described in claim 10, as well as a method for mounting a valve as described. in claim 11.

BRIEF DESCRIPTION OF THE DRAWINGS) The valve according to the present invention will now be described by way of example with reference to the accompanying drawings, wherein: Figure 1 shows a view in relief of a valve according to a preferred embodiment of the description.

Figure 2 shows the valve in the assembled position, Figure 3 shows a sectional view taken along lines III-III in Figure 2, Figures 4a and 4b show two different side views of the first membrane mounted in the inhalation channel of the valve, Figure 5 shows a side view of the second membrane mounted in the exhalation channel of the valve.

Figure 6 shows a side view of a preferred construction of a first part of the valve.

DETAILED DESCRIPTION OF THE DRAWINGS The valve is now described in relation to a preferred embodiment of the valve according to the invention. The valve according to the invention has a housing 2 consisting of two parts, a first part 4 and a second part 6, which are designed to be joined together. The first part 4 is adapted to be adjusted to the outlet end of an inhalation device having a body, for example, a so-called spacer or spacer. The separator is preferably constructed for use by young children, having a volume between 150 to 300 ml, preferably about 250 ml, but could of course have any volume and preferred shape. The adapter part 5 of the first part 4 is adapted to be fitted to a spacer, and is preferably constructed to be fully inserted into the corresponding part of the spacer. In addition, the end part 7 of the second part 6 is adapted to be fitted to a buccal piece or facial mask, and is preferably constructed to be fully inserted into the corresponding part of the facial mask or mouthpiece. By constructing the end portions to be completely inserted into the corresponding parts of the separator and the face mask or mouthpiece, a contribution is made for the purpose of minimizing dead space within the device. The other end part of the second part 6 is designed to be joined with the first part, and has a greater cross sectional area than this first part 4. The first and second parts are provided with a hole forming the inhalation channel 8, when the two parties are joined together. In the preferred embodiment the hole is provided along the central axis XX of the first part 4, is provided along an axis that is parallel with and placed in relation to the central axis of the second part 6. Due to this displacement of the hole in the second part, a part 10 is formed that projects beyond the extension of the first part 4, when the two parts are joined together. In the part of the inhalation channel that is placed in the second part 6, a first membrane 12 is provided. This first membrane 12 constitutes the inhalation valve and is formed to be opened by the inhalation air flow., through the inhalation channel 8 during inhalation. As can be seen in Figures 4a and 4b, the membrane 12 is formed with an edge 14 at one end of the main body 16. The main body 16 has the shape of a cylinder that is cut by two planes 18a and 18b. The two planes 18a and 18b form an angle substantially of approximately 60 ° with respect to each other. In the angle between the two planes a line is formed in which an opening 20 is provided as indicated in Figures 4a and 4b. The edge 14 is designed to be placed within a gap 22 provided in the wall of the inhalation channel 8 in the second part 6. When the first and second parts are joined together, the edge of the membrane will be held within the gap 22 by the end edge of the first part 4. It is important for the function of the valve that the membrane 12 be made of a soft and flexible material. In particular, the walls of the membrane must be flexible, which means that they have to be as thin as possible so that the opening in the membrane must be opened at a small air pressure. The membrane 12 in the inhalation valve is constructed to open at an air pressure just above 0 Pa or mmHg. In the preferred embodiment the membrane is made of Silicone, EPDM, or Chloroprene, but any other suitable material having similar characteristics can be used, for example that is soft and flexible. In a preferred construction of the valve, a thin perforated wall 38 is provided in the inhalation channel of the second part 6. This perforated wall 38 is provided with a plurality of holes 40 for the air flow and as a wall of air. safety that prevents the membrane 12 from being damaged if a foreign object is inserted into the inhalation channel. This is also a safety wall for the user to ensure that the membrane 12 can not enter the mouth and lungs of the user, if it is released from its position. The perforated wall could be formed as a net or mesh. The function of the membrane will now be described in order to explain the importance of the choice of the material and the thickness of the wall in order to reduce the resistance during inhalation, this being one of the main objectives of the invention. When the user inhales, the air flows through the inhalation channel 8, and through the membrane 12 as indicated by the arrow A in Figure 2. Due to the air flow, the surfaces defined by the two planes 18a and 18b they are separated, whereby the opening 20 opens and the air can flow to the mouth piece or to the face mask fitted in the outlet opening of the valve. The thickness of the walls of the valve is preferably 0.15-0.2 ml for the materials in the preferred embodiment, but if another material is used, the thickness of the walls may be different for an optimal function of the valve. The second part 6 is provided with an additional hole, as can be seen in Figures 1, 2 and 3. This additional hole is provided adjacent to the inhalation channel 8 and in the part of the second part projecting beyond the extension of the first part 4. The second orifice functions as the exhalation channel 24, and extends from the end part 7 of the second part 6, to the ambient air. The second membrane 26 is provided in the exhalation channel 24, and constitutes the exhalation valve, as can be seen in Figure 5. The second membrane 26 is preferably substantially planar and circular, and is provided with at least one, preferably two. retention elements 28, in projection, provided adjacent to each other and near the periphery of the membrane. The exhalation valve? of the preferred embodiment is constructed to open at an air pressure of about 30-40 Pa (40.8-54.4 mmHg). Arrow B in Figure 2 indicates the air flow during exhalation. In the preferred embodiment the retaining elements 28 extend substantially perpendicular to the plane of the membrane and are provided with a thickening 30 at their ends, as can be seen in Figure 5. The thickening 30 is designed to form retaining means for the membrane 26. The membrane 26, the retaining elements 28 and the thickenings 30 are preferably made of the same material. Said material must be soft and flexible, in order to simplify the manufacture of the valve according to the invention, the first and second membranes are made from the same material. Adjacent to the exhalation channel 24, the second part is provided with at least one, preferably two, holes 32. The holes 32 have two parts, a part having a diameter corresponding to the diameter of the retaining elements 28 and a portion that it has a diameter corresponding to the diameter of the thickenings 30. The retaining elements 28 with their thickenings 30 are designed to be used for mounting the second membrane, as follows. When the second membrane 26 is to be mounted in the exhalation channel 24, the retaining elements 28 with the thickenings, are inserted into the holes 32 in such a way that the thickenings 30 extend beyond the holes. The thickenings in this way will prevent the membrane 26 from falling. When the different parts of the valve are joined together, the first 12 and the second 26 membranes are first placed in their respective positions. The first membrane 12 is placed in the recess 22 in the second part 6, and in the second membrane 26 is mounted as described above. The first and second parts 4, 6 are thereafter joined together in an appropriate manner. In the preferred embodiment these two parts are joined together by a snap fit. The second part 6 is provided with a collar 36, and the first part 4 is provided as a rim 34. When the parts are joined the collar 36 of the part 6 will snap behind the rim 34 of the part 4, and the two parts will be joined together in a safe way. It is also possible to join the two parts by pressure adjustment during the actual manufacture of the valve. In this case, is a part provided with a? end part formed to be inserted into the corresponding end part of the second part. The two parts could also be screwed together by mutual coupling into screw threads accommodated in the respective portions of the first and second parts, or by gluing or welding. However, it is important that no edges or gaps are formed inside the inhalation or exhalation channels, when the two parts are joined together, on whose surface particles, moisture and dust could adhere during the use of the valve. This also facilitates a valve cleaning, which could simply be done by letting the water or any other appropriate cleaning fluid flow through the two valve channels. In a preferred embodiment, the two parts of the valve are produced from a plastic material, which can be injection molded. A preferred material is polysulfone.

