Breathing protector

A breathing protector may include a filter housing having a central axis, a distal end, a proximal end, a first opening and a second opening. The second opening may be located in a proximal end of the filter housing and the first opening may be located distally of the second opening, such that the first opening is located upstream of the second opening. An exchanging filter may be disposed in the filter housing and a valve seat may extend around the first opening. A rail, located circumferentially of the valve seat, may extend axially and distally away from the first opening. The rail may include a distal end and at least one rib. A valve member may be arranged in a transversal plane to the central axis and engage the valve seat in a closed position. A return spring may press the valve member into the open position.

CROSS-REFERENCES TO RELATED APPLICATION

This application claims priority to European Patent Application 0850108-2 filed on Nov. 28, 2008 and PCT/EP2009/065961 filed on Nov. 27, 2009, which are hereby incorporated by reference in their entireties.

TECHNICAL FIELD

This invention pertains in general to the field of a breathing protector for use in a stoma of a laryngectomized or tracheotomised person, said breathing protector having a housing with at least one inlet and at least one outlet, such that an air flow in use will pass from the surroundings of said person through said inlet to said outlet, into trachea of said person, said breathing protector comprising a heat-moisture exchanger in said housing in between the at least one inlet and the at least one outlet, such that the air flow will pass through said heat-moisture exchanger when said air flow in use passes through said inlet to said outlet.

BACKGROUND

A tracheostomy is a surgical procedure in which an opening is formed through the anterior surface of the neck into the trachea. The opening is referred to as a tracheostoma. A tracheostomy tube can be provided to extend between the tracheostoma and the trachea. A tracheotomy is performed for example when there is a malfunction, such as a result from injury or disorder, in respect of the nervous system or the respiratory passages, which malfunction results in an incapacity to obtain enough air. An inferior lung capacity or need of respiratory treatment may also result in a tracheotomy.

A laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and the creation of a tracheostoma. A consequence of the procedure is that the trachea is no longer connected to the pharynx but is diverted to the tracheostoma. After this procedure, normal nasal function is not possible. In a subject whose breathing functions normally, the nose and the mucous membrane lining of the nasal cavity perform important functions in conditioning inhaled air. The convoluted passages and rich blood supply serve to increase both the temperature and humidity of the inhaled air to minimise the differential in these parameters with those of the surface of the lungs. Normally some heat and moisture is also captured from exhaled air prior to its release to the atmosphere. The mucous lining of the nasal passages also serves to remove particulate matter, such as fine dust particles, pollutants and microorganisms, from the inhaled air, and the action of cilia transports mucous and any particles away from the lungs.

When a patient has received a laryngectomy, in effect all inhaled air enters the lungs via the tracheostoma, and the nose is effectively not involved in the inhalation process. Exhaled air may pass through the tracheostoma or, if a voice prosthesis has been fitted, the stoma can be occluded so that the exhaled air is diverted through the voice prosthesis into the pharynx and the mouth, enabling the patient to speak. It is desirable that the flow of the exhaled air be controlled by means of a tracheostoma valve. In these situations, the valve can be arranged to remain open during breathing but, with a small additional increase in exhaled air flow, can be closed to divert the airflow.

In this respect filter devices and breathing protectors have been developed to enable moisturizing of inhaled air and removal of small particles and bacteriological substances in said inhaled air. This is to resemble the functions of a nose. However, there are several complications related to the manufacturing of such devices. Firstly, the user of such devices is in need of good moisturizing and filtering effect while keeping the size, such as the surface area, of the device as small as possible. Secondly, the moisturizing effect and filtering effect is in need of large surface area, while not creating a too large resistance over the device. These criterions are contradictive, which the observant reader already has acknowledged. Also, a person with a laryngectomy has to hold his finger over these devices when wishing to speak, to thereby obstruct the air flow through the device and the stoma through the tracheal wall, which will burden the filter with undue contamination, due to transfer of impurities from the finger of the user to the filter. Also, if a patient turns unconscious, clothing etc may hinder air-flow through the device.

