Patent Publication Number: US-9427542-B2

Title: Breathing protector

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application a continuation-in-part of U.S. patent application Ser. No. 13/583,542, filed Sep. 7, 2012. U.S. patent application Ser. No. 13/583,542 is a National Stage application which claims the benefit of International Application No. PCT/EP2011/053455 filed Mar. 8, 2011, which claims priority based on U.S. Provisional Patent Application 61/311,446, filed on Mar. 8, 2010. All of these applications are hereby incorporated by reference in their entirety. 
    
    
     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 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 and a bacteriological filter, such that said air flow will pass through said heat-moisture exchanger and said bacteriological filter 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 tracheostomy 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 tracheostomy. 
     A laryngectomy is a surgical procedure, used for example to treat a carcinoma, which involves removal of the larynx or voice box and 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, to ensure minimized spreading of virus and bacteria. This has especially being an issue when the same respirator is used for multiple patients. This is to resemble the functions of a nose. However, there are several complications related to the design 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 dead space area or volume, of the device as small as possible. Otherwise, the device will be unsuitable for children. Secondly, the moisturizing effect and filter 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 laryngectomy has to hold his finger or thumb 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. 
     U.S. Pat. No. 5,848,590 discloses a filter assembly for filtering air that is to be breathed through a tracheostoma, comprising a housing and a filter component. The filter component is however movable within the housing, forcing the filter component and heat-moisture exchanger to be glued into one piece, forcing the additional manufacturing steps, making the manufacturing procedure complicated, time consuming, and thus costly. U.S. Pat. No. 5,666,950 discloses a similar filter component and device arrangement. Also, the filtering effect of these planar filters is very low. 
     WO 2008/132222 discloses a breathing protector for use in a stoma of a laryngectomized person. The breathing protector is provided with a heat-moisture exchanger, a bacteriological filter, and a closing mechanism. However, the proximal side is prone to contact the skin of the patient, and thus there is a risk for clogging and contaminating the filter. Also, because of the closing mechanism, the breathing protector of this kind has a large dead space, making the device large and increasing dead space, and hence not so usable for children. Also, a too large dead space results in a decrease in fresh air reaching the lungs of the patient. Furthermore, the arrangement of the different parts into the breathing protector necessitates gluing/welding, or other attachment means, making the manufacturing procedure complicated, time consuming, and thus costly. 
     Hence, it would be beneficial with a new breathing protector, allowing for a small, and space effective device, said device comprising a heat-moisture exchanging and bacterial/viral filtrating function with guarded filter surfaces, while simultaneously allowing for the possibility to omit specially designed filter bodies with unnecessary adhesion substances/elements there between. It would also be beneficial with arrangements and parts allowing for an easy assembling of such new breathing protectors. 
     SUMMARY 
     Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing a breathing protector for a tracheostoma, comprising an inlet and an outlet, such that an air flow in use will pass from the surroundings of the user through said inlet to said outlet, into trachea of said user, said breathing protector comprising a filter housing, said filter housing comprising an inner housing part, an outer housing part, and a filter body; wherein the inner housing part, comprising the outlet, a tracheal tube fitting and a support structure extending longitudinally and distally from the tracheal tube fitting, wherein a base plate is arranged in a proximal zone of the tracheal tube fitting, said base plate extending radially outwards from the tracheal tube fitting; wherein the outer housing part, comprising the inlet, forming a cage enclosing the support structure; and wherein the filter body is arranged between the support structure and the outer housing part; a breathing protector assembling tool comprising a fixture part for holding an outer housing part in an assembly position, said fixture part comprising a cavity for receiving the outer housing part; channels extending transversally to the longitudinal extension of the cavity and intersecting said cavity, said channels being configured for receiving filter adjustment sticks there through; and a method for assembling a breathing protector according to above, comprising the steps: arranging an outer housing part in a cavity of a breathing protector assembling tool according to above; arranging at least a filter body at the mouth of a cavity of a breathing protector assembling tool; and pressing a inner housing part into the cavity, such that the filter body is arranged beneath said inner housing part, until the inner housing part is brought into cooperation with said outer housing part, according to the appended patent claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other aspects, features and advantages of which the invention is capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which 
         FIG. 1  is a cross sectional view of a breathing protector according to one embodiment of the present invention; 
         FIG. 2  is a cross sectional view of a breathing protector according to one embodiment of the present invention; 
         FIG. 3  is a perspective view if filter body and heat moisture exchanging body in a non-arranged state; 
         FIG. 4  is a cross sectional and exploded view of a breathing protector mounting assembly according to one embodiment of the present invention in a first position, together with components of a breathing protector; and 
         FIG. 5  is a cross sectional and exploded view of a breathing protector mounting assembly according to one embodiment of the present invention in a second position, together with components of a breathing protector. 
