MXPA06004895A - Face masks for use in pressurized drug delivery systems - Google Patents

Abstract

Face masks for use in pressurized drug delivery applications, such as aerosol drug delivery systems, and a method of reducing aerosol deposition in the region of the eyes are presented. The face masks according to the various embodiments disclosed herein contain features that reduce the inertia of the aerosolized drug in perinasal areas. This results in a reduction in the amount of aerosolized drug that is deposited in the region of the eyes by inertial impaction, while at the same time, the features are constructed to maintain the flow of the aerosolized drug into the face mask so that the aerosolized drug is effectively delivered to the respiratory system of the patient.

Description

FACIAL MASKS FOR USE IN PRESSURIZED DRUG ADMINISTRATION SYSTEMS CROSS REFERENCE TO RELATED REQUESTS The present application claims the benefit of US Patent Application Serial No. 60 / 515,382, filed on October 29 of 2003, as well as US Patent Application Serial No. 60 / 566,117, filed on April 27, 2004, both of which are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION TECHNICAL FIELD OF THE INVENTION The present invention relates to a mask and, more particularly, to a face mask for use in the administration of an aerosol or other similar drug to a patient.

DESCRIPTION OF THE RELATED TECHNIQUE Masks are commonly used in a wide variety of applications and are widely used in a variety of medical settings. For example, masks are generally used in the administration of gases to a patient, e.g. an anesthetic agent and, more recently, masks have been increasingly employed in drug delivery systems, including nebulizer drug delivery systems and metered dose inhalers using tube support chambers (MDI? / CH, for its acronym in English). Nebulization is the application of a drug to a patient by means of an aerosol produced by a gas flow. The aerosol and the drug are breathed through the mask and administered to the patient's respiratory system as the patient inhales. MDI / HCV creates its aerosol from the expansion of a volatile liquid in a gas inside the HCV. In particular, nebulization is used in the pediatric field as a means to administer a drug or other similar. In patients such as young children, whose cooperation and concentration are limited, the administration of an aerosol drug is primarily done with the use of a face mask. The facial mask is placed over the nose and mouth of the patient, held in place by a person in charge of care or using conventional straps or something similar. The face mask is connected with an aerosol drug delivery device. In the case of nebulizers, the face mask is pressurized by the flow of the nebulizer and the aerosol fills the mask, becoming available for inhalation through the nose or mouth. When the patient inhales, a negative pressure is applied to the reservoir of the facial mask and the aerosolized drug is inhaled and enters the respiratory system of the patient. Metered dose inhalers are also used with face masks to deliver a drug to a patient. These devices administer a predetermined amount of drug upon activation and the patient is required to inhale to deliver the aerosolized drug to the facial mask reservoir and subsequently to the patient's respiratory system. The administration of drugs with a nebulizer is different from the administration of drugs using a metered dose inhaler, particularly in the degree of pressurization of the face mask. The metered dose inhalers can pressurize the mask to a certain degree, especially if spray is sprayed directly into the mask and a separator is not used. A separator is a device that is placed between the face mask and the spray fountain (usually a bottle). Frequently, the separator has unidirectional valves and, therefore, is referred to as a "valve support chamber" (VCH, for its acronym in English). Facial masks are used both for the administration of drugs with nebulizer and for the applications of measured doses, although there are several disadvantages associated with it. Nebulizers easily pressurize the mask and administer more medication, but spills on the face increase, producing a greater facial accumulation of the drug. Therefore, the spill around the mask affects the performance of the particular device and, in the case of nebulizers, the spill actually increases the administration of the drug. However, this increase is achieved at the cost of an increase in facial accumulation and potentially local side effects. In order to administer the aerosol drug effectively to the patient's respiratory system, the face mask must cover the entire mouth and nostrils of the patient. The face mask is generally arranged so that it fits against the patient's cheeks and extends along an upper portion of the bridge of the patient's nose. Since the bridge of the nose rises with respect to the rest of the patient's face, e.g. the cheeks, the upper portion of the facial mask rises slightly with respect to the surrounding portions of the facial mask, which extends along the cheeks and below the patient's mouth. This occurs even when the patient tries to produce a firm seal between the mask and the face. For nebulizers, this produces certain spill areas in which the aerosolized drug can be discharged below the face mask and into the atmosphere. Due to the design of the facial masks and their previously mentioned location on the face, the effusion is universally present in the perinasal areas on either side of the nose. This produces a jet of spilled aerosol which is oriented and deposits directly into the patient's eyes. In other words, the aerosol is discharged below the facial mask in these perinasal areas and flows directly into the patient's eyes and, unfortunately, many of the conventional masks are constructed in such a way that the spills that occur are characterized by effusions. High power (high kinetic energy), due to the high speed that the fluid has as it flows under the mask and along the face, directly towards the eyes. This can lead to several undesirable side effects. For example, the accumulation of spilled aerosolized drug may be associated with direct trauma to the eyes and structures associated with them. As the effusion occurs, these organs are exposed to the aerosolized drug. There is discussion regarding the risk of developing increased cataracts as a result of aerosolized drugs that are deposited directly in the patient's eyes. At least, the spill of the aerosol drugs causes discomfort since the aerosol, which travels at high speed, is discharged under the face mask and is deposited in the perinasal areas, including the eyes. In addition, the spills of certain aerosols can cause dermatological problems in some patients, due to an adverse reaction between the facial skin and the aerosol. Other undesirable conditions could be the result of the spill of the aerosol drug and its deposit on the face. The disadvantages associated with conventional mask constructions are readily apparent if one observes Figures 1, 1a and 2. Figure 1 is a front perspective view of a typical 100 face mask (which is available commercially from Laerdal Medical Corporation of Wappingers Falls, NY). Although the face mask 100 is illustrated as being used by an adult in Figures 1 and 1a, it will be understood that the face mask 100 is designed for use by young children and that it has a particular application in the pediatric area, where the patient is unable to perform or cooperate in the administration of the drug. The face mask 100 has a body 102 which includes a peripheral edge 104 which is intended to fit the face of a patient. The body 102 defines a reservoir of face mask where the patient's mouth and nostrils are communicated. The body 102 is generally made of flexible material, as thermoplastic, e.g. a PVC material. The body 102 has a central opening 106 defined in part by an annular member in the form of a flange 108 extending outwardly from an external surface 109 of the body 102. During use, the member 108 engages with other components of the body 102. a drug delivery system (not shown), to allow administration of the aerosol drug. The opening 106 serves as a means for administering the aerosolized drug to the patient. Depending on the type of drug administration assembly that is being used, e.g. a metered dose inhaler or a nebulizer system, the aperture 106 receives the aerosolized drug as it is transported to the facial mask reservoir defined by the body 102. The patient's breathing action causes the aerosolized drug to be inhaled by the user and introduced into the patient's respiratory system. As mentioned above, one of the deficiencies of the face mask 100 is that the spill areas are formed around the peripheral edge 104. More specifically, the peripheral edge 104 does not form a complete seal with the patient's face and, in Accordingly, spill flow paths 107 with high local velocities are formed in certain areas along the periphery of the facial mask 100, especially in the perinasal areas 105. In fact, the maneuvers to reduce spillage throughout from edge 100 can increase the velocity of spills in perinasal areas 105. Perinasal areas 105 are particularly prone to spill formation and this causes the aerosolized drug to be discharged directly into eyes and structures associated therewith. As mentioned above, there are at least two different types of aerosol drug delivery systems that are commonly used with a face mask, such as face mask 100. One type employs a pressurized metered dose inhaler (MDI / HCV) and the other type uses a jet nebulizer. Figures 1 and 1a illustrate the face mask 100 as part of an aerosol drug delivery system employing a jet nebulizer 200. The nebulizer 200 is operatively coupled with a compressor (not shown) that generates compressor air to through the nebulizer 200. The nebulizer 200 has a body 210 that is coupled with a hose 220 that connects to the compressor in a first section 222 and is constructed so that compressor air flows through that site. The drug to be administered is stored in the body 210 using conventional techniques. A second section 224 of the nebulizer 200 communicates with the reservoir of the face mask, so that the aerosolized drug is administered to the reservoir of the face mask. Body 210 may include conventional ventilation and filtering mechanisms. During generation of the aerosol, compressor air flows through body 210 and into the reservoir of the face mask. This produces the pressurization of the face mask 100 and also facilitates the spills in different locations (especially in the perinasal areas) around the face mask 100, producing an increase in facial accumulation. Once the face mask 100 is completely pressurized, the excess air from the compressor (including the aerosolized drug) is vented through an exhaust port. This causes part of the aerosolized drug to lose in the surrounding environment. The face mask 100 is partially depressurized when the patient inhales but then, as soon as the patient stops inhaling and exhales, the face mask 100 is completely pressurized again due to the continuous flow of compressor air. When the facial mask is placed on a patient, an imperfect seal generally occurs between the peripheral edge 104 of the face mask 100 and the patient's face, due to a number of factors (including the contour of the specific patient's face). This occurs in young children, older children and adults. The spills that occur due to the pressurization of the face mask 100 cause the aerosol drug to flow in accordance with the flow paths indicated by the arrows 107. These spills occur around the nose (perinasal areas), the cheeks and on the patient's chin. It has also been found that the degree of pressure applied to the mask in an attempt to improve the seal between the facial mask and the face does not necessarily improve and may, in fact, worsen the spill of the aerosol drug in the perinasal areas, when the patient inhales and carries the aerosol drug to the reservoir of the facial mask. During therapy, local pressure on standard masks can facilitate the production of high local velocities that can lead to accumulation in the eyes. For example, a person in charge of the care that presses the mask can seal the spills along the cheeks, but create spills around the eyes. Spilling the aerosolized drug into the perinasal areas causes the aerosolized drug to be discharged into the patient's eyes at high speeds, due to the high kinetic energy of the fluid. This is less than ideal, because it can cause discomfort at least and can also cause other medical complications due to the drug discharged into the patient's eyes. Therefore, the accumulation in the eyes is a problem particularly for those drug delivery systems that exert greater pressure on the face mask and / or maintain the reservoir of the face mask under pressure. Since the pressurization of the face mask 100 plays an important role in a nebulizer drug delivery system and the nebulizers have increasingly become popular means of administering an aerosol drug to a patient, in such a way that it exhibits a high, degree of pressurization in the facial mask, the present applicant has studied the amount of accumulation in the eyes that occurs when the face mask 100 is used in conjunction with the nebulizer 200, since the pressurization of the face mask associated with the use of the nebulizer, promotes a higher level of effusions around the ocular region. Fig. 2 is a gamma camera image obtained using a simulation face as part of a radiolabeled facial accumulation study performed using the face mask 100 of Fig. 1, in conjunction with the nebulizer 200. In these studies, the face mask 100 is connected with a breathing emulator (not shown) that simulated the respiratory pattern of a particular type of patient. The breathing emulator includes a three-dimensional face, a contoured artificial model to which the face mask 100 was connected. A filter was placed in the mouth of the face of the artificial model to better determine the inhaled mass (actual amount of inhaled aerosol), given that the filter represents the final path of the particles that reach the patient. Using nebulized radiolabeled saline which acted as a substitute drug in the nebulizer 200, the pattern of particle accumulation can be easily determined. Figure 2 shows the accumulation after respiration of pulmonary ventilation (also called pulmonary ventilation volume) of 50 ml with a minute ventilation of 1.25 liters / minute, a pattern typical of a young child. The air flow of the nebulizer 200 is 4.7 liters / minute and, therefore, the face mask 100 is highly pressurized. Under these conditions, the aerosol drug spills from the mask at different points on the face, as evidenced by the concentrated areas that appear in the image. As seen in figure 2, there is a high level of accumulation in the area of the patient's eyes and there is also a high level of accumulation in the areas of the patient's chin and jaws. It will be noted that other aerosol drug delivery systems that cause the face mask to be pressurized will be likely to generate similar data, showing the ocular accumulation of the aerosolized drug. Although facial masks have been developed with ventilation mechanisms to satisfy the pressurization requirements of a nebulizer or similar, these face masks still have the disadvantage that they have constructions that not only allow the aerosol drug to be discharged in the perinasal areas but also , more importantly, the aerosol drug is discharged at high velocities towards the eyes, due to the imperfect interface between the face mask and the face. In fact, this imperfect interface "shoots" the aerosol drug, so that the aerosol drug leaves the face mask at a high velocity towards the eyes. What is required in the technique and so far is not available, is a facial mask that reduces the inertia of the aerosol drug in the perinasal areas, thus decreasing the accumulation in the region of the eyes by impact of inertia, at the same time time that the flow of the aerosol is maintained towards the facial mask, so that the aerosol drug is administered effectively to the patient's respiratory system. The example of the face mask described herein meets these and other needs.