U.S. Pat. No. 5,738,095 discloses a device with a push button, in form of a disc, displaceable along a central axis of the device by the aid of a centrally located piston, such disc being operable against a spring mechanism to cooperate with a valve seat in the proximal end of the device. The device according to U.S. Pat. No. 5,738,095 is also provided with an axially extending rail in the distal end of the device, to only allow closing force in the axial direction and acting from above within the cross-sectional area of the device, thus providing a safe mechanism for minimizing risk for occlusion of the device. However, the centrally located piston and the spring mechanism decrease the effective volume of the filter within the device. Also, the technical field would benefit of a spring mechanism that is easier to manufacture.

U.S. Pat. No. 6,772,758 discloses a breathing protector to be applied over a tracheostoma, including a heat-moisture exchanger body which communicates with the tracheostoma through an inlet. A closing lid is attached to the heat-moisture exchanger, and can be pressed down to close the communication by cooperating directly with a valve seat or by squeezing the heat-moisture exchanger against the valve seat. However, there is a need for glue in between the heat-moisture exchanger and the lid. Furthermore, a part of the heat-moisture exchanger has to be excluded for the lid to cooperate directly with the valve seat, otherwise the heat-moisture exchanger has to be squeezed in between the lid and the valve seat, which strains the heat-moisture exchanger unnecessarily and impairs the closing action. Also, the device according to U.S. Pat. No. 6,772,758 lacks an axially extending rail in the distal end of the device, to only allow closing force in the axial direction and acting from above within the cross-sectional area of the device.

Hence, an improved breathing protector would be advantageous and in particular a breathing protector allowing for maximized moisturizing effect in the space provided in the housing of the breathing protector, while also providing the possibility to a patient to keep the breathing protector closed, such as during speech, without undue contamination of the filter by holding a finger over said opening during the entire period of speech, and without undue substances, such as glue, prone to degradation in moist environment and repeated strain. It would also be advantageous to provide a breathing protector allowing for an excellent moisturizing effect, while still providing a small breathing protector with a satisfactory resistance over said breathing protector, and with a spring mechanism that is easier to manufacture, while simultaneously minimizing the risk for occlusion of the breathing protector.

SUMMARY

Accordingly, the present invention seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies and to provide an improved breathing protector of the kind referred to. For this purpose the breathing protector is characterized in that the resiliency of the heat-moisture exchanging filter forces the lid into the open position.

Advantageous features of the invention are defined in the dependent claims.

DETAILED DESCRIPTION

The following description focuses on embodiments of the present invention applicable to a breathing protector and in particular to a breathing protector for use in a stoma of a laryngectomized or tracheotomised person, where said stoma is communicating with trachea of said person.

The device according to one embodiment of the invention is shown inFIGS. 1,2aand2b, said device comprising a cylindrical filter housing100. The device may be a breathing protector for use in a stoma of a laryngectomized or tracheotomised person.

The cylindrical filter housing100has a distal and a proximal end, and a central axis from one end to the other. The cylindrical filter housing100has a first opening101and a second opening102, such that an air flow in use will pass from the surroundings of a patient through said first opening101to said second opening102, into trachea of said patient. The second opening102is located in the proximal end of the device. The second opening102may thus be located in a proximal end of said filter housing100, and said first opening101is located distally of said second opening102, such that said first opening101is located upstream said second opening102during inhalation. A heat-moisture exchanging filter103is received in said cylindrical filter housing100. The second opening102of the filter housing100may be provided with radial or diagonal arms104, forming a stop element for the heat-moisture exchanging filter103. The openings between the radial or diagonal arms104and the periphery of the second opening102constitute outlets of breathing air during inhalation, and consequently inlets of breathing air during exhalation. When the second opening102of the filter housing100is provided with arms104, extending across the second opening102, these arms104may hinder proximal movement of the heat-moisture exchanging filter103. These arms104may be arranged in a non-intersecting manner, such as in parallel or substantially parallel, in accordance withFIG. 1b. Arms104arranged in this manner simplify cleaning of the second opening102.