     
    
    
     DETAILED DESCRIPTION 
     The following description focuses on an embodiment of the present invention applicable to a breathing protector, and particularly to a breathing protector for application over the tracheostoma of a tracheostomized person. 
     In an embodiment of the invention, according to  FIG. 1 , a breathing protector for a tracheostoma is provided. The breathing protector comprises a filter housing  101 . The filter housing  101  comprises an inner housing part  102  and an outer housing part  103 . The inner housing part  102  and the outer housing part  103  may be injection molded in a suitable polymeric material, such as poly propylene. 
     The inner housing part  102  comprises a tracheal tube fitting, in form of a cylindrical body  104 . The cylindrical body  104  extends longitudinally in the proximodistal direction, with a central axis A. The cylindrical body  104  may have slightly decreasing cross sectional area in the transversal plane when moving distally along the cylindrical body  104 . Thus, the cylindrical body may have a conical shape or cut-conical shape. The tracheal tube fitting may preferably have an ISO-15 cone, to be connectable to standard tracheal tubes. 
     In the proximal zone of the tracheal tube fitting, such as the cylindrical body  104 , a base plate  105  extends radially outwards from the tracheal tube fitting. The base plate  105  then extends substantially in the transversal plane with respect to the cylindrical body  104 . The peripheral shape of the base plate  105  in the transversal plane may have different shapes, in correspondence with the shape of the outer housing part  103 . However, circular and elliptical shapes are preferred, due to facilitated manufacturing and assembling of the breathing protector. Also, the design is more pleasing. Other possible peripheral shapes in the transversal plane are triangular, rectangular, square, or other multiangular shapes. The outer edge of the base plate  105  may be slanting slightly laterally downwards, such that cooperation with the outer housing part  103  may be facilitated. 
     On the tracheal tube fitting, such as the cylindrical body  104 , a pinch plate  106  is arranged distally of the base plate  105 . The pinch plate  106  extends radially outwards from the tracheal tube fitting. The pinch plate  106  then extends substantially in the transversal plane with respect to the cylindrical body  104 . The peripheral shape of the pinch plate  106  in the transversal plane may have different shapes, in correspondence with the shape of the outer housing part  103  and the base plate  105 . The base plate  105  extends laterally beyond the pinch plate  106 , such that the outer housing part  103  may extend distally from the base plate, after being connected to the same, laterally of the pinch plate  106 . The pinch plate  106  may have an outer flange  107 , for improved pinching function in accordance with below. 
     Support structure  108  extends longitudinally and distally from the tracheal tube fitting, such as the cylindrical body  104 , and/or the pinch plate  106 . The support structure  108  may be support fingers, support bars, support ribs, with slots there between. The support structure  108  may also be a perforated grid or rail. The support structure shall support heat-moisture exchanger and filter body, in an evenly distributed manner outside or laterally of the support structure  108 , but inside or medially of the outer housing part  103 , in a way to allow inhaled and exhaled air to pass through the perforations or slots therein. 
     The outer housing part  103  and the inner housing part  102  are connectable along a contact plane at the proximal end of the outer housing part  103 . The outer housing part  103  and the inner housing part  102  may thus be connectable along the periphery of the base plate  105 . The outer housing part  103  is bulging distally from the neck of the wearer, during use. As such the outer housing part  103  will form or constitute a cage, enclosing the pinch plate  106 , the flange  107 , and the support structure  108 . Suitable bulging shapes are dome shaped, elliptically dome shaped, cube shaped, cone shaped, etc., as long the outer surface of the outer housing part  103  extends distally from the contact plane with the inner housing part  102 , allowing for an increase in inner surface in comparison with the cross sectional area of the outer housing part  103  along said contact plane, i.e. the cross sectional area of the base plate  105  in the transversal plane. In this way, the volume may be effectively used, whereby dead space is decreased, making the device smaller. 
