The present invention relates to a breathing aid device for subjects affected by very enervating pathologies, more particularly related to their respiratory autonomy, thus needing a mechanical aid to breathe correctly.

It is known that the respiration physiology consists of a complex set of coordinated and integrated processes which are essential for keeping a stable internal environment. The normal operation of the respiratory system assures to tissues an adequate supply of oxygen (O2) and a prompt removal of carbon dioxide. Moreover this process and the control mechanics should protect and maintain the homeostasis notwithstanding the variability of the environmental conditions and the needs of the body.

The respiratory system consists of an integrated set of regulated processes comprising the ventilation of the lungs, the exchange and conveyance of gases and regulation of the ventilation of the lungs by the nerve centers.

The ventilation of the lungs is a technical term indicating what is normally called breathing, consisting of two stages:

1 ) The inspiration phase, allowing to inhale air into the lungs, wherein the lungs expand, the diaphragm and the intercostal muscles contract;

2) The expiration phase, allowing discharge of air from the lungs, wherein the lungs contract, the diaphragm and the intercostal muscles relax.

Air enters the respiratory system due to the contraction of the inspiration muscles, while expiration is a passive phenomenon. Air flows into and from the lungs because there is a pressure gradient causing the motion of fluids.

On inspiration, the diaphragm contracts, lowers and flattens causing the vertical axis of the chest to increase. The contraction of the intercostal muscles raises the fore end of each rib, allowing to raise the breast bone increasing the chest diameter. When the chest size increases, it drags together the lungs due to the cohesive force between visceral pleura and parietal pleura.

However there are subjects affected by particular degenerative disorders such as the Amyotrophic Lateral Sclerosis (ALS), who are not able to breathe autonomously, since the complications of this disorder often involve the bulbar muscles which are deputed to the swallowing and speaking functions. When ALS affects the motoneurons controlling the respiratory muscles, breathing becomes difficult and exhausting. This condition may arise gradually in the course of weeks or months or in very rare circumstances suddenly, even without any warning sign. In subjects with a neuromuscular pathology, generally there is a restrictive ventilator deficiency, with a reduction of the values of total and vital pulmonary capacity. Moreover the reduced performance of the expiratory muscles causes a high amount of residual volume (RV), namely the quantity of air left in the lungs at the end of a forced expiration, while the residual functional capacity is often normal or reduced. In the subjects affected by a neuromuscular pathology, the reduced muscular strength and the alteration of the elastic properties of the respiratory system prevent to reach adequate pulmonary volumes at the end of a deep inspiration. This limits the amount of air available for the coughing discharge phase and consequently causes a reduction of the expiration flow.

One of the techniques known in the scientific background as a breathing aid for subjects affected by these degenerative disorders is the mechanical ventilation consisting in using a portable respirator supporting the lungs and helping to breathe, allowing to compensate the insufficient operation of the respiratory muscles.

The non-invasive ventilation consists in using a nasal, buccal or facial mask connected to a small portable ventilator, that may be operated with positive or negative displacement. These ventilators are small, light and portable devices, that may generate two different pressure level, a higher pressure on inspiration and a lower pressure on expiration.

The non-invasive ventilation is easy to be managed, does not require particular maintenance, has few complications and the cost is much lower when compared with invasive ventilation.

Many types of nasal, buccal and facial masks are available on the market, including those custom-made. The patient should test the various types so as to choose the most comfortable and appropriate for himself, that does not irritate the skin and allows a ventilation with few air escape. Some side-effects of ventilation with nasal or facial mask comprise skin irritation or abrasion, nose dryness or inflammation, conjunctivitis due to air escape, swallowed air stretching the stomach. The nasal masks may generate too many air escapes from mouth in sleep, causing an insufficient night ventilation. Another non-negligible drawback arises from the fact that the patient, being obliged in the most serious cases to use the mask steadily, is hindered when eating or talking.