Distally of the second opening102of the cylindrical filter housing100the first opening101is provided. The heat-moisture exchanging filter103will then be partly located within said first and second opening when the device is in an open position, and fully located within said first and second opening, when the device is in a closed position. The first opening is encircled by a valve seat105. Thus, the valve seat105is arranged around the first opening. Radially and/or circumferentially outwards from the valve seat105, a rail is extending axially and distally from said first opening101. The rail comprises ribs106, extending axially and distally from the first opening101. A ring107connects the ribs106in the distal end of the device. Between the ribs106, proximally of the ring107apertures108are provided. The apertures108may be perpendicular to the central axis of the housing100, which may be seen at least inFIG. 1. Apertures108constitute outlets of breathing air during exhalation, and consequently inlets of breathing air during inhalation. Thus, the heat-moisture exchanging filter103is located in said housing100in between the apertures108and the second opening102, such that the air flow will pass through said heat-moisture exchanger103, when said air flow during inhalation passes through said apertures108to said second opening102.

Proximally of the ring107and distally of the valve seat105a valve member, such as circular lid109, is provided. The circular lid109has a surface area covering the first opening101, such that the circular lid109peripherally will sit on valve seat105to close the first opening101. The valve member, such as the lid109, may then be arranged in a transversal plane to the central axis of the device. The valve member is adapted to cloyingly engage with the valve seat105in a closed position, said valve member109being reciprocatingly arranged within the rail between the closed position and an open position. The circular lid109has a diameter allowing for axial displacement, while said circular lid109being arranged in a transversal plane in respect of a central axis of the cylindrical filter housing100, within the ribs106. The opening of the ring107does not allow the lid109to pass there through. This may be accomplished if the ring107is circular with a diameter smaller than the diameter of the circular lid109. The circular lid109may also be peripherally provided with radially extending protrusions110, said protrusions110engaging with the apertures108, to stop the axial movement in a distal direction of lid109. The lid/valve member109is thus hindered from distal movement by the rail in the open position.

In one embodiment the rail, such as the ring107, is provided with inwardly and radially extending protrusions, which may hold the lid109in place. In this embodiment there is no need for protrusions110on the lid109, even such a possibility not is excluded, and is well inside the scope of the present invention.

The heat-moisture exchanging filter103is of a flexible/resilient material, such as a resilient foam. Furthermore, the size of heat-moisture exchanging filter103is adapted to press the lid109distally towards and against the ring107. Thus, the heat-moisture exchanging filter103acts both as heat-moisture exchanger and return spring, pressing the lid109axially and distally into the open position. In order to generate talk the lid109is exposed to a pressure from a finger until the lid109sits or rests on the valve seat105and covers said first opening101, whereby the first opening is closed, thus closing the communication between the trachea and the surroundings. The device can be closed in this manner even if it is covered by garments. At the same time the device is prevented from coming loose from the stoma because it is pressed against the throat by the finger during talking.

The radial or diagonal arms104and the lid109, due to the shape thereof, holds heat-moisture exchanging filter103in position, while the heat-moisture exchanging filter103simultaneously acts as a return spring so that the lid109after the pressure having been relieved will resiliently return to an open position thereof.

The ribs106and ring107reduces the risk of the valve member being inadvertently closed, since a force in an axial and proximal direction within the ring107has to be applied to close the valve member. Since the lid109, in the starting position thereof, is in close contact with the heat-moisture exchanging filter103, the volume of the heat-moisture exchanging filter103may be maximized in the device, and breathing air can pass through the apertures108directly into contact with the heat-moisture exchanging filter103when the device is open, i.e. when the lid109is in the outer non-actuated position thereof.

FIGS. 2aand2bdiscloses the embodiment according toFIG. 1in an elevated view from above and below, respectively, to more clearly identify the diagonal arms104, the valve seat105, the ribs106, the ring107, the apertures108, the lid109, and the protrusions110.