     The outer housing part  103  has gripping means  109  distributed circumferentially of the proximal end of the outer housing part  103 , for gripping the periphery of the inner housing part  102 , such that the two are brought into connected cooperation. The gripping means  109  may be a gripping flange extending circumferentially of the outer housing part  103 . The gripping flange may then be somewhat laterally displaced when pushed against the inner housing part  102 , until it snaps over the outer edge of the base plate  105  on the inner housing part  102 . The outer edge of the base plate  105  and or the gripping means  109  may have corresponding slanting surfaces for facilitating cooperation between the inner housing part  102  and the outer housing part  103 . Also, the inner housing part  102  may be welded to the outer housing part  103 . 
     The outer housing part  103  is perforated, or provided with ribs, extending distally to the top of the outer housing part  103 , where the ribs connect at a connection point in the distal top of the outer housing part  103 . Naturally, the space between the ribs may then form slots through which inhaled and exhaled air may pass during use of the breathing protector. 
     Along the inner surface of the outer housing part  103 , a filter body  110  is arranged. In this way, the filter body  110  may be kept from coming into contact with contaminating items, such as fingers etc. Also, the volume of the breathing protector is used in a maximized way in respect of filtering area/effect. The filter body  110  may have a circular shape, with a preferred diameter of 50 to 70 mm. The filter body  110  may for example be an electrostatic filter, made of polypropylene. The filter body is pressed by the support structure  108  to conform to the inner surface of the outer housing part  103 , whereby large interaction area with exhaled and inhaled air is kept. The filter body  110  is pinched between the pinch plate  106  and the outer housing part  103 , such that its position may be maintained. Also, the pinching of the filter body between the outer housing part  103  and the pinch plate  106  decreases the risk of bacteria and virus entering the interior of the breathing protector. Also, this arrangement allows for the avoidance of additional filter body attachment means, such as glue. 
     In one embodiment, disclosed in  FIG. 2 , a breathing protector for a tracheostoma, comprising an inlet and an outlet, such that an air flow in use will pass from the surroundings of the user through said inlet to said outlet, into trachea of said user, in similarity with above, is illustrated. The breathing protector comprises the filter housing  101 , wherein the filter housing  101  comprises the inner housing part  102 , the outer housing part  103 , and a valve member  114   a ,  114   b . The inner housing part  102  comprises the outlet, the tracheal tube fitting  104  and the support structure  108 . The support structure  108  extends longitudinally and distally from the tracheal tube fitting  104 , wherein the base plate  105  is arranged in a proximal zone of the tracheal tube fitting  104 . The base plate  105  extends radially outwards from the tracheal tube fitting  104 . The outer housing part  103 , comprising the inlet, forms a cage enclosing the support structure  108 . 
     The valve member  114   a ,  114   b  comprises a valve seat  114   b  on the inner housing part  102  and a flexible valve lid  114   a  arranged on the outer housing part  103 . The valve seat  114   a  is arranged proximally of a grid  115  on the inner housing part  102 , and the valve lid ( 114   a ) is arranged at the distal end of the grid  115 . The valve lid  114   a  is connected to the outer housing part  103  via a flexible pleat section  116 . The pleat section  116  is arranged circumferentially of said valve lid  114   a . The filter body  110  may be pinched in between the flexible pleat section  116  and the distal end of the grid  115 . 
     Medially of the filter body  110  and laterally of the supporting structure  108 , a heat moisture exchanging body  111  is arranged. The heat moisture exchanging body  111  may have the same diameter as the filter body  110 , and thus also be pinched between the pinch plate  106  and the outer housing part  103 . The heat moisture exchanging body  111  may also have a smaller outer diameter, such that the heat moisture exchanging body  111  ends at distally of the pinch plate  106 . The, the heat moisture exchanging body  111  is not pinched together with the filer body  110 , between the pinch plate  106  and the outer housing part  103 . Then moisture accumulation at the pinch plate  106  may be decreased. The heat moisture exchanging body  111  may be manufactured in a suitable foam for such heat moisture exchanging bodies, as known in the art. The foam may also be impregnated with calcium chloride, to increase heat moisture exchanging ability. Centrally, the heat moisture exchanging body  111  may be provided with a through hole  112 , such that the heat moisture exchanging body  111  is configured in a ring shape. In this way the height of the breathing protector may be reduced, while maintaining adequate functionality of the breathing protector with respect to heat moisture exchanging property. The heat moisture exchanging body  111  is disclosed in  FIG. 3  in non-arranged state. 