In view of the drawbacks when using the existing masks, in the past a device known with the trade name PNEUMOBELT or exsufflation belt was used, consisting of a rubber bladder inside a rigid corset provided with adjustable side straps, applied and worn around the patient's abdomen just under the diaphragm. Such a device is connected through a hose with a ventilator alternately inflating and deflating the bladder. On inflation the bladder applies a pressure under the diaphragm, forcing air to come out from the patient's lungs for his expiration; thereafter the bladder deflation lowers the diaphragm causing a suction or negative pressure, causing air to enter passively the lungs for his inspiration. More particularly the position of the device on the patient's bust must be with the upper part just above the lower level of the ribs and the bottom curved edge beyond the epigastric region.

The prior art mechanical ventilation device comprising the above described bladder had a number of drawbacks. First of all the bladder was made of a butyl rubber welded with neoprene glue that, following its constant use by the patient, had a scarce resistance to wear, since the used material was very prone to failure and the glueing method was not sufficiently tight.

Moreover the prior art bladder tended to inflate inhomogeneously, not fitting in easily with the physiologic conformation of the patient, who in view of his degenerative pathology unfortunately is in serious physical conditions, often obliged to use a wheelchair, so the bladder swells up considerably at the points of less resistance inside the corset in which it is arranged.

Other known devices are disclosed in documents US 3961626 A and JP H11- 42265 A; these two devices are not congruent with the subject matter of the present invention, since they do not comprise any corset among the various technical features of the present invention. In addition document JP H11 -42265 A has not the shape of a bladder, being instead provided in the form of a doughnut.

Moreover it has to be pointed out that document US 2014/277465 A1 does not disclose a breathing aid device arranged outside the human body and indeed discloses a set of balloons mutually connected by rings to be inserted by surgery in the human body, thus being a different technical solution not compatible with the present invention.

The above discussed problems are brilliantly solved by the breathing aid device of the present invention, consisting of simple and cheap components with reduced manufacturing costs.

An object of the present invention is to provide for a breathing aid device that may easily conform autonomously to the physiology of the patient wearing the device under any condition of bodily health, warranting a better comfort, thus avoiding any excess pressure of the bladder and at the same time providing for a more homogeneous pressure on the entire abdomen irrespective of the position of the trunk and the patient's physiologic condition.

A further object of the present invention is to provide for a breathing aid device made of fatigue resistant and durable materials for a continuous use, and more particularly components manufactured with highly innovative glueing techniques involving a stable and durable welding operation.

Still another object of the present invention is to implement the connection of the device with the respirator in such a way that the system may be better managed by the patient, being also less bulky, avoiding at the same time any event of accidental obstruction of the respirator hose.

An additional object of the present invention is to provide for a device adapted to work with lower air volumes but at the same pressure compared with the prior art devices, so as to warrant a quicker cycle of inflation / deflation of the bladder.

A further object of the present invention is to provide for a device not prone to inconveniences of accidental obstructions due to a Venturi effect at the air inlet portion of the device.

Finally another object of the present invention is to provide for a simple manufacturing method with a small number of steps, affecting not only the time but also the cost of manufacturing each individual device.

These and other objects are achieved by the present invention, comprising a breathing aid device for subjects affected by respiratory disorders due to very enervating pathologies, said device being applicable to a respirator, configured to contain on use a greater volume of air in the bladder portion of the abdominal side than the volume of air present in the bladder portion of the outer side.

In a particularly advantageous way, the breathing aid device of the present invention is configured to withstand very long cycles of operation, and may conform much better than the prior art devices, to the physiological structure of the users, even in the more or less enervating stages of the affected pathologies.

In addition the device of the present invention is comfortable to be used, in combination with the respirator to which the device may be connected, and is so configured that the connection hose with the respirator be not uncomfortable when contacting the patient's side, and is also easy to be connected by the user to the respirator hose, while at the same time is not prone to accidental obstructions by Venturi effect.

At last an advantage of the present invention is the easy and cheap manufacturing method, thus adapted to minimize any possible defect of the finished product due to the manufacturing operation.

The breathing aid device of the present invention, possibly combined with the features of one or more annexed claims, may also be provided with different materials and/or connections allowing the device to achieve the mentioned objects of the invention.