The device according to another embodiment of the invention is shown inFIG. 3, said device comprising a cylindrical filter housing200. The device may be a breathing protector for use in a stoma of a laryngectomized or tracheotomised person.

The cylindrical filter housing200has a distal and a proximal end, and a central axis from one end to the other. The cylindrical filter housing200has a first opening201and a second opening202, such that an air flow during inhalation will pass from the surroundings of a patient through said first opening201to said second opening202, into trachea of said patient. The second opening202is located in the proximal end of the device. The second opening202may thus be located in a proximal end of said filter housing200, and said first opening201is located distally of said second opening202, such that said first opening201is located upstream said second opening202during inhalation. A heat-moisture exchanging filter203is received in said cylindrical filter housing200. The second opening202of the filter housing200may be provided with radial or diagonal arms204, forming a stop element for the heat-moisture exchanging filter203. The openings between the radial or diagonal arms204and the periphery of the second opening202constitute outlets of breathing air during inhalation, and consequently inlets of breathing air during exhalation.

Distally of the second opening202of the cylindrical filter housing200the first opening201is provided. The heat-moisture exchanging filter203will then be partly located within said first and second opening when the device is in an open position, and fully located within said first and second opening, when the device is in a closed position. The first opening is encircled by a valve seat205. Thus, the valve seat205is arranged around the first opening. Radially and/or circumferentially outwards from the valve seat205, a rail is extending axially and distally from said first opening201. The rail comprises ribs206, extending axially and distally from the first opening201. A ring207connects the ribs206in the distal end of the device. Between the ribs206, proximally of the ring207apertures208are provided. Apertures208constitute outlets of breathing air during exhalation, and consequently inlets of breathing air during inhalation. The heat-moisture exchanging filter203is located in said housing200in between the apertures208and the second opening202, such that the air flow will pass through said heat-moisture exchanger203, when said air flow during inhalation passes through said apertures208to said second opening202.

Substantially in the same transversal plane as the ring207and distally of the valve seat205a valve member, such as circular lid209, is provided. The circular lid209has a surface area covering the first opening201, such that the circular lid209peripherally will sit or rest on valve seat205to close the first opening201. The circular lid209has a diameter allowing for axial displacement, while said circular lid209being arranged in a transversal plane in respect of the cylindrical filter housing200, within the ribs206. The circular lid209is attached to a circular flexible cover210. The resilience of the flexible cover210allows the flexible cover210to be pressed down, axially in a proximal direction, to force the lid209to closingly fit with the valve seat205, while still being attached to the ring207. The valve member, such as the lid209, may then be arranged in a transversal plane to the central axis of the device. The valve member is adapted to closingly engage with the valve seat205in a closed position, said valve member209being reciprocatingly arranged within the rail between the closed position and an open position. The lid/valve member209is thus hindered from distal movement by the rail in the open position.

According to another embodiment the circular lid209is peripherally provided with radially extending protrusions, said protrusions engaging with the apertures208, to stop the axial movement in a distal direction of lid209. This may relieve the flexible cover210from undue strain, and may keep the lid209in place even if the attachment means, such as glue or snap-in function, between the flexible cover210and ring207breaks. The combination of the lid209and the flexible cover210provides a distinct interaction between the lid209and the valve seat205, while simultaneously providing the possibility to alter the appearance of the breathing protector, in excess of the advantages presented below. The flexible cover210may for example smoothen the outer surface of the breaching protector, minimizing abrasion on fingers. Also, the flexible cover210can minimize the risk of foreign objects getting stuck in between the rail and the lid209, which may impair breathing.

The circular flexible cover210is peripherally attached to the ring207. The heat-moisture exchanging filter203is of a flexible/resilient material, such as a resilient foam. Furthermore, the size of heat-moisture exchanging filter203is adapted to press the lid209distally towards and against the circular flexible cover210. Thus, the heat-moisture exchanging filter203acts both as heat-moisture exchanger and return spring, pressing the lid209axially and distally into the open position. In order to generate talk the lid209is exposed to a pressure from a finger until the lid209sits on the valve seat205and covers said first opening201, whereby the first opening is closed, thus closing the communication between the trachea and the surroundings. The device can be closed in this manner even if it is covered by garments. At the same time the device is prevented from coming loose from the stoma because it is pressed against the throat by the finger during talking.