BRIEF DESCRIPTION OF THE INVENTION In one embodiment example, a face mask is presented for use in pressurized drug delivery applications, such as aerosol drug delivery systems, as well as a method for reducing aerosol accumulation in the eye region. The one facial mask according to the different modalities described herein contains characteristics that reduce the inertia of the aerosolized drug in the perinasal areas. This produces a reduction in the amount of aerosol drug that is deposited in the eye region by an impact of inertia and, at the same time, the characteristics are designed to maintain the flow of the drug in aerosol towards a facial mask, in a manner that the aerosolized drug is administered effectively to the patient's respiratory system. According to an example of modality, the face mask has a body that has an edge or surface in its lower part to be placed against a patient's face. A nasal bridge section is formed in an upper section of the body of the mask, to settle against the nose of the patient when the mask is placed against the face during application. The body has a pair of eye holes formed in that site, with an eye hole forming on one side of the nasal bridge section and the other nostril forming on the other side of the nasal bridge section. When the mask is worn by the patient, the eye holes are usually oriented under the patient's eyes. Therefore, the eye holes are cuts or eye openings formed along the peripheral edge of the mask body when removing material from the mask. The present applicant has found that opening the face mask at the highest risk sites (ie the eyes), where the flow of the aerosolized drug is undesirable, forces to perform and ensures the local reduction of the inertia of the particles in the places with greater risk of suffering facial damage and irritation. Therefore, the excisions in the facial mask that serve as eye holes minimize the local speed and inertness of the particles, so that the particles do not hit the surface of the face and eyes and, in reality, cross the face and eyes without accumulating in those places, as shown by the arrows in figure 3. This produces a substantial reduction in the accumulation in the region of the eyes, compared to conventional facial masks. Ocular cuts or openings can be formed in any number of different sizes and in any number of different ways (eg, semicircular), based on performance characteristics (ie, value of inhaled mass, amount of facial accumulation, etc.) that are desired in the application of the aerosol drug. The eye holes can also be used in conjunction with a supplementary orifice that is also formed in the body of the face mask. For example, the supplemental orifice may have the shape of an opening formed in the mask in a lower chin section near the peripheral edge. By providing eye holes in the face mask, a face mask is provided that substantially alleviates or eliminates the discomfort and potential harmful consequences associated with facial masks that have spills in the perinasal areas, which cause the aerosolized drug to be " shoot "between the peripheral edge of the facial mask and the face and causing the aerosolized drug to flow at high viscosities towards the patient's eyes. In addition, by optimizing the distance of the face to a point of insertion of the nebulizer into a connection portion of the mask, a reduction of the inertia of the aerosol drug is made in the perinasal areas, as well as along the face, and estrous. produces a reduction in the amount of aerosol drug accumulated in the face, including the ocular regions. Additional aspects and features of the present invention can be appreciated from the accompanying figures and the accompanying written description.BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a front elevated view of a conventional face mask shown as part of a nebulizer drug delivery system and in a typical administration position in a patient, which is arranged in such a way that the mask covers the nose and mouth of the patient. Figure 1a is a side elevational view of the face mask of Figure 1 with a section cut away to illustrate the flow paths of the aerosolized drug when the face mask is used by a patient. Figure 2 is an image obtained using camera digitalization of a facial model as part of a radiolabeled facial accumulation study performed using the conventional face mask of Figure 1, which illustrates the accumulation of particles (aerosolized drug) that is produced as response to a pediatric breathing pattern (volume of lung ventilation of 50 ml, respiration rate of 25 breaths per minute, duty cycle of 0.4). Figure 3 is a top perspective view of a face mask according to a first embodiment example, to be used as part of a nebulizer drug delivery system and before being placed in a typical administration position in a patient. Figure 4 is a bottom perspective view of the facial mask of Figure 3. Figure 5 is a perspective view of the facial mask of Figure 3 placed in the typical administration position in the patient, with the body partially folded being compressed and bent, producing a reduction in the size of the eye holes. Figure 6 is a top perspective view of a face mask according to a second embodiment example for use as part of a nebulizer drug delivery system and before being placed in a typical administration position in a patient. Figure 7 is a bottom perspective view of the face mask of Figure 6. Figure 8 is a perspective view of the face mask of Figure 6 placed in the typical administration position in the patient, with the body partially folded being compressed and bent, producing a reduction in the size of the eye holes. Figure 9 is a top perspective view of a face mask according to a third embodiment example for use as part of a nebulizer drug delivery system and before being placed in a typical administration position in a patient.