The features and advantages of the breathing air device of the present invention will anyway be apparent from the following detailed description of the structural elements of a preferred embodiment given as an illustrative non limiting example, to be read together with the accompanying illustrative drawings, in which:

Fig. 1 is a view of the abdominal side portion of the bladder of the breathing aid device of the invention;

Fig. 2 is a view of the outer side portion of the bladder of the breathing aid device of the invention;

Fig. 3 is a rear view of the corset with inserted bladder, of the breathing aid device of the invention; and

Fig. 4 is a front view of the corset of the breathing aid device of the invention.

With reference now to the accompanying drawings, the breathing aid device of the present invention comprises a bladder 1 consisting in laminating two portions along a lamination contour 6, more particularly an abdominal side portion 10, which in use is in contact with the patient's abdomen, and an outer side portion 11. The lamination contour 6 and consequently the breathing aid device of the invention, is so configured as to be comfortable for the patient during its use, thus having a substantially straight upper contour disposed slightly above the ribs at the diaphragm height and a symmetric curved lower contour disposed up to the height of the patient's pubic symphysis.

Both the abdominal side portion 10 and the outer side portion 11 have a connection part 101 and 111 , respectively, adapted to enclose laterally a spiraled hose 3, which is soft to be bent in use lying on the patient's side, at the same time achieving some comfort of use. The connection parts 101 and 111 and the spiraled hose 3 may be provided indifferently on either the left-hand or the right-hand side of the breathing aid device of the invention, in respect of the position of the air outlet or delivery hose 80 of the respirator 8 using the breathing aid device.

The spiraled hose 3 at its outer end is inserted into a connection pipe 4, in turn connected to a coupling 5 allowing the connection of the device with the delivery hose 80 of the respirator 8. The spiraled hose 3 covers the full length of both the connection part 101 of the abdominal side portion and the connection part 111 of the outer side portion 11 , and this feature is useful to prevent the occurrence of accidental obstruction of the device inlet part, consisting in the lamination of the connection part 101 with the connection part 11 , caused by possible Venturi effect events.

After several careful durability and fatigue tests, the choice was focused on specific technical materials adapted to solve the problems of the prior art devices, achieving the objects of the present invention. The abdominal side portion 10 is preferably made of a layer of polyether TPU, while the outer side portion 11 is preferably made of a nylon coated polyurethane. The particular choice of the stated different materials between the abdominal side portion 10, that is the portion in direct contact with the treated patient's abdomen, and the outer side portion 11 , allows the device to be able to conform autonomously to the specific physiology of the patient to be treated, besides warranting a more efficient pressure / mechanical thrust exerted on the abdominal tender tissues, thus a more efficient suction of air into the lungs, exerted through upward compression and subsequent release of the visceral thrust on the diaphragm, said innovative features being just achieved by the technical characteristics of the used materials. Indeed the particular chosen polyurethane is characterized by an elasticity compatible with the pressure of air insufflated by the known respirators and at the same time compatible with the resistance given by the patient's abdomen during use, in addition to being compatible with the resistance given by the nylon material used for the outer side portion 11 , which is much stiffen Therefore the stiffness of the material used for the outer side portion 11 allows, the insufflated pressure being equal, that bladder 1 contains a greater volume of air in the abdominal side portion 10 (thus having less resistance to its expansion) relative to the expansion of the outer side portion 11 , since the abdominal side portion 10 has a layer of material with greater elasticity in comparison with the material of the outer side portion 11.

The lamination contour 6 between the layers of outer side portion 11 and abdominal side portion 10 is obtained by radio frequency welding. The spiraled hose 3 is made of polyvinylchloride (PVC) and is glued with cyclohexanone to the connection pipe 4 also made of PVC, in turn connected to coupling 5 made of polyurethane. The assembly comprising the spiraled hose 3, the connection pipe 4 and the coupling 5 is radio frequency welded jointly with the lamination contour 6.

Outside the lamination contour 6, the bladder 1 is provided with an external edge (not shown in the drawings) of a proper size and having a plurality of buttonholes and/or buttons required to stably insert the bladder 1 inside a pocket of a suitable corset 7, which is provided with a set of longitudinal adjustable straps 70 with buttoning / buckling members, that will be worn by the patient around the abdomen just below the diaphragm.