     Of course, when other shapes than circular shape of the base plate  105  is used, naturally the filter body  110  and the heat moisture exchanging body  111  may be configured into corresponding shapes, instead of circular. 
     In  FIGS. 4 and 5  a breathing protector assembling tool and a method for assembling a breathing protector are disclosed. The breathing protector assembling tool comprises a fixture part  201  for holding the outer housing part  103  in an assembly position. The fixture part  201  comprises a cavity  202  for receiving the outer housing part  103 . The cavity  202  may have a negative conical shape, i.e. that the cavity becomes narrower with depth, such that the outer housing part  103  may be inserted through the opening of the cavity, and displaced into the cavity until the outer housing part  103  get stuck in the cavity  202 . In another embodiment, the cavity proceeds all through the fixture part  201 , such that the outer housing part  103  may be inserted from beneath into an outer housing part seat  203 . Transversally to the longitudinal extension of the cavity  202 , channels  204  for receiving filter adjustment sticks  205  are arranged. The adjustment sticks  205  have adjustment pins  206 . These adjustment pins correspond in width to the groove  113  between the base plate  105  and the pinch plate  106 , such that the adjustment pins  206  can press the filter body  110  into the groove  113 , once the inner housing part  102 , covered by the heat exchanging body  111  and the filter body  110 , has been advanced from the top into the cavity  202  into a position where the groove  113  is at the same height as the pins  206 . The adjustment pins  206  may be semi circular towards the cavity  202 , such that the pins enclose the inner housing part  102 , and push the filter body  110  into the groove  113  along the circumference of the groove  113 . 
     At the top surface of the fixture part  201 , a filter body seat  207  may be arranged circumferentially of the cavity  202 . The filter body  105  may then be arranged in said filter body seat  207 , where after the heat moisture exchanging body  111  may be placed on top. Subsequently, the inner housing part  102  may be pressed onto the filter body  110  and the heat exchanging body  111  to press them all into the cavity into later cooperation with the outer housing part  103 . The inner housing part  102  may be pressed into the cavity with aid of a pressing part  208 . The pressing part  208  may preferably be a cylindrical rod, corresponding to—or having a somewhat smaller diameter than—the diameter of the cylindrical body  104  of the inner housing part  102 . When the cavity  202  has a negative conical shape, i.e. that the cavity becomes narrower with depth, the filter body  110  and the heat exchanging body  111 , together with the inner housing part  102 , may be pressed downwards into the cavity  202  by the pressing part  208 , such that the filer body  110  and the heat exchanging body  111  successively close in towards the inner housing part  102 . In this way, the alignment of the different parts may be improved. Once the inner housing part  102  has travelled down into the cavity  202  to a position where the groove  113  and the channels  204 , and thus the adjustment sticks  205  and adjustment pins  206 , are substantially aligned, the adjustment sticks  205  are pushed inwardly/medially, such that the adjustment pins  206  presses the filter body  110  and optionally the heat moisture exchanging body  111  into the groove  113 . Then the adjustment sticks  205  and the adjustment pins  206  are retracted, and the pressing part  208  is further pressed down into the cavity  202 , until the inner housing part  102  is brought into cooperation with the outer housing part  103 . The cooperation may be realized by pushing the inner housing part, such that the gripping means  109  snaps into cooperation with the base plate  105 . 
     When the filter body  110  is pushed by the inner housing part  102  in the assembly tool, the filter body will assume a corrugated shape, thus allowing for an increase in surface area in small volume, resulting in decreased dead space. Simultaneously, the distal top part will remain flat, allowing for adequate height of the device. Hence the filter body  110  and/or the heat moisture exchanger  111  may be arranged in between the outer housing part  103  and the support structure  108  in a corrugated/pleated form, while the distal part, i.e. the top of the filter body  110  and/or the heat moisture exchanging body  111  is substantially flat, and extends transversally to the central axis A. 
     The embodiments according to the present invention allows for a breathing protector comprising a minimal number of components. Also, the components of the breathing protector disclosed herein may be manufactured in inexpensive manufacturing materials. The manufacturing process is easy to automate, whereby manufacturing costs are kept down. 
     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. 
     In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second” etc do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.