Figure 10 is a bottom perspective view of the face mask of Figure 9. Figure 11 is a perspective view of the face mask of Figure 9 placed in the typical administration position in the patient, with the body partially folded being compressed and bent, producing a reduction in the size of the eye holes. Figure 12 is a schematic diagram in the form of a bar graph comparing the data of facial accumulation and administration of drug obtained from the performance of tests of a set of the examples of facial masks described herein, with saline solution marked serving as the aerosol drug. Figure 13 is a schematic diagram in the form of a bar graph comparing the data of facial accumulation and drug administration obtained from the testing of a set of the facial mask examples described herein, with budensonide serving as the aerosol drug. Figures 14A-14D illustrate a series of different modalities of facial masks showing the nozzle insertion distances that are measured between the nebulizer and the facial surface. Figures 15A and 15B. are images obtained using gamma camera scanning of a facial model as part of a radiolabeled facial accumulation study using a conventional facial mask and one showing a larger budensonide eye design that is a larger area around the eyes, for the purpose of illustrating the accumulation of particles in that site. And Figure 16 is a camera digitalization of a facial model as part of a radiolabeled facial accumulation study using a face mask of the Salter type.

DESCRIPTION OF THE PREFERRED MODALITIES Additional details related to the present invention are described in commonly assigned U.S. Patent No. 6,748,949, issued June 15, 2004 and which is hereby incorporated by reference in its entirety. It will also be understood that, although the face masks herein, in accordance with the present invention, are particularly well suited for young children, the face masks of the present and the teachings described herein are also applicable for use in adults. . In other words, the aforementioned disadvantages that are associated with the face mask not only apply to infant-sized facial masks, but also apply to adult-sized face masks and, therefore, the undesirable accumulation of drug occurs in the adult facial masks. Accordingly, the facial masks described herein that include eye holes and / or optimization of other mask features are not limited to infant mask designs, but apply equally to other facial masks, including adult face masks. Returning now to FIGS. 3 to 5, where a face mask 300 is shown in accordance with a first embodiment example, which is to be used as a part of a nebulizer drug delivery system. Figures 3 and 4 show the face mask 300 before being placed in a typical administration position in a patient, where it is arranged so that the mask covers the nose and mouth of the patient, while figure 5 shows the mask 300 in the typical management position. In one embodiment, facial mask 300 is formed from a flexible polymeric material and is commercially available in Laerdal, marketed as a pediatric silicone mask used for resuscitation purposes. More specifically, the mask 300 is formed of a body 310 that is not too stiff, but rather is compressible since it is formed from a flexible polymeric material and, therefore, when the mask 300 is placed against the face of a user, body 310 deforms slightly. It will be noted that the illustrated mask 300 is merely an example and is described for purposes of illustration only, just as there are a number of other flexible pediatric face masks that can be used in accordance with the present invention. The body 310 has a first central opening 312 defined in part by an annular flange-shaped member 314 extending outwardly from an external surface 316 of the body 310. The body 310 is formed from a flexible material, so that It deforms or compresses easily when a force is applied against it, such as when the user applies face mask 300 on the patient's face. The body 310 extends outwardly from the flange-shaped member 314 and then folds (curves) inwardly and underneath a second central opening 320 that is placed over the patient's mouth. An edge 322 of the body 310 defines the second central opening 320 and, given the folded or arched nature of the body 310, the edge 322 is not the lowermost portion of the body 310. Instead, a lowermost portion 324 of the body 310 is formed by the folded or curved section of the body 310. It is this section 324 that makes initial contact with the patient's face, as shown in Figure 5 and, because the body 310 is deformable, the body 310 is it deforms and collapses slightly as the user presses the mask 300 against the face. As shown in Figure 5, the mask 300 actually folds even more in the lower portion 324. In this embodiment, and in contrast to a more rigid face mask, the face mask 300 does not include a clearly defined peripheral edge that it sits against the patient's face, but rather the portion that sits against the patient's face is the folded portion of the face mask 300.