The radial or diagonal arms204and the circular flexible cover210, due to the shape thereof, holds heat-moisture exchanging filter203in position, while the heat-moisture exchanging filter203simultaneously acts as a return spring so that the lid209after the pressure having been relieved will resiliently return to an open position thereof, in which open position the lid209is distally stopped by circular flexible cover210.

The ribs206and ring207reduces the risk of the valve member being inadvertently closed, since a force in an axial and proximal direction within the ring207has to be applied to close the valve member. Since the lid209, in the starting and open position thereof, is in close contact with the heat-moisture exchanging filter203, the volume of the heat-moisture exchanging filter203may be maximized in the device, and inhaled breathing air can pass through the apertures208directly into contact with the heat-moisture exchanging filter203when the device is open, i.e. when the lid209is in the outer non-actuated and open position thereof.

The device according to another embodiment of the invention is shown inFIG. 4, said device comprising a cylindrical filter housing300. The device may be a breathing protector for use in a stoma of a laryngectomized or tracheotomised person.

The cylindrical filter housing300has a distal and a proximal end, and a central axis from one end to the other. The cylindrical filter housing300has a first opening301and a second opening302, such that an air flow during inhalation will pass from the surroundings of a patient through said first opening301to said second opening302, into trachea of said patient, in accordance with the embodiments disclosed inFIGS. 1 to 3. The second opening302is located in the proximal end of the device. The second opening302may thus be located in a proximal end of said filter housing300, and said first opening301is located distally of said second opening302, such that said first opening301is located upstream said second opening302during inhalation. A heat-moisture exchanging filter303is received in said cylindrical filter housing300. The second opening302of the filter housing300may be provided with radial or diagonal arms, forming a stop element for the heat-moisture exchanging filter303. The openings between the radial or diagonal arms and the periphery of the second opening302constitute outlets of breathing air during inhalation, and consequently inlets of breathing air during exhalation. This is also in line with the embodiments disclosed inFIGS. 1 to 3.

Distally of the second opening302of the cylindrical filter housing300the first opening301is provided. The heat-moisture exchanging filter303will then be partly located within said first and second opening when the device is in an open position, and fully located within said first and second opening, when the device is in a closed position. The first opening is encircled by a valve seat305, corresponding to the valve seat105,205inFIGS. 1 to 3. Thus, the valve seat305is arranged around the first opening301. Radially and/or circumferentially outwards from the valve seat305, a rail is extending axially and distally from said first opening301. The rail comprises ribs306, extending axially and distally from the first opening301. Bars307connects the ribs306in the distal end of the device. Between the ribs306, proximally of the ring207apertures308are provided. Apertures308constitute outlets of breathing air during exhalation, and consequently inlets of breathing air during inhalation. The heat-moisture exchanging filter303is located in said housing300in between the apertures308and the second opening302, such that the air flow will pass through said heat-moisture exchanger303, when said air flow during inhalation passes through said apertures308to said second opening302.

Substantially in the same transversal plane as the bars307and distally of the valve seat305a valve member, such as circular lid309, is provided. The circular lid309has a surface area covering the first opening301, such that the circular lid309peripherally will sit or rest on valve seat305to close the first opening301. The circular lid309has a diameter allowing for axial displacement, while said circular lid309being arranged in a transversal plane in respect of the cylindrical filter housing300, within the ribs306.

The circular lid309is provided with at least two peripheral hook elements310, extending proximally at the edge of the lid309. The hook elements310are configured to grip around the lip311, to hold the lid in place, whereby axial movement in the distal direction of the lid309is hindered when the hook elements310engage the lip311. The lid/valve member309is thus hindered from distal movement by the hook elements310in the open position. The hook elements310runs in through slots in the rail, said through slots having an open end in the distal end of the rail.