MODIFICATIONS OF THE INVENTION The valve according to the invention could of course be modified within the scope of the appended claims. In this way the membranes in the inhalation and exhalation valve could have other shapes and be constructed differently. In the preferred embodiment, the membrane in the inhalation valve is formed with two inclined planes 18a and 18b, and an opening provided in the line along which these two planes meet with each other, see Figure 4b. The membrane could also be constructed with three planes inclined towards each other, and a central opening provided at the point where the planes meet one another. This construction corresponds to the construction of a biological heart valve. In addition, the exhalation channel, and the membrane provided in the exhalation channel could be semilunar and be provided adjacent and around the inhalation channel. This construction could give a larger exhalation valve and a channel, and at the same time reduce the size of the valve housing It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Having described the invention as above, the content of the following is claimed as property:

Claims (11)

1. A valve designed to be used in particular in inhalation devices having a body, such as a separator, said valve having a housing comprising a first part, which is adapted to be mounted on an outlet opening of the body of the device. Inhalation, a second part on which a buccal piece or a face mask can be mounted, the first and second part are provided with a first hole defining an inhalation channel and a second hole provided in the second part, which defines the channel of exhalation, whereby the two channels are provided separated from each other and placed adjacent to each other, a first membrane is provided in the inhalation channel and a second membrane, characterized in that the second membrane is substantially planar, preferably circular, and provided with at least one, preferably circular, and provided with at least one, preferably two pro elements. projections provided adjacent to each other and close to the periphery of the second membrane, whereby at least one, preferably two, holes are provided adjacent to each other in the wall surrounding the exhalation channel, the holes are provided to receive the elements in projection of said membrane, when mounted in the exhalation channel.

2. The valve according to claim 1, characterized in that the end part of the first part is constructed to be fully inserted into the corresponding part of a spacer, and in that the end part of the second part is constructed to be fully inserted into the corresponding part of a face mask or a mouth piece, whereby the distance between the inhalation inlet and the inhalation outlet of the valve is minimized.

3. The valve according to claim 1 or 2, characterized in that the first membrane has the shape of a cylinder having an edge and is cut by two planes, which form an angle substantially of approximately 60 °, one with respect to the other.

4. The valve according to claim 1 or 3, characterized in that in the angle between the two planes a line is formed in which an opening is provided.

5. The valve according to claim 4, characterized in that the wall of the inhalation channel inside the second part is provided with a recess for receiving the edge of the first membrane.

6. The valve according to claim 5, characterized in that the retaining elements are provided with engregations, and in that the orifices have two parts having different diameters for the reception of retaining elements and the thickening, respectively.

7. The valve according to any of claims 1 to 6, fitted to a separator having a volume of 150 to 500 ml, * preferably of 250 ml.

8. The use of a valve according to any of claims 1 to 6, in connection with a metered dose inhaler, 1 pressurized.

9. The method for mounting a valve according to any of claims 1 to 6, characterized in that the edge of the first membrane is inserted into the gap of the inhalation channel, the second membrane is placed in the exhalation channel and the elements of Retention and the thickenings are inserted into the holes, and extend beyond the holes, after which the first and second parts are joined together by mutual coupling.

10. The method according to claim 9, characterized in that the two parts of the valve are joined together by pressure adjustment.

11. The method according to claim 10, characterized in that the two parts of the valve are joined together by tight fitting.