Similar to the other embodiments, the face mask 300 includes a pair of eye holes 330 that are formed on each side of a bridge section 332 of the body 310, by removing material from the mask at this location. Figures 3 to 5 illustrate the eye holes 330 in accordance with one embodiment, which have an exemplary shape with one of the eye holes 330 having an inner edge 334 and with the eye hole 330 being designed to extend from the inner edge 334 to the second central opening 320. Thus, the eye hole 330 is formed in the lower, folded portion 324 of the body 310. The eye hole 330 can have any number of different shapes, such as oval, square, rectangular, oblong, triangular , etc., since the shape is not essential as long as the eye holes provide an adequate outlet for the escape of the drug. When the face mask 300 is placed against the face during an application, as shown in Figure 5, the body 310 is compressed a little, with the lowermost portion 324 being additionally folded (i.e., collapsing inwardly). The result of this is that the distance between the inner edge 334 and a lowermost section 324 of the face mask 300 is reduced, as can be seen. In other words, the area of the open eye hole 330 is correspondingly reduced due to this folding action. As seen in Figure 5, each eye hole 330 extends from and is open from the bridge section 332 to another opposite surface or edge associated with the lowermost edge of the face mask 300. However, the eye hole 330 it is still open, even if the mask 300 has been folded further on itself and compressed, since there is still an opening formed between the inner edge 334 and the patient's face. In other words, a slit or opening is present between the inner edge 334 and the patient's face, in a location generally below one eye of the patient and this allows the desired ventilation effect to occur and all the advantages to be realized. indicated above, even in this embodiment where the face mask 300 is of a flexible type that is compressed along the face when pressure is exerted there. The eye holes 330 ventilate the aerosol drug flow from the mask to the region of the eyes. Contrary to the initial inclination to not provide holes directly in the area where aerosol drug flow is not desired, the Applicant has discovered that the provision of eye holes 330 in the eye region really greatly improves performance and the safety of the face mask 300, by altering the flow characteristics of the aerosol drug in the ocular region (ie, the perinasal areas). One way to understand the advantages provided by eye holes 330 is to investigate the inertia of the fluid particles in the area of interest, in particular the region of the eyes. In general, the accumulation of particles is related to the diameters of the particles (hereinafter "a"), the speed of movement of the particles imparted by the local flow through the spill (hereinafter "U") in the facial mask, as well as the local geometry between the face mask and the face (hereinafter "D"). All these factors can be described together through Stokes numbers (hereafter "Stk"). Stk is a term not associated with dimensions, which is related to the inertia of the particles. The greater the inertia of the particles, the greater the tendency of these particles to impact on the face (eyes) and accumulate on the face. Equation (1) establishes the general relationship between the different variables: Stk a [a2 (U)] / D (Equation 1) where D can be related to U as established in Equation (2): U to Q / D (Equation 2) Where Q is the flow rate outside the area of the mask that shows spillage. It will be noted that increases in the local diameter of the spill site reduce the local linear velocity. That is to say, the inertia of the particles is affected by the diameter of the particles (a), the local velocity of the fluid (U) and has an inversion relation with respect to the local diameters (D). The facial mask example 300 reduces Stk by increasing D, which results in a reduction of U (Equation 2) and Stk, additional effects are produced in U through mask decompression as the pressure reduction inside the mask reduce Q additionally. The latter is achieved through the opening D, which acts as an exhaust hole.

The mask -300 provides a face mask where the flow of aerosol to the face mask is maintained (which is necessary for effective administration of the drug) while, at the same time, the design of the face mask 300 reduces the accumulation of the mask. spray in the region of the eyes and the rest of the face when opening the face mask 300 in the region of the eyes. Opening the face mask 300 in the most risky places and in the same locations where the flow of aerosolized drug is not desirable (the eyes) makes it necessary to perform and ensures the local reduction of the inertia of the particles in the sites with the greatest risk of facial damage and irritation. Advantageously, the provision of eye openings 330 reduces the velocity of the particles by increasing the space between the mask (Stokes diameter increasing (D)) and, additionally, by decompressing the reservoir of the face mask (the area between the face and the inner surface of the facial mask 300 when used), the pressure within the facial mask reservoir is reduced and this minimizes the linear flow to the eyes (ie, the variable (U) of Equation 2). It will be understood that the local Stokes numbers are merely a tool to describe the advantages of the face masks herein and in no way limit the scope of the present face masks, since the principle can be achieved by other means. The large excisions in the facial mask 30 that serve as the eye holes 300 minimize the local velocity and inertia of the particles, so that the particles (ie, aerosolized drug) do not impact the surface of the face and eyes and, in fact, they cross the face and the eyes without accumulating in those places. Accordingly, the eye holes 300 are generally formed below the eyes (while leaving the bridge section of the face mask intact), in order to obviate the high pressure effects that were previously observed in the lowermost portion 324 of face mask 300 due to the aerosol drug escaping in this region at high speeds. By forming the eye holes 330 by removing sections of the facial mask 300, including the sections of the lowermost portions 324 thereof, the interface between the lowermost portion 324 and the face is eliminated in this region and, therefore, the Spray drug is no longer "fired" out of the 300 mask in the perinasal areas at high speeds. Therefore, the low speeds in this region are assured independently of other multiple uncontrollable variables (pressure of the mask on the face, flow of the nebulizer towards the mask) and the accumulation is always minimized. Therefore, facial mask 30 improves the safety performance of the face mask by reducing the speed of the aerosolized drug as it leaves face mask 300 due to the facial mask / face interface that is obviated in the ocular region. . In this embodiment, the eye holes 330 have reduced dimensions, in comparison with other modalities.

Since the excision of more and more mask material to form the eye holes 330 can serve to weaken the overall structural rigidity of the face mask 300, the eye holes 330 can be formed in such a way that each of them has a reinforcing member. (not shown, but similar to those described in the previously incorporated patent application), which serves to reinforce the structural rigidity of the face mask 300 and ensure the strength of the face mask 300. Therefore, the strengthening member is formed , preferably, around an internal edge 334 and other edges defining the eye holes 330, so as to increase the structural rigidity in the region of the eye holes 330. This ensures that the eye holes 330 substantially maintain their shape and shape. contour when the facial mask 300 is placed on the patient's head and pressure is applied to produce some kind of seal between the face face 300 and face. The reinforcement member may be any number of structures that may be either integral with the face mask 300 itself or connected and subsequently fixed to the face mask 300, after that has been manufactured and the eye holes 330 are formed. For example, the strengthening member may be in the form of a rigid part of plastic that is fixedly attached to the face mask 300 using conventional techniques, such as using a adhesive, union, etc. By incorporating a rigid element in the design of the face mask, the region of the face mask 300 that includes the eye holes 330 is less likely to deform or collapse and, rather, remains well defined during the use of the face mask 300 The reinforcing member may also be in the form of a metal bearing that attaches to the face mask 300 using conventional techniques, such as those described above. Additionally, the strengthening member can be integrally formed with the remainder of the facial mask 300 when the face mask 300 is manufactured. For example, the strengthening member for each eye hole 330 can be inserted into a mold and subsequently the face mask 300 is formed around that site, so that the reinforcing members are integral with the face mask 300. It will also be noted that, if the face mask 300 is formed using a molding process, two or more different materials can be used to form the mask reinforced facial, and one material can be used to form the reinforced limbs and another material can be used to form the rest of the facial mask. In yet another embodiment, the face mask example 300 has a supplementary orifice (not shown) formed in the face mask 300 for decompressing the face mask 300 and also for modifying the flow of the aerosol drug flowing under the face mask 300 (especially in the perinasal areas) during a normal application when the face mask is placed against the face. The hole example is an opening generally in a circular shape. However, the shape of the hole is not essential. The hole is formed in the body of the face mask 310 at the 6 o'clock position on the watch. In other words, the hole is generally formed in the chin area of the face mask 300. The peripheral edge extends completely around the face mask 300 and, therefore, the hole is formed slightly away from the face of the face. patient. This is desirable, since the hole serves to discharge the aerosol and, therefore, it is preferred to direct the aerosol down and away from the patient's face. The dimensions of the orifice may vary depending on a number of factors, including precise application, size of the face mask, etc., as long as the orifice is large enough to allow a desired amount of aerosolized drug to be inhaled by the patient while, at the same time, the accumulation in the face and eyes is reduced. Although the orifice serves to reduce the accumulation of the aerosol in the facial areas and also serves to decompress the face mask 300, the Applicant has warned that (1) even those face masks with holes continue to have spills between the facial mask and the face (especially the perinasal areas thereof), which allows the aerosol drug to escape and (2) to increase the safety of the facial masks, it is more desirable to control the flow characteristics of the aerosolized drug that is discharged into the perinasal areas. Based on this information, the applicant has developed a face mask that reduces the accumulation in the face and eyes by modifying the flow characteristics of the aerosolized drug in the perinasal areas.