It is however also possible for the hook elements310to extend through apertures108, proximally of the ring107, to thereafter grip around the lip311, in an embodiment being a combination of the embodiments disclosed inFIG. 1andFIG. 4.

The heat-moisture exchanging filter303is of a flexible/resilient material, such as a resilient foam. Furthermore, the size of heat-moisture exchanging filter303is adapted to press the lid309distally until the hook elements310engage with the lip311stopping axial and distal movement of the lid309. Thus, the heat-moisture exchanging filter303acts both as heat-moisture exchanger and return spring, pressing the lid309axially and distally into the open position, in accordance with the heat-moisture exchanging filter103,203inFIGS. 1 to 3. The hook elements310and the lid309, due to the shape thereof, holds heat-moisture exchanging filter303in position, while the heat-moisture exchanging filter303simultaneously acts as a return spring so that the lid309after the pressure having been relieved will resiliently return to an open position thereof.

In accordance with the previous embodiments, the ribs306of the rail according to the embodiment inFIG. 4reduces the risk of the valve member being inadvertently closed, since a force in an axial and proximal direction within the ribs306has to be applied to close the valve member. Since the lid309, in the starting position thereof, is in close contact with the heat-moisture exchanging filter303, the volume of the heat-moisture exchanging filter303may be maximized in the device, and breathing air can pass through the apertures308directly into contact with the heat-moisture exchanging filter303when the device is open, i.e. when the lid309is in the outer non-actuated position thereof.

Preferably, the hook elements310are provided at opposite positions around the lid309, whereby the function of maintaining the lid within a centralized position, and also in level with and proximal of the distal ends of the ribs306may be improved.

In another embodiment the lid309comprises a single hook element310, whereby the action of maintaining the lid309in place is obtained by the combination of the hook element310according toFIG. 4and at least one protrusion110, according toFIGS. 1 and 2, said protrusion cooperating with the apertures308.

The heat-moisture exchanging filter303is a heat-moisture exchanger filter in accordance with the heat-moisture changing filter103,203according to the embodiments inFIGS. 1 to 3. The material of the heat-moisture exchanger should include flow passages therein, and should have an open structure in which the flow passages are randomly oriented. The material may comprise paper, foamed plastics, wadding made of different fibres, or combinations thereof, having adequate resiliency to push the lid109,209,309towards the ring107, flexible cover210, or bars307, respectively. It may also be impregnated with a moisture absorbing substance. Furthermore, it is advantageous if the pores or interstices in the material do not have any special direction, such that the breathing air easily may pass through the material in a number of directions in order to achieve the intended deflection.

According to one embodiment the ribs106,206,306are not connected by a ring, such as ring107,207, or bars307. Instead, the ribs106,206,306may be angled inwards in the distal end thereof, to enclose the lid109,209,309within the ribs106,206,306. When the ribs206not are connected by ring207, the flexible cover210may be attached directly to the ribs206.

In one embodiment the valve member109,309or the flexible material210of the device is provided with a central boss111,211at the outer pushing surface of the breathing protector, said pushing surface facing the surroundings during use. The central boss111,211provides guidance for the user where to push to obtain the best closing effect of the device.

The device according to the embodiments of the invention may then inserted into a holder of known configuration for application to a tracheostoma.

In the embodiments described above, a breathing protector for use in a stoma of a laryngectomized or tracheotomised person has been described. This breathing protector is configured with at least one inlet and at least one outlet, such that an air flow in use will pass from the surroundings of said person through said inlet to said outlet, into trachea of said person. It is obvious to the skilled artisan, even if it has not been specifically disclosed, that the inlets and outlets may be divided into an increased amount by merely dividing the specific inlets and outlets already disclosed.

Although the present invention has been described above with reference to specific embodiments, it is not intended to be limited to the specific form set forth herein. Rather, the invention is limited only by the accompanying claims and, other embodiments than the specific above are equally possible within the scope of these appended claims.