More particularly the corset 7 consists of a front portion 78 suitable to cover the patient's abdomen, and a rear portion 79, each other connected by said longitudinal buttoning / buckling straps 70, said corset being configured to surround firmly the patient at his abdomen and keep the bladder 1 at a central position relative to the patient's abdomen by adjusting said longitudinal straps 70 parallel to the longitudinal development of said corset 7.

The front portion 78 is inside provided with a pocket (not shown) sewn to the front portion 78 only at its top and bottom, but not sideways so as to allow insertion of bladder 1 inside the pocket.

Each longitudinal strap 70 is provided with a first with a first buckle 71 to adjust the length of the longitudinal strap 70 at the right side, a second buckle 72 to adjust the length of the longitudinal strap 70 at the left side, once the device is used, so as to allow the correct adjustment and arrangement on the patient's abdomen.

On the front portion 78 there is a central seam 75 fastening to the front portion 78 the second buckle 72 at one side and the closure clip 73 at the other side. The first buckle 71 is disposed on the end part of the closure clip 73. These closure clips 73 have the function of stable closure of the longitudinal straps 70.

When the device is worn by the patient, he will find at his left hand the bladder coupling 5 coming out from a proper hole made on the front portion 78, for the connection with the delivery hose 80 of respirator 8. The part of each longitudinal strap 70 at his left hand is provided with a loop 76 to hold a stable position of the corresponding terminal part of the strap coming out from the second buckle 72. At his right hand the longitudinal strap 70 is provided with a Velcro® closure 77 holding together the parts of each longitudinal strap 70 incoming and outgoing relative to the first buckle 71.

The first buckle 71 , the second buckle 72, the closure clip 73 and the loops 76 are preferably made of plastic materials.

The basic textile fabric of corset 7 is preferably cotton. The bladder 1 is inserted in the mentioned inner pocket (not shown) of the corset, said pocket being made of anti-allergic elastic material adapted to conform and support the deformations of bladder 1 on use of the device.

Finally the corset 7 is provided with a plurality of rigid bones 74 arranged parallel to each other vertically and orthogonal to the longitudinal development of the corset, and so positioned in the corset as to correspond with the patient's dorsal part once the device is being used, said rigid bones 74 having the function of further stiffening the corset 7 and prevent that it may wrap on itself on use, and at the same time avoid that use of the device causes decompensations in the patient's spinal column.

The manufacturing process of the bladder 1 of the breathing aid device of the invention comprises the following steps: creating the desired shape of the abdominal side portion 10 and the outer side portion 11 ; preparing the lamination contour 6; inserting the spiraled hose 3 between the two overlapping forms of the abdominal side portion 10 and the outer side portion 11 ; glueing with cyclohexanone one of the ends of the spiraled hose 3 inside the connection pipe 4 and then the latter to coupling 5; radiofrequency welding the assembly of the above steps along the lamination contour 6. The manufacturing process may also provide for preparing buttonholes and/or applying buttons on the external edge of the lamination contour 6.

It has to be pointed out that the scope of the present invention encompasses also use of different materials having characteristics of elasticity and strength similar to those of the above mentioned materials, or in any case materials having different elasticity from each other, more particularly a material with greater elasticity for the abdominal side portion 10 and a material with lower elasticity for the outer side portion 11.

The above described features are only some of the possible and preferred embodiments of the breathing aid device and of the manufacturing method thereof; further variations in which the elements of the product / system are coupled / implemented in different ways, or may have alternative forms, but anyway suitable for carrying out the stated object of the invention, or materials of any kind, or any modification that falls within the described scope of the present invention, should be considered as embodiments alternative to the above described preferred embodiments, wherein modifications and changes for instance related to geometries chosen for the individual fixed and movable elements, the materials adopted for each element and also the specifications of the operative system, that may be resorted to, fall within the scope of protection of the present invention as defined in the appended claims.

List of reference numerals

I bladder

10 abdominal side portion, 101 connection part

I I outer side portion, 111 connection part

3 spiraled hose

4 connection pipe

5 coupling

6 lamination contour

7 corset

70 longitudinal strap

71 first buckle

72 second buckle

73 closure clip

74 rigid bones

75 central seam

76 loop

77 Velcro® closure

78 front portion

79 rear portion

8 respirator

80 delivery hose