It will be noticed that the provision of eye holes (of different dimensions) in the facial mask not only maintains an acceptable inhaled mass (and, in most cases, produces an increase in the inhaled mass), but also, in a more Importantly, the eye holes serve to modify the flow characteristics of the aerosolized drug (ie, reduce the inertia of aerosolized drug particles), so that greater safety occurs, since the high drug speeds are eliminated. aerosol that escapes in the region of the eyes that characterized the conventional facial mask designs. In other words, the kinetic energy of the aerosol drug in the region of the eyes is reduced by controlling the velocity of the aerosol drug in the region of the eyes. In the pediatric population, an inhaled mass value of approximately 4% is considered efficient for a drug delivery system. Low percentages are inherent in pediatric drug delivery systems, as a large amount of drug is wasted because the drug either escapes from the mask or becomes trapped in the nebulizer or the like. The amounts accumulated in the face and eyes are low in percentage, but quite high in relation to the administration of the drug and, therefore, it will be appreciated that the facial and ocular accumulation in said pressurized drug delivery systems is a This issue deserves attention, as it can lead to patient discomfort and can potentially lead to more serious complications, especially with the eyes. Another advantage of the formation of eye holes in a facial mask that is intended to be used with a pressurized drug delivery system, such as a nebulizer, is that existing facial masks can be modified retroactively with ease by simply forming the eye holes in the region. of the eyes, using conventional techniques, such as a cutting procedure or any other type of procedure that is able to eliminate or perform a split of the material of the facial mask along different lines, to form the eye holes. The applicant has recognized that certain drug delivery systems, particularly nebulizer drug delivery systems, increase acial and ocular exposure to aerosols. The administration of aerosol with nebulizer that use the facial masks, pressurizes the face mask and facilitates the production of spills at different points around the facial mask, with an increase in facial accumulation. Maneuvers to reduce this pressurization reduce spills and concomitant accumulation. By incorporating eye holes in the face mask, the disadvantages of conventional face masks have been eliminated in a basic way. The facial orifices act to reduce the inertia of the particles in the region of the eyes. Based on the data displayed in the images and quantified in the tables herein, the incorporation of eye holes can cause a substantial reduction in the amount of aerosolized drug that has accumulated in the eye region. It will be noted that the size and transverse shape of the eye holes could be altered and optimized to minimize leakage and maximize drug administration. The size of the eye holes should be adapted so that the inhaled mass value is within acceptable ranges for the given application. It will be understood that any facial mask described herein can be used in any number of applications where the face mask is pressurized by a fluid to such an extent that pressurization in the face mask produces spills formed around the face mask. Preferably, the facial mask is used in those applications in which it is desirable to preserve the values of inhaled mass. In other words, the use of the face mask must allow a sufficient amount of aerosol drug to flow into the reservoir of the face mask and subsequently, subsequently, into the patient's respiratory system. The eye holes can be incorporated into a vast number of medical face masks that are intended to be used in drug delivery or other similar systems. Additionally, the use of any of the examples of facial masks is not limited only to aerosol drug delivery systems. It will be noted that the face mask can be used in other types of fluid delivery systems having characteristics similar to or similar to the aerosol drug delivery system described, e.g. pressurization of the mask and spill, et cetera. Although a series of illustrations and experimental data are aimed at using different facial masks in pediatric applications, it will be understood that facial masks according to the modalities herein can be used in other applications, in addition to pediatric applications. For example, facial masks can be used by adults to administer an aerosol drug, et cetera. Figures 6 to 8 illustrate another embodiment wherein the eye holes 330 are most pronounced, both in a state in which the mask 300 relaxes before the face mask 300 is applied to the face and after the face mask 300 is applied. compress as a result of a force applied to the face. In other words, the eye holes 330 of Figures 6 to 8 are larger than the eye holes 330 formed in Figures 3 to 5. As with the other embodiments, the eye holes 330 of Figures 6 and 7 can be formed to have any number of different forms. The embodiment of Figures 6 to 8 is used to illustrate that the eye holes can be formed in different sizes, which directly produces a difference in the size of the opening of the orifice when the face mask is applied against the user's face. Therefore, it will be noted that the facial mask with the largest eye hole 330 in terms of surface area in the relaxed state, will have the largest eye holes in the applied or normal operating state, when the face mask is in contact and settle against the patient's face. In any of the embodiments, there is at least one small slit or other similar that is formed between the inner edge 324 and the face, to allow the drug to escape as described above. As used herein, the term "lower edge or surface" describes an edge or surface of the face mask that is in contact with and sits against the patient's face during normal application of the face mask to the face of the patient. patient. As such, at least a portion of the lower edge or surface will contact and settle against the facial tissue (cheeks) of the patient. Now with respect to Figures 9 to 11, in yet another embodiment, the eye holes 340 are formed in the partially deformable face mask 300, so that each eye hole 340 is a fully delimited opening. In other words, the eye hole is defined by and has the body of the mask completely surrounding the eye hole ("fully demarcated"). However, when the face mask 300 is placed against the user's face, the lower portion of the face mask is compressed (collapsed) or folded further, so that the eye opening is located with respect to the face so that it is form an opening between an inner eye edge 342 and the surface below the patient's eyes. In this modality, the eye holes 340 are not open towards and in communication with the second central opening 320 that is formed in the body of the mask and is to be placed over the mouth of the patient. The eye holes 340 can have any number of different shapes, such as circular, oval, square, rectangular, oblong, etc., as well as sizes, as long as each of them is a fully delimited opening that is located in the lower portion. so that, when the face mask is placed and held against the face producing the collapse of the facial mask, the eye hole is placed against the face, in such a way that an opening is formed between the inner edge 342 and the face, so as to allow the passage and escape of the drug. Although the eye hole 340 may be formed so that initially it is not part of the lowermost portion of the face mask, the deformability of the face mask between the inner edge 342 and the face itself does not allow the passage and exit of the aerosolized drug. which is present inside the interior cavity. In other words, the collapse or additional folding action of the mask body causes the eye holes 340 to move to a position against the user's face. It will be understood that the eye holes 340 do not have to be in direct contact with the patient's face but, rather, the eye holes 340 can be located close to the face with material from the mask body that lies between the eye hole 340 and the eye. second opening 320, a surface lying against the patient's face. However, even in this configuration, the eye holes 340 are located directly below the eyes and serve to effectively vent the aerosolized drug, as described herein. It will also be noted that the eye holes 340 may be formed in a more rigid type of mask, identical or similar to that described in the patent application described above. In other words, the eye holes 340 are spaced apart from the peripheral edge of the rigid mask that comes into contact and sits against the patient's face during drug administration. In this embodiment, the mask does not "slide" on itself and, therefore, the eye holes 340 remain very well defined throughout the application, while they are still separated from the peripheral edge. However, the eye holes should be formed in close proximity to the peripheral edge, since the release action should cause the unburned drug to pass directly in front of, but not in contact with, the patient's eyes, as shown in a general manner. in Figure 5. As reflected in the data contained in Table 1 below, the use of a conventional Laerdal mask (pediatric silicone mask for resuscitation) with a nebulizer made the 1.00% of the aerosolized drug (in this case, saline solution marked Te "m) initially placed in the nebulizer, will accumulate in the region of the patient's eyes (1.54% of aerosolized drug accumulated in the face) .The inhaled mass for the facial mask was 6.09. % of the amount placed in the nebulizer.) When the face mask 300 of Figure 3 was used, the inhaled mass was increased to 8.05% while, at the same time, the amount of drug Spray that accumulated in the eye region was 0.12%, compared to 1.00% that accumulates in the region of the eyes in the conventional standard face mask, as shown in table 1. Therefore, the use of facial mask 300 produces a substantial reduction in the amount of aerosolized drug that accumulated in the eye region, compared to a standard conventional face mask. However, these data merely quantify the results and do not characterize the flow properties of the aerosolized drug that escapes below the face mask and flows into the eyes. In other words, as previously mentioned, the safety benefits provided by the face mask are improved because not only less aerosol drug accumulates in the eye region, as well as in the face, but also the flow characteristics of the drug in spray that escapes are modified in the region of the eyes. The provision of eye holes in the face mask achieves these goals and improves the overall safety of the face mask. When the face mask 300 of Figure 6 was used, the inhaled mass was increased to 6.92% while, at the same time, the amount of aerosol drug that accumulated in the eye region was substantially reduced to 0.10%, in comparison with the 1.00% that accumulated in the region of the eyes in the conventional face mask, as shown in table 1. Therefore, the use of the facial mask 300 produces a substantial reduction in the amount of aerosolized drug that accumulated in the eye region, compared to a standard conventional face mask. More specifically, the modification of the facial mask when forming eye holes substantially reduced the accumulation in the eyes while, at the same time, there was an increase in the percentage of the aerosolized drug that was inhaled. The full advantages of the eye holes have been described hereinabove. Figure 12 is a bar graph representing a first set of data set forth in table 1. A second experiment was performed where Budensonide steroid was used as the aerosol drug and the three previous masks were used in a nebulization system . As reflected in the data contained in Table 1, using a conventional Laerdal mask with a nebulizer caused 2.20% of the aerosolized drug (Budensonide) initially placed in the nebulizer to accumulate in the region of the patient's eyes (3.48% of the drug in spray accumulated on the face). The inhaled mass for the facial mask was 12.90% of the amount placed in the nebulizer. When the face mask 300 of Figure 3 was used, the inhaled mass did not change significantly and had a value of 12.68% while, at the same time, the amount of aerosolized drug that accumulated in the eye region was reduced substantially to 0.48% (1.86% accumulated in the face), compared to 2.20% accumulated in the region of the eyes in the conventional facial mask, as shown in table 1. Therefore, the use of facial mask 300 it produces a substantial reduction in the amount of aerosolized drug that accumulated in the eye region, compared to a standard conventional face mask. However, these data merely quantify the results and do not characterize the flow properties of the aerosolized drug that escapes below the face mask and flows into the eyes. In other words, as mentioned above, the safety benefits provided by the face mask are improved not only because the aerosolized drug accumulates less in the eye region, as well as in the face, but also because the characteristics of escaping aerosol drug flow are modified in the eye region. The provision of the eye holes in the facial mask achieves these goals and improves the overall safety of the face mask. When the face mask 300 of Figure 6 is used, the inhaled mass did not change significantly and had a value of 12.84% while, at the same time, the amount of aerosol drug that accumulates in the eye region was substantially reduced to 0.21% (1.30% accumulated in the face), compared to 2.20% accumulated in the region of the eyes in the conventional face mask, as shown in table 1. Therefore, the use of the face mask 300g produced a substantial reduction in the amount of aerosolized drug that accumulated in the eye region, compared to a standard conventional face mask. More specifically, modification of the facial mask by forming eye holes substantially reduced eye accumulation while, at the same time, there was an increase in the percentage of aerosolized drug that was inhaled. The full advantages of the eye holes have been described hereinabove. Figure 12 is a bar graph representing part of the data set forth in Table 1.

TABLE 1 TABLE 1 (continued) The following examples are merely for the purpose of illustration and do not limit the present invention in any way.

EXAMPLE 1 A face mask was constructed as shown in Figures 3 to 5, in accordance with the first embodiment, which has the following dimensions. An external diameter of the body of the mask 310 is approximately 77 millimeters and an external diameter of the flange 314 is approximately 20 millimeters. The second opening 320 has a diameter of approximately 46 millimeters. As will be seen when viewing the figures, the eye holes 330 have a tapered design because a width thereof is greater than the inner edge 334 and is smaller when the eye hole 330 communicates with the second opening 320. In accordance with one embodiment, the width of the eye hole 330 at the inner edge 334 is approximately 20 millimeters and then narrows to a diameter of approximately 10 millimeters, wherein the eye opening 330 communicates with the second aperture 320. The depth of the eye hole 330 measured from the inner edge 334 to the lowermost portion 324 is approximately 9 millimeters in the relaxed state in Figures 3 to 4 and, when applied to the face during drug administration, the depth is reduced to approximately 5 millimeters.

EXAMPLE 2 A face mask was constructed as shown in Figures 6 to 8, in accordance with the first embodiment, which has the following dimensions. The facial mask has the same dimensions as those established in example 1 above, with the following exceptions. The depth of the eye hole 330 measured from the inner edge 334 to the lowermost portion 324 is approximately 27 millimeters in the relaxed state in Figures 3 to 4 and, when applied to the face during drug administration, the depth is reduces to approximately 17 mm.

It will be noted that, during application, the depth of the eye hole 330 or eye holes 340 in the embodiment of Figures 9 to 11, is reduced anywhere from approximately 30% to 70% with respect to its original depth, in accordance with one modality In another embodiment, the depth is reduced from about 40% to about 60% of its original depth, e.g. approximately 50%. The present applicant has determined that the main determinant of facial accumulation during inhalation of aerosolized drug using a pressurized system with wet nebulizer, is the effect of the facial mask design on the ballistic properties of the aerosolized particles, as they approach the surface of the face. There are two areas of facial accumulation that illustrate these principles, in particular (1) the velocity of the gas that transports aerosol particles through spills at the interface of the mask and face, is important, and (2) accumulation patterns On the entire face, including the forehead, the cheeks and other facial areas, they are influenced by the general speed of the particles, as they enter the mask from connections coming from the nebulizer itself. With respect to the first area, the data and description that appear in the present demonstrate the importance of the velocity of the gas that transports aerosol particles, especially in the areas of the nasal labial folds and the eyes. The high speeds in this region direct particles towards the eyes, producing accumulation. This pattern of accumulation is greatly mitigated by localized eye holes or "eye slices" formed in the mask, which reduce the linear velocity of aerosolized particles, preventing accumulation. With respect to the second area, the patterns of accumulation on the entire face are influenced by the general velocity of the particles, as they are introduced into the mask from the nebulizer connection and this pattern is best illustrated using conventional nebulizers and masks that are inserted perpendicular to the axis of the mouth, such as the facial mask system that is commonly referred to as the of facial mask "Salter" (see Figure 14D). Under these conditions, the particles accumulate uniformly on the face, as well as in the eyes. There are experiments that have determined that this accumulation is significantly reduced by increasing the distance of the insertion point of the nebulizer in the facial mask from the face itself. More specifically, and as illustrated in FIG. 5, an example of a face mask 300 includes the mask body 310 and the flange-shaped member 314 extending outward from an outer surface 316 of the body 310 and where it is defined the first central opening 312. The flange-shaped member 314 serves as a connector or interface between the nebulizer and the mask 300. The nebulizer generally has a rod or the like similar that is received within the flange-shaped member 314, way that you couple the two together. Accordingly, the point where the drug is discharged from the nebulizer is not the distal end of the flange-shaped member 314, but rather is closer to the end of the flange-shaped member 314 that joins and it is integrally connected to the body 310. Accordingly, the distance that is of interest begins with the location where the rod of the nebulizer ends and extends to the face itself. The distance is shown as the distance "A" in Figures 14A to 14D. This increase in distance allows the particles to proceed through the mask at a reduced speed, since the flow of particles that leave the nebulizer to enter the mask has the opportunity to mix with the flow regime inside the mask which, due to the increased linear cross-section, it produces reduced linear speeds, as will be understood when viewing the designs and data presented in the figures herein. By optimizing and making changes in the increasing distance from the facial surface ("nozzle insertion distance"), the accumulation is significantly reduced for all of the different mask designs and is best illustrated in the facial accumulation component for the mask "panda" that, after the modification of the "ocular cut", has the lowest accumulation along the face, separated from that of the eyes. The review of the data in Table 2, as well as the illustrative images of Figures 15A to 15B and 16, shows that eye cuts, as well as nozzle insertion distance, minimize facial and ocular accumulation throughout all the facial regions (particularly the eyes, from a maximum of 4.8% to 0.11-0.35%, while in the rest of the face, from a maximum of 1.74% to 0.98%). The inspection of Table 2 indicates that the ocular accumulation for the Laerdal mask is the highest overall in this standard configuration. The ocular accumulation is minimized with the presence of the modification of the ocular cut. However, the accumulation along the rest of the face, although it is significantly reduced, is not as low as in the panda mask with the modified eye cut. The main difference between the Laerdal and panda design is the increased distance from the nozzle insertion point of the panda to the Laerdal, which is approximately 1.7 centimeters. Therefore, a mask design incorporating both principles (ocular cut plus optimal nozzle length from the face to the nebulizer) will produce the greatest reduction in facial and ocular accumulation. The limitations of the distance of the nozzle insertion point from the face, will be determined by design limitations of the masks, since they have different sizes for the faces of children and adults of different ages.

TABLE 2 P = Prototype PP = Prototype Painted The Marple Casscade apparatus operated for 2 minutes for MMAD In an example of modality, the nozzle insertion distance measured from the insertion point of the nebulizer in the mask to the face, is optimized so that a reduction in the general rate of facial accumulation is of the order of at least 10%, preferably of approximately 20% and, more preferably, greater than 20% compared to the same facial mask containing just the eye cuts and a non-modified nozzle insertion distance. It will be understood that these values are merely illustrative in nature and that there are acceptable values that may fall outside these scales. For example, a reduction of less than 10% could be achieved and continue to be completely effective and acceptable. Accordingly, the method of optimizing the accumulation index on the face is at least a two-part procedure in accordance with one embodiment and, more specifically, includes the formation of eye cuts at selected predetermined locations, as described above. in the present and, secondly, the nozzle insertion distance is selected so as to optimize the reduction of facial accumulation. In other words, the speed of the aerosolized drug that is discharged to the facial mask is modified and controlled by forming eye cuts in the facial mask and subsequently reducing the speed by increasing the distance from the insertion point of the nebulizer to the face.

In table 2, under the heading "type of mask", there are a number of different types of masks listed by a set of abbreviations. For example, the abbreviation "STD" refers to the standard outside the shelf mask that does not include any modification; the term "LEC" refers to large eye cuts that form in the body of the mask; and the term "LEC-MOD" refers to a mask having large eye cuts, as well as a hole at the 6 o'clock position on the watch, as mentioned above. In addition, when the term "eye cut" is used under this heading, it refers to a mask that has standard eye cuts formed in that site, as opposed to the large eye cuts that are denoted by the term "LEC". Additionally, it will be noted that the nozzle insertion distance is selected so that, even if a reduction in facial and ocular accumulation is made, the amount of inhaled drug (eg, measured as a percentage of inhaled mass) remains within a acceptable scale. For example, and in accordance with one embodiment, the nozzle insertion distance is greater than 5 centimeters and, preferably, greater than 5.5 centimeters. In other modalities, the nozzle insertion distance may be less than 5 centimeters or may be greater than 5.5 centimeters, as long as the effectiveness of the administration of the drug is not threatened and, equally, the resistance of the mask is not seen threatened as a result of the increase in the length of the flange member 314.

Once again, the designs and constructions of the anterior facial mask not only apply to facial masks for children, but apply equally to facial masks for adults and young adults. This aspect of the present invention can be observed by inspecting the data in Table 2 and, more particularly, by referring to experiments with budensonide that can be used to see the results obtained with a face mask containing the eye sections described above and the optimized spout . In particular, the comparison can be made between the "bubble eye cut" mask and the "original PP LEC" mask. In practice, these masks are, in essence, the same mask and all the factors, such as eye cuts, particle size, scum, etc., in the experiment are controlled, except that the spout length is different. In particular, the spout size is increased from 5.0 to 7.1 (an increase in size of 42%), which produces a facial accumulation value ranging from 2.40 to 1.33 (an increase in facial accumulation of 55%). Similarly, another comparison and the same effect can be observed when comparing the Ler Laerdal (large eye cut) with the LEC Panda. Again, the facial mask is, in essence, the same or very similar and the other factors, in addition to the spout length, remain basically the same. In this comparison, the spout was increased from 3.5 (Laerdal) to 5.2 (Panda), which is a 49% increase in the spout length, which causes the facial accumulation to fall from 2.42 to 1.50 (a reduction of 62). %). Another comparison of basically the same masks is the following: Laerdal Standard compared to Panda Standard, where both of these masks are sealed to the face (without holes), the only difference being the length of spout, and here the facial accumulation is reduced 2.42 to 1.72. Another is the Standard Laerdal with the Standard Panda, where the facial accumulation was reduced from 6.51 to 1.72. Therefore, in accordance with one aspect of the present invention, the spout length of the mask is optimized by increasing the spout length by at least 40% (compared to the original length) while at the same time , the facial accumulation is reduced by at least 50%, when compared to the unmodified facial mask. It will be noted that this is merely an example of the present invention and that other scales can be used as well to achieve the purpose of the present invention, which is to optimize the spout length of the face mask so as to reduce facial accumulation. The above written description is of a preferred embodiment and of particular features of the present invention, and does not limit the many applications of the scope of the present invention which, instead, is defined by the claims appended hereto and the basic equivalents. from the same.

Claims (33)

NOVELTY OF THE INVENTION CLAIMS

1. - A face mask for use in a pressurized drug delivery system, the face mask comprising: a body at least partially deformable having a surface to be placed against a patient's face and a nose bridge section formed in a section upper body, the body having a pair of eye holes formed in that site, with an eye hole being formed on one side of the bridge section of the nose and the other eye hole being formed on the other side of the bridge section of the nose, the eye holes being to be placed below the patient's eyes when the face mask is placed against the patient's face, where the eye holes are designed so that, when the body is placed against the face, forms an opening between an innermost edge of the eye hole and the face, below the eyes, to allow the escape, where the associated opening or with the eye hole is open to atmospheric conditions and the body of the facial mask includes an integral connection with it, the connector defining a fluid path to an interior of the face mask and which is designed to receive, under pressure , an aerosol drug.

2. - The face mask according to claim 1, further characterized in that the face mask is coupled with a drug delivery system with a nebulizer to administer an aerosol drug through the face mask.

3. The facial mask according to claim 1, further characterized in that each pair of holes comprises an eye cut that is formed by removing material from the body.

4. The facial mask according to claim 1, further characterized in that the body includes a lower surface to contact the face when the face mask is applied against the face and the body is at least partially deformed.

5. The facial mask according to claim 1, further characterized in that the body has a folded lower section, wherein a portion of the body is folded on itself, the lower section folded being to be placed against the face.

6. The facial mask according to claim 5, further characterized in that a central opening is formed in the lower section folded that is for placement on the mouth of a patient, the central opening being defined by a first body edge .

7. The facial mask according to claim 6, further characterized in that the eye hole extends from the inner edge to the central opening, so that the central opening and the eye hole are open with respect to each other.

8. - The face mask according to claim 5, further characterized in that the eye hole is formed at least partially in the folded lower section.

9. The facial mask according to claim 5, further characterized in that the body is designed in such a way that the folded lower section collapses at least partially when the face mask is applied against the face; However, the eye hole remains open so that it defines the opening between the inner edge and the face, to allow escape.

10. The facial mask according to claim 1, further characterized in that the eye holes abut and define the bridge section of the nose.

11. The facial mask according to claim 5, further characterized in that each eye hole is a completely delimited eye hole, formed at least partially in the folded lower section, the facial hole located in the lower section folded in such a way that When the face mask is applied against the face, the facial orifice is close to the face, so that the opening is formed between the inner edge and the face.

12. The facial mask according to claim 11, further characterized in that the opening of the completely delimited orifice has a shape selected from the group consisting of an oval, circle, square and rectangle.

13. - The facial mask according to claim 6, further characterized in that the body material completely surrounds the eye hole that is separated from the central opening.

14. The facial mask according to claim 1, further characterized in that one end of each eye cut defines an external section of the bridge section of the nose.

15. A facial mask for use in a pressurized drug delivery system, the facial mask comprising: a deformable body at least partially having a surface to be placed against a patient's face and a bridge section of the nose formed in an upper section of the body, the body having a pair of eye holes formed in that site, with an eye hole being formed on one side of the bridge section of the nose and the other eye hole being formed on the other side of the nose. bridge section of the nose, the eye holes being to be placed below the patient's eyes when the face mask is placed against the patient's face, where the eye holes are designed so that, when the body is placed against the face, an opening is formed between an innermost edge of the eye hole and the face, below the eyes, to allow escape, where the holes Eyepieces occupy more than 10% of a total body surface area of the facial mask.

16. A face mask for use in a pressurized drug delivery system, the face mask comprising: a partially deformable body having a front section for coupling with drug delivery system equipment and a rear section for positioning against the face of a patient, the rear section having a folded body configuration because a wall defining the body is folded at least partially on itself and leads to a central opening for placement over a patient's mouth, the folded body being deformable when a force is applied against the front section to place the body against the face, the rear section including a nose bridge section and a pair of eye holes formed on each side of the bridge section the nose, the eye holes being to be placed below the patient's eyes when A facial mask is placed against the face of the patient, wherein the eye holes are formed at least partially along the folded body and are designed so that, when the body is pressed against the face in an opening between a innermost edge of the eye hole and the face, below the eyes, to allow escape, where the eye hole has a first depth, measured from the inner edge thereof to the lowermost portion of the facial mask, in a non-compressed state, as well as a second depth in a compressed state when the mask is applied to the face, the second depth being approximately 30% to 70% smaller than the first depth.

17. - The face mask according to claim 16, further characterized in that the second depth is approximately 40% to 60% less than the first depth.

18. A drug delivery system comprising: an aerosol drug source; and a face mask that includes: a body at least partially deformable having a surface to be placed against a patient's face and a nose bridge section formed in an upper body section, the body having a pair of eye holes formed at that site, with an eye hole being formed on one side of the bridge section of the nose and the other eye hole being formed on the other side of the bridge section of the nose, the eye holes being to be placed below of the patient's eyes when the facial mask is placed against the patient's face and the body of the facial mask is folded on itself, wherein the facial mask is operatively and fluidly connected to the aerosol drug source and delivers the aerosolized drug to the atmosphere through the eye orifices.

19. The system according to claim 18, further characterized in that the aerosol drug source includes a drug delivery system with nebulizer to administer the drug in aerosol through the face mask.

20. - The system according to claim 18, further characterized in that each of the pair of holes comprises an eye cut that is formed by removing material from the body.

21. The system according to claim 18, further characterized in that the body includes a lower surface to contact the face when the face mask is applied against the face and the body is at least partially deformed.

22. The system according to claim 18, further characterized in that the body has a folded lower section, wherein a portion of the body is folded on itself, the lower section folded being to be placed against the face.

23. The system according to claim 22, further characterized in that a central opening is formed in the folded lower section that is for placement over the mouth of a patient, the central opening being defined by a first edge.

24. The system according to claim 23, further characterized in that the eye hole extends from the inner edge to the central opening, so that the central opening and the eye hole are open with respect to each other.

25. The system according to claim 22, further characterized in that the eye hole is formed at least partially in the folded lower section.

26. - The system according to claim 22, further characterized in that the body is designed in such a way that the folded lower section collapses at least partially when the face mask is applied against the face; however, the facial orifice remains open, so that it defines the opening between the inner edge and the face, to allow the escape.

27. The system according to claim 18, further characterized in that the eye holes colindad with and define the bridge section of the nose.

28. The system according to claim 22, further characterized in that each eye hole is a completely delimited eye hole, formed at least partially in the folded lower section, the eye hole being located in the lower section folded so that, When the face mask is applied against the face, the eye hole is close to the face, so that the opening between the inner edge and the face is formed.

29. The system according to claim 18, further characterized in that one end of each eye cut defines an external section of the bridge section of the nose. 30.- A facial mask for use in a pressurized drug delivery system, the face mask comprising: a deformable body at least partially having a surface to be placed against a patient's face and a bridge section of the nose formed in an upper section of the body, the body having a pair of eye holes formed in that site, with an eye hole being formed on one side of the bridge section of the nose and the other eye hole being formed on the other side of the nose. bridge section of the nose, the eye holes being to be placed below the patient's eyes when the face mask is placed against the patient's face, the body including a flange member extending outwardly from the body of the patient. mask to receive a stem associated with the drug delivery system and establish a connection between the pressurized delivery system n of drugs and the mask, where a distance from a distal end of the rod to the face itself is optimized, in such a way that optimization produces a reduction of facial accumulation that is less than 40%, compared to the facial mask having only eye holes formed therein. 31.- The facial mask according to claim 30, characterized also because the reduction of the facial accumulation due to the optimization of the distance, is greater than 50%. 32. The face mask according to claim 1, further characterized in that the distance between the distance of the distal end of the rod to the face is at least about 5 centimeters. 33.- A face mask for use in a drug delivery system that administers an aerosol drug to a patient, the face mask comprising: a deformable body at least partially having a surface contact face to be placed against the face of a patient and a bridge section of the nose formed in an upper section of the body, the body having a pair of eye holes formed in that site, on each side of the bridge section of the nose and being provided in the perinasal sections of the mask that are prone to spillage of the aerosol drug during administration of the aerosol drug, wherein the characteristics are designed to reduce the inertia of the particles of any aerosolized drug that is spilled through the perinasal sections and reduce, in this way, the accumulation of the aerosolized drug in the ocular regions of the patient, relieving the drug aerosolized into the atmosphere through the eye holes where, in an applied state, when the mask is pressed against the face, the eye holes are placed against the face so that they form an opening between an inner edge of each eye hole and the face for venting the aerosolized drug, wherein the eye holes comprise fully delimited openings, formed adjacent to and adjacent to a peripheral edge of the body of the facial mask so that, when the mask is applied, it folds over itself to define the opening, with a fold line of the facial mask extending along and intersecting the opening.